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…)
Author Interviews, Geriatrics, JAMA, Pharmacology / 17.10.2018

MedicalResearch.com Interview with: Dr. Emily Reeve BPharm(Hons) PhD NHMRC-ARC Dementia Research Fellow Northern Clinical School University of Sydney MedicalResearch.com: What is the background for this study? What are the main findings? Response: Older adults commonly take multiple medications. All medications carry the potential for both benefit and harm. When a medication is started a decision has been made between the healthcare professional and the patient that the likely benefits outweigh the potential risks. But over time the potential benefits and harms can change. So, part of good clinical care is discontinuation of medications when the benefit no longer outweighs the risks – for example when it is no longer needed or high risk. This is called “deprescribing”. Previously we knew that older adults could have mixed feelings about their medications, that is, they believe that all their medications are necessary but also feel that they are a burden to them. Qualitative research has explored this further, finding that there are a number of barriers and enablers to deprescribing from the patient perspective. For example, someone might have fear of deprescribing because they are worried that their symptoms may come back. But if they know that deprescribing is a trial and they will be monitored and supported by their physician or other healthcare professional they might be more open to deprescribing. From the physician perspective, there were concerns that older adults and their families were resistant to deprescribing and so there was fear that discussing possible medication discontinuation could damage the doctor-patient relationship. In this study of almost 2000 older adults in the United States, we found that over 90% were willing to stop one of more of their medications if their doctor said it was possible. Additionally, one third of participants wanted to reduce the number of medications that they were taking.  (more…)
Author Interviews, JAMA, Neurology, Outcomes & Safety, Parkinson's, Pharmacology, University of Pennsylvania / 04.10.2018

MedicalResearch.com Interview with: Allison W. Willis, MD, MS Assistant Professor of Neurology Assistant Professor of Biostatistics and Epidemiology Senior Fellow, Leonard Davis Institute Senior Scholar, Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study was motivated by my own experiences as a neurologist-neuroscientist. I care for Parkinson disease patients, and over the year, have had numerous instances in which a person was taking a medication that could interact with their Parkinson disease medications, or could worsen their PD symptoms. (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA, Pharmacology / 17.08.2018

MedicalResearch.com Interview with: Dr Ruth Webster PhD, BMedSc(hons), MBBS(hons), MIPH(hons) Head, Research Programs, Office of the Chief Scientist Senior Lecturer, Faculty of Medicine UNSW Sydney The George Institute for Global Health Australia MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We know from previous research that 80% of the blood pressure lowering efficacy of any medication occurs in the first half of the dose whilst most side effects occur at higher doses. We also know that most people will require at least 2 blood pressure lowering medications to reach their target blood pressure and that combining multiple pills into one combination medication helps patients take their medication more reliably. There was therefore good evidence to believe that using three half strength doses in one pill would be better than usual care in helping patients to achieve their blood pressure targets. We showed that, compared with patients receiving usual care, a significantly higher proportion of patients receiving the Triple Pill achieved their target blood pressure of 140/90 or less (with lower targets of 130/80 for patients with diabetes or chronic kidney disease). It's estimated more than a billion people globally suffer from high blood pressure with the vast majority having poorly controlled blood pressure. Our results could help millions of people globally reduce their blood pressure and reduce their risk of heart attack or stroke. (more…)
Alzheimer's - Dementia, Author Interviews, Pharmacology / 16.08.2018

MedicalResearch.com Interview with: MedicalResearch.comVesa Tapiainen, MD School of Pharmacy, University of Eastern Finland Research Centre for Comparative Effectiveness and Patient Safety University of Eastern Finland Kuopio, Finland  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alzheimer’s disease is a non-curable dementing disease and a major health concern and thus, identification of potential modifiable risk factors, such as benzodiazepines, is important. Benzodiazepines and related drugs are commonly used among older people as every fourth older people use them. Benzodiazepines and related drugs were associated with modestly increased risk of Alzheimer’s disease. A dose-response relationship was observed with higher cumulative dose and longer use periods being associated with higher risk of Alzheimer’s disease. The risk associated with larger cumulative doses was partly explained by more common use of other psychotropics among these persons.  (more…)
Addiction, Author Interviews, Opiods, Pharmacology / 06.08.2018

MedicalResearch.com Interview with: Mark Pirner, MD, PhD Senior Medical Director Clinical Research and Medical Affairs US WorldMeds MedicalResearch.com: What is the background for this announcement? How does lofexidine differ from other opioid withdrawal medications? Response: LUCEMYRA™ (lofexidine) was FDA-approved on May 16 as the first and only non-opioid, non-addictive medication for the management of opioid withdrawal in adults. LUCEMYRA mitigates the acute and painful symptoms of opioid withdrawal by suppressing the neurochemical surge in the brain that occurs when opioids are abruptly discontinued. In clinical studies, patients receiving treatment with LUCEMYRA experienced greater symptom relief and were significantly more likely to complete their withdrawal. LUCEMYRA is not an opioid drug and is not a treatment for opioid use disorder; it should be used as part of a longer-term treatment plan. (more…)
Author Interviews, Eli Lilly, Lancet, Pharmacology, Rheumatology, UCLA / 26.07.2018

