May 17th, 2012
FDA Approves Generic Clopidogrel as Plavix Loses Patent Protection
Larry Husten, PHD
For the second time in the past 6 months, a cardiology mainstay drug has lost patent protection and gone generic. Today, the FDA announced that it had approved several generic versions of clopidogrel (Plavix), the antiplatelet drug that for many years was the second best-selling drug in the world. Last November, the best-selling drug of all time, […]
May 17th, 2012
Large Meta-Analysis Finds Statins Effective in Low-Risk Patients
Larry Husten, PHD
A very large meta-analysis provides strong evidence that the relative reduction in vascular risk with statins is at least as great in low-risk patients as in high-risk patients. The finding, write the authors, provides evidence that expansion of guidelines to lower-risk populations should be considered. In their paper in the Lancet, the Cholesterol Treatment Trialists’ (CTT) Collaborators […]
May 15th, 2012
No Benefit Found for Exercise Echocardiography in Asymptomatic Patients Following CABG Or PCI
Larry Husten, PHD
Routine exercise echocardiography in asymptomatic patients after revascularization does not lead to better outcomes, according to a new study published in Archives of Internal Medicine. Although guidelines generally discourage the practice, post-revascularization stress tests are still commonly performed. Serge Harb and colleagues performed exercise echocardiography on 2105 patients after CABG surgery or PCI and followed them […]
May 15th, 2012
Xience Stents Gain European Nod for 3-Month Dual Antiplatelet Therapy
Larry Husten, PHD
The biggest drawback to drug-eluting stents has been the requirement for prolonged dual antiplatelet (DAPT) therapy following stent implantation to prevent stent thrombosis and other potential complications. The precise length of DAPT has been the subject of considerable discussion and research. Now the Xience Prime and Xience V everolimus-eluting stents have received the CE Mark in […]
May 15th, 2012
Returning to Detroit, William O’Neill Heads to Henry Ford Hospital
Larry Husten, PHD
Interventional cardiology leader William O’Neill is leaving the University of Miami Miller School of Medicine to become the medical director of the new Center for Structural Heart Disease at Henry Ford Hospital in Detroit. The new center will focus on new minimally invasive treatments for heart failure and heart valve disease. Prior to going to Miami in 2006, […]
May 14th, 2012
Revascularization in New York State: High Questionable Rates for PCI but Not CABG
Larry Husten, PHD
A large study looking at real-world use of elective coronary artery bypass surgery (CABG) and stenting (PCI) in New York State finds that nearly two thirds of PCI procedures have inappropriate or uncertain indications. By contrast, 90% of CABG procedures were deemed appropriate and 1.1% inappropriate. In a paper published in the Journal of the American College […]
May 10th, 2012
FDA Advisory Panel Recommends Approval for Weight Loss Drug Lorcaserin
Larry Husten, PHD
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The vote was 18 in favor of approval, 4 against, and 1 abstention.
May 10th, 2012
Atorvastatin Lifts Ranbaxy While Pfizer Abandons Its Lipitor Marketing Efforts
Larry Husten, PHD
Pfizer will no longer aggressively market Lipitor (atorvastatin), its former crown jewel and the most lucrative pharmaceutical product ever. At the same time, generic drug manufacturer Ranbaxy posted record revenue for the last business quarter, growth fueled largely by sales of generic atorvastatin in the United States. Pfizer told the Wall Street Journal that it was abandoning efforts […]
May 8th, 2012
In AF, Women Have a Higher Stroke Risk Than Men
Larry Husten, PHD
In an elderly population, when compared to men with atrial fibrillation, women with AF have a significantly elevated risk for stroke. This increased risk occurs regardless of warfarin use.
May 8th, 2012
Persistent Concerns About Lorcaserin (Lorqess) from FDA Reviewers
Larry Husten, PHD
The FDA has posted briefing documents for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reconsider the new drug application for lorcaserin (Lorqess, Arena). The reviewers do not appear to have substantially altered their view of lorcaserin.