Author Interviews, Cannabis, Pharmacology, Tobacco Research / 08.03.2023

MedicalResearch.com Interview with: Philip Lazarus, PhD Boeing Distinguished Professor, Pharmaceutical Sciences Professor, Dept of Pharmaceutical Sciences College of Pharmacy and Pharmaceutical Sciences Washington State University Spokane, WA 99210   MedicalResearch.com: What is the background for this study? Response: Smoking and tobacco use remains a major health issue. Smokers use cigarette over the course of the day because the levels of nicotine, the addictive agent in cigarettes and other forms of tobacco, dimmish with time in the bloodstream due to the breakdown of nicotine by enzymes in the body. By inhibiting the breakdown of nicotine in smokers, one would expect that the levels of nicotine would remain higher after smoking a single cigarette, and that these individuals may not require lighting up another cigarette so quickly, reducing the number of cigarettes smoked over the course of a day. This could have a profound effect on reducing the overall harm incurred from smoking or from using other forms of tobacco. In a single previous study, smokers who used a CBD inhaler exhibited a 40% reduction in cigarette use. In addition, while cannabis users are often smokers, previous studies have indicated that they smoke less cigarettes than non-cannabis-using cigarette smokers. In previous studies published in 2021, we found that major cannabinoids present in cannabis like THC and CBD inhibit major metabolizing enzymes in our body, including several that are important in drug metabolism. We hypothesized that CBD and its major active metabolite, 7-hydroxy (OH)-CBD, may also be inhibiting one or more of the enzymes important in the metabolism (or breakdown) of nicotine. (more…)
Author Interviews, Diabetes, JCEM, Pharmacology / 28.01.2023

This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Contact a qualified medical professional before engaging in any physical activity, or making any changes to your diet, medication or lifestyle, MedicalResearch.com Interview with: Tingting Geng PhD Department of Nutrition and Food Hygiene Hubei Key Laboratory of Food Nutrition and Safety Ministry of Education Key Lab of Environment and Health State Key Laboratory of Environment Health (Incubating) School of Public Health, Tongji Medical College Huazhong University of Science and Technology Wuhan, China MedicalResearch.com: What is the background for this study? Response: Previous studies have suggested that proton pump inhibitors (PPIs) may lead to an increase in cardiovascular events due to the drug-drug interactions between PPIs and clopidogrel and gut microbiota dysbiosis. Patients with Type 2 Diabetes (T2D) are at more than three times higher prevalence of using PPIs, and two- to fourfold higher risk of developing cardiovascular complications and premature death than general populations. However, evidence regarding the influence of PPI use on subsequent risks of cardiovascular disease and mortality among patients with T2D is scarce. We conducted a prospective study using the UK Biobank study to examine the association of PPI use with risks of coronary artery disease, myocardial infarction, heart failure, stroke and mortality among patients with T2D. Using multivariable-adjusted Cox regression models and a propensity score-matched cohort, researchers found robust results that PPIs use was associated with a higher risk of coronary artery disease (adjusted HR=1.27), myocardial infarction (adjusted HR=1.34), heart failure (adjusted HR=1.35), and mortality (adjusted HR=1.30). (more…)
Pharmacology / 06.01.2023

Xanax (generic name is alprazolam) is a prescription medication commonly used to treat anxiety and panic disorders. It is important for those taking this or any other medication to understand how long the substance stays in their system, as this can affect the efficacy of the medication over time. Let’s take a look at how long Xanax typically remains in your system and what factors may influence its duration. The length of time that an individual's body takes to metabolize any drug depends on several different factors, such as age, weight, genetics, and overall health. Generally speaking, it takes between 4-6 hours for half of a dose of Xanax taken orally to leave the system. This means it could take up to 12 hours for the entire dose to be eliminated from your body. (more…)
Allergies, Annals Internal Medicine, Author Interviews, Pharmacology / 29.03.2022

