Current Statin Guidelines May Miss Young Adults At Risk of Heart Attack

MedicalResearch.com Interview with:

Avinainder Singh, M.B.B.S. Research Fellow Cardiovascular Medicine Brigham & Women's Hospital Harvard Medical School Boston, MA

Dr. Singh

Avinainder Singh, M.B.B.S.
Research Fellow
Cardiovascular Medicine
Brigham & Women’s Hospital
Harvard Medical School
Boston, MA 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Overall, the incidence of myocardial infarction (MI) in the US has declined. However, it has remained stable in adults <50 years of age.

We evaluated the statin eligibility of a cohort of adults who had an MI at a young age using current guidelines – the 2013 ACC/AHA guidelines for cholesterol treatment and the 2016 USPSTF guidelines on use of statins for primary prevention.

In, our study we found that only 49% of these young adults would have been eligible for statin therapy prior to their MI according the 2013 ACC/AHA guidelines, and only 29% would have been eligible according to the USPSTF guidelines, despite a high prevalence of cardiovascular risk factors. These numbers were even more striking for women where only 18% were eligible for statin therapy according to the USPSTF guidelines.

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Study Finds ACE Inhibitors and Statins Can Be Safe In Type I Diabetes

MedicalResearch.com Interview with:
M. Loredana Marcovecchio, M.D.
Clinical Scientist and
Professor David Dunger M.D.
Director of Research
Professor of Paediatrics
University of Cambridge

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The efficacy and safety of ACE Inhibitors and statins in adolescents have been shown in the context of hypertension and familial hypercholesterolemia, respectively. However, there is a lack of data on the long-term use of these drugs in those with type 1 diabetes and, in particular, there is no clear indication for their use in patients with increased albumin excretion.

The Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT) was a multi-centre, international study, set up by investigators in the UK, Australia and Canada to explore if drugs already used to lower blood pressure (ACE inhibitors) and cholesterol levels (Statins) in adults with diabetes could reduce the risk of kidney, eye and cardiovascular disease in adolescents with Type 1 diabetes.

Neither ACE inhibitors nor statins significantly reduced the albumin-creatinine ratio during the 2-4 year trial period. However, some of the secondary outcomes suggest that the drugs may have important benefits.

Treatment with the ACE inhibitor resulted in a 43% reduction in the rates of progression to microalbuminuria, which was not statistically significant, but it could have important clinical implications. Preventing even intermittent cases of microalbuminuria is known to reduce the future risk of kidney and cardiovascular complications.

Statin therapy led to reduced levels of lipid levels, which could reduce long-term risk for cardiovascular complications.

These findings could translate into long-term benefits, but follow-up of this unique cohort will be essential. The essential biological samples and data provided by the participants will continue to inform our future understanding and our options for effective therapies for this vulnerable group of young people with type 1 diabetes.

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Hyperlipidemia Linked To Lower Breast Cancer Mortality, Perhaps Due To Statin Therapy

MedicalResearch.com Interview with:

Dr Rahul Potluri Senior author and founder of the ACALM Study Unit Aston Medical School Aston University Birmingham, UK

Dr. Potluri

Dr Rahul Potluri
Senior author and founder of the ACALM Study Unit
Aston Medical School
Aston University
Birmingham, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The links between hyperlipidaemia and cancer has been exciting scientists in recent years.  We have previously shown an association with breast cancer and hyperlipidaemia using a cross-sectional dataset in 2014.

In 2016 we showed that in patients with the four main cancers in the UK (namely Breast, Lung, Colon and Prostate) that the presence of hyperlipidaemia improved the long term mortality and prognosis of these patients.  In this study utilising a big data, longitudinal study methodology, we looked at 16043 healthy women above the age of 40 with hyperlipidaemia and compared these to an age and gender matched control sample of 16043 healthy women without high cholesterol. We then followed up these patients and found that subsequent breast cancer rates in the women with hyperlipidaemia were 45% lower. Subsequent mortality in those patients who developed breast cancer was also 40% lower in the hyperlipidaemia group compared to the non-hyperlipidaemia controlled sample.

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Trying Statins Again After Adverse Effect Linked To Lower Risk of Heart Attack

MedicalResearch.com Interview with:

Alexander Turchin, MD,MS Director of Quality in Diabetes Associate Professor, Harvard Medical School Brigham and Women's Hospital Boston, MA

Dr. Turchin

Alexander TurchinMD,MS
Director of Quality in Diabetes
Associate Professor, Harvard Medical School
Brigham and Women’s Hospital
Boston, MA

MedicalResearch.com: What is the background for this study?

Response: Cardiovascular disease is the # 1 cause of death in the U.S. and worldwide. Statins are some of the most effective medications available for prevention of cardiovascular events.

However, many patients stop statins, frequently because of adverse reactions. In our study we aimed to assess the risk-benefit balance of trying a statin again after experiencing an adverse reaction.

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May Be No Benefit To Statins For Primary Prevention in Older Adults

MedicalResearch.com Interview with:
Benjamin Han, MD, MPH
Assistant professor
Departments of Medicine-Division of Geriatric Medicine and Palliative Care, and Population Health
NYU Langone Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There are an increasing number of older adults being prescribed statins for primary prevention, but the evidence for the benefit for older adults is unclear.

Our study finds that in the ALLHAT-LLT clinical trial, there were no benefits in either all-cause mortality or cardiovascular outcomes for older adults who did not have any evidence of cardiovascular disease at baseline.

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Improving Statin Adherence Would Reduce Need For Expensive PCSK9 Inhibitors

MedicalResearch.com Interview with:
Julia M. Akeroyd, MPH

Center for Innovations in Quality, Effectiveness, and Safety (IQuESt)
Michael E. DeBakey Veteran Affairs Medical Center
Salim S Virani, MBBS, Ph.D.
Baylor College of Medicine

MedicalResearch.com: What is the background for this study?

Response: In the recently published Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial, treatment with evolocumab resulted in a 15% relative (1.5% absolute) risk reduction of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD) at a median follow-up of 2.2 years. Given the high cost of evolocumab, there is a need to identify what proportion of ASCVD patients would qualify for evolocumab based on FOURIER entry criteria and how eligibility would change if maximal doses of evidence-based lipid lowering therapies were required.

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Statins Users May Have Higher Likelihood of Back Disorders

MedicalResearch.com Interview with:

Una Makris MD, MSc Clinical Investigator at the VA North Texas Health System Assistant Professor at UT Southwestern Medical Center Departments on Internal Medicine and Clinical Sciences

Dr. Makris

Una Makris MD, MSc
Clinical Investigator at the VA North Texas Health System
VA North Texas Health Care System
Assistant Professor at UT Southwestern Medical Center
Departments on Internal Medicine and Clinical Sciences
Dr. Makris is a Rheumatologist, clinically, and spends the majority of time focused on clinical research investigating how to improve outcomes for adults with back pain.

MedicalResearch.com: What is the background for this study?

Response: Back pain is the most common type of musculoskeletal (MSK) pain. We know that expenditures for back pain exceed $100 billion each year (and this was in 2005). Back pain results in tremendous disability (including reduced mobility) and impaired quality of life (not exclusive to physical consequences, but also including important psychosocial repercussions). We also know that statins are prescribed very often, and frequently in younger populations who are active. Some reports suggest that statins may have a protective effect on  musculoskeletal conditions such as back pain.

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More Work Needed To Ensure Compliance With High Intensity Statins After Heart Attack

MedicalResearch.com Interview with:

Robert Rosenson, MD Professor of Medicine and Cardiology Icahn School of Medicine at Mount Sinai New York

Dr. Rosenson

Robert Rosenson, MD
Professor of Medicine and Cardiology
Icahn School of Medicine at Mount Sinai
New York

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: High intensity statin therapy is underutilized in patients with acute coronary syndromes. In 2011, 27% of patients were discharged on a high intensity statin (Rosenson RS, et al. J Am Coll Cardiol).

In this report, we investigate the factors associated with high adherence to high intensity statin. High adherence to high intensity statins was more common among patients who took high intensity statin prior to their hospitalization, had fewer comorbidities, received a low-income subsidy, attended cardiac rehabilitation and more visits with a cardiologist.

