GlaxoSmithKline (GSK) AVANDIA
Results from the DREAM trial may have shattered hopes for a diabetes prevention therapy, as they and show mixed results for GSK's Avandia. Indeed, the findings may undermine GSK's hopes of generating double-digit sales growth for its drug.
The DREAM trial, (Diabetes Reduction Assessment with Rampiril and Rosiglitazone Medication) was designed to tested GlaxoSmithKline's Avandia (rosiglitazone) for a reduction in incidence of diabetes.
Although Avandia showed an impressive reduction for progression to diabetes, the clinical relevance of the co-primary endpoint seems questionable; no improvement in cardiovascular outcomes related to such glucose lowering was demonstrated, and the relationship was not able to be evaluated.
Avandia also caused a statistically significant seven-fold increase in heart failure, and resulted in an average weight gain of 2.4kg over the three-year period, which could encourage physical inactivity.
With further analysis, the risk/benefit assessment of Avandia administration does not seem positive; and GSK may struggle to receive approval for a label for prevention of diabetes from the FDA based on the DREAM study results.
The DREAM trial, (Diabetes Reduction Assessment with Rampiril and Rosiglitazone Medication) was designed to tested GlaxoSmithKline's Avandia (rosiglitazone) for a reduction in incidence of diabetes.
Although Avandia showed an impressive reduction for progression to diabetes, the clinical relevance of the co-primary endpoint seems questionable; no improvement in cardiovascular outcomes related to such glucose lowering was demonstrated, and the relationship was not able to be evaluated.
Avandia also caused a statistically significant seven-fold increase in heart failure, and resulted in an average weight gain of 2.4kg over the three-year period, which could encourage physical inactivity.
With further analysis, the risk/benefit assessment of Avandia administration does not seem positive; and GSK may struggle to receive approval for a label for prevention of diabetes from the FDA based on the DREAM study results.
posted by Spelunca at 12:59 PM
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