FDA
ORION-1: 1-Year Follow-Up Data Affirms 2-dose Regimen Using 300 mg of Inclisiran For Persistent LDL-C Lowering 360-day follow-up results published in September edition of JAMA Cardiology
A randomized, double blind, placebo-controlled, phase II clinical trial studying the effect of a novel protein proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis inhibitor (inclisiran) on serum low density lipoprotein cholesterol (LDL-C) levels has shown that twice a year subcutaneous injections of inclisiran leads to a sustained dose-dependent reduction in serum LDL-C levels over a period of 1 year.
Total Event Analysis from REDUCE-IT Showcases a Substantial Reduction in the Burden of Ischemic Events, Experts Debate Possible Mechanisms of Action of Icosapent Ethyl Presented at ACC 2019, New Orleans, Los Angeles
The total event analysis from the REDUCE-IT trial, presented at ACC 2019 showed that among statin-treated patients with elevated triglycerides and cardiovascular disease or diabetes, icosapent ethyl substantially reduced the burden of first, subsequent, and total ischemic events. The results are exciting as this is one of the first non-LDL targeted trials to demonstrate a cardiovascular benefit, and is likely to be featured in future guidelines. Continue reading
HeartMate3 Found to be More Superior Than Other LVADs on Endpoints of Stroke, Pump Thrombosis and Bleeding Complications ACC 2019: A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report
The largest LVAD trial ever to be performed, led by Dr. Mandeep Mehra published the final analysis of a fully magnetically levitated left ventricular assist device in the New England Journal of Medicine. According to this, among patients with advanced heart failure, a fully magnetically levitated centrifugal- flow pump has been found to be superior to a mechanical-bearing axial-flow pump in advanced heart failure patients in terms of survival free of disabling stroke or reoperation for removal in case of device malfunction. Continue reading
COAPT Analysis Affirms Quality of Life Advantage of MitraClip for Secondary MR ACC 2019: Health Status After Transcatheter Mitral-Valve Repair in Heart Failure and Secondary Mitral Regurgitation
NEW ORLEANS — Transcatheter repair of functional mitral regurgitation (or secondary MR) with MitraClip improved quality of life and hemodynamics better than optimal medical therapy alone, COAPT trial analyses showed. Indeed, the COAPT QOL study showed that among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. Continue reading
U.S. Food and Drug Administration (FDA) Continues To Investigate Recall of Contaminated Blood Pressure Medication Potentially carcinogenic nitrosamine impurities found in angiotensin receptor blockers (ARBs)
The US food and drug Administration (FDA) has recently been conducting an investigation on voluntary recalls of multiple generic angiotensin II receptor blocker (ARB) drug products used to treat high blood pressure and heart failure. The recalls initiated in July 2018 and continue to date due to the presence of Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which are potential human carcinogens in different ARB products. Last week, AurobindoPharma USA notified that it is expanding its recall to include 38 more lots of valsartan and amlodipine/valsartan tablets due to objectionable levels of N-Nitrosodiethylamine (NDEA). This was later followed by an expanded voluntary recall of losartan potassium produced by Hetero Labs (India) when they were found to be contaminated by N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Camber Pharmaceuticals called back 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg), 114 lots of losartan potassium or losartan potassium/hydrochlorothiazide tablets, and one lot of losartan potassium/hydrochlorothiazide tablets. Continue reading