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USPSTF Recommendations Would Lead to Fewer Individuals Being Treated With Statin Therapy, But Maybe Some Who Would Benefit

MedicalResearch.com Interview with:

Neha Pagidipati, MD MPH Duke Clinical Research Institute Duke University Durham, North Carolina

Dr. Pagidipati

Neha Pagidipati, MD MPH
Duke Clinical Research Institute
Duke University
Durham, North Carolina

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The 2013 ACC/AHA guidelines for treatment of blood cholesterol to prevent cardiovascular disease created a new paradigm for lipid management and raised numerous ongoing controversies.

In 2016, the US Preventive Services Task Force released recommendations for primary prevention statin therapy which were different in some important ways from the 2013 ACC/AHA guidelines. We aimed to understand the practical difference between these two sets of guidelines in terms of the number of Americans who would be potentially eligible for statin therapy. Using U.S. cross-sectional survey data between 2009 and 2014, we found that, if fully implemented, the USPSTF recommendations would reduce the percentage of US adults age 40-75 who should initiate statin therapy from 24% to 16% as compared to the 2013 ACC/AHA guidelines. Those newly recommended for statin therapy would be in addition to the 21% of US adults already taking lipid-lowering therapy.

Of the approximately 9 million adults who would no longer be recommended to receive statin therapy under the new USPSTF recommendations, over half of them would be younger adults with a high long-term risk of cardiovascular disease (about 1 in 3), and over one quarter would be individuals with diabetes.

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Why Do So Many Stroke Survivors Give Up On Preventive Medications?

MedicalResearch.com Interview with:
Anna De Simoni

NIHR Academic Clinical Lecturer in Primary Care Research
Centre for Primary Care and Public Health
Barts and The London School of Medicine and Dentistry
London E1 2AB

MedicalResearch.com: What is the background for this study?

Response: Three in 10 stroke survivors will go on to have a further stroke, which causes greater disability or even death. Secondary prevention medications, including antihypertensives, blood thinning and lipid lowering agents, such as statins, can reduce risk of stroke recurrence by up to 75 per cent. However, patients’ persistence with these medications decreases over time because a minority of people experience side effects, which are mild in most cases.

The analysis, involving Queen Mary University of London and the University of Cambridge and published in the journal Family Practice, was performed on the archives from TalkStroke, a UK online forum hosted by the Stroke Association. The forum is used by patients with stroke and their carers, and generated 21,596 posts during 2004-2011. 50 participants were found to discuss GP advice on prevention medications in 43 discussion threads.

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Older Women Face Greater Risk of Diabetes From Statins

MedicalResearch.com Interview with:
Dr Mark Jones, Senior Lecturer
Faculty of Medicine and Biomedical Sciences, School of Public Health
The University of Queensland

MedicalResearch.com: What is the background for this study?

Response: Multiple clinical trials have shown statins reduce LDL cholesterol, cardiovascular events, and all-cause mortality. However statins are also associated with adverse events, including type 2 diabetes. There have been very few older women included in statin trials hence effects of the drug in this population are somewhat uncertain. Also, more generally, results from clinical trials may not translate well into clinical practice.

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Many Eligible Groups Not Receiving Recommended Statin Therapy

MedicalResearch.com Interview with:
Dr. Yashashwi Pokharel MD, MSCR
Department of Cardiovascular Research
Saint Luke’s Mid-America Heart Institute
Kansas City, Missouri and
Salim S. Virani, MD PhD, FACC, FAHA
Associate Professor, Section of Cardiovascular Research
Associate Director for Research, Cardiology Fellowship Training Program
Baylor College of Medicine
Investigator, Health Policy, Quality and Informatics Program
Michael E. DeBakey Veterans Affairs Medical Center HSR&D Center of Innovation
Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center
Houston, TX

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Unlike the previous cholesterol management guideline that recommended use of either statin and non-statin therapy to achieve low density lipoprotein cholesterol (LDL-C) target, the 2013 American College of Cardiology/American Heart Association cholesterol management guideline made a major paradigm shift by recommending statin focused treatment in 4 specific patient groups and replaced LDL-C target with fixed statin intensity treatment (moderate to high intensity statin therapy).

With this change, it was speculated that a large number of patients would be eligible for statin treatment (in one study, up to 11.1% additional patients were expected to be eligible for statin therapy). Our study provided the real world trends in the use of statin and non-statin lipid lowering therapy (LLT) from a national sample of cardiology practices in 1.1 million patients 14 months before and 14 months after the release of the 2013 guideline.

We found a modest, but significant increasing trend in the use of statin therapy in only 1 of the 4 patient groups eligible for statin therapy (i.e., 4.3% increase in the use of moderate to high intensity statin therapy in patients with established atherosclerotic cardiovascular disease). We did not find any significant change in non-statin LLT use. Importantly, about a third to half of patients in statin eligible groups were not receiving moderate to high intensity statin therapy even after the publication of the 2013 guideline.

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Statins Linked to Reduced Risk of Venous Thromboembolism

MedicalResearch.com Interview with:

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab) Research Fellow/Epidemiologist Musculoskeletal Research Unit University of Bristol School of Clinical Sciences Learning & Research Building (Level 1) Southmead Hospital

Dr. Setor Kunutsor

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab)
Research Fellow/Epidemiologist
Musculoskeletal Research Unit
University of Bristol
School of Clinical Sciences
Southmead Hospital

MedicalResearch.com: What is the background for this study?

Response: Statins are well established for the prevention of cardiovascular disease and this is based on their ability to lower levels of circulating lipids in the blood. However, statins are also known to have pleotropic effects and these include potential protective effects on multiple disease conditions.

Based on their anti-inflammatory and antithrombotic properties, there have been suggestions that statins may prevent venous thromboembolism (VTE) (which comprises of pulmonary embolism and deep vein thrombosis). The evidence is however uncertain. Several studies utilizing both observational cohort and randomized controlled designs have been conducted to evaluate whether statin therapy or use is associated with a reduction in the incidence of VTE, but the results have been inconclusive. In a recent review that was published in 2012, Rahimi and colleagues pooled the results of several randomized controlled trials (RCTs), but found no significant reduction in the risk of VTE with statin therapy [REF]. Given the publication of new studies since this study was published and the existing uncertain evidence on the effect of statins on VTE, we decided it was time to bring all the evidence together and evaluate if statin therapy really did have a protective effect on the risk of venous thromboembolism.

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Some Type 2 Diabetics May Benefit From Adding Fenofibrate To Statins

MedicalResearch.com Interview with:

Marshall B. Elam PhD MD Professor Pharmacology and Medicine (Cardiovascular Diseases) University of Tennessee Health Sciences Center Memphis

Dr. Marshall B. Elam

Marshall B. Elam PhD MD
Professor Pharmacology and Medicine
(Cardiovascular Diseases)
University of Tennessee Health Sciences Center
Memphis

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This manuscript presents the findings of extended follow up of patients with Type 2 Diabetes who were treated with fenofibrate, a member of a group of triglyceride lowering medications known as fibrates or PPAR alpha agonists, as part of the Action to Control Cardiovascular Risk in T2DM (ACCORD) study.

ACCORD was designed to test the effect of intensive treatment of cardiovascular risk factors including blood glucose, blood pressure and lipids on risk of heart attack, stroke and cardiac death in patients with Type 2 Diabetes.

The lipid arm of ACCORD tested the hypothesis that adding fenofibrate to statin therapy would further reduce risk of these cardiovascular events.

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High Intensity Statins Increase For High Risk Atherosclerotic Patients, But Lagging in Women and Minorities

MedicalResearch.com Interview with:

Fatima Rodriguez, MD, MPH Division of Cardiovascular Medicine and Cardiovascular Institute Stanford University Stanford, CA

Dr. Fatima Rodriguez

Fatima Rodriguez, MD, MPH
Division of Cardiovascular Medicine and Cardiovascular Institute
Stanford University
Stanford, CA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The 2013 ACC/AHA cholesterol management guidelines emphasized that high-risk patients with atherosclerotic disease should be on high-intensity statins. We sought to determine how these guidelines are being adopted at the Veterans Affairs (VA) Health System and to identify treatment gaps.

