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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

ater than 70 years of age, and demonstrated the safety profile of rosiglitazone to be consistent with the control medicine (sulfonylurea).

Importantly, the results of this study do not reproduce what is already known about the risk of CHF in TZD users. TZDs can cause fluid retention which can lead to or exacerbate heart failure. TZDs also have a similar increased risk of CHF. Yet, in this analysis, pioglitazone is not associated with an increased risk of CHF (Adjusted RR of 0.91 (95% CI = 0.52-1.59) whereas rosiglitazone is associated with 2 fold-increased risk of CHF (Adjusted RR = 1.98 and 95% CI=1.44-2.72) compared to oral anti-diabetic combination therapy. This is inconsistent with the product labeling.

Moreover, the authors of this retrospective analysis fail to acknowledge the findings of large epidemiological studies, encompassing over 1.3 million patients with type 2 diabetes, as well as other similar studies presented during the recent FDA Advisory Committee meeting. These studies have investigated whether use of rosiglitazone in the real world setting is associated with an increase in myocardial infarction or coronary revascularization. The majority of these studies show that rosiglitazone is not associated with an increased risk of myocardial infarction compared to other anti-diabetic agents.

GSK cites the following as examples of the limitations of this retrospective analysis:

-- As the authors state, patients on TZDs in their analysis may represent

an older, select group of patients with advanced diabetes and therefore

higher baseline risk for cardiovascular disease.

-- The ODB database is composed of a select group of patients.

Rosiglitazone is only prescribed for those patients who fail

treatment on metformin and sulfonylurea, or for whom sulfonylurea or

metformin are contraindicated. The rosiglitazone patients are

therefore ones with higher
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SOURCE GlaxoSmithKline
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