MedicalResearch.com Interview with: Daniel J. Wallace M.D., FACP, MACR Associate Director, Rheumatology Fellowship Program Board of Governors, Cedars-Sinai Medical Center Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA In affiliation with Attune Health Beverly Hills, Ca 90211 MedicalResearch.com: What is the background for this study? What are the main findings?   Response: This is the first positive study of systemic lupus erythematosus (SLE) using baricitinib,  a small oral molecule that blocks the JAK system. The human kinome consists of 500 genes and helps regulate cell surface receptor interaction. While agents that inhibit certain pathways are approved for rheumatoid arthritis and certain malignancies, this is the first study of its kind in SLE. (more…)
Author Interviews, BMJ, Boehringer Ingelheim, McGill, Pharmacology / 19.07.2018

MedicalResearch.com Interview with: Samy Suissa, PhD Director, Centre for Clinical Epidemiology, Lady Davis Institute Professor, Departments of Epidemiology and Biostatistics and of Medicine McGill University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sulfonylureas are widely used oral antidiabetic drugs that are recommended as second-line treatments after first-line metformin to treat patients with type 2 diabetes. While their safety has been studied extensively, studies in patients with poorly controlled diabetes in need of pharmacotherapy escalation have been sparse and limited. Our study evaluated whether adding or switching to sulfonylureas after initiating metformin treatment is associated with increased cardiovascular or hypoglycaemic risks, compared with remaining on metformin monotherapy. Using a large cohort of over 77,000 patients initiating treatment with metformin monotherapy, we found that adding or switching to sulfonylureas is associated with modest increases of 26% in the risk of myocardial infarction and 28% in the risk of death, as well as an over 7-fold major increase in the risk of severe hypoglycaemia leading to hospitalisation. In particular, we found that switching from metformin to sulfonylureas was associated with higher risks of myocardial infarction and death, compared with adding sulfonylureas to metformin.  (more…)
Author Interviews, Education, Mental Health Research, Pharmacology / 28.06.2018

MedicalResearch.com Interview with: Kiyohito Iigaya PhD Gatsby Computational Neuroscience Unit and Max Planck UCL Centre for Computational Psychiatry and Ageing Research University College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Serotonin (5-HT) is believed to play many important roles in cognitive processing, and past experiments have not crisply parsed them. We developed a novel computational model of mice behavior that follows reinforcement learning principles, which are widely used in machine learning and AI research. By applying this model to experimental data, we found that optogenetic 5-HT stimulation speeds up the learning rate in mice, but the effect was only apparent on select subset of choices. (more…)
Author Interviews, Dermatology, Environmental Risks, Pharmacology / 28.06.2018

MedicalResearch.com Interview with: Sidsel Arnspang Pedersen MD Department of Public Health, Clinical Pharmacology and Pharmacy Anton Pottegård PhD Associate professor, Clinical Pharmacy Odense University Hospital University of Southern Denmark, The following is based on results from three published papers in JAAD and JAMA Internal Medicine. (1–3)   MedicalResearch.com: What is the background for this study? Response: Hydrochlorothiazide is one of the most frequently used diuretic and antihypertensive drugs in the United States and Western Europe. The drug is known to be photosensitizing and has previously been linked to lip cancer.4–6 Based on these previous findings, the International Agency for Research on Cancer (IARC) has classified hydrochlorothiazide as ‘possibly carcinogenic to humans’ (class 2B). This prompted us to investigate whether use of hydrochlorothiazide was associated to other UV dependent skin cancers, including non-melanoma skin cancer (i.e. basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)), cutaneous melanoma, as well as the more rare non-melanoma skin cancers Merkel cell carcinoma and malignant adnexal skin tumours. (more…)
Addiction, Author Interviews, Opiods, Pharmacology / 30.04.2018