MedicalResearch.com Interview with: Chintan V. Dave, PharmD, PhD Assistant Professor Ernest Mario School of Pharmacy Institute for Health, Health Care Policy and Aging Institute Rutgers University MedicalResearch.com:  What is the background for this study?  What are the main findings?  Response: The risks of anaphylaxis among intravenous (IV) iron products currently in use has not been assessed. Older adults have a higher risk of experiencing drug-induced anaphylaxis. Accordingly, our study objective was to elucidate the risk of anaphylaxis  among older adults receiving the five frequently used IV iron products: ferric carboxymaltose, ferumoxytol, ferric gluconate, iron dextran, and iron sucrose. (more…)
ADHD, Author Interviews, Cost of Health Care, Eating Disorders, Pharmacology / 09.01.2022

MedicalResearch.com Interview with: Sneha Vaddadi, BS Department of Medical Education Geisinger Commonwealth School of Medicine Scranton, Pennsylvania MedicalResearch.com: What is the background for this study? Response: The prescription stimulants methylphenidate, amphetamine, and lisdexamfetamine, classified as Schedule II substances, are sympathomimetic drugs with therapeutic use widely used in the US for Attention Deficit Hyperactivity Disorder. Changes in criteria for diagnosis of Attention Deficit Hyperactivity Disorder in 2013 and approval of lisdexamfetamine for binge eating disorder in 2015 may have impacted usage patterns. The goal of this study1 was to extend upon past research2 to compare the pharmacoepidemiology of these stimulants in the United States from 2010–2017, including consideration to variation within geographic regions, the Hispanic population, and the Medicaid population. (more…)
Author Interviews, Electronic Records, Pharmacology / 08.12.2021

MedicalResearch.com Interview with: Bernard Esquivel Zavala, MD, PhD, MHA GenXys Chief Medical Officer MedicalResearch.com: What is the mission of GenXys? Response: Our mission at GenXys is to tailor the right treatment for each individual patient at the right time. GenXys founders, including Professors Pieter Cullis and Martin Dawes, were heavily involved in the precision medicine field from the very beginning, and they noticed a functional gap between the expectations and the actual clinical implementation of precision medicine Particularly, when it came to, at the time, the new field of pharmacogenetics. Their solution was to provide a comprehensive, user-friendly platform that organizes all patient data relevant to prescribing to provide the safest and most appropriate personalized prescribing options. Simply put, GenXys’ solutions were made by clinicians, for clinicians. The GenXys software suite collects patient information and categorizes that information, including pharmacogenetic data, based on clinical relevance and runs it through advanced condition -based algorithms to provide real time accurate prescribing options. It makes my life as a clinician easier and safer and gives me the confidence that I am not practicing ‘trial and error’ prescribing. Ideally, every healthcare provider should be using a real time medication decision support solution like ours, and not just for pharmacogenetic test results. Pharmacogenomics is just one piece. In fact, our core product, TreatGx™ can run with or without pharmacogenomics. Let's say that you've run it without pharmacogenomics, meaning that you are using this tool to organize and rapidly identify how biophysical factors, liver function, kidney function, comorbidities, and drug-drug interactions may impact the medication you're about to prescribe to your patient. This functionality alone is incredibly helpful. In fact, the factors I just mentioned likely account for 95% of the reasons why a patient does not respond to a particular medication or might have an adverse drug reaction. But the TreatGx platform will also highlight when the evidence supports bringing pharmacogenomic information into the mix. The right approach is bringing all those relevant clinical, biochemical, and molecular factors closer to the provider which will ultimately foster personalization. We will start treating the individual instead of the disease(s). As with any new technology, there are barriers to precision prescribing. This includes educational and emotional barriers. It’s important to educate providers and keep them up to date to help them understand the power that precision prescribing can bring into their practice—and the limitations—to set the right level of expectation. The Human Genome Project was finished in 2000, and there was a lot of buzz about pharmacogenomics even back in 2003. The field got a lot of traction in 2015. So, everyone thought, "Oh, this is going to be groundbreaking and quite disruptive. From now on my prescription is going to be a hundred percent accurate and safe." But it's not quite the whole story. Pharmacogenomics has to be considered as another piece of the puzzle. It's like saying that by having an MRI, you're curing cancer. It's just another piece of the treatment puzzle. There are also emotional barriers, where ego can factor into a decision. It can be uncomfortable for a physician to say, "I don't know this. Let me check it out. Let me explore it further, review, and come back to you." It's easier to say if I don't know it, that it doesn't work or isn’t relevant, rather than exposing yourself. And so that, in terms of the emotional piece, I would say is a big component. We can tackle the emotional component that element by fostering education and bringing education closer to providers. (more…)
Alzheimer's - Dementia, Author Interviews, Memory, Pharmacology / 12.09.2019

