June 26th, 2012
Aspirin Reduces Risk for Recurrent VTE
John Ryan, MD and ceciliabecattini690
John Ryan interviews Cecelia Beccatini about her new study that found that aspirin treatment in patients with first-time unprovoked VTE resulted in a significant reduction in VTE but did not increase the risk for bleeding.
June 25th, 2012
FDA Once Again Delays Approval of Apixaban (Eliquis)
Larry Husten, PHD
The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The two companies reported that […]
June 7th, 2012
Growing Popularity of Dabigatran Leads to Increased Complications
Larry Husten, PHD
Since its approval in the United States in October 2010, dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now includes the statement […]
May 31st, 2012
Women at Increased Risk for Stroke in Atrial Fibrillation
Larry Husten, PHD
Among patients with atrial fibrillation (AF), women have a higher risk than men of having a stroke, according to a new study published in BMJ. The increased risk was mostly found in women over 65 years of age and in women with multiple risk factors. Leif Friberg and colleagues analyzed data from more than 100,000 Swedish patients with […]
May 30th, 2012
Reality Check: Do Reporters Spin Trial Results?
Harlan M. Krumholz, MD, SM
Do reporters spin trial results – or do some reporters just not understand the science well enough to report results accurately? I was thumbing through Nature Reviews/Cardiology when I happened on this headline in the section on Research Highlights: Vorapaxar beneficial in setting of prior MI, but not in patients who have experienced stroke. This long […]
May 24th, 2012
Aspirin Found to Prevent Recurrent Venous Thromboembolism
Larry Husten, PHD
Aspirin can help prevent the recurrence of venous thromboembolism (VTE) after discontinuation of anticoagulation therapy, according to results of the WARFASA (the Warfarin and Aspirin) study published in the New England Journal of Medicine. Following 6 to 18 months of oral anticoagulation, 403 patients with first-time unprovoked VTE were randomized to aspirin (100 mg daily) or placebo for 2 […]
May 23rd, 2012
FDA Advisory Committee Recommends Against ACS Indication for Rivaroxaban
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted today against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS 2-TIMI […]
May 21st, 2012
Rivaroxaban for ACS Gets Positive FDA Review, but Questions About ATLAS Trial Conduct Persist
Larry Husten, PHD
The FDA will offer generally positive – but also highly mixed – advice to the FDA’s Cardiovascular and Renal Drugs Advisory Committee when it meets on Wednesday to consider the supplemental new drug application for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. The FDA posted the briefing […]
May 11th, 2012
A ‘Brilinta’ Theory on Why Ticagrelor Doesn’t Work as Well in the U.S.
Harry Peled, md
Harry Peled wonders whether intermediate-dose aspirin may simply be so effective that it obviates the need for a P2Y12-receptor antagonist.
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.