Author Interviews, Geriatrics, Heart Disease, Lipids / 18.07.2019

MedicalResearch.com Interview with: Richard G. Bach, MD FACC Professor of Medicine Washington University School of Medicine Director, Cardiac Intensive Care Unit Director, Hypertrophic Cardiomyopathy Center Barnes-Jewish Hospital St. Louis, MO 63110 MedicalResearch.com: What is the background for this study? Response: Elderly patients represent the largest group of those hospitalized for an acute coronary syndrome, and age is an important marker of increased risk. The risk of death and recurrent cardiovascular events is greatest among the elderly. High intensity lipid lowering by statins has been shown to reduce the incidence of recurrent cardiovascular events after an acute coronary syndrome in general, but there remains limited data on efficacy and safety of that treatment in the elderly, and guidelines do not routinely advocate higher intensity treatment for patients older than 75 years. In practice, older age has been associated with a lower likelihood of being prescribed intensive lipid lowering therapy. IMPROVE-IT evaluated the effect of higher-intensity lipid lowering with ezetimibe combined with simvastatin compared with simvastatin-placebo among patients after ACS, and observed that ezetimibe added to statin therapy incrementally lowered LDL-cholesterol level and improved CV outcomes. IMPROVE-IT enrolled patients with no upper age limit, which gave us the opportunity to examine the effect of age on outcome on the benefit of more intensive lipid lowering with ezetimibe combined with simvastatin vs. simvastatin monotherapy. (more…)
Author Interviews, Cancer Research, ENT, JAMA, Surgical Research / 18.07.2019

MedicalResearch.com Interview with: Megan Rist Haymart MD Associate Professor Metabolism, Endocrinology and Diabetes Clinic Michigan Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Thyroid cancer is a common malignancy with surgery considered one of the primary treatments. Complications from thyroid surgery can lead to long-term voice problems. However, few studies have used validated scales to quantify the impact of thyroid surgery on patient voice. Prior work has largely focused on single institution studies with high volume surgeons or claims data with reports of specific nerve injury. We surveyed a diverse cohort of patients affiliated with SEER sites Georgia and Los Angeles to identify the prevalence, severity and correlates of poor voice outcomes following surgery for differentiated thyroid cancer. We found that out of 2,325 patients 25.8% reported voice changes lasting greater than 3 months after surgery, 12.7% had abnormal voice per a validated voice scale (Voice Handicap Index- 10), and 4.7% reported a diagnosis of vocal fold motion impairment. We also identified patient factors associated with abnormal voice 2-4 years post op. (more…)
Addiction, Author Interviews, Cannabis, Columbia, JAMA, Opiods / 18.07.2019

MedicalResearch.com Interview with: Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University  MedicalResearch.com: What is the background for this study? Response: Prior studies have suggested t6hat medical marijuana legalization might play a role in decreasing opioid use. We aimed to test this hypothesis using individual level data on nonmedical use of prescription opioids and opioid use disorder  from the US National Survey on Drug Use and Health.  (more…)
Author Interviews, JAMA, Opiods, Pediatrics, UCSD / 17.07.2019

MedicalResearch.com Interview with: Lorraine Kelley-Quon, MD, MSHS, FAAP Assistant Professor | Division of Pediatric Surgery Children's Hospital Los Angeles Department of Surgery & Preventive Medicine Keck School of Medicine of USC  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Prescription opioids are pharmacologically similar to heroin, and previous research has shown an association between nonmedical opioid use and heroin use. This is the first study to follow a group of teenagers through all 4 years of high school and identify an association between nonmedical prescription opioid use and later heroin use. (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics, Social Issues / 15.07.2019

MedicalResearch.com Interview with: Dr. Marina Mendonca PhD RECAP project (Research on European Children and Adults Born Preterm) Department of Psychology University of Warwick, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous research on the social lives of adults born preterm (under 37 weeks gestation) was inconsistent. This meta-analysis brought together data from up to 4.4m adult participants and has shown that those who were born preterm are less likely to form romantic relationships, to have had sexual relations or experience parenthood than full terms. For example, those born preterm were 28% less likely to form romantic relationships and 22% less likely to become parents, when compared to those born full term. When looking at sexual relations, preterm born adults were 2.3 times (or 57%) less likely to ever have a sexual partner. These associations were found for both men and women, and were stronger the lower gestational age. This means that the chances of finding a romantic partner or having children were lower for those born very (<28 weeks gestation) or extremely preterm (<28 weeks gestation), with the extremely pre-term born adults being for example 3.2 times (78%) less likely to ever having had sexual relations when compared to their full term peers. Despite having fewer relationships, we found that when adults who were born preterm had friends or a partner, the quality of these relationships was at least as good as those born full term.  (more…)
Author Interviews, Cancer Research, Outcomes & Safety, Surgical Research, Yale / 12.07.2019

