16 Mar 2010 Rosiglitazone Update
Rosiglitazone (Avandia) suspended from the Saudi Arabian market
The Saudi Food and Drug Authority (SFDA) announced on March 14, 2010 that the marketing authorization for rosiglitazone (Avandia) and all combination products containing rosiglitazone was suspended for safety reasons. The suspension is for a period of six months during which time no rosiglitazone or rosiglitazone containing combination products can be imported into Saudi Arabia. During the six month suspension the manufacturer has the opportunity to provide the SFDA with evidence as to why rosiglitazone and combination products containing rosiglitazone should not be permanently removed from the Saudi Arabian market.
The basis for the suspension was that there have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with rosiglitazone or any other oral antidiabetic drug. And internal US Food and Drug Administration (US-FDA) documents evaluating the benefit and risks of rosiglitazone. These documents were made available to the public for the first time in a letter from Senators Max Baucus and Grassley to US-FDA Commissioner Margaret A. Hamburg. These documents are the primary source of data used by the SFDA in its assessment of the comparative safety and effectiveness of rosiglitazone. This letter and the attached FDA internal documents are available on the U.S. Senate Committee on Finance’s Web site at http://finance.senate.gov/press/Gpress/2010/prg022010b.pdf
Impact of rosiglitazone meta-analysis on use of glucose-lowering medications
Open Medicine, Vol 4, No 1 (2010)
RICHARD L MORROW, GREG CARNEY, JAMES M WRIGHT, KEN BASSETT, JENNY SUTHERLAND, COLIN R DORMUTH
ABSTRACT
Background
In May 2007 Nissen and Wolski reported the results of a meta-analysis showing an association between use of rosiglitazone and increased risk of myocardial infarction (N Engl J Med 2007;35624:2457–2471). Rosiglitazone is an insulin-sensitizing agent used to control blood glucose levels in patients with type 2 diabetes. Subsequent analyses provided evidence that the meta-analysis led to a decline in new and prevalent use of rosiglitazone. We sought to evaluate the impact of the meta-analysis on patterns of use of glucose-lowering drugs and patterns of initiation, cessation and switching of drug therapy, and to estimate these effects in relation to other predictors of initiation and cessation of rosiglitazone
Methods
We used an interrupted time series analysis to test the impact of the meta-analysis on monthly utilization of glucose-lowering drugs for the 4.3 million residents of the province of British Columbia. We used multivariate logistic regression with generalized estimating equations to test predictors of initiation and cessation of rosiglitazone, including the influence of microvascular and macrovascular comorbidities, before and after the meta-analysis.
Results
A comparison of predicted and observed utilization for November 2007 showed that use of rosiglitazone declined by 40% (95% confidence interval 39%–42%), whereas use of pioglitazone, insulin and sulfonylureas increased. The presence of macrovascular comorbidities strengthened both the negative impact of the meta-analysis on initiation of rosiglitazone therapy and the positive impact of the meta-analysis on cessation of this drug.
Interpretation
The shift in utilization from rosiglitazone to insulin and sulfonylureas and the modest increase in use of pioglitazone suggest that the latter drug was not embraced as a less harmful alternative to rosiglitazone. Macrovascular comorbidities played a greater role in decisions to start or stop rosiglitazone therapy after the meta-analysis was published.
Full Article in Open Medicine (www.openmedicine.ca)
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