PCSK9 Inhibitor Praluent Substantially Reduced LDL-C Cholesterol

MedicalResearch.com Interview with:

Dr. Eli M. Roth MD, FACC President, Medical Director Sterling Research Group Cincinnati, OH

Dr. Eli Roth

Dr. Eli M. Roth MD, FACC
President, Medical Director
Sterling Research Group
Cincinnati, OH

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

Response: At this year’s AHA 2016, we presented a pharmacodynamics analysis of ODYSSEY CHOICE I, which evaluated the effects of Praluent 300 mg administered every four weeks (Q4W) for 24 weeks in hypercholesterolemia patients at moderate to very high cardiovascular risk who were on maximally tolerated statin or no statin and/or other lipid-lowering therapies.

The pharmacodynamic analysis of CHOICE I in patients on statins supports the use of Praluent 300 mg Q4W as an alternative starting dose for patients who prefer a Q4W dosing regimen and demonstrates the value of LDL-C based dosing interval adjustment. The findings from this analysis were consistent with prior ODYSSEY Phase 3 studies, showing that Praluent substantially reduced circulating free PCSK9 concentration, resulting in significant LDL-C reductions. Additionally, Praluent was generally well tolerated.

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Idarucizumab For Dabigatran Reversal: Updated Results Of The Re-verse Ad Study

MedicalResearch.com Interview with:

Dr. Charles Pollack MD Professor of Emergency Medicine Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia.

Dr. Charles Pollack

Dr. Charles Pollack MD
Professor of Emergency Medicine
Sidney Kimmel Medical College at
Thomas Jefferson University, Philadelphia.

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

Response: RE-VERSE AD™ is a multinational, open-label cohort Phase III trial studying the safety and efficacy of idarucizumab (PRAXBIND) to reverse the anticoagulant effects of dabigatran (PRADAXA) in patients with life-threatening or uncontrolled bleeding, or those who require emergency procedures.

It is the largest patient study investigating a reversal agent for a novel oral anticoagulant (NOAC) in real world emergency settings. At the American Heart Association’s Scientific Sessions 2016, we presented updated results from 494 patients participating in the ongoing study, showing that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran.

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Costs of Generic Drugs for Heart Failure Can Vary Widely

MedicalResearch.com Interview with:

Paul J. Hauptman, MD</strong> Professor Internal Medicine, Division of Cardiology Health Management & Policy, School of Public Health

Dr. Paul Hauptman

Paul J. Hauptman, MD
Professor Internal Medicine, Division of Cardiology
Health Management & Policy, School of Public Health

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

Response: We decided to evaluate the cost of generic heart failure medications after an uninsured patient of ours reported that he could not fill a prescription for digoxin because of the cost for a one month’s supply: $100. We called the pharmacy in question and confirmed the pricing. At that point we decided to explore this issue more closely.

We called 200 retail pharmacies in the bi-state, St. Louis metropolitan area, 175 of which provided us with drug prices for three generic heart failure medications: digoxin, carvedilol and lisinopril. We found significant variability in the cash price for these medications. Combined prices for the three drugs ranged from $12-$400 for 30 day supply and $30-$1,100 for 90 day supply.

The variability was completely random, not a function of pharmacy type, zip code, median annual income, region or state. In fact, pricing even varied among different retail stores of the same pharmacy chain.

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Heart Disease Patients Admitted To Critical Care Units in Teaching Hospitals May Fare Better

MedicalResearch.com Interview with:

Dr. Sean van Diepen, MD, FRCPC Assistant Professor of Critical Care Medicine and Cardiology Coronary Intensive Care Unit Co-Director University of Alberta Hospital

Dr. Sean van Diepen

Dr. Sean van Diepen, MD, FRCPC
Assistant Professor of Critical Care Medicine and Cardiology
Coronary Intensive Care Unit Co-Director
University of Alberta Hospital

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

Response: Studies have documented a wide variation in CCU admission rates for patients hospitalized with acute coronary syndromes (ACS) or heart failure (HF). The reasons underpinning these differences are incompletely understood and little is known about the associations between hospital type, resource utilization, and clinical outcomes among patients admitted to the CCU with an ACS or HF.
In a national cohort of 220,759 patients, we observed that CCU admission rates varied by hospital type: 41% in teaching hospitals, 29.9% in large teaching hospitals, 42.6% in medium community hospitals and13.7% in small community hospitals. The percentage of patients that did not receive critical care therapies within the first 2 days of admission were: 35.5%, 58.0%, 83.3% and 95.6%, respectively. Compared large community hospitals, community hospitals all had higher adjusted in hospital mortality rates.

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Marijuana (Cannabis) Use is Independent Predictor of Broken Heart Syndrome in Younger Men

MedicalResearch.com Interview with:

Amitoj Singh MD Chief Cardiology Fellow St. Luke’s University Health Bethlehem, Pennsylvania

Dr. Amitoj Singh

Amitoj Singh MD
Chief Cardiology Fellow
St. Luke’s University Health
Bethlehem, Pennsylvania

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

Response: Marijuana use in steadily increasing and it is the most commonly used illicit drug in the US and worldwide. There has been a recent increase in reports of heart and vascular complications associated with its use. These include Myocardial infarctions, stroke and takotsubo.

We had two questions that we wanted to answer with our study:

a) Is there an association between marijuana use and development of Transient Regional Ventricular Ballooning [TVRB] (aka Stress Cardiomyopathy /Broken Heart Syndrome/ Takotsubo)?

b) If the above is true, what are the differences between Marijuana users (MU) and Non Marijuana Users (NMU) who developed Stress Cardiomyopathy.

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Phase1 Trial Supports PCSK9-Inhibitor Inclisiran For Reducing LDL Cholesterol

MedicalResearch.com Interview with:

Kevin Fitzgerald, Ph.D. Alnylam Pharmaceuticals Cambridge, MA 02142

Dr. Kevin Fitzgerald

Kevin Fitzgerald, Ph.D.
Alnylam Pharmaceuticals
Cambridge, MA 02142

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

Response: Inclisiran (ALN-PCSsc) is a subcutaneously administered RNAi therapeutic targeting PCSK9 in development for the treatment of hypercholesterolemia. The Phase 1 trial of inclisiran was conducted in the U.K. as a randomized, single-blind, placebo controlled, single ascending-and multi-dose, subcutaneous dose-escalation study in 69 volunteer subjects with elevated baseline LDL-C (≥ 100 mg/dL). The primary objective of the study was to evaluate the safety, side effect profile, and pharmacodynamics effects of inclisiran.

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