MedicalResearch.com Interview with: Maria Sullivan, M.D., Ph.D Senior Medical Director of Clinical Research and Development Alkermes MedicalResearch.com: What is the background for this study? Response: Extended release injectable naltrexone is approved for the prevention of relapse to opioid dependence after detoxification and when used with counseling. It is recommended that patients abstain from opioids for a minimum of seven to 10 days prior to induction onto XR-naltrexone to avoid precipitating opioid withdrawal. This requirement of detoxification represents a substantial clinical challenge, particularly in the outpatient setting. There is currently no single recognized best method for opioid detoxification prior to first dose of extended-release naltrexone (XR-naltrexone). A number of induction regimens have been explored, including the use of low doses of oral naltrexone to shorten the transition period from dependence on opioids to XR-naltrexone treatment. The goal of the study was to help establish an outpatient regimen to transition subjects from physiological opioid dependence to XR-naltrexone treatment and mitigate the severity of opioid withdrawal symptoms. We hypothesized that low-dose oral naltrexone, combined with buprenorphine and psychoeducational counseling, would assist with the transition of patients with opioid use disorder onto XR-naltrexone. In this 3-arm trial, we examined the utility of oral naltrexone, buprenorphine, and a fixed regimen of ancillary medications (oral naltrexone + buprenorphine vs. oral naltrexone + placebo buprenorphine vs. placebo +placebo), to determine whether any of these regimens was associated with higher rates of induction onto XR-naltrexone. (more…)
Author Interviews, Diabetes, Gastrointestinal Disease, Pharmacology / 22.03.2018

MedicalResearch.com Interview with: Devin Abrahami, graduate student Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal Department of Epidemiology, Biostatistics, and Occupational Health McGill University, Montreal, QC, Canada MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The goal of our study was to assess whether a class of antidiabetic drugs, the dipeptidyl peptidase-4 (DPP-4) inhibitors, is associated with the risk of inflammatory bowel disease (IBD). While these drugs control blood sugar levels in patients with type 2 diabetes, there is some evidence that they may also be involved in immune function, and possibly in conditions such as IBD. In our study, we found that the use of DPP-4 inhibitors was associated with a 75% increased risk of IBD, with the highest risk observed after three to four years of use. (more…)
Author Interviews, Pharmacology, Schizophrenia / 04.02.2018

MedicalResearch.com Interview with: Hsien-Yuan Lane, MD,PhD Distinguished Professor, Director, Graduate Institute of Biomedical Sciences China Medical University, Taichung, Taiwan Director, Brain Diseases Research Center (BDRC), Addiction Research Center, and Department of Psychiatry, China Medical University and Hospital, Taichung, Taiwan PI, Taiwan Clinical Trial Consortium for Mental Disorders  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Schizophrenia is a chronic and severe mental illness affecting more than 21 million people worldwide. Clozapine has been regarded as the last-line antipsychotic agent for patients with refractory schizophrenia. However, an estimated 40–70% of patients with refractory schizophrenia fail to improve even with clozapine , referred to as “clozapine-resistant”. To date, there is no convincing evidence for augmentation on clozapine. Activation of N-methyl-D-aspartate (NMDA) receptors, including inhibition of D-amino acid oxidase (DAAO) that may metabolize D-amino acids, has been reported to be beneficial for patients receiving antipsychotics other than clozapine. Sodium benzoate is a DAAO inhibitor. A recent randomized, double-blind, placebo-controlled clinical trial found that add-on sodium benzoate improved the clinical symptoms in patients with clozapine-resistant schizophrenia, possibly through DAAO inhibition and antioxidation as well. (more…)
Author Interviews, Pharmacology / 26.01.2018

MedicalResearch.com Interview with: “#Headache situation #ibuprofen” by Khairil Zhafri is licensed under CC BY 2.0David Kaufman, ScD Director, Slone Epidemiology Center, Boston Universit Professor of Epidemiolog Boston University School of Public Health  MedicalResearch.com: What is the background for this study?   Response: Ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most-used medicines in the US, but, if too much is taken, can cause harm. This was an internet-based diary study.  1326 individuals who reported taking an ibuprofen medication in the preceding month completed a daily diary of their NSAID use for one week.  The daily dosage ingested was computed from the diary, which allowed us to determine whether a user exceed the recommended daily maximum dose. (more…)
Author Interviews, Parkinson's, Pharmacology / 14.12.2017

MedicalResearch.com Interview with: Dr. Youcef Mehellou PhD Lecturer in Medicinal Chemistry Cardiff School of Pharmacy and Pharmaceutical Sciences Cardiff University MedicalResearch.com: What is the background for this study? Response: Over the last decade or two, there has been many reports linking genetic mutations to the pathogenesis of Parkinson’s disease (PD). Among the proteins that have been found to be mutated in PD is a protein called PINK1. Indeed, PINK1 mutations that disturb its function in cells were found to be causal of PD in humans. Subsequent studies showed that PINK1 is a major player in maintaining healthy neurons. This is because it is one of the components involved in controlling the quality of the mitochondria, an organelle within the cell, and it does this by triggering the disposal of unhealthy mitochondria. Overall, studies into PINK1 indicated that the activation of PINK1 as a plausible strategy for maintaining health neurons and hence slowing down the development and progress of Parkinson’s disease. (more…)