Navigation Links
FDA Updates Label for AVANDIA(R) to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years
Date:7/14/2008

Data Provides Further Information on AVANDIA as a Safe and Effective

Treatment Option for Appropriate Type 2 Diabetes Patients

PHILADELPHIA, July 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announces today that the U.S. Food and Drug Administration (FDA) updated the prescribing information for AVANDIA(R) (rosiglitazone maleate) to include clinical findings from A Diabetes Outcome Progression Trial (ADOPT), a 4- to- 6 year head-to-head study of AVANDIA versus metformin and glyburide monotherapy in recently diagnosed type 2 diabetes patients. The percentage of patients with inadequate glucose control at five years was 34 percent with glyburide, 21 percent with metformin and only 15 percent with AVANDIA. The difference between AVANDIA and the comparators was statistically significant.

"GSK is pleased that the FDA has approved inclusion of the results from ADOPT, an important clinical trial that provides substantial long-term efficacy and safety data on AVANDIA compared to metformin and sulfonylurea," said Alexander R. Cobitz, MD, PhD, Senior Director, Metabolism, Clinical Development and Medical Affairs, GlaxoSmithKline. "As demonstrated in this study, patients treated with AVANDIA achieved greater sustained glycemic control. Better glycemic control has been proven to reduce risks of serious complications associated with type 2 diabetes including blindness, loss of limbs and kidney failure."

Study Design

ADOPT was a large, international, multi-center, randomized, double-blind, parallel-group study involving 4,351 people, aged 30-75 years who were recently diagnosed with type 2 diabetes (less than or equal to 3 years) from more than 400 sites throughout North America and Europe. ADOPT, conducted over a period of 4 to 6 years, assessed the cumulative incidence of monotherapy failure at five years with AVANDIA, metformin, glyburide, as defined by consecutive fasting plasma glucose (FPG) >180 mg/dL.

Patients were randomized to receive either AVANDIA 4 mg once daily, glyburide 2.5 mg once daily, or metformin 500 mg once daily, and doses were titrated to optimal glycemic control up to a maximum of 4 mg twice daily for AVANDIA, 7.5 mg twice daily for glyburide, and 1,000 mg twice daily for metformin. Initial treatment with AVANDIA reduced the risk of monotherapy failure in people with type 2 diabetes by 32 percent compared to metformin (p<0.001), and 63 percent compared to glyburide (p<0.001) at five years.

Safety Information from ADOPT

In ADOPT, AVANDIA was reported to be generally well-tolerated among the large cohort of people with type 2 diabetes who were followed for up to six years. Incidence of congestive heart failure (CHF) adverse events was the same among patients treated with AVANDIA (0.8 percent) and metformin (0.8 percent); however, people given glyburide experienced a lower rate of CHF events (0.2 percent).

Over the duration of the study, commonly reported adverse events included edema, weight gain and hypoglycemia.

In ADOPT, significantly more women treated with AVANDIA experienced fractures than did those who received either metformin or glyburide. The majority of fractures observed were in the upper arm, hand, or foot. However, the number of women with a hip or spine fracture was low and similar among the three treatment groups. The incidence of fractures for men in ADOPT was similar among the three treatment groups.

Other cardiovascular safety data for AVANDIA in ADOPT were added to the label in November 2007 and show that the results for three endpoints (major cardiovascular events, heart attacks and total mortality) were not statistically significantly different between AVANDIA and comparators.

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 http://www.gsk.com.

Important Safety Information for AVANDIA(R) (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.

Bernadette King

GlaxoSmithKline

215-751-3632


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
2. Diamyd Updates Gene Therapy Program and Outlines Plans for Phase I Clinical Trial for Treatment of Cancer Pain
3. Alfacell Updates Status of ONCONASE(R) Phase III Clinical Program
4. Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
5. Alliance Pharmaceutical Corp. Updates Oxygent(TM) Clinical Development Plan
6. Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System
7. BioCryst Updates Peramivir Clinical Development Plan
8. Alfacell Updates Status of ONCONASE(R) Phase III Clinical Program
9. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
10. Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status
11. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... appointment of Dr. Edward Futcher to ... Director, effective June 23, 2016.Dr. Futcher was also ... and Governance Committees.  As a non-executive member of ... expertise and strategic counsel to VolitionRx in connection ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... report to their offering. ... failure, it replaces the function of kidneys by removing the ... the treatment helps to keep the patient body,s electrolytes such ... Increasing number of ESRD patients & substantial healthcare expenditure on ...
(Date:6/23/2016)... -- In a startling report released today, National Safety Council ... comprehensive, proven plan to eliminate prescription opioid overdoses. Prescription ... are tackling the worst drug crisis in recorded U.S. history, assigned ... Kentucky , New Mexico , ... 28 failing states, three – Michigan , ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the ... Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , “We ... new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
(Date:6/25/2016)... ... , ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter ... bar too high can result in disappointment, perhaps even self-loathing. However, those who set ... , Research from PsychTests.com reveals that behind the tendency to set low ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
Breaking Medicine News(10 mins):