GlaxoSmithKline Responds to JAM...( PHILADELPHIA Sept. 11 /- GlaxoSmi...),Health

PHILADELPHIA, Sept. 11 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) believes that conclusions drawn from the most recent meta-analyses published by Drs. Nissen et. al. and Furberg et. al. in the Journal of the American Medical Association (JAMA) do not confirm a difference in the safety profile of Avandia(R) (rosiglitazone) and Actos(R) (pioglitazone). These analyses reflect limitations that are common to all meta-analyses, by the authors' own admission. These analyses do not yield data robust enough to guide doctors in selecting appropriate diabetes treatments for their patients. Comparisons between different meta-analyses with different endpoints and patient populations are even more unreliable.

The Actos meta-analysis is based on a small number of studies (19) provided directly by Takeda, and is heavily biased by data from the PROactive study (5,238 patients) which contributed 80 percent of the endpoint data. The patient population in the PROactive study was at high risk of cardiovascular disease.

-- PROactive compared diabetic patients on Actos to those on placebo.

Patients taking Actos to control blood sugar might be expected to have

fewer cardiovascular events than those who were not controlled on

medication, consistent with the primary results of PROactive (Hazard

Ratio 0.90 p=0.095). However, as described by FDA in the recent

Advisory Committee, at six months PROactive actually showed an

increased risk of heart attack (HR 1.2).

-- Applying the endpoint of CV death, myocardial infarction and stroke to

the data on Avandia across long-term clinical trials to enable a closer

like-for-like comparison with the Actos meta-analysis shows no

statistical difference between Avandia and comparators (a hazard ratio

of 1.03). In RECORD, a study specifically designed to look at

cardiovascular events, no real difference was seen between Avan
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