CardioExchange Archive

September 7th, 2010

BMJ Papers Increase Pressure on Avandia

Larry Husten, PHD

A trio of papers in BMJ are turning up the heat on rosiglitazone (Avandia), prompting the editor-in-chief of the journal, Fiona Godlee, to say that she believes rosiglitazone “should not have been licensed and should now be withdrawn.” The detailed investigative report by BMJ features editor Deborah Cohen reviews the long and troubled history of rosiglitazone, with […]

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August 9th, 2010

FDA Issues Warning About Inferior Vena Cava Filters

Larry Husten, PHD

The FDA has issued an initial communication informing health professionals that it is evaluating reports of adverse events with the long-term use of inferior vena cava (IVC) filters. The FDA “recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection […]

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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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August 5th, 2010

Three Questions about Ticagrelor: Part 3 — Jonathan Halperin

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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August 4th, 2010

Three Questions about Ticagrelor: Part 2 — Mori Krantz

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 were found to have no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses […]

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August 3rd, 2010

Three Questions about Ticagrelor: Part 1 — Sanjay Kaul

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 […]

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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 26th, 2010

Questions for Sanjay Kaul about TIDE and Avandia

Sanjay Kaul, MD and Harlan M. Krumholz, MD, SM

CardioExchange’s editor-in-chief Harlan Krumholz discussed the TIDE trial on email with Sanjay Kaul, who was a member of the FDA’s advisory panel last week on Avandia. Here is a lightly edited version of their exchange. Krumholz: What is your response to the FDA announcement that it has placed TIDE on a “partial clinical hold”? Do you […]

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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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July 22nd, 2010

Lessons Learned from 2 Avandia Panels

Larry Husten, PHD

In a perspective published online in the New England Journal of Medicine, Clifford Rosen, who was the chair of the 2007 FDA Advisory Panel that allowed rosiglitazone (Avandia) to remain on the market and also a member of the panel that met last week, writes about “lessons learned” from the extraordinary series of events involving […]

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