MedicalResearch.com Interview with: Daniel Boffa, MD Professor of Surgery Yale School of Medicine  MedicalResearch.com: What is the background for this study? Response: We have previously demonstrated that top-ranked hospitals are significantly safer than their affiliates for complex cancer surgery (patients 1.4 times more likely to die after cancer surgery at affiliate hospitals).  A logical extension of this work was to compare affiliate hospitals to hospitals that were not affiliated with a top ranked hospital. (more…)
Author Interviews, Genetic Research, Heart Disease, Imperial College, JAMA / 12.07.2019

MedicalResearch.com Interview with: Ben Cordon, PhD NIHR Post-doctoral Academic Clinical Fellow Specialist Registrar training in cardiology  James S. Ware, PhD, MRCP  Reader in Genomic Medicine Group head within the Cardiovascular Genetics & Genomics Unit Imperial College London     MedicalResearch.com: What is the background for this study?   Response: Non-ischaemic dilated cardiomyopathy is a common cause of heart failure and carries the risk of life-threatening ventricular arrhythmia. An implantable cardioverter defibrillator (ICD) can be life-saving in this condition. However, the decision to implant an ICD is not one that can be taken lightly - ICD insertion carries its own risks, such as infection or inappropriate shocks, and our ability to predict who will benefit from a device is currently far from perfect. Genetic sequencing is affordable and widely available and for DCM, like many diseases, it is hoped that genetic stratification may one day help deliver personalised management. In DCM, variants in the Lamin A/C gene for example are known to cause a phenotype with early and severe arrhythmias and, as a result, international guidelines advocate a lower threshold for ICD insertion in these patients. However, Lamin A/C is an infrequent cause of DCM. The commonest known genetic cause of DCM are protein-truncating variants in the gene encoding Titin (TTNtv), accounting for ~15% of DCM cases. We wanted to know if this group had a higher risk of arrhythmia than the general DCM population. Earlier work from our group on this topic found that patients with TTNtv-associated DCM were more likely to have a clinical history of arrhythmia (composite of atrial and ventricular arrhythmia, including NSVT), at the time of their initial DCM diagnosis. But it was unclear if this was driven by ventricular arrhythmia, atrial arrhythmia, or both or if it would translate into a long-term risk of potentially dangerous ventricular arrhythmia of the sort for which an ICD can be life-saving. In another study we analysed a larger cohort of ambulant DCM patients but did not find an increased risk of ventricular arrhythmia – but this was a relatively low-risk group, with comparatively mild symptoms (NHYA I/II heart failure) and moderately impaired LV function. As a result, the overall arrhythmic event rate was low, meaning that the power to detect differences between the TTNtv and non-TTNtv groups was reduced. (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JAMA / 12.07.2019

MedicalResearch.com Interview with: Dr Kazem Rahimi Deputy Director of the George Centre for Healthcare Innovation James Martin Senior Fellow in Essential Healthcare Honorary Consultant Cardiologist at the John Radcliffe Hospital Deputy Director of the George Institute for Global Health MedicalResearch.com: What is the background for this study? Response: In the last century, we have witnessed a dramatic change in the spectrum of valvular heart disease and the prevalence of this condition has been rapidly increasing, due to population ageing, with poor patient outcomes and high healthcare costs associated with the only effective treatment available, which is valve repair or replacement. However, modifiable risk factors for valvular heart disease remain largely unknown, which limits prevention and treatment. We used a state-of-the-art, gene-based method called Mendelian randomization to determine the causality of the association between systolic blood pressure and risk of valvular heart diseases.  (more…)
Anemia, Author Interviews, Heart Disease, JAMA, Karolinski Institute / 11.07.2019

MedicalResearch.com Interview with: Dr. Niels Grote Beverborg, MD PhD Post-doctoral research fellow Department of experimental cardiology University Medical Center Groningen, Groningen, The Netherlands Integrated CardioMetabolic Center Karolinska Institutet, Stockholm Sweden  MedicalResearch.com: What is the background for this study?   Response: Iron deficiency is very prevalent worldwide and a significant cause of morbidity and mortality, especially in vulnerable populations such as patients with heart failure. It is well known that iron deficiency can be a consequence of an insufficient iron uptake or increased iron loss (termed low iron storage), or of a chronic low inflammatory state (defective iron utilization). However, so far, we had no tools to distinguish these causes from each other in patients and have not been able to assess their potential consequences. (more…)
Author Interviews, JAMA, Nutrition, Weight Research / 11.07.2019

