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
-- 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
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