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GlaxoSmithKline Responds to JAMA Article on the ICES Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes
Date:12/11/2007

baseline risk for cardiovascular disease.

The use of rosiglitazone in this database does not reflect its use

among patients in the real world.

-- Patients prescribed rosiglitazone alone suffered from more chronic

diseases compared with those prescribed pioglitazone alone;

therefore they were sicker patients. However this difference is not

corrected for in the analysis of the data and in the study

conclusions.

-- The TZD monotherapy patient population in the ICES analysis had a

4-fold higher rate of kidney impairment, which is indicative of

patients with more progressive type 2 diabetes.

-- The authors state that the study may have been underpowered to detect

adverse effects associated with pioglitazone because of the relatively

small number of persons prescribed pioglitazone alone. It is stated

that larger studies are needed to better determine the relative

effect of each agent on cardiovascular outcomes.

-- The ICES analysis included insulin therapy within the TZD combination

group but excluded insulin combinations within the comparison group.

Insulin is known to be associated with increased CHF and cardiovascular

risk. Therefore, this biases the TZD combination group towards

increased cardiovascular risk relative to the comparison group. This

also permits more advanced patients, with poor glycemic control and who

are at greater risk of cardiovascular complications, to be included in

the TZD population while excluding them from the control group.

Avandia(R) (rosiglitazone maleate) is a widely studied oral anti-diabetic medicine for the treatment of type 2 diabetes, and importantly, Avandia has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines - up to five years. When used in the a
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SOURCE GlaxoSmithKline
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