Our main findings were that the use of high-intensity statins increased from 23 to 35% following the guideline release for these high-risk patients. However, high-intensity statin use was lowest in Hispanics and Native Americans. Women, older adults, and patients with peripheral arterial and cerebrovascular disease were also less likely to undergo statin intensification after the release of the guideline. We also noted geographic and institutional differences across VA hospitals in rates of high-intensity statin use for secondary prevention.

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Cardioprotective Effect of PCSK9 Inhibitors Should Outweigh Potential Harm of Diabetes Risk

MedicalResearch.com Interview with:
Brian A. Ference, M.D
Division of Cardiovascular Medicine
Wayne State University School of Medicine
Detroit, MI

MedicalResearch.com: What are the main findings?

Response: Lifelong exposure to modestly lower plasma LDL-C levels caused by rare loss-of-function mutations in the PCSK9 gene is associated with a substantially lower lifetime risk of developing cardiovascular disease. This discovery motivated the development of monoclonal antibodies directed against PCSK9 which have now been shown to reduce plasma LDL-C levels by 50-60%. The cardiovascular medicine community is early anticipating the results of two large cardiovascular outcome trials that will determine if lowering LDL-C levels by inhibiting PCSK9 will reduce the risk of cardiovascular events.

Because monoclonal antibodies and other therapies directed against PCSK9 are designed to recapitulate the phenotype of PCSK9 loss-of-function mutations, we reasoned that it may be possible to anticipate the efficacy and safety results of the ongoing cardiovascular outcome studies by more precisely characterizing the effect of genetic variants in the PCSK9 gene on the risk of both cardiovascular events and new onset diabetes.

To do this, we a constructed genetic score consisting of multiple independently inherited variants in the PCK9 gene to create an instrument that mimics the effect of PCSK9 inhibitors. We then compared the effect of genetic variants that mimic the effect of PCSK9 inhibitors with the effect of genetic variants in the HMGCR gene that mimic the effect of statins to make inferences about the likely effect of PCSK9 inhibitors on the risk of cardiovascular events and new onset diabetes as compared to treatment with a statin.

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Association Between Statin Use and Ischemic Stroke or Hemorrhage in Patients Taking Dabigatran for A Fib

MedicalResearch.com Interview with:

Dr-Tony-Antoniou.jpg

Dr. Tony Antoniou

Dr. Tony Antoniou, PhD Research Scholar
Department of Family and Community Medicine and a Scientist
Keenan Research Centre of the Li Ka Shing Knowledge Institute
St. Michael’s Hospital
Assistant Professor in the Department of Family and Community Medicine and
Leslie Dan Faculty of Pharmacy
University of Toronto, Toronto, Ontario

MedicalResearch.com: What is the background for this study?
What are the main findings?

Response: Dabigatran etexilate is an anticoagulant that is commonly used for stroke prevention in patients with atrial fibrillation. Absorption of dabigatran etexilate is opposed by intestinal P-glycoprotein, an efflux transporter. Once absorbed, dabigatran etexilate is converted to its active form by carboxylesterase enzymes. Unlike other statins, simvastatin and lovastatin can inhibit P-glycoprotein and carboxylesterase. This may result in increased absorption of dabigatran etexilate, thereby increasing the risk of bleeding. Conversely, inhibition of carboxylesterase may decrease the effectiveness of dabigatran etexilate.

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USPSTF Updates Recommendation of Statins for Prevention of Heart Disease

MedicalResearch.com Interview with:

Dr. Doug Owens MD former USPSTF Task Force member Professor at Stanford University Henry J. Kaiser, Jr. Professor Director of the Center for Health Policy Freeman Spogli Institute for International Studies Center for Primary Care and Outcomes Research Department of Medicine and School of Medicine Stanford

Dr. Doug Owens

Dr. Doug Owens MD
former USPSTF Task Force member
Professor at Stanford University
Henry J. Kaiser, Jr. Professor
Director of the Center for Health Policy
Freeman Spogli Institute for International Studies
Center for Primary Care and Outcomes Research
Department of Medicine and School of Medicine
Stanford

MedicalResearch.com: What is the background for review and statement?

Response: Cardiovascular disease is serious—it can lead to heart attacks and strokes, and is responsible for one in every three adult deaths in the U.S. People with no signs or symptoms and no past history of cardiovascular disease can still be at risk. Fortunately, some people can benefit from taking a medication called statins to reduce that risk.

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High Intensity Statins Linked To Lower Risk of Rheumatoid Arthritis

MedicalResearch.com Interview with:

Marie Hudson, MD MPH FRCPC Jewish General Hospital and Lady David Research Institute Montreal, QC

Dr. Marie Hudson

Marie Hudson, MD MPH FRCPC
Jewish General Hospital and Lady David Research Institute
Montreal, QC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Statins are widely used to treat hypercholesterolemia. In addition to their effect on cholesterol levels, statins also attenuate inflammation and have immunomodulatory properties. Whether this translates into meaningful differences in health outcomes, though, remains uncertain. We therefore undertook this study to determine whether people exposed to high doses of statins were at a lower risk of developing rheumatoid arthritis compared to those at lower doses. We studied a large population-based cohort of over half a million people exposed to statins for the first time and followed them on average for 3 years.

We found that those exposed to the highest intensity statin quintile had a 33% lower risk of developing rheumatoid arthritis compared to those in the lowest intensity quintile (adjusted HR 0.77; 95% CI: 0.63-0.95). We conducted several additional secondary analyses that all pointed in the same direction and suggested that statins reduce the risk of rheumatoid arthritis.

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Statins Reduce Inflammation As Well As LDL

MedicalResearch.com Interview with:

Dr. Johan Frostegård MD PhD Professor of medicine Karolinska Institutet's Institute of Environmental Medicine and Consultant at Karolinska University Hospital's Emergency Clinic.

Dr. Johan Frostegård

Dr. Johan Frostegård MD PhD
Professor of medicine
Karolinska Institutet’s Institute of Environmental Medicine and
Consultant at Karolinska University Hospital’s Emergency Clinic

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Statins are one of the worlds most sold medications, which has generated large profits, but also, in my opinion, helped many people. Still, side effects are much discussed after more than 2 decades of use, as exemplified by a current debate between Lancet and BMJ (the former has the opinion that side effects are not major issues, but the latter do not agree). Also the exact role of LDL (low density lipoprotein, also known as the ”bad cholesterol”) as a risk factor is discussed, and can vary, according to many researchers. LDL levels are important among middle aged persons, especially men, as a risk markers for cardiovascular disease, especially myocardial infarction. LDL is most likely less important as a risk factor in individuals above 60 years of age, and also among women – as compared to middle aged men.

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Statin Users Have Lower Incidence of Uterine Fibroids

MedicalResearch.com Interview with:

Mostafa Borahay, MD, PhD, FACOG Assistant Professor Department of Obstetrics and Gynecology Galveston, TX

Dr. Mostafa Borahay

Mostafa Borahay, MD, PhD, FACOG
Assistant Professor
Department of Obstetrics and Gynecology
Galveston, TX

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Uterine fibroids are the commonest tumors of the female reproductive system. More than 50% of women are estimated to have uterine fibroids. In fact, 1 out of 4 women undergo a hysterectomy in the United States and half of these hysterectomies are due to fibroids.
Recently we demonstrated that statins, drugs used to fight high cholesterol, have anti-tumor effects on uterine fibroids as shown in cells and animal models.

In this current study, we examined the incidence of uterine fibroids and fibroid-associated symptoms in women taking statins for high cholesterol. We performed this using large national patient database.
We found that compared to non-users, statin users have lower incidence of uterine fibroids. Furthermore, they have less heavy bleeding, pelvic pain and other fibroid-associated symptoms. Also, they needed less surgeries to remove tumors (myomectomy).

MedicalResearch.com: What should readers take away from your report?

Response: Currently, we don’t have a successful, safe long term medical treatment for uterine fibroids. Surgeries, typically a hysterectomy, is commonly performed for fibroids. This study provide some evidence that a safe long term medical treatment can be available for treating these tumors. This provides hope for many women, especially those interested in preserving their childbearing potential.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: After finding strong evidence from cellular and animal experiments and using patient databases, our next step is clinical trials. We plan to start a clinical trial for statins in women with fibroids in the near future. The established safety of statins represents a huge advantage.

