Pharmaceutical industry
Post Hoc Analyses of GLOBAL LEADERS Trial: Compared with Standard 12-Month Dual Anti-Platelet Therapy, Ticagrelor Monotherapy Reduced the Ischemic and Bleeding Events by up to 8% Following Percutaneous Coronary Intervention
The post hoc analyses of GLOBAL LEADERS study by Dr. Hara, published in Circulation: Cardiovascular Quality and Outcomes reported that in multiple statistical analyses considering the total number and severity of bleeding and ischemic events, ticagrelor monotherapy consistently decreased the risk of these events by 5% to 8% compared to 1-year conventional dual antiplatelet therapy. This analysis supported the beneficial effects of ticagrelor monotherapy after percutaneous coronary intervention. Continue reading
Meta-Analysis of Randomized Trials Shows Early Aspirin Discontinuation with P2y12 Inhibitor Monotherapy Decreases Risks of Major Bleeding After Percutaneous Coronary Intervention
A recent study by Dr. O’Donoghue, published in Circulation, shows that early aspirin discontinuation with continued P2Y12 inhibitor monotherapy, after the percutaneous coronary intervention (PCI), was associated with a significant reduction in major bleeding compared to dual antiplatelet therapy. This study did not show a significant increase in major adverse cardiovascular events (MACE) after aspirin discontinuation in the participants.
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Nationwide Study Shows Pharmacy Closure Associated with Significant Decrease in Adherence to Cardiovascular Medications
According to a new national study led by Dr. Dima M. Qato that was recently published in JAMA Network Open, among 3.1 million Americans 50 years and older filling cardiovascular medications at pharmacies that eventually closed, there was a significant and immediate decline in medication adherence. This change in adherence persisted over 12 months and was prominent among older adults living in neighborhoods with fewer pharmacies.
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