MedicalResearch.com Interview with: James O’Donnell, PhD Dean and professor Pharmacy and Pharmaceutical Sciences University at Buffalo School of Pharmacy Ying Xu, MD, PhD Research associate professor University at Buffalo School of Pharmacy and Pharmaceutical SciencesYing Xu, MD, PhD Research associate professor University at Buffalo School of Pharmacy and Pharmaceutical Sciences     MedicalResearch.com: What is the background for this study? Response: We have been studying cyclic nucleotide phosphodiesterase (PDE), an enzyme, for quite a while as a potential target for neuropsychiatric disease.  One aspect involves the effects of PDE inhibitors on memory.  This was prompted by our earlier finding that one form of the enzyme, PDE4, is in the NMDA receptor signaling pathway in neurons; this pathway has been implicated in memory.  (more…)
Author Interviews, Pharmacology / 17.07.2019

MedicalResearch.com Interview with: Craig A. Pedersen, RPh, PhD, FAPhA Manager, Sterile Compounding and Investigational Drug Service, Pharmacy Clinical Professor University of Washington MedicalResearch.com: What is the background for this study? Response: The ASHP national survey of pharmacy practice in hospitals originated with the Mirror to Hospital pharmacy, the first comprehensive, national audit of pharmaceutical services in hospitals, published in 1964.  Since that time, ASHP has conducted national surveys to document practices and technologies for managing the improving the medication-use system and the role that pharmacist play in that effort.  Beginning in 1998, the national survey became an annual project by ASHP.  This survey provides important information to pharmacists, managers, and external stakeholders to document the current state of pharmacy practice. (more…)
Author Interviews, Melatonin, Pharmacology, Sleep Disorders / 23.06.2019

MedicalResearch.com Interview with: David C. Brodner, M.D. Founder and Principle Physician The Center for Sinus, Allergy, and Sleep Wellness Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine Assistant Clinical Professor Florida Atlantic University College of Medicine Medical Director, Good Samaritan Hospital Sleep Laboratory Senior Medical Advisor, Physician’s Seal, LLC® MedicalResearch.com: What is the background for this study? Response: Chronic disorders of sleep and wakefulness affect an estimated 50-70 million adults in the United States. The cumulative long-term effects of sleep loss have been associated with a wide range of damaging health consequences, including obesity, diabetes, impaired glucose tolerance, cardiovascular disease, hypertension, anxiety and depression. In terms of preventing health consequences, sleeping 6-8 hours per night consistently may provide optimal health outcomes. Comprehensive data from two recently completed patient-reported outcomes (PRO) studies provide further evidence of the observed hypnotic effects of REMfresh, demonstrating statistically significant improvements in sleep onset, sleep duration, sleep maintenance and sleep quality. PRO studies of this kind, which more closely address real-world patient experience, are increasingly being recognized by regulatory authorities and academia in evaluating new therapies. In addition to the traditional randomized, placebo-controlled trial studies, regulatory authorities are now incorporating the patient perspective in their decision making, including PRO studies. A PRO study is a measurement based on a report that comes directly from the patient about the status or change in their health condition and without amendment or interpretation of the patient's response by health-care intermediaries. PRO measures can be used to capture a patient's everyday experience outside of the clinician's office, and the effects of a treatment on the patient's activities of daily living. Together, clinical measures and PRO measures can provide a fuller picture of patient benefit. REMfresh, the first and only continuous release and absorption melatonin (CRA-melatonin) formulation, is designed to give patients up to 7 hours of sleep support. It is a clinically studied, drug-free, nonprescription, #1 sleep doctor-recommended melatonin sleep brand. (more…)
Author Interviews, Hepatitis - Liver Disease, JAMA, Kaiser Permanente, Pharmacology / 10.06.2019

MedicalResearch.com Interview with: Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue.  We found no evidence of increased risks of significant side effects associated with taking these drugs.  In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events:  death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia.  (more…)
Author Interviews, Gastrointestinal Disease, Heart Disease, Pharmacology / 31.05.2019

MedicalResearch.com Interview with: Ziyad Al-Aly, MD, FASN Assistant Professor of Medicine Director of the Clinical Epidemiology Center Chief of Research and Education Department of Veterans Affairs Health Care System Saint Louis  MedicalResearch.com: What is the background for this study?   Response: In 2017, we published a paper showing increased risk of death associated with Proton-pump inhibitors (PPI) use. Following the publication of that 2017 paper, several key stakeholders including patients, doctors, research scientists, medical media folks, mainstream media folks, and others asked us: what do these people die from? Did you study causes of death attributable to PPI use? In the study published today, we developed a causal inference framework to answer this question. (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, Heart Disease, Pharmacology / 14.05.2019

MedicalResearch.com Interview with: Sami Viskin MD Tel-Aviv Medical Cente Sackler School of Medicine Tel-Aviv University, Israel. MedicalResearch.com: What is the background for this study? What are the main findings?  Response: There are >200 medications with reported QT-prolonging risk. The majority of these medications do not even have cardiac indications, yet cause unintended QT-prolongation because they block IKr potassium channels in myocardial cells. With so many drugs, of such varied composition, blocking the IKr channel, it is reasonable to assume that food compounds also have IKr-channel-blocker properties, raising the possibility that proarrhythmic food exists. We tested the effects of grapefruit on the QT interval with the rigorous methodology used by the pharmaceutical industry to test new medications before they are released to the market. (more…)
ADHD, Author Interviews, JAMA, OBGYNE, Pediatrics, Pharmacology / 08.04.2019

MedicalResearch.com Interview with: Dr. Angela Lupattelli, PhD School of Pharmacy University of Oslo MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Between 1-4% of pregnant women take at least once a benzodiazepine and/or a z-hypnotic medication during the course of gestation. These medications are generally used intermittently in pregnancy, mainly for treatment of anxiety disorders and sleeping problems, which are not uncommon conditions among pregnant women. However, data regarding the safety of benzodiazepine and/or a z-hypnotic in pregnancy on child longer-term development are sparse. For instance, studies on child motor skills are only available up to toddler age, and little is known in relation to other child developmental domains. So, there is an urgent need to better understand whether prenatal use of benzodiazepine and/or a z-hypnotic medication may pose detrimental longer-term child risks. (more…)
Allergies, Author Interviews, Brigham & Women's - Harvard, Pharmacology / 23.03.2019

MedicalResearch.com Interview with: Daniel Reker, PhD Koch Institute for Integrative Cancer Research Massachusetts Institute of Technology MedicalResearch.com: What is the background for this study? Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios. We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Pharmacology, University of Pittsburgh / 01.03.2019

MedicalResearch.com Interview with: Alvaro San-Juan-Rodriguez, PharmD Pharmacoeconomics, Outcomes and Pharmacoanalytics Research Fellow Pharmacy and Therapeutics School of Pharmacy University of Pittsburgh MedicalResearch.com: What are the main findings? Response: Currently, there are 4 antidementia drugs approved by the FDA for the treatment of Alzheimer’s disease, including 3 acetylcholinesterase inhibitors (AChEIs)—donepezil, rivastigmine, and galantamine—and the N-methyl-D-aspartic receptor antagonist memantine. On the one hand, evidence about the effect of these drugs at delaying nursing home admission is still sparse and conflicting. On the other, all these antidementia medications have been associated with several cardiovascular side effects, such as bradycardia, ventricular tachycardia, syncope, QT interval prolongation, atrioventricular block or even myocardial infarction. In this study, we aimed to compare time to nursing home admission and time to cardiovascular side effects across all drug therapies available for the treatment of Alzheimer’s disease. In doing so, we used 2006-2014 medical and pharmacy claims data from Medicare Part D beneficiaries with a new diagnosis Alzheimer’s disease who initiated antidementia drug therapy. (more…)
Author Interviews, JAMA, Mental Health Research, Pharmacology / 01.03.2019

