Results show risk of heart attack comparable to two widely used diabetes medicines

Issued – Wednesday 6 June 2007, London, UK

A study of more than 33,000 type 2 diabetes patients in a real-world setting was published today. This study shows that the incidence of hospitaliations for heart attack, and/or for a surgery known as coronary revascularization for patients on Avandia is the same as for other diabetes treatments. The study results were released in a paper titled “Coronary Heart Disease Outcomes in Patients Receiving Antidiabetic Agents” in Pharmacoepidemiology and Drug Safety.

These data, also described in a letter published online last week (May 30, 2007) in the medical journal The Lancet, are further evidence that the ischemic cardiovascular safety of Avandia is comparable to the most commonly used type 2 diabetes treatments – as evidenced in long-term prospective trials, such as ADOPT and DREAM. The findings conflict with a hypothesis generated by the recently published meta-analysis in the New England Journal of Medicine that raised concerns regarding ischemic risks with Avandia.

Based on an observational cohort study from a large U.S.managed-care database, this research was commissioned by GlaxoSmithKline as part of its commitment to the ongoing monitoring and assessment of the safety of Avandia. The study was designed to compare the risk of heart attack and coronary revascularization in type 2 diabetes patients taking Avandia, metformin or sulfonylurea – either alone, as two medicines combined and in combination with insulin. The study populations were matched to ensure that the cohort groups were similar in terms of their baseline risk factors for cardiovascular disease. Patients were followed for an average of slightly over a year.

The results demonstrate that:

- there was no difference in the overall incidence of heart attack and coronary revascularization with Avandia-containing therapies (1.75 events per 100 person-years) versus non-Avandia containing therapies (1.76 events per 100 person-years) (hazard ratio 0.93, 95% CI 0.80 – 1.10);

- there was no difference in the risk of either heart attack (hazard ratio 0.92, 95% CI 0.73 – 1.16) or coronary revascularization (hazard ratio 0.94, 95% CI 0.79 – 1.12) - with Avandia-containing therapies compared to non-Avandia containing therapies;

- there was no difference in the risk of the composite outcome with Avandia monotherapy compared to metformin monotherapy (hazard ratio 1.07, 95% CI: 0.85 – 1.34), and similarly with Avandia monotherapy compared to sulfonylurea monotherapy (hazard ratio 0.82, 95% CI: 0.67 – 1.02);

- there was no difference in the risk of composite outcome with Avandia in combination with insulin therapy compared to other oral antidiabetic agents in combination with insulin (hazard ratio 0.88, 95% CI: 0.59 – 1.32).

Avandia is an effective medicine that is an important treatment for millions of patients who are using it to manage their diabetes, a disease with potentially devastating consequences if left unmanaged.

Glossary of terms:

Coronary revascularization - the process of restoring blood flow of oxygen to the heart via a surgical procedure to bypass blockages or obstructions in the coronary arteries

Cohort - a group within a given population followed over a period of time

CI (confidence interval) - quantifies the range that covers the mean via an upper and lower limit for the actual value

Patient year - the cumulative amount of time that a patient has taken a particular medicine as measured in years.

Enquiries:

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	David Mawdsley	(020) 8047 5564
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	Tom Curry	(215) 751 5419