MedicalResearch.com: Is there anything else you would like to add?

Response: The successful work over the last few years stresses the huge benefits from and the critical need for a multidisciplinary teams in medical research. Our team included clinicians, basic scientists and biostatisticians and epidemiologists.

Also, there is a need for more funding for medical research. Scientific research to discover innovative treatments requires funding and therefore the National Institutes of Health (NIH) and other funding bodies have a large responsibility to fulfil.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Am J Obstet Gynecol. 2016 Jun 28. pii: S0002-9378(16)30381-7. doi: 10.1016/j.ajog.2016.06.036. [Epub ahead of print]
Statin Use and Uterine Fibroid Risk in Hyperlipidemia Patients: A Nested Case-Control Study.
Borahay MA1, Fang X2, Baillargeon JG2, Kilic GS3, Boehning DF4, Kuo YF2.

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Statin-Related Diabetes Has Same Impact as Non-Statin Diabetes on Heart Health in Women

MedicalResearch.com Interview with:
Dr-Yunsheng-MaYunsheng Ma, MD, PhD MPH
University of Massachusetts Medical School
Worcester

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Ma: The cardiovascular benefit of lowering LDL cholesterol with statins exceeds all known risk, even in individuals with < 5% risk of CVD over 5 year. Nevertheless, statins are associated with increased incidence of new-onset diabetes, women were disproportionately at higher risk for diabetes while on statins. However, there are no studies comparing CVD and CVD mortality outcomes for women who develop diabetes while not taking statins, to compare their CVD and CVD mortality outcomes against those who develop diabetes while taking statins.

We hypothesized that new clinical diabetes related to statin use may be milder on CVD. However, our findings did not support this hypothesis, as we discovered that statin-related diabetes is no different from diabetes developed outside statin use in its significant impact on CVD and CVD mortality.

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High Dose Statins Reduce Amputations In PAD

MedicalResearch.com Interview with:

Shipra Arya MD, SM Assistant Professor, Division of Vascular Surgery Emory University School of Medicine Assistant Professor of Epidemiology (Adjunct) Rollins School of Public Health Staff Physician, Atlanta VA Medical Center Director, AVAMC Vascular Lab and Endovascular Therapy

Dr. Shipra Arya

Shipra Arya MD, SM
Assistant Professor, Division of Vascular Surgery
Emory University School of Medicine
Assistant Professor of Epidemiology (Adjunct)
Rollins School of Public Health
Staff Physician, Atlanta VA Medical Center
Director, AVAMC Vascular Lab and Endovascular Therapy 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Arya: Peripheral Arterial Disease is the next cardiovascular epidemic. It is poorly recognized and not adequately treated compared to heart disease – and research is lacking on the optimal use of statins for PAD patients. Very few randomized clinical trials have been done specifically in PAD patients to assess the impact of statins on cardiovascular outcomes and none on limb related outcomes. The 2013 ACC/AHA guidelines for cholesterol lowering medications recommends high intensity statins for PAD patients extrapolated from the level 2 and 3 evidence and empirically based on CAD and stroke data.

In this study we looked at the amputation and mortality risk based on statin dosage in a large cohort of patients from the VA population and found that high intensity statins are associated with a significant reduction in limb loss (~30%) and mortality (~25%) in PAD patients followed by a smaller risk reduction [~23% for amputation risk reduction and 20% reduction in mortality risk] by low-moderate intensity statins as compared to no statin therapy.

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Is Atherosclerotic Risk of Cardiovascular Disease Overestimated?

MedicalResearch.com Interview with:
Alan S. Go, MD
, chief of Cardiovascular and Metabolic Conditions Research at the Kaiser Permanente Northern California Division of Research

Jamal S. Rana, MD, PhD, cardiologist at Kaiser Permanente Oakland Medical Center and adjunct investigator with the Division of Research

MedicalResearch.com: What is the background for this study?

Response: In 2013, the American College of Cardiology and American Heart Association published the Pooled Cohort risk equation for estimating the likelihood of atherosclerotic cardiovascular disease events. However, the equation was developed from several groups of enrolled volunteers primarily conducted in the 1990s with limited ethnic diversity and age range, so its accuracy may vary in current community-based populations.

To determine whether the risk equation might be improved by being recalibrated in “real world” clinical care, we examined a large, multi-ethnic, community-based population of Kaiser Permanente members in Northern California whose cholesterol levels and other clinical measures could theoretically trigger a discussion about whether to consider starting cholesterol-lowering therapy based on estimated risk using the ACC/AHA Pooled Cohort tool. The study followed a population of 307,591 men and women aged 40 to 75 years old, including non-Hispanic whites, non-Hispanic blacks, Asian, Pacific Islanders and Hispanics, from 2008 through 2013 and had complete five-year follow-up. The study population did not include patients with diabetes, prior atherosclerotic cardiovascular disease or prior use of lipid-lowering therapy such as statins, as the application of this risk tool is meant for primary prevention of heart disease and stroke.

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Four Reasons Why Women Receive Fewer Statins Than Men For Heart Disease

MedicalResearch.com Interview with:

Alexander Turchin, MD, MS Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Endocrinology Boston, MA 02115

Dr. Alexander Turchin

Alexander Turchin, MD, MS
Associate Physician, Brigham and Women’s Hospital
Associate Professor of Medicine, Harvard Medical School
Brigham and Women’s Hospital
Department of Medicine
Endocrinology
Boston, MA 02115 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Turchin: It is known that fewer women than men at high risk for cardiovascular disease are treated with statins.

However, the reasons for this sex disparity are not fully understood.

Our study identified 4 factors that accounted for over 90% of the difference in statin therapy between women and men with coronary artery disease:

  • Age (women were older than men),
  • Amoking (men were more likely to smoke),
  • Evaluation by a cardiologist (men were more likely to have been seen by a cardiologist) and
  • History of adverse reactions to statins (women were more likely to have experienced an adverse reaction).

    This is the first time that a near-complete explanation for the sex disparities in statin therapy was found.

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Statins Improve Outcomes in Acute Ischemic Atherothrombotic Stroke

MedicalResearch.com Interview with:

Georgios Tsivgoulis , M.D., Ph.D., MSc, FESO Assistant Professor of Neurology University of Athens, Athens, Greece Visiting Associate Professor of Neurology Director of Stroke Research Department of Neurology University of Tennessee Health Science Center

Dr. Georgios Tsivgoulis

Georgios Tsivgoulis , M.D., Ph.D., MSc, FESO
Assistant Professor of Neurology
University of Athens, Athens, Greece
Visiting Associate Professor of Neurology
Director of Stroke Research
Department of Neurology
University of Tennessee Health Science Center

Medical Research: What is the background for this study? What are the main findings?

Dr. Tsivgoulis: Literature data suggest that taking statins before an acute ischemic stroke may improve early outcomes including early neurological deterioration, mortality and disability in patients with acute ischemic stroke. However,the potential beneficial effect of statin pretreatment has never been investigated in acute ischemic stroke due to large artery atherosclerosis. The research question in this specific subgroup of ischemic stroke patients is of great importance, as large-artery atherosclerotic stroke carries the highest risk of early recurrent stroke in comparison to other acute ischemic stroke subtypes.

Using prospectively collected data from over 516 consecutive patients with acute large-artery atherosclerotic stroke from seven tertiary-care stroke centers during a three-year period we found that statin pretreatment in patients with acute large-artery atherosclerotic stroke is associated with better early outcomes in terms of neurological improvement, disability, survival and stroke recurrence.

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High Dose Statins Did Not Reduce Risk of Kidney Injury After Cardiac Surgery

MedicalResearch.com Interview with:

Frederic T. Billings

Dr. Frederic T.Billings

Frederic T. Billings IV, MD, MSc
Assistant Professor of Anesthesiology and Medicine
Additional Specialty: Cardiothoracic Anesthesiology
Vanderbilt University

Medical Research: What is the background for this study? What are the main findings?

