Grapefruit Juice Can Cause an EKG Change, Prolonged Q-T Interval, Aggravated by Some Medications

Posted on May 14, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Electrocardiogram showing QT interval calculated by tangent method – Wikipedia image

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.

Continue reading →

Is There a Link Between Benzodiazepines During Pregnancy and Childhood ADHD?

Posted on April 8, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Lupattelli

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. Continue reading →

Some ‘Inactive’ Pill Ingredients Can Trigger Allergic Reactions

Posted on March 23, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Reker

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.

Continue reading →

Alzheimer Disease Medications: Progression to Nursing Home & Cardiac Side Effects

Posted on March 1, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Alvaro San-Juan-Rodriguez

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. Continue reading →

Delirium: Treatment Options and Prevention Measures

Posted on March 1, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Kuan-Pin Su

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. Continue reading →

Injectable Zilretta for Knee Osteoarthritis

Posted on February 28, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Spitzer

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.

Continue reading →

Not All Polypharmacy for Schizophrenia is Bad

Posted on February 24, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Tiihonen

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.

Continue reading →

Some Patients Purchasing Over-the-Counter Insulins Due to High Prescription Costs

Posted on February 21, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Goldstein

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.

Continue reading →

Price of Existing Biologics Increased When New Drugs Entered Market

Posted on February 19, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Alvaro San-Juan-Rodriguez

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. Continue reading →

Systematic Reviews May Not Address Adverse Side Effects

Posted on February 8, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Golder

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. Continue reading →

Age, Gender and Drug Should Factor Into Statin Recommendation

Posted on December 4, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Prof. Puhan

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.

Continue reading →

Use of Biosimilar Growth Factor Increases in Supportive Cancer Care

Posted on November 26, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Agiro

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.

Continue reading →

Aggression in Dementia: Alternatives to Antipsychotics Also Have Side Effects

Posted on November 26, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Watt

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. Continue reading →

Not All Pharmacies Have Naloxone for Opioid Overdose in Stock

Posted on November 14, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Puzantian

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.

Continue reading →

D-PRESCRIBE: Pharmacist-Led Intervention Can Reduce Inappropriate Medications in Older Adults

Posted on November 14, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:
Cara 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.
Continue reading →

Phase 3 Study of Novel, Once-Daily, Antipsychotic Drug Candidate for Schizophrenia

Posted on October 31, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Kunovac

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.

Continue reading →

New Drug Class Offers Hope for Calcified Blood Vessels

Posted on October 29, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Ivarsson

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. Continue reading →

New Point-of-Care Troponin Assay Can Rapidly Rule Out Heart Attack

Posted on October 20, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Prof. Pickering

Dr John W Pickering, BSc(Hons), PhD, BA(Hons)
Associate Professor , Senior Research Fellow in Acute Care
Emergency Care Foundation, Canterbury Medical Research Foundation, Canterbury District Health Board | Christchurch Hospital
Research Associate Professor | Department of Medicine
University of Otago Christchurch

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

Response: The assessment of patients with suspected myocardial infarction is one of the most common tasks in the emergency department. Most patients assessed (80 to 98% depending on the health system) are ultimate not diagnosed with an MI. High-sensitivity troponin assays have been shown to have sufficient precision at low concentrations to allow very early rule-out of myocardial infarction. However, these are lab-based assays which typically result in a delay from blood sampling before the result is available and the physician is able to return to a patient to make a decision to release the patient or undertake further investigation. Point-of-care assays provide results much quicker, but have to-date not had the analytical characteristics that allow precise measurements at low concentrations.

In this pilot study we demonstrated that a single measurement with a new point-of-care assay (TnI-Nx; Abbott Point of Care) which can measure low troponin concentrations, could safely be used to rule-out myocardial infarction a large proportion of patients (57%). The performance was at least comparable to the high-sensitivity troponin I assay, if not a little better (44%).

Continue reading →

Most Older Americans Willing To Discuss ‘De-Prescribing’ Some Medications

Posted on October 17, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Reeve

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. Continue reading →

Abbott’s ID NOW Can Confirm Flu Infection in 13 Minutes or Less

Posted on October 8, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Abbott’s molecular point-of-care flu test, ID NOW

Dr. Norman Moore PhD
Abbott’s Director of Scientific Affairs for Infectious Diseases

MedicalResearch.com: What is the background for this test? How does ID NOW differ from other tests for influenza?

Response: This test was developed to give providers – and their patients – lab-accurate results more quickly than ever, right at the point of care. It was designed for ease of use, as well as to be portable and small enough that it can be used in a broad range of healthcare settings, including walk-in clinics, urgent care centers, doctors’ offices and emergency rooms.

Prior to ID NOW, traditional molecular tests offered great performance, but took too long to impact treatment decisions. ID NOW is able to deliver the performance and accuracy of lab-based tests in a timeframe that offers the best chance of improving treatment decisions. Continue reading →

Errors in Dementia Drugs Surprising Common in Parkinson’s Disease

Posted on October 4, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Willis

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.
Continue reading →

Triple Low Dose Combination Pill May Lower Blood Pressure With Fewer Side Effects

Posted on August 17, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Webster

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.

Continue reading →

Benzodiazepines Linked to Modest Increased Risk of Alzheimer’s

Posted on August 16, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:
Vesa 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. Continue reading →

LUCEMYRA (Lofexidine) Now Available to Reduce Opioid Withdrawal Symptoms

Posted on August 6, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Mark Pirner

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.

Continue reading →

Lupus: Phase 2 Trial of Baricitinib Improved Signs and Symptoms

Posted on July 26, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Wallace

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.

Continue reading →

Diabetes: Switching to Sulfonylureas from Metformin Linked to Increased Side Effects

Posted on July 19, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Suissa

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. Continue reading →

Study Finds Serotonin Boosts Neural Plasticity By Speeding Up Rate of Learning

Posted on June 28, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Iigaya

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.

Continue reading →

Common Diuretic HCTZ Associated With Increase Risk of Skin Cancers

Posted on June 28, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

“Hydrochlorothiazide (HCTZ or HCT) is a diuretic medication often used to treat high blood pressure and swelling due to fluid build up” – Wikipedia

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.

Continue reading →

Can Opioid Users Be Transitioned To Extended-Release Naltrexone?

Posted on April 30, 2018 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Sullivan

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.

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DPP-4 inhibitor Class of Diabetes Medications Linked To Increase Risk of Inflammatory Bowel Disease

Posted on March 22, 2018 by Marie Benz MD FAAD

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. Continue reading →

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DPP-4 inhibitor Class of Diabetes Medications Linked To Increase Risk of Inflammatory Bowel Disease