MedicalResearch.com Interview with: Anne Thorndike, MD, MPH Massachusetts General Hospital General Internal Medicine Division Boston, MA 02114 MedicalResearch.com: What is the background for this study? Response: Nearly one-third of the 150 million US adults who are employed are obese. Employees frequently eat meals acquired at work, and workplace food is often high in calories. Effective strategies for reducing non-nutritive energy intake during the workday could help address the rising prevalence of obesity. Simplified labeling, such as traffic-light labels, provide understandable information about the relative healthfulness of food and can be placed on menu boards, shelf labels, and individual packages to help employees make healthier choices. Choice architecture (e.g., product placement) interventions make it easier and more convenient for employees to choose a healthy item. It is unknown if labeling interventions are associated with sustained reductions in calorie intake, or if there are only temporary effects after which most people revert to higher-calorie choices. A previous study demonstrated that a hospital cafeteria traffic-light labeling and choice architecture program resulted in a higher proportion of healthy green-labeled purchases and lower proportion of unhealthy red-labeled purchases over two years. The current study analyzed calories purchased by a longitudinal cohort of 5,695 hospital employees who used the cafeteria regularly. The study examined changes in calories purchased over time and hypothesized the effect of the change in calorie intake on employees’ weight. (more…)
Author Interviews, JAMA / 04.07.2019

MedicalResearch.com Interview with: Lucy Schulson, MD MPH Section of General Internal Medicine Boston University School of Medicine Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Response: Research in the early 2000s in California demonstrated that racial and ethnic minorities, immigrants, and those with limited English proficiency (LEP) experienced high rates of discrimination in healthcare. Since those studies were published, California has made concerted efforts at the state and local level to address health equity; these efforts may have impacted perceptions of discrimination in health care. However, it is not known how perceptions of discrimination in healthcare have changed over the last ten years overall and for specific groups. This study sought to compare perceptions of discrimination in health care in 2003-2005 compared to 2015-2017 overall, for racial and ethnic minorities, among immigrants, and among those with Limited English Proficiency (LEP).  (more…)
Author Interviews, JAMA, Pediatrics, Sexual Health, Technology / 28.06.2019

MedicalResearch.com Interview with: texting, sextingCamille Mori, B.A. (hons) M.Sc. candidate Clinical Psychology Program Determinants of Child Development Lab University of Calgary  MedicalResearch.com: What is the background for this study? Response: Sexting, which is the sharing of sexual messages, images, or videos over technological devices, has recently become a cause for concern among parents, teachers, and policy makers. However, the research on sexting among youth is still in early stages, and evidence of the risks associated with sexting is inconsistent. One way to resolve discrepancies in the field is to conduct a meta-analysis, which statistically summarizes existing research. We conducted a meta-analysis in order to examine the association between sexting and sexual activity (having sex, multiple sexual partners, and lack of contraception use). The associations between sexting and mental health related variables, including delinquent behaviour, substance use, and depression/anxiety were also examined. (more…)
Author Interviews, Cancer Research, Genetic Research, Pediatrics / 24.06.2019

MedicalResearch.com Interview with: Philip J. Lupo, PhD, MPH Co-Director, Childhood Cancer Epidemiology and Prevention Program, Texas Children's Cancer Center Associate Professor, Department of Pediatrics Section of Hematology-Oncology, Member, Dan L. Duncan Comprehensive Cancer Center Baylor College of Medicine Adjunct Associate Professor, Human Genetics Center, Division of Epidemiology, Human Genetics and Environmental Sciences University of Texas School of Public Health   MedicalResearch.com: What is the background for this study?   Response: While cancer risk in children with certain chromosomal defects like Down syndrome is well established, much less is known for children with birth defects where there is no known genetic cause, sometimes called non-chromosomal defects. Non-chromosomal defects, as a group, affect more children, but one of the primary challenges of understanding risk among these children is that limited sample sizes make studying specific defects, like spina bifida, more difficult. Because of that, we gathered data from birth, birth defect, and cancer registries across Texas, Arkansas, Michigan, and North Carolina to generate a birth cohort of more than 10 million children born between 1992 and 2013. We looked at diagnoses of cancer until 18 years of age to determine differences in cancer risk between those with and without birth defects. (more…)
Amgen, Author Interviews, Cost of Health Care, JAMA, Lipids, UCLA / 24.06.2019

