Continuing Statins from Late Chronic Kidney Disease through ESRD Linked to Improved Survival

MedicalResearch.com Interview with:
"Plugged into dialysis" by Dan is licensed under CC BY 2.0

Elani Streja MPH PhD

Division of Nephrology and Hypertension
University of California, Irvine | UCI ·
Elvira O. Gosmanova, MD, FASN
Medicine/Nephrology
Albany Stratton VA Medical Center


Csaba P Kovesdy MD

Fred Hatch Professor of Medicine
Division of Nephrology, University of Tennessee Health Science Center
Nephrology Section Chief, Memphis VA Medical Center
Director, Clinical Outcomes and Clinical Trials Program
Memphis TN, 38163 

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

Response:  Cardiovascular disease (CVD) is one of the leading causes of mortality and morbidity in patients with chronic kidney disease (CKD).

Statins are lipid-lowering drugs that have a proven track record in reducing risk of CVD in patients with advanced CKD who did not yet reach its terminal stage or end-stage renal disease (ESRD). Paradoxically, new prescription of statins after ESRD onset failed to reduce CVD related outcomes in three large clinical trials. However, benefits of statin continuation at transition from advanced CKD to ESRD was never formally tested.

Therefore, we identified a cohort of 14,298 US Veterans who used statins for at least half of the year during 1 year before ESRD transition and evaluated mortality outcomes based on whether statins were continued or stopped after ESRD onset.

We found that ESRD patients who continue statins for at least 6 months after transition had 28% and 18% lower risk of death from any cause or cardiovascular causes, respectively, during 12-months of follow up, as compared with statin discontinuers. Continue reading

Rare Inflammatory Muscle Inflammation Increased With Statin Exposure

MedicalResearch.com Interview with:

Dr Gillian E. Caughey PhD Senior Research Fellow | School of Medicine | Discipline of Pharmacology THE UNIVERSITY OF ADELAIDE Australia

Dr. Caughey

Dr Gillian E. Caughey PhD
Senior Research Fellow | School of Medicine
Discipline of Pharmacology
THE UNIVERSITY OF ADELAIDE
Australia

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

Response: Statins are one of the most commonly prescribed medications worldwide.  Muscular adverse effects (myalgia and myopathy) are well recognised adverse effects and symptoms resolve with cessation of statins.

Idiopathic inflammatory myositis (IIM) is a heterogeneous group of autoimmune myopathies that may also be associated with statin use. IIM does not resolve with cessation of statin therapy, requires treatment with immunosuppressive agents and is a severe, debilitating condition. To date, there have been no epidemiological studies examining exposure to statins and the association of histologically confirmed IIM.

In our case control study of 221 cases o fIdiopathic inflammatory myositis, there was an almost 2-fold increased likelihood of statin exposure in patients with IIM compared with controls (adjusted odds ratio, 1.79; 95%CI, 1.23-2.60). After observing a significant association of statin exposure with IIM, we conducted a sensitivity analysis where we excluded those patients with necrotizing myositis as recent studies have reported this type of IIM to be associated with statin use and the presence of autoantibodies against HMG-CoA reductase. Exclusion of these specific cases from the analysis did not change our study findings and an increased risk of Idiopathic inflammatory myositis with statin exposure remained (adjusted OR, 1.92; 95% CI, 1.29-2.86).  This suggest the potential association of all types of Idiopathic inflammatory myositis with statin exposure.

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Statins May Reduce Need For Surgery in Chronic Subdural Hematoma

MedicalResearch.com Interview with:
Jianning Zhang MD, Ph.D Chairman, II, VII Chinese Medical Association of Neurosurgery President, Tianjin Medical University General Hospital, China  Jianning Zhang MD, Ph.D
Chairman, II, VII Chinese Medical Association of Neurosurgery
President, Tianjin Medical University General Hospital,
China  

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

Response: The elderly population is growing dramatically world widely, especially in China. The incidence of chronic subdural hematoma has been rising over the past years. Although the surgery is not a difficult process, the risk of death and recurrence persist, and the affliction and economic expenditure of the patients are relatively higher in the elderly. For these reasons, it is urgent to develop novel pharmacological therapies with sufficient safety and efficacy. 

It has been known that the high expression of VEGF and inflammatory factors in chronic subdural hematoma can lead to abundant angiogenesis of immature vessels on the wall of hematoma. In our previous study, patients with chronic subdural hematoma have impaired ability to promote vascular maturation. For example, the number of endothelial progenitor cells in circulating blood is about 67% of the healthy individuals with similar age. 

Atorvastatin can mobilize endothelial progenitor cells to reduce inflammation. It increases the number of circulating endothelial cells that are inversely correlated with the volume of hematoma. We have demonstrated that atorvastatin can promote endothelial cell formation and reduce the leakage of endothelial cell barrier in vitro. Results from in vivo experiments in animal models of subdural hematoma suggest that atorvastatin can promote the maturation of blood vessels and reduce inflammation on the margin of hematoma, and thus improve the neurological outcome. Continue reading

Statins Underused in Veterans with Severely Elevated Cholesterol

MedicalResearch.com Interview with:

Fatima Rodriguez, MD, MPH Division of Cardiovascular Medicine Stanford University Stanford, CA 94305-5406,

Dr. Rodriguez

Fatima Rodriguez, MD, MPH
Division of Cardiovascular Medicine
Stanford University
Stanford, CA 94305-5406,

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

Response: Individuals with LDL-cholesterol levels above 190mg/dL are often underdiagnosed and undertreated, yet remain at high-risk of cardiovascular disease. In a national sample of veterans, we identified over 60,000 patients who met criteria for uncontrolled, severe hypercholesterolemia based on an index LDL-C value ≥190mg/dL. We found that only half of these high-risk patients are being treated with statins, and less than 10% are on high-intensity statin therapy as recommended by the 2013 ACC/AHA guidelines. We also found that both older and younger patients were less likely to be treated with statins. Women were less likely to be treated with statins, whereas minority groups and those with a diagnosis of hypertension were more likely to be treated. Disparities in use of statins were also noted by geographic region and hospital teaching status. Continue reading

African Americans Less Likely To Be Treated With Statins

MedicalResearch.com Interview with:

Michael G. Nanna, MD Fellow, Division of Cardiology Duke University Medical Center Durham, NC

Dr. Nanna

Michael G. Nanna, MD
Fellow, Division of Cardiology
Duke University Medical Center
Durham, NC

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

Response: We know that African Americans are at higher risk for cardiovascular disease than white patients. We also know that African American individuals have been less likely to receive statin therapy compared to white individuals in the past. However, the reasons underlying these racial differences in statin treatment are poorly understood. We set out to determine if African American individuals in contemporary practice are treated less aggressively than whites and, if so, we wanted to investigate potential reasons why this might be the case.

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LPA Gene Variants Linked To Cardiac Events Despite Statins

MedicalResearch.com Interview with:

Wei-Qi Wei, MD, PhD Assistant Professor Department of Biomedical Informatics Vanderbilt University Nashville, TN 37203

Dr. Wei-Qi Wei

Wei-Qi Wei, MD, PhD
Assistant Professor
Department of Biomedical Informatics
Vanderbilt University
Nashville, TN 37203

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

Response: The study was motived by the clinical observation that some patients develop coronary heart disease events despite taking statins, one of our most effective drugs to reduce cardiovascular risk. We collected data within the eMERGE network of people taking statins and monitored them for development of coronary heart disease events over time.  We  conducted a genome-wide association study of those with events compared to those without events.

Our results showed that single nucleotide polymorphisms (SNPs) on the LPA gene were associated with a significantly increased risk of coronary heart disease events. Individuals with the variant were 50% more likely to have an event. More importantly, even among patients who achieved ideal on-treatment LDL cholesterol levels (<70 mg/dL), the association remained statistically significant.