MedicalResearch.com Interview with: Kuan-Pin Su, MD, PhD China Medical University Taichung, Taiwan MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Delirium, also known as acute confusional state, is a serious disturbance in mental abilities that results in confused thinking and reduced awareness of the environment. Delirium can often be traced to one or more contributing factors, such as a severe or chronic illness, changes in metabolic balance (such as low sodium), medication, infection, surgery, or alcohol or drug intoxication or withdrawal. It’s critically important to identify and treat delirium because some of the contributing factors could be life-threatening. However, there is no sufficient evidence for choice of medication to treat or prevent the symptoms of delirium. A recent paper, Association of Delirium Response and Safety of Pharmacological Interventions for the Management and Prevention of Delirium A Network Meta-analysis, published in JAMA Psychiatry provides important findings of this missing piece in that important clinical uncertainty. The leading author, Professor Kuan-Pin Su, at the China Medical University in Taichung, Taiwan, concludes the main finding about treatment/prevention of delirium: “In this report, we found that the combination of haloperidol and lorazepam demonstrated the best option for treatment of delirium, while ramelteon for prevention against delirium.  (more…)
Author Interviews, Orthopedics, Pharmacology, Rheumatology / 28.02.2019

MedicalResearch.com Interview with: Dr. Andrew Spitzer MD Co-director Joint Replacement Program Cedars-Sinai Orthopedic Center Los Angeles, CA MedicalResearch.com: What is the background for this study? How does this product differ from other steroid injections for inflammatory arthritis? Dr. Spitzer: Many patients receive repeat injections of intra-articular corticosteroids to manage recurrent osteoarthritis pain and other symptoms. However, in most clinical trials to date, patients only received a single corticosteroid injection, and patients were only followed for 12 to 24 weeks after treatment. For trials that have evaluated repeated injections of corticosteroids over a longer period of time—2 years, for example—injections were administered every 3 months, regardless of the timing of the return of OA symptoms. This is not reflective of what is done in clinical practice, where corticosteroids are administered again in response to the return of pain or a flare of inflammation in the knee. In this study, we used a flexible dosing schedule based on the patients’ symptoms, meaning that patients received the second injection of a recently approved extended-release corticosteroid only when their pain and/or symptoms returned, not before. Safety was monitored for 52 weeks—this length of time should be sufficient to identify any associated side effects, including any potential impact on the knee tissue. Triamcinolone acetonide extended-release (TA-ER; Zilretta®) was approved in late 2017 as an intra-articular injection for the management of osteoarthritis pain of the knee. The formulation utilizes microspheres which enable a slow release of the active agent (triamcinolone acetonide) into the synovial fluid for 12 weeks following injection. Previously, a Phase 3 study demonstrated safety and efficacy of a single injection of TA-ER (Conaghan PG, et al. J Bone Joint Surg Am. 2018;100:666-77). This is the first study evaluating the safety and patient response to repeat administration of TA-ER. This study also included patients that were more typical of who we see in the clinic—those who have higher body mass index, more severe disease, and received prior treatments for their osteoarthritis pain. (more…)
Author Interviews, JAMA, Karolinski Institute, Pharmacology, Schizophrenia / 24.02.2019

MedicalResearch.com Interview with: Jari Tiihonen, MD, PhD Professor, Department of Clinical Neuroscience Karolinska Institutet Stockholm, Sweden  MedicalResearch.com: What is the background for this study? Response: The effectiveness of antipsychotic combination therapy in schizophrenia relapse prevention is controversial, and use of multiple agents is generally believed to impair physical well-being. But the evidence for this are weak and antipsychotic polypharmacy is widely used. (more…)
Author Interviews, Cost of Health Care, JAMA, Pharmacology / 21.02.2019

