CardioExchange Archive

December 8th, 2010

Third Time’s the Charm: FDA Panel Finally Backs an Obesity Pill

Larry Husten, PHD

Following rejections earlier this year of two previous anti-obesity drugs, the FDA’s Endocrinologic and Metabolic Drugs advisory committee has recommended approval for Contrave, the combination of sustained-release formulations of naltrexone and buproprion from Orexigen Therapeutics. The committee voted 13-7 in favor of the drug, saying that the benefits of Contrave outweighed its risks. The committee also […]

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October 22nd, 2010

What Do I Plan to Do with Dabigatran?

Richard A. Lange, MD, MBA

1. Discuss its pros (no need for INR monitoring, less bleeding than coumadin) and cons (cost, dyspepsia) with my atrial fibrillation patients 2. Avoid its use in patients with renal dysfunction (CrCl  <60), liver disease, pregnancy or stroke within the past 6 months 3. Lament the absence of the INR monitoring requirement, which I currently […]

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October 20th, 2010

FDA Approves Dabigatran for Stroke Prevention in Atrial Fibrillation

Larry Husten, PHD

The FDA announced on Tuesday that it has approved Pradaxa (dabigatran, Boehringer Ingelheim) for the prevention of stroke and blood clots in patients with atrial fibrillation. The drug will be available in 75-mg and 150-mg capsules. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” said […]

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August 6th, 2010

Three Questions about Ticagrelor: Part 4 — Bob Harrington

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used in the […]

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July 28th, 2010

FDA Cardiorenal Advisory Panel Recommends Ticagrelor Approval

Larry Husten, PHD

The Cardiovascular and Renal Drugs Advisory Committee recommended today that ticagrelor (Brilinta, AstraZeneca) be approved for the treatment of STEMI and NSTEMI patients intended to be managed both invasively and medically. The committee spent most of the day trying to sort through the confusing finding in the pivotal PLATO trial that U.S. patients, unlike patients […]

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July 23rd, 2010

FDA Approves Generic Enoxaparin

Larry Husten, PHD

The FDA announced on Friday that it had approved the first generic enoxaparin sodium injection for multiple indications including prevention of deep vein thrombosis (DVT). The action represents the FDA’s first generic approval of a low molecular weight heparin. The original version of enoxaparin, Lovenox, was first approved in 1993. To gain approval as a generic, […]

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