Posts Tagged ‘ACS’

September 23rd, 2014

ACC and AHA Release New Guideline for Non–ST-Elevation Acute Coronary Syndromes

A new guideline released today by the American College of Cardiology and the American Heart Association reflects important changes in the last 7 years in the understanding of what is now known as non–ST-elevation acute coronary syndromes (NSTE-ACS). The previous 2007 guideline used different terminology and referred to the same patient population as “unstable angina and […]

May 13th, 2014

A Second Darapladib Phase 3 Trial Misses Its Endpoint

GSK said today that a large phase 3 trial of a once highly promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, […]

February 14th, 2014

FDA Once Again Rejects New Indication For Rivaroxaban

The third time wasn’t the charm. The FDA today turned turned down — for the third time — the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke, or death. In addition, the FDA — for the second time — turned down the sNDA for rivaroxaban in […]

January 29th, 2014

What’s the Best Blood Transfusion Protocol for Anemic ACS Patients?

Sunil V. Rao discusses his editorial about TRANSFUSION-2, a study of the platelet and inflammatory effects of blood transfusions in ACS and non-ACS patients with anemia.

January 17th, 2014

FDA Panel Once Again Rejects ACS Indication for Rivaroxaban

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has once again turned down the supplemental new drug application for an acute coronary syndrome (ACS)  indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. Although originally the subject of high praise when […]

December 16th, 2013

Possible New Lease on Life for Vorapaxar and Rivaroxaban for ACS

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 […]

October 23rd, 2013

Flu Vaccine May Help Prevent Cardiovascular Events

A new meta-analysis published in JAMA offers the best evidence yet that the flu vaccine may help prevent cardiovascular events. Jacob Udell and colleagues analyzed data from five published clinical trials in which 6469 patients were randomized to flu vaccination or placebo (or no treatment). People who received the flu vaccine were significantly less likely than controls to […]

September 18th, 2013

Younger Women with ACS Less Likely to Have Chest Pain

Younger women with an acute coronary syndrome are slightly less likely than men to present with the classic symptom of chest pain, according to a new study published in JAMA Internal Medicine. In recent years there has been a growing understanding that women with ACS are less likely to have chest pain and, partly as a result, […]

June 28th, 2013

FDA Turns Back New Indication for Rivaroxaban to Prevent Stent Thrombosis in ACS Patients

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of […]

May 24th, 2013

Rivaroxaban Gains Approval in Europe for ACS Indication

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive […]