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Avandia: Adherence Data presented at the American Diabetes Association

San Francisco, June 8, 2008 – Findings from a new retrospective analysis conducted by GlaxoSmithKline (GSK) in a medical claims database suggests that patients receiving the addition of AVANDIA^® (rosiglitazone maleate) to metformin monotherapy were more likely to adhere to treatment compared to metformin and sulfonylurea combination therapy.  A separate retrospective analysis of medical claims showed that for patients on monotherapy and progressing to dual therapy, a fixed-dose combination of rosiglitazone and glimepiride – better known as AVANDARYL^® – may also help improve adherence compared to dual therapy with two separate medications.  These data [posters #441, 1200] were presented at the 68^th Annual American Diabetes Association (ADA) Scientific Sessions in San Francisco, CA.

“It is important that we provide patients with a treatment regimen that they can follow so that their condition is properly managed and the risk of developing serious diabetes-related complications is minimized,” said R. Paul Aftring, MD, PhD, Clinical Group Director, Cardiovascular and Metabolic Medicines Development Center, GlaxoSmithKline (GSK).  “A growing body of evidence suggests that the right combination of medicines can help improve adherence, and when combined with proper exercise and diet, will help patients achieve better blood sugar control.”

Additional data [posters #1227, 1228] were presented that demonstrated the value and accuracy of a simple screening tool developed by GSK to help estimate the probability of a person having, currently and in the future, either undiagnosed diabetes or pre-diabetes (impaired fasting glucose or impaired glucose tolerance) as well as elevated plasma glucose.  The screening tool, which was created using data from the Center for Disease Control and Prevention’s (CDC) Third National Health and Nutrition Examination Survey (NHANES III), was applied to a cohort of individuals using the Atherosclerosis Risk in Communities (ARIC) database, and compared favorably in accuracy to NHANES data in estimating undiagnosed diabetes and elevated plasma glucose. 

Benefits of Adding AVANDIA to Metformin Monotherapy

A retrospective analysis [poster #441] identified 3,713 patients through the PharMetrics claims database as receiving metformin from 1 July 2000 through 31 December 2004.  These patients were further identified based on their add-on therapy (29% AVANDIA cohort, 71% sulfonylurea cohort) and evaluated for treatment adherence based on Medication Possession Ratio (MPR) – a formula used to determine compliance by calculating how much medication a patient obtained to how much medication the patient should have ideally obtained.  The study found that a significantly greater proportion of patients who received AVANDIA were adherent to therapy than those who received sulfonylurea (74% vs. 69%, p< 0.01).  These patients also experienced fewer hospitalizations (23% vs. 27%, p< 0.01), ER visits (26% vs. 29%, p=0.05) and outpatient visits (54% vs. 58%, p=0.02).  These differences did not change after adjusting for baseline demographic and clinical characteristics.

Impact of AVANDARYL on Treatment Adherence

A separate retrospective, claims-based analysis [poster #1200] using data from a large, U.S. managed care plan included more than 10,000 subjects and assessed changes in medication adherence rates in patients switching from monotherapy or dual therapy with AVANDIA and/or sulfonylurea to AVANDARYL, a fixed-dose combination of AVANDIA and the glimepiride (a sulfonylurea).  The study identified a relationship between adherence to therapy and drug regimen and showed a significantly less reduction in the mean Medication Possession Ratio (MPR) when monotherapy users switched to fixed-dose combinations versus dual therapies (-0.03 vs. -0.10, p< 0.001).  The study also showed greater improvements in mean MPR when dual therapy users switched to fixed-dose combinations versus remaining on dual therapies (0.09 vs. 0.05; p<0.0001).

Diabetes: A Disabling Condition with Devastating Consequences

More than 19 million Americans have type 2 diabetes and a third are undiagnosed or unaware that they have diabetes.  Type 2 diabetes is a chronic, progressive and serious disease that occurs either when the body does not produce enough insulin or when the body does not respond properly to its natural insulin.  Improving blood sugar control in people with type 2 diabetes can help reduce the risk of diabetes-related complications, which include heart disease, stroke, eye damage, kidney failure and foot problems that lead to amputations.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For company information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

Important Safety Information for AVANDIA^® (rosiglitazone maleate)

AVANDIA, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes.

AVANDIA can cause or worsen heart failure.  If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on AVANDIA.  AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction).  This risk appeared higher in patients taking medicines called nitrates or insulin.  Taking AVANDIA with insulin or with nitrates is not recommended.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking.

If you take AVANDIA, tell your doctor right away if you:

• Have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness
• Experience changes in vision
• Become pregnant

Review your medical history and tell your doctor if you: 

• Have heart failure or other heart problems
• Have liver problems or liver disease
• Are pregnant or are nursing

 

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy.

More fractures have been observed in women taking AVANDIA.

For more information about AVANDIA, please see Patient Information.  For further information on AVANDIA, please see full Prescribing Information.

Important safety information for AVANDARYL^® (rosiglitazone maleate and glimepiride)

AVANDARYL, along with diet and exercise, helps improve blood sugar control.  AVANDARYL is a combination of two drugs – rosiglitazone maleate and glimepiride.

AVANDARYL may cause low blood sugar.  Lightheadedness, dizziness, shakiness or hunger may mean that a patients’ blood sugar is too low.  If patients have kidney problems, they may need a lower dose of Avandaryl to reduce problems with low blood sugar.  Patients should talk to their doctor if low blood sugar is a problem for them.

Patients should tell their doctor if they have heart problems or heart failure.  AVANDARYL can cause the 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 patients have swelling or fluid retention, shortness of breath or trouble breathing, an unusually rapid increase in weight, or unusual tiredness while taking AVANDARYL, they should call their doctor right away.

Patients should not take AVANDARYL if they have liver problems.  Blood tests should be used to check for liver problems before starting and while taking AVANDARYL.  Patients should tell their doctor if they have liver disease, or if they experience unexplained tiredness, stomach problems, dark urine or yellowing skin while taking AVANDARYL.

Patients should tell their doctor about all of the medicines they are taking.

AVANDARYL may increase the risk of pregnancy.  Patients should talk to their doctor before taking AVANDARYL if they could become pregnant or if they are pregnant.  If patients are nursing, they should not take Avandaryl.

Doctors should check their patients’ eyes regularly.  Very rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone, a component of AVANDARYL.

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