Dr. Billings: Acute kidney injury (AKI) affects up to 30% of patients following cardiac surgery and is associated with long-term kidney function decline as well as a 5-fold increase in death during hospitalization following surgery. Statins affect several mechanisms of AKI following cardiac surgery including improvement of endothelial function and attenuation of oxidative stress, so we performed a clinical trial to test the hypothesis that high-dose atorvastatin (brand name Lipitor) use prior to and following surgery reduces AKI following cardiac surgery.

In 615 patients who completed the study high-dose atorvastatin treatment, compared to placebo administration, did not reduce the risk of AKI overall, among patients naïve to statins, or patients already using a statin. In fact, among patients naïve to statins with baseline chronic kidney disease we found some evidence that atorvastatin may increase risk for kidney injury, although the number of patients was small in this subgroup.

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Statins May Reduce Risk of Complications and Death After Cardiac Surgery

Islam Elgendy, MD Clinical Pharmacology, Cardiology University of Florida

Dr. Islam Elgendy

MedicalResearch.com Interview with:
Islam Elgendy, MD
Clinical Pharmacology, Cardiology
University of Florida

Medical Research: What is the background for this study? What are the main findings?

Dr. Elgendy: This study aimed to review the current evidence for the effect of statin therapy before and after bypass surgery on different outcomes. The evidence suggests that statins can help reduce cardiac complications, such as atrial fibrillation, following the surgery. Statin use also seemed to be associated with a reduced risk of death during and immediately after bypass surgery.

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Drug Repurposing Trial Suggests Statins May Improve Survival in Small Cell Lung Cancer

MedicalResearch.com Interview with:
Glen Weiss, MD, MBA

Director of Clinical Research & Medical Oncologist
and Dr. Zoltan Lohinai MD
National Koranyi Institute of Pulmonology
Budapest, Hungary

Western Regional Medical Center
Cancer Treatment Centers of America
Goodyear, Arizona

MedicalResearch: What is the background for this study? What are the main findings?

Response: With nearly 1.4 million deaths each year, lung cancer is the world’s leading cause of cancer-related mortality. In the U.S., more than 162,000 die annually of this disease.

One subtype of this cancer, small cell lung cancer (SCLC), is one of the most progressive tumor types. No new class of systemic treatment has been adopted as a new benchmark for standard therapy against SCLC for nearly three decades. Lung cancer researchers focus on SCLC not only because of its scientific challenge, but also because of their great desire to help patients suffering from this aggressive tumor.

Drug repurposing bioinformatical analysis, a new research direction, has found that FDA-approved drugs in non-malignant diseases may have antitumor effects. Our study attempted to evaluate the recent laboratory findings in a clinical setting. Statins are a class of drugs primarily used to lower cholesterol in patients at risk for heart disease. They have been hypothesized by preclinical data to affect tumor cells through the extracellular signal-regulated kinase (ERK) pathway, which regulates many cellular functions.

Our study of 876 metastatic-stage  small cell lung cancer patients, published Jan. 6, 2015, in the peer-reviewed scientific journal PLOS ONE, showed that statins appeared to provide an increase in overall survival for those cancer patients who were prescribed those medications. Patients prescribed other classes of drugs, including aspirin, antidepressants, and blood pressure-lowering agents, have reportedly shown anti-SCLC activity in previous preclinical studies. However, our study found no such survival benefits.

All in all, our study is a good example of how to evaluate drug repurposing in oncology, and that statins might have clinical relevance in the treatment of SCLC.

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Acute Kidney Injury Following Heart Surgery: Do Statins Help?

Frederic T. (Josh) Billings IV, MD, Msc Assistant Professor of Anesthesiology and Critical Care Medicine Vanderbilt University Medical Center

Dr. Frederic T.Billings

MedicalResearch.com Interview with:
Frederic T. (Josh) Billings IV, MD, Msc
Assistant Professor of Anesthesiology and Critical Care Medicine
Vanderbilt University Medical Center 

Medical Research: What is the background for this study? What are the main findings?

Dr. Billings: Acute kidney injury (AKI) following cardiac surgery is common (affects 20-30% of patients), and even mild forms of AKI are independently associated with a five-fold increase in death. Statins, commonly prescribed to reduce cholesterol concentrations and cardiovascular disease, affect several mechanisms underlying surgical AKI. Observational studies comparing rates of AKI between statin users and non-users have yielded inconsistent results and don’t assess the effect of statin use during the surgical period.

In a double blind, placebo-controlled, randomized clinical trial of 653 cardiac surgery patients, we found that high-dose atorvastatin given prior to surgery, the day of surgery and daily postoperatively did not affect AKI. In fact, among statin-naïve patients with pre-existing kidney disease, rates of AKI were higher in those randomized to atorvastatin compared to those randomized to placebo. In patients who were using statins prior to the study, rates of AKI were similar between those randomized to atorvastatin and those randomized to placebo (short-term withdrawal), regardless of baseline kidney function. Safety markers of muscle and liver toxicity were not affected by statin treatment.
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Statins May Dampen Efficacy of Flu Vaccination

Saad Omer MBBS MPH PhD Associate Professor Emory Vaccine Center Associate Professor Global Health and Epidemiology Rollins School of Public Health Emory University

Dr. Saad Omer

MedicalResearch.com Interview with:
Saad Omer MBBS MPH PhD

Associate Professor Emory Vaccine Center
Associate Professor Global Health and Epidemiology
Rollins School of Public Health
Emory University

MedicalResearch: Can you give us a little background on this study?

Dr. Omer: My background is in global health, epidemiology and pediatrics and I have been fortunate to conduct field and clinical vaccine trials in a number of countries and with multiple infectious diseases including influenza, polio, measles and pneumococcal vaccines.

We were familiar with the data on investigating the potential effects of statins on other infections i.e. sepsis and community acquire pneumonia including

Dr. Vandermeer’s study in 2012 suggesting that “statin use may be associated with reduced mortality in patients hospitalized with influenza”.

Statins have lipid-lowering effects but they also exhibit anti-inflammatory and immunomodulatory properties. For lack of a better image, I think of statins as acting like a ‘big hammer made of Jell-O’: they have a broad, small dampening effect on immune response (as opposed to a narrow or deep effect).

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Use of Statins in Very Elderly Rises Sharply

Michael Johansen MD MS Assistant Professor - Clinical Dept of Family Medicine The Ohio State UniversityMedicalResearch.com Interview with:
Michael Johansen MD MS
Assistant Professor – Clinical
Dept of Family Medicine
The Ohio State University

Medical Research: What is the background for this study? What are the main findings?

Dr. Johansen: -Over the last 15 years there has been increasing emphasis placed on the use of statins to decrease people’s risk of heart attacks and strokes. Individuals with known heart disease are recommended to be on statins. However, there is no convincing evidence that elderly individuals (>79 years of age) without heart disease benefit from statins.

Therefore, we investigated how use patterns of statins has changed over the last ~14 years. We identified a dramatic increase in statin use in the very elderly during the time of the study. As of 2012, around 1/3 of very elderly individuals without heart disease took a statin during that year.

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Evaluating Liver Fat On Cardiac CT Helps Predict Risk vs Benefit of Statin Therapy

MedicalResearch.com Interview with:
Venkatesh L. Murthy, MD, PhD, FACC, FASNC University of Michigan
Venkatesh L. Murthy, MD, PhD, FACC, FASNC

University of Michigan

Dr. Ravi Shah MD Beth Israel Deaconess Medical Centerand Dr. Ravi Shah MD
Beth Israel Deaconess Medical Center

 


MedicalResearch: What is the background for this study?

Response: Recent changes recommend statin therapy for cardiovascular risk reduction in an increasingly large number of Americans. Conversely, a number of studies have identified an increased risk of diabetes with statin treatment. Thus, there is increasing need for tools to target statin therapy to those with a favorable risk-benefit profile.

MedicalResearch: What are the main findings?

Response: In our study, we analyzed data from 3,153 individuals from the Multi-Ethnic Study of Atherosclerosis who underwent CT scanning at baseline for assessment of calcium score. The CT scans were analyzed to assess liver attenuation as a measure of the amount of liver fat. We demonstrated that high liver fat doubled the risk of diabetes over a median of 9 years of follow-up. Importantly, statin therapy also doubled the risk of diabetes. The two together had an additive effect, even after adjusting for BMI, age, gender, family history of diabetes, waist circumference, lipids, hsCRP and exercise habits. As in prior studies, the risk of cardiovascular disease (CVD) events increased with increasing calcium score, as has previously been shown in MESA and in other studies.

