April 13th, 2013
FDA Schedules Another 2-Day Avandia Advisory Panel
Larry Husten, PHD
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2-day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on April 15, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to “discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.”
The RECORD trial was one of the major topics of contention at the 2010 rosiglitazone advisory panel. Designed ostensibly to test the effect of rosiglitazone on cardiovascular outcomes, RECORD was the subject of intense and often brutal criticism from FDA reviewers and Steve Nissen. One result of the 2010 panel was that GSK commissioned Duke University to perform an independent review and analysis of RECORD. This review will apparently be the subject of the June meeting.
2 Responses to “FDA Schedules Another 2-Day Avandia Advisory Panel”
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Rosiglitazone has diminished importance in the context of alternative classes of drugs and more refined approach to mgmt of DM2 that have come along in the wake of safety concerns about Avandia. At this point I perhaps this round of hearings will concern GSK shareholders more than patients.
Rosiglitazone is an important drug that adds to the treatment of type II DM. To have withdrawn it from the market based on a study as poorly executed as the RECORD trial is unthinkable.
When one looks at this selective meta-analysis, it is apparent that the only drugs not associated with a similar increase in coronary events were insulin and placebo.
I have found that patients on rosiglitazone tend to have more stable coronary calcium scores over time and a very good clinical outcome when the rosiglitazone is combined with a comprehensive treatment of atherosclerosis and hypoglycemia is avoided.
To take rosiglitazone off the market but leave the family of sulfonylureas available makes no sense. Nissen himself in the periscope trial demonstrated that pioglitazone, rosie’s weaker cousin, is associated with atherosclerosis regression while sulfonylureas are associated with plaque progression by IVUS.
Similar inconsistent judgements have been made with respect to Vioxx. While vioxx is off the market, little noise is made about oral diclofenac which has about the same coronary risk as vioxx yet remains easily available.
This does beg the question as to why these individuals rail at one drug while not commenting on other drugs with similar or worse side effects. Something seems rotten in the state of Denmark, and other states as well.