CardioExchange Archive

July 1st, 2010

Countdown to the FDA Panel: Avandia Resource Center

Larry Husten, PHD

Source is CardioExchange News, unless otherwise noted. FDA Releases Briefing Documents for Avandia Panel, 09 Jul 2010 More Evidence Goes Against Avandia, 28 Jun 2010 FDA Panels to Review Rosiglitazone and Dabigatran, 10 Jun 2010 CANOE Paddles Into the Avandia Storm, 03 Jun 2010 European Heart Journal Editors Defend Nissen Editorial, 03 May 2010 Industry […]

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July 1st, 2010

• Trial Raises Concerns Over CV Safety of Testosterone Gel
• Prasugrel and Cancer: Is There a Link?

Larry Husten, PHD

Trial Raises Concerns Over CV Safety of Testosterone Gel: Shehzad Basaria and colleagues planned to randomize 252 men 65 years or older with limitations in mobility to testosterone gel or placebo for 6 months. The trial was terminated after enrolling 209 subjects after a higher rate of adverse events occurred in the testosterone group. The results […]

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June 30th, 2010

• Responding to the News
• Retinopathy in ACCORD

Larry Husten, PHD

Responding to the News: It’s been an extraordinary week for cardiology news, with major papers and controversies about rosiglitazone, statins, JUPITER, and clopidogrel. Here are a few statements and news reports that you might want to know about:  ACC/AHA release clinical alert in response to FDA boxed warning about anti-platelet agent, clopidogrel (ACC/AHA) New analyses report […]

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June 28th, 2010

• Study Raises Questions About Statins for Primary Prevention
• JUPITER Under Attack

Larry Husten, PHD

Study Raises Questions About Statins for Primary Prevention: A new meta-analysis raises questions about the benefits of statins when given to people without a clinical history of heart disease. Kausik Ray and colleagues, in a paper in Archives of Internal Medicine, analyzed data from 65,229 subjects in 11 studies. There were 2793 deaths in the studies, 1447 among those […]

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June 28th, 2010

ACC and AHA Offer Detailed Guidance on the Plavix Warning

Larry Husten, PHD

In response to the addition in March of a boxed warning on the Plavix (clopidogrel) label, the ACC and the AHA have published a clinical alert intended to provide guidance to clinicians. David Holmes, Jr, the chair of the writing group, said in a press release that “the majority of patients do very well with standard […]

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June 28th, 2010

More Evidence Goes Against Avandia

Larry Husten, PHD

Two new studies looking at rosiglitazone seem likely to increase pressure on the drug prior to the July FDA advisory panel that will be making recommendations about its future. In the first study, published online in JAMA, the FDA’s David Graham, along with colleagues from Acumen and CMS, analyzed data from 227,571 Medicare beneficiaries taking either rosiglitazone or […]

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June 25th, 2010

• News from the American Diabetes Association & The Lancet
• Vernakalant Gains Recommendation for Approval in Europe 

Larry Husten, PHD

Diabetes Doubles the Risk of Vascular Disease: An international group of investigators analyzed data from nearly 700,000 subjects without previous vascular disease enrolled in 102 prospective studies and found that diabetes appeared to double the risk of coronary disease, stroke, and other vascular deaths. In a presentation at the annual meeting of the American Diabetes Association and in a paper […]

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June 24th, 2010

• 30% of Echocardiograms Misread at Milwaukee Hospital
• AHA and ACCME Kiss and Make Up

Larry Husten, PHD

30% of Echocardiograms Misread: A Milwaukee hospital found that nearly 30% of diagnostic echocardiograms were misread, according to an article by John Fauber in the Journal-Sentinel. An internal review of 235 echocardiograms performed at Aurora St. Luke’s Medical Center turned up 5 cases in which patients “actually went into the operating room with a faulty diagnosis, […]

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June 23rd, 2010

• Lowering Homocysteine Fails Again to Reduce Events
• European Atherosclerosis Society Will Recommend Lp(a) Screening and Niacin

Larry Husten, PHD

Lowering Homocysteine Fails Again to Reduce Events: U.K. investigators randomized 12,064 MI survivors to folic acid and vitamin B12 or placebo. No difference was observed between the two groups in either major vascular events or in the incidence of cancer. In their report in JAMA, the SEARCH (Study of the Effectiveness of Additional Reductions in […]

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June 22nd, 2010

• Aggrenox Fails to Beat Aspirin in Japanese Study
• Livalo Now Available in the U.S.
• New York Times Spotlights ICDs with Benefits

Larry Husten, PHD

Aggrenox Fails to Beat Aspirin in Japanese Study: Aggrenox, the combination of extended-release dipyridamole and aspirin, is indicated for the reduction of subsequent stroke in patients who have had a TIA or ischemic stroke. But results from JASAP (Japanese Aggrenox Stroke Prevention vs. Aspirin Programme), which compared Aggrenox to aspirin in 1294 patients, found that Aggrenox […]

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