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

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

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

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

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.

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Common Diuretic HCTZ Associated With Increase Risk of Skin Cancers

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

“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.

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Can Opioid Users Be Transitioned To Extended-Release Naltrexone?

MedicalResearch.com Interview with:

Dr. Maria Sullivan MD PhD Senior Medical Director of Clinical Research and Development Alkermes

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

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

Add-On Preservative May Improve Outcomes in Refractory Schizophrenia

MedicalResearch.com Interview with:

Hsien-Yuan Lane

Dr. Hsien-Yuan Lane

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.

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15% of Ibuprofen Users May Take More Than Recommended Dose

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.

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Tapeworm Drug May Be Repurposed To Fight Parkinson’s Disease

MedicalResearch.com Interview with:

Dr. Youcef Mehellou PhD Lecturer in Medicinal Chemistry Cardiff School of Pharmacy and Pharmaceutical Sciences Cardiff University

Dr. Mehellou

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.

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Atopic Dermatitis: IF Used At All, Systemic Steroids Should Be Short Term Bridge To Other Therapies

MedicalResearch.com Interview with:

Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois

Dr. Jonathan Silverberg

Dr. Jonathan L. Silverberg MD PhD MPH
Assistant Professor in Dermatology
Medical Social Sciences and Preventive Medicine
Northwestern University, Chicago, Illinois

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

Response: Systemic corticosteroids are commonly used as systemic treatments for atopic dermatitis. However, few studies assessed the efficacy and safety of systemic corticosteroids in atopic dermatitis. This systematic review sought to summarize the available evidence for their use in atopic dermatitis.

Overall, 52 reviews and 12 studies were included in this systematic review. Most studies suffered from small sample size, low quality. In one of the only randomized-controlled trials performed, systemic corticosteroids were less effective than cyclosporine and led to more rebound flares. There were numerous safety and tolerability concerns with both short and long-term treatment with systemic corticosteroids. One study found that even short-term use of systemic corticosteroids was associated with increased sepsis, venous thromboembolism and fractures.

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Database Analyses May Find Supplemental Uses For Established Drugs In Cost-Effective Manner

MedicalResearch.com Interview with:

Michael Fralick, MD FRCPC Research Fellow at the Division of Pharmacoepidemiology and Pharmacoeconomics Harvard University and General Internist at the University of Toronto

Dr. Fralick

Michael Fralick, MD FRCPC
Research Fellow at the Division of Pharmacoepidemiology and Pharmacoeconomics
Harvard University and
General Internist at the University of Toronto

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

Response: Manufacturers of Food and Drug Administration (FDA)-approved prescription drugs often apply for additional indications based on randomized trials. “Real-world” data based on a medication’s actual use and outcomes in routine settings of care might help to inform decision-making regarding such supplemental indications.

MedicalResearch.com: What are the main findings?

Response:  In this non-randomized study we were able to replicate the results of the randomized trial that established the supplemental indication for telmisartan using data from a US healthcare database (insurance claims data) available at the time the randomized trial was completed.

We were also able to confirm the known decreased risk of angioedema with telmisartan compared to ramipril.

MedicalResearch.com: What should readers take away from your report?

Response: If done selectively and with principled methodologies, it might be feasible to use non-randomized real-world data to provide supportive evidence in establishing supplemental drug indications. To improve the validity of the studies, they should ideally be registered prior to them starting.

MedicalResearch.com: Is there anything else you would like to add?

Response: We used real-world data to recreate both the benefits and the harms found in a randomized controlled trial. The randomized trial costed 10s of millions of dollars and took over 7 years to complete. By contrast, our study took a few months to complete and was a small fraction of the cost of the randomized trial.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Michael Fralick, Aaron S. Kesselheim, Jerry Avorn, Sebastian Schneeweiss. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. Published online November 20, 2017. doi:10.1001/jamainternmed.2017.3919

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

 

 

 

 

 

Zoledronic Acid Cost-Effective In Preventing Skeletal Events in Patients With Bone Metatstases

MedicalResearch.com Interview with:

Dr-Charles L Shapiro.jpg

Dr. Shapiro

Charles L.Shapiro MD
Professor of Medicine
Director of Translational Breast Cancer Research
Director of Cancer Survivorship
Division of Hematology/Oncology
Tisch Cancer Institute
New York, NY

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

Response: The new 2017 ASCO guidelines for the use bone-modifying in individuals with bone metastases recently endorsed every 3-month zoledronic, because of high level evidence from three randomized trials, including our trial (published in Jama in Jan 2017, first author Himelstein et al) that giving zoledronic acid every 3-months was non-inferior to the standard of monthly zoledronic. The guidelines also concluded that there was not one preferred bone modifying agent of the other, despite the fact the comparing monthly zoledronic to monthly denosumab in women with bone metastases, denosumab delayed the time to first skeletal-related event (pathological fractures, necessity for radiation or surgery, and spinal cord compression) and subsequent events by 23% (or in absolute terms about 3 months) . Zoledronic acid became generic in 2013, whereas monthly denosumab is still patented until 2022-25.

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Novel PDE4 Inhibitor Improves Symptoms of Autism Disorder Fragile X Syndrome in Animal Model

MedicalResearch.com Interview with:

Dr. Mark E. Gurney, PhD MBA

Dr. Gurney

Dr. Mark E. Gurney, PhD MBA
Chairman & CEO, Tetra Discovery Partners Inc.

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

Response: Fragile X is a genetic condition. Affected patients display a range of behavioral and other symptoms, including seizures, sleep disorders, anxiety, irritability, hyperactivity, autism, mild-to-severe cognitive impairment and intellectual disability.

BPN14770 is a novel therapeutic agent that selectively inhibits phosphodiesterase-4D (PDE4D). Inhibition of PDE4 has been validated as a treatment strategy by many research groups in the Fragile X field, but non-selective PDE4 inhibitors have been associated with significant GI side-effects that have limited those drugs’ use. As a selective inhibitor, such side-effects were not seen for BPN14770 in a Phase 1 clinical trial in healthy young and elderly adults.

In the current study, daily treatment of Fragile X knock-out (FXS) mice with BPN14770 showed a reduction in hyperarousal, improved social interactions and natural behaviors, and changes in nerve structure in the prefrontal cortex of the brain, the portion of that brain associated with cognition. Moreover, the drug’s benefit persisted for two weeks after all drug was cleared from the mice. At the same time, the behavior of normal mice treated with the drug remained unchanged. Examination of neurons from the prefrontal cortex of the treated FXS mice showed an improvement in dendritic spine morphology.

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Oral Semaglutide As Effective As Injectable In Reducing A1C and Weight Loss

MedicalResearch.com Interview with:

Melanie J Davies CBE MB ChB MD FRCP FRCGP Professor of Diabetes Medicine  NIHR Senior Investigator Emeritus Diabetes Research Centre Leicester Diabetes Centre – Bloom University of Leicester

Prof. Davies

Melanie J Davies CBE MB ChB MD FRCP FRCGP
Professor of Diabetes Medicine
NIHR Senior Investigator Emeritus
Diabetes Research Centre
Leicester Diabetes Centre – Bloom
University of Leicester

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

Response:  This was the first study to test the effectiveness of an oral GLP-1 in patients with type 2 diabetes.

The main findings were that compared to both placebo and a GLP-1, Semaglutide, delivered by sub-cutaneous injection weekly, the oral therapy delivered once a day produced better results than placebo and similar results to injectable GLP-1 with regard to reductions in HbA1c and weight loss.

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