MedicalResearch.com Interview with: Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA  MedicalResearch.com: What is the background for this study? Response: Last year, Amgen made the PCSK-9 inhibitor evolocumab available at a reduced list price of $5,850 per year This 60% reduction was aimed at improving patient access by lowering patient copays, especially for Medicare beneficiaries. Additionally, the treatment landscape for PCSK9 inhibitors was further defined in 2018 when the American College of Cardiology/American Heart Association Multisociety Clinical Guideline on the Management of Blood Cholesterol recommended PCSK9 inhibitors for, among other patient populations, patients with very high-risk (VHR) ASCVD whose low-density lipoprotein cholesterol levels remain at 70 mg/dL or more  despite a heart-healthy lifestyle and treatment with standard background therapy. (more…)
Author Interviews, CDC, JAMA, Nutrition, Pediatrics, Weight Research / 24.06.2019

MedicalResearch.com Interview with: Liping Pan, MD, MPH Epidemiologist Division of Nutrition, Physical Activity, and Obesity National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? Response: Children with severe obesity face significant health and social challenges. Children with obesity are at higher risk for having other chronic health conditions and diseases, such as asthma, sleep apnea, bone and joint problems, and type 2 diabetes. They also have more risk factors for heart disease such as high blood pressure, impaired glucose tolerance, and high cholesterol than their healthyweight peers. Children with obesity can be bullied and teased more than their healthyweight peers. They are also more likely to suffer from social isolation, depression, and lower self-esteem. Children with obesity are also more likely to have obesity as adults. This can lead to lifelong physical and mental health problems. Adult obesity is associated with a higher risk of type 2 diabetes, heart disease, and many types of cancers.  Childhood obesity is more common among children from lower-income families, as many lack access to healthy, affordable foods and beverages and opportunities for low-cost physical activity. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pain Research / 21.06.2019

MedicalResearch.com Interview with: Changchuan (Charles) Jiang MD, MPH MSSLW Internal Medicine Residency Program Class of 2020 Ichan School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Chronic pain is one of the common side effects of cancer treatments and it has been linked to low life quality, lower adherence to treatment, higher medical cost. As the population of cancer survivors grows rapidly, chronic pain will be a major public health issue in this population. We know from previous studies that chronic pain is common in certain cancers such as breast cancer. However, little was known about the epidemiology of chronic pain in the cancer survivors until our study. (more…)
Author Interviews, CT Scanning, JAMA, Surgical Research, Technology / 21.06.2019

MedicalResearch.com Interview with: Christian Krautz, MD Department of Surgery, Universitätsklinikum Erlangen Friedrich-Alexander-Universität Erlangen Nürnberg Erlangen, Germany  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this preclinical study that included 720 case evaluations, visualization with Cinematic Rendering allowed a more correct and faster comprehension of the surgical anatomy compared to conventional CT imaging independent from the level of surgical experience. Therefore,Cinematic Rendering is a tool that may assist HPB surgeons with preoperative preparation and intraoperative guidance through an improved interpretation of computed tomography imaging data. (more…)
Author Interviews, HIV, USPSTF / 20.06.2019

MedicalResearch.com Interview with: John W. Epling, Jr., M.D., M.S.Ed Professor of Family and Community Medicine Virginia Tech Carilion School of Medicine Roanoke, VA USPSTF Task Force Member Medical Director of Employee Health and Wellness Carilion Clinic Dr. Epling maintains an active clinical primary care practice  MedicalResearch.com: What is the background for this study? Response: HIV continues to be a significant public health issue, with about 40,000 people diagnosed each year. The U.S. Preventive Services Task Force reviewed the most recent evidence on how primary care clinicians can best help prevent HIV and its devastating health consequences. We looked at the research on two different topics: screening for HIV, and pre-exposure prophylaxis—a medication that prevents HIV, commonly known as PrEP.  (more…)
Author Interviews, JAMA, Johns Hopkins, Kidney Disease, Surgical Research / 13.06.2019

MedicalResearch.com Interview with: Caitlin W. Hicks, M.D., M.S. Assistant Professor of Surgery Recipient of the Department of Surgery Rothman Early Career Development Award for Surgical Research Johns Hopkins Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Arteriovenous fistula are associated with better long-term patency, lower rates of infection, and lower long-term costs compared to arteriovenous graft. As a result, the Fistula First Catheter Last Guidelines recommend placement of an arteriovenous fistula over an AVG whenever possible. We looked at individual physician utilization of AVF vs AVG for first-time AV access in Medicare beneficiaries. We found that the median physician utilization rate for AVG was only 18%, but that 21% of physicians use AVG in more than 34% of cases, which is above currently recommended  practice guidelines.  (more…)
Author Interviews, JAMA, PTSD / 13.06.2019

