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VICTORY: "Reassuring" Atherosclerosis/Metabolic Data on Rosiglitazone
The drug showed a trend toward a slowing of the progression of atherosclerosis and an overall positive effect on metabolic factors in the VICTORY study in post-CABG diabetes patients.
News, April 2008
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FDA Reprimands GlaxoSmithKline Over Missing Data on Rosiglitazone
In a letter to GlaxoSmithKline, the FDA said that an inspection in late 2007 focusing on compliance with postmarketing adverse drug experience reporting requirements found that the company failed to report data from clinical usage and failed to disclose or submit data from clinical trials.
News, April 2008
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Rosiglitazone to Stay on US Market With New Warnings About MI
The US FDA adds new information to the existing boxed warning while safety assessment continues. The Canadian authorities have taken similar action, albeit with a more strongly worded warning.
News, November 2007
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Fresh Fuel for the Glitazone Controversy: New Pioglitazone and Rosiglitazone Meta-Analyses
One study shines the spotlight on pioglitazone, suggesting that it may indeed have a better safety profile than rosiglitazone, at least in terms of ischemic events, while yet another meta-analysis of rosiglitazone, looking only at studies in diabetics, reaffirms the increased risk of MI seen in other recent studies.
News, September 2007
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Rosiglitazone Wrangling Continues in NEJM Correspondence
Letters to the editor published in this week's print issue of the journal quibble with the statistical methods used in Nissen and Wolski's original meta-analysis, while online letters trade barbs over a subsequent rosiglitazone Perspective.
News, August 2007
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Rosiglitazone Story a Reminder of Need for FDA Reform
Dr Clifford Rosen, who chaired the recent FDA panel meeting, says rosiglitazone's rise and fall highlight the need for a tougher preapproval process, and postmarketing trials with teeth.
News, August 2007
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Reanalysis of Nissen/Wolski Rosiglitazone Meta-Analysis Scrutinizes Findings, Methods
A new analysis of the same 42 trials, but using a number of different statistical methods to account for all the zero events, found no significant increase in either MI or CV death and highlights flaws in the original study. In response, Nissen counters that the report is now neither useful nor relevant in the wake of the FDA hearing.
News, August 2007
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Cochrane Review Urges Caution on Rosiglitazone Use
The new review found no evidence of any benefits with the drug over other available treatments for diabetes and, because of side effects such as edema, fractures, and possible increased risk of MI, recommends that other antidiabetic medications be used in preference.
News, July 2007
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ADOPT Analysis Shows Rosiglitazone Increases Risk of Fracture in Women
Not unlike a prizefighter battered and bruised, rosiglitazone continued to take it on the chin this week with an analysis of ADOPT expanding upon the increased risk of fracture among diabetic women taking the controversial TZD.
News, June 2007
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Nissen Responds to Rosiglitazone Debate at ADA Meeting
Much in the spotlight in the past month, Dr. Steven Nissen's audience this time, instead of politicians on Capitol Hill, was a house full of physicians and researchers in a hastily added panel discussion.
News, June 2007
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Rosiglitazone: Policy Implications and Continuing Debate
The rosiglitazone saga has led to more calls for reform of the FDA, the latest coming from drug safety expert Dr Brian Strom and former FDA commissioner Dr Donald Kennedy. While Strom and Kennedy concur that changes are needed at the FDA, they disagree on the merits of Nissens meta-analysis. Dr Valentin Fuster also comments on the rosiglitazone saga.
News, June 2007
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A House Divided: No Clear Answers on Rosiglitazone Safety or Political Backstory
New black-box warnings about CHF risk are in the works for the glitazone drugs, but whether rosiglitazone increases MI and CV death rates, debated during Wednesday's oversight committee hearing, remains unresolved. Participants also quibbled over the FDA's handling of drug data and the role of partisan politics in medical matters.
News, June 2007
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RECORD Interim Analysis of Rosiglitazone Safety: No Clear-Cut Answers
One RECORD investigator calls interim findings from RECORD "moderately reassuring": at 3.75 years there are no differences in risk of hospitalizations or death from cardiovascular causes. While MI trends higher, deaths trend lower in the results so far. Three accompanying editorials take a considerably dimmer view.
News, June 2007
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Rosiglitazone Meta-Analysis Continues to Drive Controversy in Second Week
The rosiglitazone story rumbles on this week, with some observers claiming that the meta-analysis was timed to get data into the public arena without the FDAs knowledge, thereby bringing the subject of drug safety to the fore once more. In the meantime, the one ongoing trial that everyone agrees will give definitive information on cardiovascular outcomes with rosiglitazone could be in jeopardy,
News, May 2007
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The Rosiglitazone Aftermath: Legitimate Concerns or Hype?
Experts give heartwire their take on the furor that has resulted from the meta-analysis published earlier this week. The prevailing view appears to be that there is no need for panic and that while the analysis does suggest a safety signal, it does not justify removing the drug from the market at this time or the general chaos that has occurred.
News, May 2007