We then did a phenome-wide association study to see if other diseases or conditions were associated with these LPAvariants. The major associated conditions were all cardiovascular. This sort of study can highlight potential other indications for a drug targeting this pathway and suggest potential adverse events that might be experienced from targeting this pathway. Clearly, more and larger studies will be needed to truly understand the potential risks and benefits of a future drug targeting this pathway.  Continue reading

Most Patients With Adverse Reaction To Statins, Can Ultimately Tolerate Them

MedicalResearch.com Interview with:

Alexander Turchin, M.D., M.S. FACMI Associate Professor of Medicine ENDOCRINOLOGY, DIABETES AND HYPERTENSION BRIGHAM AND WOMEN'S HOSPITAL

Dr. Turchin

Alexander Turchin, M.D., M.S. FACMI
Associate Professor of Medicine
ENDOCRINOLOGY, DIABETES AND HYPERTENSION
BRIGHAM AND WOMEN’S HOSPITAL

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

Response: Statins are known to reduce the risk of cardiovascular events and death, and are some of the most commonly prescribed medications. However, many patients stop taking statins, most commonly because of adverse reactions. It has been shown previously that many individuals who discontinued statin therapy after an adverse reaction are ultimately able to tolerate statins, and that reattempting statin therapy after an adverse reaction is associated with reduced risk of cardiovascular events and death. However, optimal patient selection criteria and methods of reattempting treatment with statins are unknown. We therefore conducted this study to identify patient and treatment characteristics associated with an increased chances of successful reattempt of statin therapy after an adverse reaction.

Through analysis of EMR data of over 6,000 patients we found that the following were associated with higher chances of successful statin therapy reattempt:

  • Reattempted treatment with a different statin
  • Patient at high cardiovascular risk (prior history of CAD, stroke or diabetes)

On the other hand, the following were associated with lower chances of success:

  • Adverse reaction was reported in the first year after starting statin therapy
  • Adverse reaction was myalgia or myopathy
  • Previous history of adverse reactions to other (non-statin) medications 

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Statins: Large Disparity Between US/Canadian/UK and European Guidelines

MedicalResearch.com Interview with:

Borge G. Nordestgaard,

Borge G. Nordestgaard

Børge G. Nordestgaard, MD, DMSc
Department of Clinical Biochemistry
Herlev and Gentofte Hospital, Copenhagen University Hospital
Herlev, Denmark

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

Response: Five major organizations recently published guidelines for using statins to prevent atherosclerotic cardiovascular disease  — the American College of Cardiology/American Heart Association (ACC/AHA) in 2013, the United Kingdom’s National Institute for Health and Care Excellence (NICE) in 2014, and in 2016 the Canadian Cardiovascular Society (CCS), the US Preventive Services Task Force (USPSTF), and the European Society of Cardiology/European Atherosclerosis Society (ESC/EAS). We applied these five guidelines to a contemporary study cohort of 45,750 40-75 year olds from the Copenhagen General Population Study.

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No Convincing Evidence of Memory Dysfunction Due To Statins

MedicalResearch.com Interview with:

Dr-Beth-Taylor

Dr. Taylor

Beth A. Taylor, PhD
Director of Exercise Physiology Research, Hartford Hospital Associate Professor, Kinesiology
University of Connecticut

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

Response: Hydroxy-methyl-glutaryl (HMG) CoA reductase inhibitors (statins) are the most effective medications for managing elevated concentrations of low-density lipoprotein cholesterol (LDL-C).  Although statins are generally well-tolerated, they are not without side effects, and mild central nervous system (CNS) complaints such as memory loss and attention decrements are the second most commonly reported adverse effect of these drugs.

Studies assessing cognitive effects of statins vary widely and have produced inconclusive findings. Despite the equivocal data on adverse cognitive side effects with statin therapy, in 2012 the FDA announced a safety label change for statins, based on published case reports of memory loss and confusion and data from the Adverse Events Reporting System. One possibility for these equivocal findings is that studies involving the effects of statins on cognition typically have assessed cognitive function using traditional cognitive tests, which may yield small effect sizes and demonstrate high intra-participant variability. This may explain the discrepancy between clinical trials and patient self-reports, and could be addressed by utilizing CNS tests that directly assess brain parameters.

To the best of our knowledge and literature review, this study is the first to investigate the effects of statins on the central nervous system by utilizing fMRI to assess brain neural activation in healthy adults treated with 80 mg atorvastatin or placebo.

We detected few changes attributable to statin therapy with standardized neuropsychological tests, a finding similar to that from previous clinical trials. However, participants on atorvastatin demonstrated altered patterns of neural activation on vs. off statin compared to participants treated with placebo. Unexpectedly, the treatment groups differed at both timepoints. The clinical implications of these findings are unclear and warrant additional clinical trials.

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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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