Pharmacists Increasingly Managing Medication Therapy

MedicalResearch.com Interview with:

Craig A. Pedersen, RPh, PhD, FAPhA Manager, Sterile Compounding and Investigational Drug Service, Pharmacy Clinical Professor University of Washington

Dr. Pedersen

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. Continue reading

REMfresh Study of Continuous Release Melatonin Demonstrated Improved Sleep Duration and Quality

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®

Dr. Brodner

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.

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Hepatitis C Treatment: Study Finds No Liver, Kidney or Cardiovascular Adverse Effects

MedicalResearch.com Interview with:

Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety 

Dr. McGlynn

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.  Continue reading

Proton-pump inhibitors (PPIs) Linked to Increased Risk of Death

MedicalResearch.com Interview with:

Ziyad Al-Aly, MD, FASNAssistant Professor of MedicineDirector of the Clinical Epidemiology CenterChief of Research and EducationDepartment of Veterans Affairs Health Care SystemSaint Louis

Dr. Ziyad Al-Aly

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.

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Only 1 in 5 Cancer Drugs Receiving FDA Accelerated Approval Have Proven Benefits in Confirmatory Trials

MedicalResearch.com Interview with:

Bishal Gyawali  MD PhD Med Onc. Asst. Professor 

Dr. Gyawali

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.  Continue reading

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

MedicalResearch.com Interview with:

Electrocardiogram showing QT interval calculated by tangent method Wikipedia image

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.

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

MedicalResearch.com Interview with:

Dr. Angela Lupattelli, PhDSchool of PharmacyUniversity of Oslo

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

MedicalResearch.com Interview with:

Daniel Reker, PhDKoch Institute for Integrative Cancer ResearchMassachusetts Institute of Technology

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.

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

MedicalResearch.com Interview with:

Alvaro San-Juan-Rodriguez

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

MedicalResearch.com Interview with:

Kuan-Pin Su, MD, PhDChina Medical UniversityTaichung, Taiwan

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

MedicalResearch.com Interview with:

Dr. Andrew Spitzer MDCo-director Joint Replacement ProgramCedars-Sinai Orthopedic CenterLos Angeles, CA

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

MedicalResearch.com Interview with:

Jari Tiihonen, MD, PhD Professor, Department of Clinical Neuroscience Karolinska Institutet Stockholm, Sweden

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.

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

MedicalResearch.com Interview with:

Jennifer N. Goldstein, MD, MSc Assistant  program Director of Internal Medicine Christiana Care Health System Newark, Delaware

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.

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Price of Existing Biologics Increased When New Drugs Entered Market

MedicalResearch.com Interview with:

Alvaro San-Juan-Rodriguez

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

MedicalResearch.com Interview with:

Dr Su Golder, PhD Department of Health Sciences University of York

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

MedicalResearch.com Interview with:

Prof. Dr. Milo Puhan Epidemiology, Biostatistics and Prevention Institute University of Zurich

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.

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Use of Biosimilar Growth Factor Increases in Supportive Cancer Care

MedicalResearch.com Interview with:

Abiy Agiro, PHD HealthCore Inc Wilmington, Delaware

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.

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Aggression in Dementia: Alternatives to Antipsychotics Also Have Side Effects

MedicalResearch.com Interview with:

Jennifer Watt, PhD Clinical Epidemiology and Health Care Research Institute of Health Policy, Management, and Evaluation University of Toronto

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

MedicalResearch.com Interview with:

Talia Puzantian,  PharmD, BCPP Associate Professor of Clinical Sciences,  School of Pharmacy and Health Sciences Keck Graduate Institute 

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.

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

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.
  Continue reading

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

MedicalResearch.com Interview with:

Jelena Kunovac, M.D., M.S. Founder and Chief Executive Chief Medical Officer Altea Research Las Vegas, Nevada

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.

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New Drug Class Offers Hope for Calcified Blood Vessels

MedicalResearch.com Interview with:

Dr Mattias Ivarsson PhD CEO, Inositec, co-author of data  

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

MedicalResearch.com Interview with:

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

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%).

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

MedicalResearch.com Interview with:

Dr. Emily Reeve BPharm(Hons) PhD NHMRC-ARC Dementia Research Fellow Northern Clinical School University of Sydney

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

MedicalResearch.com Interview with:

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

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

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

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

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

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.

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Benzodiazepines Linked to Modest Increased Risk of Alzheimer’s

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.  Continue reading

LUCEMYRA (Lofexidine) Now Available to Reduce Opioid Withdrawal Symptoms

MedicalResearch.com Interview with:

Mark Pirner, MD, PhD Senior Medical Director Clinical Research and Medical Affairs US WorldMeds

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.

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Lupus: Phase 2 Trial of Baricitinib Improved Signs and Symptoms

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

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.

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