GlaxoSmithKline Responds to JAMA Article on the ICES Thiazolidinediones and Cardiovascular Outcomes in Older Patients wit...( PHILADELPHIA Dec. 11 /- The follo...)

PHILADELPHIA, Dec. 11 /PRNewswire-FirstCall/ -- The following is GlaxoSmithKline's (NYSE: GSK) response to the retrospective analysis by the Institute for Clinical Evaluative Sciences (ICES) titled "Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes".

GSK believes that the ICES retrospective analysis of the Ontario Drug Benefit (ODB) database has significant limitations and generates misleading conclusions regarding acute myocardial infarction and death. These conclusions are inconsistent with a more robust body of evidence from large, long-term, prospective, well-designed clinical studies, including ADOPT and RECORD.

-- These long-term trials in diabetic patients comparing rosiglitazone to

other oral anti-diabetic medicines show no increased risk for

cardiovascular events compared to other commonly used medications,

other than the well-known risk of congestive heart failure (CHF) with

thiazolidinedione (TZDs).

-- RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of

Glycaemia in Diabetes) was specifically designed to evaluate the

cardiovascular safety of rosiglitazone, and is therefore the most

robust data available. A recently published interim analysis for

myocardial infarction and death from cardiovascular causes, or from any

cause, showed no statistically significant difference between

rosiglitazone in combination with either metformin or sulfonylurea vs.

the active comparators of metformin plus sulfonylurea.

In addition, the RESULT clinical study specifically examined an elderly diabetic population, ages 59 to 89, in which 43 percent of the patients were gre
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