We then divided the cohort into six groups based on calcium score (0, 1-100 and >100) and liver fat (low/high). Using published data from meta-analyses of statin trials, we computed the number needed to treat to prevent one hard CVD event for statin therapy. Using data from our study, we computed the number needed to harm to cause one additional case of diabetes from statin therapy. The numbers needed to treat with ranged from 29-40 for calcium score of >100 to 218-252 for calcium score of 0. Conversely, the numbers needed to harm were approximately 63-68 for those with low liver fat versus 22-24 for those with high liver fat. Thus the combination of calcium score and liver fat assessment, from a single standard calcium score scan, allows for physicians to provide better assessment of risk and benefit of statins in discussion with their patients. Continue reading

Putting More People On Statins Would Be Cost Effective and Improve Heart Health

Dr. Ankur Pandya Ph.D. Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com Interview with:
Dr. Ankur Pandya Ph.D.

Assistant Professor of Health Decision Science
Department of Health Policy and Management
Harvard T.H. Chan School of Public Health
Boston, MA

Medical Research: What is the background for this study? What are the main findings?

Dr. Pandya: The American College of Cardiology and the American Heart Association (ACC-AHA) cholesterol treatment guidelines were controversial when first released in November 2013, with some concerns that healthy adults would be over-treated with statins.

We found that the current 10-year ASCVD risk threshold (≥7.5%) used in the ACC-AHA cholesterol treatment guidelines has an acceptable cost-effectiveness profile (incremental cost-effectiveness ratio of $37,000/QALY), but more lenient ASCVD thresholds would be optimal using cost-effectiveness thresholds of $100,000/QALY (≥4.0%) or $150,000/QALY (≥3.0%). Continue reading

Lipid-Lowering Drugs Substantially Reduced Stroke Risk In Elderly Population

Christophe Tzourio, MD, PhD Professor of Epidemiology University of BordeauxMedicalResearch.com Interview with:
Christophe Tzourio, MD, PhD

Professor of Epidemiology
University of Bordeaux

Medical Research: What is the background for this study? What are the main findings?

Dr. Tzourio: The efficacy of lipid-lowering drugs (LLD) – which include statins and fibrates – to reduce the risk of coronary events and stroke has already been demonstrated in randomized trials. However, these trials were performed on highly selected patients, usually of middle-age (50-70 yrs) and with a history of cardiovascular disease or a high vascular profile. There is therefore currently no indication on the benefit of these drugs in elderly individuals of the general population without a past-history of cardiovascular disease and guidelines do not recommend the use of lipid-lowering drugs in elderly individuals without clinical atherosclerotic disease.

As there are not randomized trials in non-selected individuals in this age category, observational population-based cohorts are therefore the only alternative to study the impact of lipid-lowering drugs on the risk of cardiovascular diseases in the elderly.

We analyzed data from the Three-City study, a community-based cohort in 7484 elderly individuals (mean age 74 years), followed-up during 9 years, without known history of vascular disease at baseline. We observed a one third decrease in the risk of stroke in lipid lowering drug users (hazard ratio 0.66, 0.49 to 0.90) compared with non-users. Reduction in stroke risk was similar for the statin and fibrate groups. No protective effect was seen on the risk of coronary heart disease. Continue reading

Statin Users Have Increased Risk Of Diabetes and Obesity

Ishak Mansi, MD Staff Internist, VA North Texas Health System.   Professor in Department of Medicine & Department of Clinical Sciences, Division of Outcomes and Health services Research, University of Texas Southwestern, Dallas, TXMedicalResearch.com Interview with:
Ishak Mansi, MD
Staff Internist, VA North Texas Health System.
Professor in Department of Medicine &
Department of Clinical Sciences, Division of Outcomes and Health services Research, University of Texas Southwestern, Dallas, TX

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Mansi:  Statin use is associated with increased incidence of diabetes, and possibly increased body weight, and less exercise capacity. Data on the long-term effects of these associations in healthy adults are very limited. Additionally, the effects of these associations on diabetic complications have not been adequately studied.

Dr. Mansi at VA North Texas Health System, Dallas and Professor of Medicine and Clinical Sciences at the University of Texas Southwestern, Dallas, TX and his colleagues found that among generally healthy individuals, statin-users in comparison to non-users had a higher odds of being diagnosed with new onset diabetes, diabetes with complications, and overweight/obesity.

The researchers examined the records of tens of thousands of Tricare beneficiaries, during the period from 10/1/2003 to 3/1/2012. After excluding patients who had at baseline a preexisting cardiovascular diseases or severe chronic diseases that may be life-limiting (including diabetes mellitus), they identified a cohort of 25,970 patients as “healthy cohort”. They, further, matched 3,351 statins-users and 3,351 nonusers on several baseline characteristics to ensure comparability.

There are 3 main important findings for our study:

  1. Statin use was associated with significantly higher risk of new onset diabetes even in a very healthy population. Whereas the risk of diabetes with statins is known, it was thought that this may be due to the overall multiple risks of statin-users (that caused them to receive statins as a therapy).
  2. Statin use was associated with very high risk of diabetes complications in this healthy population: this was never shown before.
  3. Statin use is associated with higher risk of obesity: this also is widely unknown. However, few studies have noted this (one study using patient survey noted this, another study using Mendelian randomization showed it, and post-hoc analysis of a clinical trial showed that statin user gained more weight). Our study, which used a different methodology (retrospective cohort study) add another piece of evidence. Obesity is at endemic level in the US and treatment options are limited.

High-intensity statins was associated with greater risks of all outcomes.

This article is published in the Journal of General Internal Medicine (JGIM). JGIM is the official journal of the Society of General Internal Medicine.

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Familial Hypercholesterolemia Linked To Lower Type2 Diabetes Risk

Joost Besseling PhD-student Academic Medical Center Dept. of Vascular Medicine AmsterdamMedicalResearch.com Interview with:
Joost Besseling PhD-student
Academic Medical Center
Dept. of Vascular Medicine
Amsterdam

Medical Research: What is the background for this study? What are the main findings?

Response: Statins are associated with an increased risk for type 2 diabetes mellitus (DM). The exact mechanism for this adverse event is largely unknown, although the upregulation of the low-density lipoprotein receptor (LDLR) has been suggested to play a role. In familial hypercholesterolemia (FH) the uptake of LDL-cholesterol via the LDLR is decreased due to a genetic defect. We found that the prevalence of type 2 DM is 50% lower in relative terms in patients with familial hypercholesterolemia. Moreover, there was a dose-response relationship: the more severe the genetic defect that causes familial hypercholesterolemia, the lower the prevalence of type 2 DM.
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Depression Remains Important Risk Factor For Cardiovascular Disease

Heidi May, Ph.D., M.S.P.H. Cardiovascular Epidemiologist Intermountain Medical Center Heart Institute Salt Lake CityMedicalResearch.com Interview with:
Heidi May, Ph.D., M.S.P.H.
Cardiovascular Epidemiologist
Intermountain Medical Center Heart Institute
Salt Lake City

 

Medical Research: What is the background for this study? What are the main findings?

Dr. Heidi May: Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Statin therapy is known to reduce the risk of cardiovascular disease incidence through the reduction of blood cholesterol levels and through its pleiotropic cardioprotective properties. Depression is a risk factor for cardiovascular disease. It has been recommended that antidepressant medications should be considered first-line treatment for depression of any severity. We hypothesized that taking both statins and antidepressants would reduce cardiovascular risk more than either medication alone. However, we did not find this. Instead we found that the effectiveness of antidepressants and statin therapy to reduce death and incident cardiovascular disease at 3 years varied by the severity of depressive symptoms. Among those with none to mild depressive symptoms, statin use, with or without antidepressant therapy, was associated with a decrease in risk, but among those with moderate to severe depression, antidepressant use was associated with a decrease in risk. The combination of antidepressant and statin use did not result in a greater risk reduction in either depressive symptom category.

