CardioExchange Archive

January 9th, 2012

Excess Risk for Cardiac Events Associated with Dabigatran

Larry Husten, PHD

A new meta-analysis finds that dabigatran is associated with a higher risk of myocardial infarction and acute coronary syndromes. An editorial raises questions about the enthusiasm to embrace new drugs.

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December 29th, 2011

J&J Applies for ACS Indication for Rivaroxaban (Xarelto)

Larry Husten, PHD

Based on the promising results of the recently published ATLAS ACS 2 TIMI 51 trial, Johnson & Johnson has submitted a supplemental new drug application to the FDA for the approval of rivaroxaban (Xarelto) to reduce the risk of thrombotic cardiovascular events in ACS patients. Following a succession of failed trials, ATLAS was the first trial to […]

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December 28th, 2011

No Mortality Benefit of Low-Molecular-Weight Heparin in Acutely Ill Patients

Larry Husten, PHD

Although venous thromboembolism (VTE) is a serious problem for acutely ill patients in the hospital, a new study published in the New England Journal of Medicine failed to find any improvement in mortality associated with thromboprophylaxis. Ajay Kakkar and the LIFENOX investigators randomized 8307 acutely ill patients to receive enoxaparin or placebo for 10 days. All patients wore elastic […]

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December 7th, 2011

FDA Undertakes Safety Review of Dabigatran (Pradaxa)

Larry Husten, PHD

The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of bleeding […]

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December 1st, 2011

Meta-Analysis Finds Benefits for Self-Monitoring in Some Warfarin Patients

Larry Husten, PHD

Despite the advent of newer anticoagulants that don’t require monitoring, millions of people will continue to take warfarin for many years to come. Now a new meta-analysis published in the Lancet suggests that some of these patients may benefit from self-monitoring. Carl Heneghan and colleagues analyzed data from 11 trials with 6417 patients on oral anticoagulation and 12,800 person-years […]

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November 13th, 2011

ADOPT Fails to Support Extended Oral Apixaban in High-Risk Post-Discharge Patients

Larry Husten, PHD

Although medically ill patients remain at risk for VTE after hospital discharge, a strategy of extended oral anticoagulation with apixaban did not prove to be successful in the ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial, which was presented by Samuel Z. Goldhaber at the American Heart Association and published simultaneously in the New England […]

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November 13th, 2011

ATLAS ACS 2-TIMI 51: Rivaroxaban Benefits Low-Risk ACS Patients

Larry Husten, PHD

Results of the highly anticipated ATLAS-ACS 2–TIMI 51 trial demonstrate that ACS patients receiving standard therapy, including dual antiplatelet therapy, may benefit from the addition of the factor Xa inhibitor rivaroxaban, although at the cost of some additional bleeding complications. The Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome  trial was […]

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November 13th, 2011

TRACER: Novel Antiplatelet Vorapaxar Runs Into Trouble in ACS

Larry Husten, PHD

The novel antiplatelet vorapaxar, which blocks the thrombin receptor to inhibit platelet activation, ran into trouble in the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial, which was stopped prematurely earlier this year due to safety concerns. TRACER was presented at the AHA by Ken Mahaffey and published simultaneously in the New England Journal of Medicine. […]

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November 4th, 2011

FDA Approves Rivaroxaban for Stroke Prevention in AF

Larry Husten, PHD

The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the […]

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October 6th, 2011

Rivaroxaban Roundup: ATLAS-ACS an AHA Late-Breaker, NEJM Perspective, NYT Overview

Larry Husten, PHD

Rivaroxaban (Xarelto, Bayer and Johnson & Johnson) is in the news today. In a rare move, the AHA has added the ATLAS ACS 2-TIMI 51 trial to its roster of Late-Breaking Clinical Trials to be presented next month at the AHA’s Scientific Sessions in Orlando. C. Michael Gibson will present the results on Sunday, November 13, at 5:13 PM. Last week, Bayer […]

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