CardioExchange Archive

July 20th, 2010

We’ve made some big changes…

Larry Husten, PHD

We’ve redesigned CardioExchange based on your participation and feedback! You’ll see a new look and feel, and functionality to make it easier to join the dialogue. New Ways to Connect with the CardioExchange Community The site includes two important new features to help you get the most out of your time on CardioExchange: The Recent […]

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July 16th, 2010

FDA reviewing link between ARBs and cancer

Larry Husten, PHD

The FDA issued a safety communication and stated that it was conducting a review of ARBs and cancer.

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July 15th, 2010

43rd Annual New York Cardiovascular Symposium

Larry Husten, PHD

New York, NY Learning Pathway: General Cardiology: Hypertension, Lipids and Prevention, Program #: 1613

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July 14th, 2010

• The Avandia Saga Comes to an End — or Does It?
• Dick Cheney Receives an LVAD

Larry Husten, PHD

The Avandia Saga Comes to an End — or Does It? The FDA advisory panel wound up its two-day marathon meeting with a decisive mixed vote. Of the 33 voting members, 12 voted for rosiglitazone to be withdrawn from the marketplace, 10 voted to keep the drug on the marketplace but with severe new restrictions, 7 […]

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July 13th, 2010

Avandia, Day 1 

Larry Husten, PHD

A few hours before the start of the FDA’s advisory panel meeting on Avandia, the New York Times published a story by Gardiner Harris that said GlaxoSmithKline (GSK) began a study comparing the safety of rosiglitazone (Avandia) to pioglitazone (Actos) back in 1999 and spent the next 11 years keeping the study a secret. The Senate […]

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July 12th, 2010

• European Medicines Agency Also Reviewing Avandia
• AHA Publishes Scientific Statement on Diet and Exercise Interventions

Larry Husten, PHD

European Medicines Agency Also Reviewing Avandia: In addition to all the rosiglitazone news surrounding the FDA advisory panel on July 13-14, the European Medicines Agency announced on Friday that it has initiated its own review of the cardiovascular safety of the drug. AHA Publishes Scientific Statement on Diet and Exercise Interventions: The AHA has published a […]

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July 12th, 2010

Clopidogrel vs. Prasugrel: How Effective? How Risky?

Richard A. Lange, MD, MBA

Here are the issues: The FDA has posted a black box warning that people with reduced CYP2C19 liver enzyme function (2% to 14% of the U.S. population) cannot effectively convert clopidogrel to its active form, which reduces its effectiveness in ACS patients. CYP2C19 function doesn’t influence prasugrel’s effectiveness. The AHA and ACC do not support routine […]

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July 9th, 2010

FDA Releases Briefing Documents for Avandia Panel

Larry Husten, PHD

The FDA has posted the briefing documents for the July 13-14 Avandia advisory panel meeting. Here are links to the documents on the FDA website: Meeting Announcement Draft Agenda (PDF – 81KB) Draft Questions (PDF – 233KB) Pre-Meeting Posting of Slides Briefing Information Draft Meeting Roster (PDF – 105KB)

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July 7th, 2010

• NEJM Editorial: DSMBs Need Protection and Independence
• Promising Results for Telemonitoring and Self-Management to Control Hypertension

Larry Husten, PHD

NEJM Editorial: DSMBs Need Protection and Independence: Data and safety monitoring boards (DSMBs) need more protection and independence, according to an editorial in the New England Journal of Medicine by the journal’s editor, Jeffrey M. Drazen, and Alastair J.J. Wood. Responding to recently uncovered events, in which company sponsors interfered with the independence and authority of the […]

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July 6th, 2010

Study Finds No Benefits for Tight BP Control in Diabetics with CAD

Larry Husten, PHD

Target systolic blood pressure in people with diabetes should be below 130 mm Hg, according to current guidelines, although there are no data for diabetics who also have coronary artery disease (CAD). Now, a large post-hoc analysis from INVEST (International Verapamil SR-Trandolapril Study) has found no evidence of benefit for tight blood pressure control below 130 […]

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