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Single Step Process May Speed Production of Statins

Professor Andrew W. Munro FRSC FSB Professor of Molecular Enzymology Manchester Institute of Biotechnology Faculty of Life Sciences University of Manchester Manchester UKMedicalResearch.com Interview with:
Professor Andrew W. Munro FRSC FSB
Professor of Molecular Enzymology
Manchester Institute of Biotechnology
Faculty of Life Sciences University of Manchester
Manchester UK

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Munro: Statins are blockbuster drugs that inhibit the key enzyme in cholesterol synthesis: 3-beta-hydroxymethylglutaryl CoA reductase (HMG-CoA reductase), which catalyzes the rate-limiting step in the biosynthesis of cholesterol. As a consequence, statin drugs reduce levels of low-density lipoprotein (LDL-) cholesterol, are effective against hypercholesterolemia and reduce the risk of atherosclerosis and heart attack. One of the major statin drugs is pravastatin, which is derived from a fungal natural product called compactin. The process of conversion of compactin into pravastatin involves the use of an oxygen-inserting enzyme called a cytochrome P450 (or P450), which catalyzes the hydroxylation of compactin to form pravastatin. In order to produce a more cost-efficient and streamlined route to pravastatin production, our teams from the University of Manchester (UK) and DSM (Delft, The Netherlands) developed a single-step process for pravastatin production. This process involved harnessing the productive efficiency of an industrial strain of the beta-lactam (penicillin-type) antibiotic producing fungus Penicillium chrysogenum. The beta-lactam antibiotic genes were deleted from this organism, and replaced by those encoding for compactin biosynthesis (transferred from a different Penicillium species). This led to high level production of compactin, but also to substantial formation of a partially degraded (deacylated) form. To get around this problem and in order to further improve compactin production, the enzyme responsible for the deacylation (an esterase) was identified and the gene encoding this activity was deleted from the production strain. The final stages of development of the novel, one-step pravastatin production process involved the identification of a suitable P450 enzyme that could catalyze the required hydroxylation of compactin. A bacterial P450 was identified that catalyzed hydroxylation at the correct position on the compactin molecule. However, the stereoselectivity of the reaction was in favour of the incorrect isomer – forming predominantly epi-pravastatin over the desired pravastatin. This was addressed by mutagenesis of the P450 – ultimately leading to a variant (named P450Prava) that hydroxylated compactin with the required stereoselectivity to make pravastatin in large amounts. Determination of the structure of P450Prava in both the substrate-free and compactin-bound forms revealed the conformational changes that underpinned the conversion of the P450 enzyme to a pravastatin synthase. The expression of P450Prava in a compactin-producing strain of P. chrysogenum enabled pravastatin production at over 6 g/L in a fed-batch fermentation process, facilitating an efficient, single-step route to high yield generation of pravastatin.

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High-Intensity Statin Therapy Underutilized After Heart Attack

Dr. Robert S. Rosenson, MD Professor, Cardiology Icahn School of Medicine at Mount Sinai Cardiovascular Institute New York, New York 10029MedicalResearch.com Interview with:
Dr. Robert S. Rosenson, MD

Professor, Cardiology
Icahn School of Medicine at Mount Sinai
Cardiovascular Institute
New York, New York 10029

Medical Research: What is the background for this study? What are the main findings?

Dr. Rosenson: High intensity statin therapy is evidence-based and guideline directed for patients with acute coronary syndromes.  In a 5 percent random sample of Medicare patients, we investigated the utilization of high vs low-moderate dosage statin in older adjusts who were admitted with an acute myocardial infarction of severe myocardial ischemia requiring hospitalization for a revascularization procedure (PCI or CABG).

We report that only 27 percent of hospitalized patients received high-intensity statin therapy based on their first outpatient fill for a statin medication.  The most important determinant for the utilization of statin therapy is the dosage of the statin previously prescribed as an outpatient.  When patients were started on a high-intensity statin, the continued use diminished in the ensuing year

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Statins Not Helpful For Joint Disease of Osteoarthritis

Dr Geeske Peeters Postdoctoral Research Fellow School of Public Health The University of Queensland AustraliaMedicalResearch.com Interview with:
Dr Geeske Peeters

Postdoctoral Research Fellow
School of Public Health
The University of Queensland Australia

Medical Research: What is the background for this study? What are the main findings?

Dr. Peeters:

The hypothesis we set out to investigate was that statin use is associated with reduced joint pain/stiffness and consequently improved physical functioning and quality of life. This hypothesis was based on findings from previous studies suggesting that statin use may prevent the development of radiographic osteoarthritis. However, in contrast with this hypothesis, results from this large study did not demonstrate an association between statin use and reduced onset of joint pain or stiffness. Moreover, statin use did seem to be associated with an increased risk of functional limitations and poorer self-reported health, especially in the middle-aged women.

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Study Finds Coenzyme Q10 Has No Effect On Statin Myopathy

Beth Taylor, PhD Director of Exercise Physiology Research Department of Preventive Cardiology Hartford Hospital Hartford, CT 06102MedicalResearch.com Interview with:
Beth Taylor, PhD
Director of Exercise Physiology Research

Department of Preventive Cardiology
Hartford Hospital
Hartford, CT 06102

Medical Research: What is the background for this study?

Dr. Taylor:  Statins reduce incidence of cardiac events, and thus are extremely effective drugs. However, they may cause muscle side effects such as pain, weakness and soreness (i.e., statin myalgia) in up to 10% of patients. One potential mechanism underlying statin myalgia may be the depletion of Coenzyme Q10, a mitochondrial transport element used in energy production, as statin therapy produces a 30-50% reduction in intramuscular Coenzyme Q10. Seven previous studies to date have produced conflicting results, yet CoQ10 supplementation is used by many patients and recommended by many clinicians despite the absence of definitive results. The purpose of the present study was to assess the effect of CoQ10 on muscle pain, muscle strength and aerobic performance in confirmed myalgics (i.e., patients who tested positive for  myalgia during a randomized, double-blinded cross-over trial of statin therapy vs. placebo to confirm myalgia prior to CoQ10 treatment).

Medical Research: What are the main findings?

Dr. Taylor:  The first main finding was that after our randomized double-blind cross-over run-in phase, only 35.8% of patients experienced myalgia on simvastatin and did not experience it on placebo, what we term true or confirmed statin myalgia, and 17.5% of patients had no symptoms on simvastatin or placebo which could have been because the dose we selected was too low.  However, 29.2% experienced pain on placebo but not on simvastatin and 17.5% experienced pain on both simvastatin and placebo during the confirmation phase.

Secondly, we found that Coenzyme Q10 supplementation had no effect on the incidence and severity of myalgia, time to onset of pain, muscle strength, or aerobic performance.  Serum levels of CoQ10 went up, suggesting dosing worked, and LDL-C went down similarly in both groups, suggesting the statin was not compromised. Therefore we did not find an observable effect of CoQ10 on any muscle outcome.

Finally, there were no reductions from baseline in muscle strength or aerobic performance when statins were combined with placebo in our verified statin myalgics. This is notable because while there have been observational reports of decreased muscle strength and aerobic performance in statin myalgics, there have been few rigorous assessments of muscle strength and aerobic performance with statins and myalgia. In our previous study, the The Effect of STatins On Skeletal Muscle Performance (STOMP) trial , we randomized healthy, statin-naïve patients to atorvastatin 80 mg daily or placebo for 6 months, confirming myalgia via a challenge-dechallenge protocol. In that study, we also found no significant differences in the two groups  in muscle and exercise performance, and thus the present results confirm those findings.

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Statin Use Linked to Cataract Risk

B. John Mancini, MD, FRCPC, FACP, FACC Professor of Medicine; University of British Columbia; Department of Medicine, Division of Cardiology; Research Director, Division of Cardiology; Director, Cardiovascular Imaging Research Core Laboratory (CIRCL); President, Vancouver Hospital Medical, Dental and Allied Staff; Staff Cardiologist, VH Cardiology Clinics and Cardiac Computed Tomographic Angiography Program; Staff Cardiologist, St. Paul's Hospital Healthy Heart/Prevention Clinic.MedicalResearch.com Interview with:
B. John Mancini, MD, FRCPC, FACP, FACC

Professor of Medicine; University of British Columbia;
Department of Medicine, Division of Cardiology;
Research Director, Division of Cardiology;
Director, Cardiovascular Imaging Research Core Laboratory (CIRCL);
President, Vancouver Hospital Medical, Dental and Allied Staff;
Staff Cardiologist, VH Cardiology Clinics and Cardiac Computed Tomographic Angiography Program; Staff Cardiologist, St. Paul’s Hospital Healthy Heart/Prevention Clinic.

MedicalResearch: What are the main findings of this study?

Dr. Mancini: The main findings are that we found evidence of a relationship between statin use and the need for cataract surgery. The unique nature of the study is that it looked for the association in two distinctly different populations (a Canadian database and a separate, American database) and found a consistent association in both populations.

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Elderly: Who Should and Shouldn’t Take Statins?

Dr. Mike Miedema MD, MPH Minneapolis Heart InstituteMedicalResearch.com Interview with:
Dr. Mike Miedema MD, MPH
Minneapolis Heart Institute

Medical Research: What is the background for this study? What are the main findings?

Dr. Miedema: ” Released in November 2013, the ACC/AHA guidelines for the treatment of blood cholesterol attempt to target individuals that are most likely to benefit from cholesterol-lowering statin therapy. These guidelines are a significant change from prior guidelines that relied heavily on levels of bad cholesterol to determine who to treat. Instead, the new guidelines recommend focusing statin therapy on the individuals that are at the highest risk for heart attack and stroke, even if their cholesterol levels are within normal limits. In addition to recommending statin therapy for individuals with known cardiovascular disease, diabetes, or markedly elevated cholesterol levels, they also recommend statin therapy for individuals without these conditions but with an elevated estimated risk of a heart attack or stroke in the next 10-year based on a risk calculator that factors in an individual’s age, gender, race, and risk factors. Patients with an estimated 10-year risk > 7.5% are recommended to consider statin therapy. While I believe the scientific evidence supports this “risk-based” approach, one potential concern is that the risk-calculator relies heavily on age to determine an individual’s risk, so we wanted to examine the implications for these guidelines in an older sample of adults.”

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Statins May Impede Growth of Uterine Fibroids

Mostafa Borahay, MD, FACOG Assistant Professor, Director of Simulation Education Department of Obstetrics and Gynecology University of Texas Medical BranchMedicalResearch.com Interview with:
Mostafa Borahay, MD, FACOG
Assistant Professor, Director of Simulation Education
Department of Obstetrics and Gynecology
University of Texas Medical BranchCo-director of Minimally Invasive Gynecologic Surgery University of Texas Medical Branch

Medical Research: What is the background for this study? What are the main findings?

Dr. Borahay: Uterine fibroids are the most common type of tumor in the female reproductive system, accounting for half of the 600,000 hysterectomies done annually in the U.S. Their estimated annual cost is up to $34 billion in the U.S. alone. Despite this, the exact cause of these tumors is not well understood, as there are several genetic, familial and hormonal abnormalities linked with their development. Even more, we currently don’t have a satisfactory medical treatment for these tumors.

Our team investigated the impact of simvastatin on human uterine fibroid cell growth. Statins, such as simvastatin, are commonly prescribed to lower high cholesterol levels. Statins work by blocking an early step in cholesterol production. Beyond these well-known cholesterol-lowering abilities, statins also combat certain tumors. Statins have previously been shown to have anti-tumor effects on breast, ovarian, prostate, colon, leukemia and lung cancers. However, the effect of statins on uterine fibroids was unknown.

We found that simvastatin impedes the growth of uterine fibroid tumor cells. We also studied the way simvastatin works to suppress these tumors. Simvastatin was shown to inhibit ERK phosphorylation, which is a critical step in the molecular pathway that prompts the growth of new cells. In addition, simvastatin stops the progression of tumor cells that have already begun to grow and induces calcium-dependent cell death mechanisms in fibroid tumor cells. Therefore, we identified a novel pathway by which simvastatin induces the death of uterine fibroid tumor cells.

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Statins May Have Additional Lipid Profile Benefit in Pre-Diabetes

Prof. Moses Elisaf Professor of Internal Medicine University of Ioannina, GreeceMedicalResearch.com Interview with:
Prof. Moses Elisaf
Professor of Internal Medicine
University of Ioannina, Greece


Medical Research: What are the main findings of the study?

Dr. Elisaf: We evaluated the effects of rosuvastatin in two groups of hyperlipidemic patients: one group had impaired fasting glucose (IFG) while the second group had normal fasting glucose. After study end, both groups had similar changes in their lipidemic profile.

However, patients with IFG had a significant greater decrease in the cholesterol concentration of the more atherogenic small dense low-density lipoprotein (sdLDL) particles (-65.7%) compared with controls (-38.5%). Moreover, a greater increase in the mean LDL particle size was observed in the impaired fasting glucose group (+1.5% vs +0.4%).

In addition, redistribution from the more atherogenic sdLDL to large buoyant
LDL (lbLDL) subfractions was observed in the IFG group.
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Diabetics on Statins May Have Fewer Microvascular Complications

Børge G. Nordestgaard, MD, DMSc Professor, University of Copenhagen Chief Physician, Herlev Hospital, Copenhagen University Hospital Dept. Clinical Biochemistry Herlev Ringvej 75, DK-2730 Herlev, DenmarkMedicalResearch.com Interview with:
Børge G. Nordestgaard, MD, DMSc
Professor, University of Copenhagen
Chief Physician, Herlev Hospital, Copenhagen University Hospital
Dept. Clinical Biochemistry
Herlev Ringvej Herlev, Denmark

Medical Research: What are the main findings of the study?

Dr. Nordestgaard: Among all patients with diabetes in Denmark during 1996-2009 and compared with non-statin users, statin users had a 40% lower risk of diabetic retinopathy, a 34% lower risk of diabetic neuropathy, and a 12% lower risk of gangrene of the foot, while the risk of diabetic nephropathy was similar.
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Surprising Number of Patients Do Not Take Their Prescribed Statin Medication

Dr. Heli Halava: Departments of Public Health and Pharmacology, Turku, FinlandMedicalResearch.com Interview with:
Dr. Heli Halava:
Departments of Public Health and Pharmacology,
Turku, Finland

MedicalResearch: What are the main findings of the study?

Dr. Halava: The associations between lifestyle factors and nonadherence to statin therapy varied by cardiovascular comorbidity status. Of the participants without cardiovascular comorbidities (n = 6458), 3171 (49.1%) were nonadherent with their statin therapy. Of the participants with cardiovascular comorbidities (n = 2827), 1155 (40.9%) were nonadherent.

People with cardiovascular comorbidities who had risky drinking behaviours or a cluster of lifestyle risks were at increased risk of nonadherence.
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Older Men Taking Statins Less Physically Active

MedicalResearch.com Interview with David S.H. Lee, Pharm.D., Ph.D. Assistant Professor Department of Pharmacy Practice College of Pharmacy Oregon State University/Oregon Health and Science University Portland OR, 97239MedicalResearch.com Interview with
David S.H. Lee, Pharm.D., Ph.D.
Assistant Professor
Department of Pharmacy Practice
College of Pharmacy
Oregon State University/Oregon Health and Science University
Portland OR, 97239

MedicalResearch: What are the main findings of the study?

Dr. Lee: We found that older men taking a statin were less physically active and had more sedentary behavior. They had about 37 minutes of less moderate exercise per week. For comparison, the American heart Association recommends about 40 minutes of moderate activity 3-4 times per week. We also found that those that started using a statin during the study had the largest drop in physical activity.
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Statins for Sepsis-Associated Acute Respiratory Distress Syndrome?

Jonathon D. Truwit, MD, MBA Enterprise Chief Medical Officer Sr. Administrative Dean Froedtert-Medical College of Wisconsin Milwaukee, WI 53226MedicalResearch.com Interview with:
Jonathon D. Truwit, MD, MBA
Enterprise Chief Medical Officer
Sr. Administrative Dean
Froedtert-Medical College of Wisconsin
Milwaukee, WI 53226

MedicalResearch.com: What are the main findings of the study?

Dr. Truwit: Rosuvastatin did not reduce mortality, nor days free of the breathing machine, in patients with sepsis-associated acute respiratory distress syndrome (ARDS). One in four patients with ARDS die.
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