MedicalResearch.com Interview with: Jennifer N. Goldstein, MD, MSc Assistant  program Director of Internal Medicine Christiana Care Health System Newark, Delaware MedicalResearch.com: What is the background for this study? Response: Human synthetic insulins have been available over-the-counter for nearly a century, and at relatively low cost for around a decade under a Walmart brand name. However, little is known about  the frequency of sale of over-the-counter insulin or the reasons why patients use it. While prescription insulins (insulin analogues) are considered by many to be easier to use and more predictable than the over-the-counter versions, the cost of these insulins has skyrocketed. Our study examined the frequency of sale of over-the-counter insulins and whether patients potentially use over-the-counter insulin as a substitute for expensive prescription insulins. (more…)
Author Interviews, Cost of Health Care, JAMA, Pharmacology, University of Pittsburgh / 19.02.2019

MedicalResearch.com Interview with: Alvaro San-Juan-Rodriguez, PharmD Pharmacoeconomics, Outcomes and Pharmacoanalytics Research Fellow Pharmacy and Therapeutics School of Pharmacy University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: Before 2009, etanercept (Enbrel®), infliximab (Remicade®), and adalimumab (Humira®) were the only tumor necrosis factor (TNF) inhibitors approved by the FDA for rheumatoid arthritis. Subsequently, 3 therapies gained FDA approval: subcutaneous golimumab (Simponi®) in April 2009, certolizumab pegol (Cimzia®) in May 2009, and intravenous golimumab (Simponi Aria®) in July 2013. All 6 agents are brand-name drugs. Our study aimed to evaluate how the prices of existing TNF inhibitors (Enbrel®, Remicade® and Humira®) changed in response to the market entry of new TNF inhibitors.  (more…)
Author Interviews, Pharmacology / 08.02.2019

MedicalResearch.com Interview with: Dr. Su Golder, PhD Department of Health Sciences University of York MedicalResearch.com: What is the background for this study? What are the main findings? Response:  Patients and providers need to know about the relative benefits and harms of an intervention. It is not just those adverse events deemed to be serious that are important but also those categorized as minor. Systematic reviews are summaries of the evidence, often used in to inform guidelines and decision-making. It is common for systematic reviews to focus on the potential benefits of an intervention without addressing the adverse effects. This leads to bias and an incomplete picture of the evidence. To aid transparency in systematic reviews, authors should published a protocol, describing what they intend to do. We look at protocols with a completed systematic review published in 2017 or 2018. We found that only 38% said that they would record adverse effects. Equally worrying of those authors that stated in their protocol that they intended to look at adverse effects – only 65% fully reported the adverse outcome exactly as they set out to do.  (more…)
Annals Internal Medicine, Author Interviews, Lipids, Pharmacology / 04.12.2018

MedicalResearch.com Interview with: Prof. Dr. Milo Puhan Epidemiology, Biostatistics and Prevention Institute University of Zurich MedicalResearch.com: What is the background for this study? What are the main findings? Response: The use of statins for primary cardiovascular prevention is controversial and there is a debate at what risks statins provide more benefits than harms. Current guidelines recommend statins if the 10 year risk for cardiovascular events is above 7.5 to 10% and they do not distinguish between men and women, different age groups and different statins. We found in our study that the benefits of statins exceeds the harms if the 10 year risk for cardiovascular events is above 14% for middle aged mean (40-44 years) but even higher for older age groups, and women. In addition, the benefit harm balance varies substantially between different statins with atorvastatin providing the best benefit harm balance. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 26.11.2018

MedicalResearch.com Interview with: Abiy Agiro, PHD HealthCore Inc Wilmington, Delaware  MedicalResearch.com: What is the background for this study? Response: Biosimilar approval pathway, authorized in 2010 by the Biologics Price Competition and Innovation Act as part of the Affordable Care Act, aims to increase adoption of biosimilar products and generate significant cost savings to payers and patients alike. Biosimilar filgrastim, used to prevent febrile neutropenia, is one of the first biosimilars to be approved in the United States. A large scale, post-approval real-world analysis was needed that compares biosimilar filgrastim to the original drug for safety and efficacy. (more…)
Alzheimer's - Dementia, Author Interviews, CMAJ, Pharmacology / 26.11.2018

