CardioExchange Archive

September 17th, 2010

FDA Announces Safety Review of Pioglitazone

Larry Husten, PHD

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data are taken from a planned 5-year analysis of […]

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September 17th, 2010

Study Identifies MicroRNA Pattern Linked to Diabetes

Larry Husten, PHD

Researchers in Britain and Europe have identified a microRNA pattern that may help identify people at risk for developing type 2 diabetes and who may go on to have cardiovascular events. “It’s very important for the clinician to define those diabetic patients who are at the highest risk of developing cardiovascular complications,” said the senior […]

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September 16th, 2010

FDA: Dabigatran Gains, Lorcaserin Loses

Larry Husten, PHD

An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at […]

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September 15th, 2010

FDA: Ticagrelor Deadline Extended; No Clear Signal on Sibutramine

Larry Husten, PHD

FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the FDA […]

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September 15th, 2010

TREAT Analysis: Target Dosing Is Tricky

Larry Husten, PHD

A new analysis of TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) is raising questions about the use of target-based strategies for the treatment of anemia in people with chronic kidney disease. (Last year, the main TREAT results showed that treatment with darbepoetin alfa was not beneficial – and was associated with an increase in the […]

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September 14th, 2010

AHA Rejects Smokeless Tobacco Products

Larry Husten, PHD

Smokeless tobacco products aren’t safe and won’t help people quit smoking, according to a policy statement from the American Heart Association published in Circulation. Although the statement acknowledges that the cardiovascular risks of smokeless tobacco products appear to be reduced compared with cigarette smoking, evidence cited in the statement links smokeless tobacco products to an increased […]

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September 9th, 2010

Protective Effect of Education Only Occurs in High-Income Countries

Larry Husten, PHD

The well-known cardiovascular protective effect of education only occurs in high-income countries (HICs), according to a new report from the REACH registry appearing in Circulation. A striking finding was that highly educated women were more likely than their less educated counterparts to smoke in both affluent countries and less affluent countries. The authors point out that […]

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September 8th, 2010

New Therapy for a Rare Syndrome

Larry Husten, PHD

A team of French and Belgian investigators have found a promising new treatment for a rare inherited disorder that often leads to vascular dissection or rupture. In a report published online in the Lancet, Kim-Thanh Ong and colleagues compared the effect of celiprolol, a beta-blocker with beta-2 agonist properties, with placebo in 53 patients with […]

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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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September 1st, 2010

NEJM Editors Call for Removal of Sibutramine from U.S. Market

Larry Husten, PHD

Earlier this year, following the discovery of signals of potential danger in a large clinical trial, the weight loss drug sibutramine (Meridia) was withdrawn from the market in Europe while the FDA added a strongly worded contraindication to its use in people with cardiovascular disease. Now, 2 weeks before an FDA advisory panel will vote […]

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