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From: GlaxoSmithKline

05/01/03

Avandia (rosiglitazone maleate)
Now Indicated for Use with Insulin

GlaxoSMithKline (GSK) is pleased to annuonce that AVANDIA is now indicated for use in combination with insulin as an adjunct to diet and exercise to improve glycemic control, in the treatment of patients with type 2 diabetes who are inadequately controlled on a single agent.

The addition on Avandia 4 mg in single or divided doses to the regimen of patients inadequately controlled on insulin demonstrated significant reductions in HbA_1c levels, which resulted in clinically and statistically significant reduction in insulin dose. As may be expected, due to the complimantary action, hypoglycemia was a commonly reported adverse event. Reduction of the insulin dose (10%-25%) is recommended id FPG levels decrease to <100mg/dL or the patient experiences hypoglycemia. Other common adverse events reported with the combination were upper respiratory tract infection and anemia. For more information regarding safety and efficacy with Avandia in combination with insulin, please see Important Clinical Considerations below, and the enclosed complete prescribing information.

With this new indication, Avandia is now indicated as monotherapy and in combination with metoformin, sulfonylureas or insulin.

Avandia offers you therapy that directly targets insulin resistance and improves estimates of beta-cell funtion.^1,2Inaddition Avandia had demonstrated durability as monotherapy,^*,2an impressive increase in HDL cholesterol,⁺ and a shift toward larger, more buoyant LDL particles.³

For more information regarding Avandia, please talk with your GlaxoSmithKline sales representative or call 1-888-825-5249.

Important Clinical Considerations

Cardiac Considerations: Avandia like other thiazlidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure. Patients should be observed for signs and symptoms of heart failure. In combination with insulin, thiazolidinediones may also increase the risk of other cardiovascular adverse events.

Patients with New York Heart Association (NYHA) Class 3 and 4 cardiac status were not studied during the clinical trials. Avandia is not recommended for these patients.

In clinical trials, and increased incidence of edema, cardiac failure and other cardiovascular adverse events was seen with Avandia in combination with insulin, including some patients not known to have prior CHF or pre-existing cardiac conditions.