MedicalResearch.com Interview with: Dr. Heike Gerger | Senior Postdoc University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy Basel | Switzerland MedicalResearch.com: What is the background for this study? Response: Posttraumatic stress disorder (PTSD) is one of the most prevalent mental disorders, with a high risk of chronicity, comorbidity, and functional impairment. PTSD is complicated to treat, and the debate on the most efficacious treatment approach is ongoing. Treatment guidelines for the treatment of PTSD typically recommend different types of trauma-focused psychotherapeutic treatments as first-line PTSD treatment. However, concerning pharmacological therapies recommendations are inconsistent. (more…)
Author Interviews, Cost of Health Care, Heart Disease, JAMA, University of Pennsylvania / 07.06.2019

MedicalResearch.com Interview with: Sameed Khatana, MD, MPH Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania  MedicalResearch.com: What is the background for this study?   Response: The Affordable Care Act (ACA) led to the largest increase in Medicaid coverage since the beginning of the program. However, a number of states decided not to expand eligibility. Studies of prior smaller expansions in Medicaid, such as in individual states, have suggested evidence of improved outcomes associated with Medicaid expansion. Additionally, studies of Medicaid expansion under the ACA of certain health measures such as access to preventive care and medication adherence have suggested some improvements as well. However, there have been no large, population-level studies to examine whether Medicaid expansion under the ACA led to changes in mortality rates. Given, a high burden of cardiovascular risk factors in the uninsured, we examined whether states that had expanded Medicaid had a change in cardiovascular mortality rates after expansion, compared to states that have not expanded Medicaid. (more…)
Accidents & Violence, Author Interviews, Cost of Health Care, JAMA, Surgical Research, University of Michigan / 05.06.2019

MedicalResearch.com Interview with: Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Traumatic injury has a tendency to be thought of as a disease that preferentially impacts younger people.  We wanted to explore the prevalence and impact of traumatic injury within the population of patients for whom Medicare is the third party payer.  (more…)
Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, JAMA / 02.06.2019

MedicalResearch.com Interview with: I-Min Lee, MD, ScD Professor of Medicine, Harvard Medical School Professor of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: While we have many studies showing that physical activity is beneficial for health, there are few data on steps and health, particularly long-term health outcomes.  An expert committee – the 2018 Physical Activity Guidelines Advisory Committee, which reviewed the scientific evidence to support the recently released Physical Activity Guidelines for Americans, 2nd edition – noted this (i.e., the relation between steps and health outcomes) to be a critical gap in knowledge, since many individuals are using wearables and monitoring their step counts. We often hear the number 10,000 steps cited as a daily goal, but the basis for this number is unclear. It likely originated as a marketing tool: in 1965, the Yamasa Clock and Instrument Company, Japan sold a pedometer called “Manpo-kei” – “ten thousand steps meter” in Japanese. For many older people, 10,000 steps/day can be a very daunting goal; thus, we wanted to investigate whether this was necessary for lower mortality rates in older women.  Additionally, steps taken can be fast or slow, and there are no published studies on step intensity and long-term health outcomes.  Note that walking pace and step intensity are not the same concept: walking pace gauges intensity when walking purposefully (e.g., for exercise or transportation), while step intensity assesses an overall best natural effort in our daily life. (more…)
Author Interviews, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: Bishal Gyawali  MD PhD
  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada
MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists. Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review. Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Lipids / 28.05.2019

MedicalResearch.com Interview with: Samia Mora, MD, MHS Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Preventive Medicine Boston, MA 02115  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk. To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy. (more…)
Author Interviews, Heart Disease, JAMA, NIH, Stroke / 27.05.2019

MedicalResearch.com Interview with: Lenore J. Launer, PhD. Chief Neuroepidemiology Section Intramural Research Program National Institute on Aging MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of cerebral infarction on MRI can be as high as 30% in community-based studies. These lesions detected on brain MRI, are often clinically silent, but are associated with impairments in cognitive and physical function and can increase the risk for clinical events. For a large number, the origin of these brain lesions is unknown. There is also a lack of population-based data on unrecognized myocardial infarction, which is associated with an increased for clinical coronary disease and mortality. Unrecognized MI was detected in 17% of participants using state-of-the-art cardia MRI, a more sensitive measure of the lesions, than the standard ECG. We investigated the contribution to these lesions of recognized and unrecognized myocardial infarction [MI] identified on cardiac MRI. We found both recognized and unrecognized myocardial infarction increased the risk for cerebral infarction, and that in particular unrecognized MI was associated with cerebral infarction of embolic origins of an unknown source. Given their prevalence, unrecognized MI may be an underestimated contributor to the risk for cerebral infarction in older persons.  (more…)