December 16th, 2013
Possible New Lease on Life for Vorapaxar and Rivaroxaban for ACS
Larry Husten, PHD
Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and […]
December 13th, 2013
Dispatch From the Wild Frontier of the Statin Wars
Larry Husten, PHD
The long simmering controversy over the relative benefits and harms of statins has heated to a high boil with the release of the new AHA/ACC U.S. guidelines. But nowhere is the battle more intense right now than in Australia, where, according to the National Heart Foundation, a TV show may be the cause of 2,000 heart attacks […]
December 12th, 2013
FDA Panel Gives Support to Left Atrial Appendage Closure Device
Larry Husten, PHD
The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority, the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the […]
December 9th, 2013
European Air Pollution Standards May Need to be Strengthened
Larry Husten, PHD
A large new analysis published in the Lancet has found a strong association between long-term exposure to air pollution and the risk of dying. The results suggest that European standards for air quality may need to be strengthened. The European Study of Cohorts for Air Pollution Effects (ESCAPE) analyzed data from 22 European studies, including 367,251 participants followed for an […]
December 5th, 2013
Large Study Finds Favorable Risk-Benefit Profile for the New Anticoagulants
Larry Husten, PHD
A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of […]
December 3rd, 2013
Stents Lose in Comparisons with Surgery and Medical Therapy
Larry Husten, PHD
Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI […]
December 2nd, 2013
ACP Recommends Conservative Treatment for Heart Patients with Anemia
Larry Husten, PHD
The American College of Physicians (ACP) is recommending more conservative use of transfusions and erythropoiesis-stimulating agents (ESAs) in anemia patients with heart disease. But the authors of the new clinical practice guidelines, published in the Annals of Internal Medicine, acknowledge that the evidence base is too flimsy to support firm conclusions. “Overall,” wrote the authors, “despite the epidemiologic and […]
November 27th, 2013
Physicians Report Alarming Increase in LVAD Pump Thrombosis
Larry Husten, PHD
Cardiac physicians from three top institutions report an abrupt and highly troubling increase over the last two years in the incidence of pump thrombosis in patients who have received the HeartMate II left ventricular assist device (LVAD) manufactured by Thoratec. The current investigation, published online in the New England Journal of Medicine, was initially prompted by an observed […]
November 26th, 2013
Little Difference in Chest Pain Between Men and Women
Larry Husten, PHD
In recent years, the medical community has grown increasingly concerned that women with heart attacks may be less likely to receive prompt and effective treatment. The difference between the sexes in the presentation of symptoms is thought to be a major barrier to better treatment for women. But now a study published in JAMA Internal Medicine finds that […]
November 25th, 2013
FDA Removes Restrictions on Avandia
Larry Husten, PHD
In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said its […]