MedicalResearch.com Interview with: Jennifer Watt, PhD Clinical Epidemiology and Health Care Research Institute of Health Policy, Management, and Evaluation University of Toronto MedicalResearch.com: What is the background for this study?   Response: Behavioral and psychological symptoms of dementia (e.g. aggression, agitation) are common among persons living with dementia. Pharmacological (e.g. antipsychotics) and non-pharmacological (e.g. reminiscence therapy) interventions are often used to alleviate these symptoms. However, antipsychotics are associated with significant harm among older adults with dementia (e.g. death, stroke). Regulatory agencies such as the Food and Drug Administration (FDA) and Health Canada issued black box warnings to advise patients and clinicians of this potential for harm. And initiatives were championed to decrease the use of antipsychotics in persons living with dementia. In response, we have seen a rise in the use of other pharmacological interventions, such as trazodone (an antidepressant). Its potential to cause harm in older adults with dementia is largely unknown. (more…)
Author Interviews, JAMA, Opiods, Pharmacology / 14.11.2018

MedicalResearch.com Interview with: Talia Puzantian,  PharmD, BCPP Associate Professor of Clinical Sciences, School of Pharmacy and Health Sciences Keck Graduate Institute   MedicalResearch.com: What is the background for this study? Response: Naloxone has been used in hospitals and emergency rooms since the early 1970s. Distribution to laypersons began in the mid-1990s with harm reduction programs such as clean needle exchange programs providing it, along with education, to mostly heroin users. In the years between 1996-2014, 152,000 naloxone kits were distributed in this way with more than 26,000 overdoses reversed (https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6423a2.htm). We have data showing that counties in which there was greater naloxone distribution among laypeople, there were lower opioid death rates (Walley AY et al BMJ 2013). However, not all opioid users at risk for overdose will interface with harm reduction programs, particularly prescription opioid users, hence more recent efforts to increase access to laypersons through pharmacists. Naloxone access laws have been enacted in all 50 states but very little has been published about how they’ve been adopted by pharmacists thus far. One small study (264 pharmacies) from Indiana (Meyerson BE et al Drug Alcohol Depend 2018) showed that 58.1% of pharmacies stocked naloxone, only 23.6% provided it without prescription, and that large chain pharmacies were more likely to do so. (more…)
Author Interviews, Geriatrics, JAMA, Pharmacology / 14.11.2018

MedicalResearch.com Interview with: Cara Tannenbaum, MD, MSc Director | Directrice Canadian Deprescribing NetworkCara Tannenbaum, MD, MSc Director | Directrice Canadian Deprescribing Network MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The D-Prescribe trial was driven by the need to show that seniors can cut down on their medication in a safe and effective manner. Pharmacists intervened in a proactive way to flag patients who were on potentially risky meds such as sleeping pills, NSAIDs and glyburide and to inform them of the risks, using an educational brochure. Pharmacists also communicated with their physician using an evidence-based pharmaceutical opinion to spark conversations about deprescribing. As a result, 43% of patients succeeded in discontinuing at least one medication over the next 6 months.   (more…)
Author Interviews, Pharmacology, Schizophrenia / 31.10.2018

MedicalResearch.com Interview with: Jelena Kunovac, M.D., M.S. Founder and Chief Executive Chief Medical Officer Altea Research Las Vegas, Nevada MedicalResearch.com: What is the background for this study? Response: We conducted the study to confirm that the addition of samidorphan to olanzapine does not have an effect on the antipsychotic efficacy of olanzapine in subjects with an acute exacerbation of schizophrenia. (more…)
Author Interviews, Kidney Disease, Mineral Metabolism, Pharmacology / 29.10.2018

MedicalResearch.com Interview with: Dr Mattias Ivarsson PhD CEO, Inositec, co-author of data MedicalResearch.com: What is the background for this study? Response: When control of factors in the blood that regulate mineral balance in the body is lost, the subsequent build-up of calcium deposits in the arterial walls and cardiac valves lead to an increase in cardiac events, particularly in patients with chronic kidney disease or diabetes, as well as all-cause mortality. There is a significant unmet need for therapeutic agents capable of reducing pathological mineral accumulation regardless of their root cause. To date, there is no approved therapy for treating calcification-dependent cardiovascular disease.  (more…)