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Courtesy Scripps Whittier Diabetes Institute
Dr. Daniel Einhorn
BARI 2D reflects real-life situations for people with access to good care, since intensive treatment of CV risk factors is the goal of appropriate therapy in the United States, he noted. As with pioglitazone (the other TZD marketed in the United States), "there are plausible and extensively researched mechanisms whereby rosiglitazone would be expected to confer cardiovascular benefit" given its mechanism(s) of action, he said.
Finally, the previous FDA panel meetings on rosiglitazone were characterized by a "politicized and media grandstanding climate ... which is not conducive to the best science," while the recent panel meeting in June "appeared more dispassionate," he added.
But even with generic formulations available, neither TZD is likely to be used extensively "because of years of safety concerns, including those regarding bone and cancer, the effect of TZDs to cause weight gain and fluid retention, patient/family concerns raised by ads from lawyers, and the advent of newer agents with a seemingly less concerning safety profile."
Dr. Einhorn has been an adviser to Halozyme Therapeutics, MannKind, and Freedom Meditech, and a consultant to Eli Lilly, Novo Nordisk, Sanofi-Aventis, Bristol-Myers Squibb/AstraZeneca and Novartis.
The study was funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, with funding from companies that included rosiglitazone manufacturer GlaxoSmithKline. The lead author, Dr. Bach, disclosed ties to several pharmaceutical companies, but not GSK; one author disclosed having received honoraria from GSK.
The results of the post hoc analysis of the BARI 2D data were first reported at the American Diabetes Association meeting in 2009.
