Healthcare Industry News:  Avandamet 

Biopharmaceuticals Endocrinology

 News Release - June 6, 2007

Newly Published Data From Large Study Support Cardiovascular Safety of Avandia (rosiglitazone maleate)

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

LONDON and PHILADELPHIA, June 6 (HSMN NewsFeed) -- 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 hospitalizations 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.

Important Safety Information for Avandia® (rosiglitazone maleate)

Avandia, along with diet and exercise, helps improve blood sugar control. It may be taken alone or with other diabetes medicines.

Tell your doctor if you have heart problems or heart failure. Avandia can cause your body to keep extra fluid, which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. If you have swelling or fluid retention, shortness of breath or trouble breathing, an unusually rapid increase in weight, or unusual tiredness while taking Avandia, call your doctor right away.

You should not take Avandia if you have liver problems. Blood tests should be used to check for liver problems before starting and while taking Avandia. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandia.

Tell your doctor about all of the medicines you are taking.

If you are taking Avandia with another diabetes medicine that lowers blood sugar, you may be at increased risk for low blood sugar. Ask your doctor whether you need to lower the dose of your other diabetes medicine.

Avandia may increase your risk of pregnancy. Talk to your doctor before taking Avandia if you could become pregnant or if you are pregnant. If you are nursing, you should not take Avandia.

Talk to your doctor for advice on how to keep your bones healthy. More fractures, usually in the upper arm, hand, or foot, have been seen in women taking Avandia.

Your doctor should check your eyes regularly. Very rarely, some people have experienced vision changes due to swelling in the back of the eye while taking Avandia.

Important Safety Information for Avandamet® (rosiglitazone maleate/metformin HCl)

Avandamet, along with diet and exercise, helps improve blood sugar control. It is a combination of two drugs -- rosiglitazone maleate and metformin HCl.

A small number of people who have taken metformin, one of the components of Avandamet, have developed a rare yet serious condition called lactic acidosis (a buildup of lactic acid in the blood). Lactic acidosis occurs most often in people with kidney problems and can be fatal in up to one half of the cases. You should not take Avandamet if you have kidney problems. Tests should be used to check your kidneys before and while taking Avandamet. You should not drink alcohol excessively when taking Avandamet. If you are taking medicines for heart failure, you may be at increased risk of lactic acidosis.

Tell your doctor if you have heart problems or heart failure. Avandamet can cause your body to keep extra fluid, which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. If you have swelling or fluid retention, shortness of breath or trouble breathing, an unusually rapid increase in weight, or unusual tiredness while taking Avandamet, call your doctor right away.

You should not take Avandamet if you have liver problems. Blood tests should be used to check for liver problems before starting and while taking Avandamet. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandamet.

Tell your doctor about all of the medicines you are taking.

Avandamet may increase your risk of pregnancy. Talk to your doctor before taking Avandamet if you could become pregnant or if you are pregnant. If you are nursing, you should not take Avandamet.

Talk to your doctor for advice on how to keep your bones healthy. More fractures, usually in the upper arm, hand, or foot, have been seen in women taking rosiglitazone, a component of Avandamet.

Your doctor should check your eyes regularly. Very rarely, some people have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone, a component of Avandamet.


Source: GlaxoSmithKline

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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