BWI: Large, Long-term Study Shows GSK’s Rosiglitazone has no Increased overall Cardiovascular Risk Compared to Other Commonly used Diabetes Medicines

Press release from Business Wire India
Source: GlaxoSmithKline Pharmaceuticals Limited
Friday, June 05, 2009 09:00 PM IST (03:30 PM GMT)
Editors: General: Consumer interest; Business: Business services, Healthcare, biotechnology & pharmaceutical; Healthcare
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Large, Long-term Study Shows GSK's Rosiglitazone has no Increased overall Cardiovascular Risk Compared to Other Commonly used Diabetes Medicines
RECORD Trial also Demonstrates Durable Blood Sugar Control over time with GSK's Rosiglitazone

Mumbai, Maharashtra, India, Friday, June 05, 2009 -- (Business Wire India) -- Clinical trial results of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study, presented at the American Diabetes Association (ADA) meeting 2009, showed that overall rates of cardiovascular hospitalization and cardiovascular death were similar in patients taking rosiglitazone compared to those receiving metformin and sulfonylurea.

RECORD is a large, prospective, randomized, controlled study initiated in 2001 and designed to compare cardiovascular outcomes of patients on Avandia (Rosiglitazone) added to metformin or sulfonylurea to those on metformin and sulfonylurea. The results from the 4,447-patients study showed that the primary endpoint consisting of cardiovascular hospitalization or cardiovascular death (which includes heart attack, congestive heart failure, and stroke) was not statistically different between the Rosiglitazone groups (321 events, 14.5%) compared to the patients receiving control medications [Metfomin and Sulfonyurea] (323 events, 14.5%).

"RECORD study provides a robust assessment of rosiglitazone's cardiovascular safety and achieving the study's primary endpoint leads us to conclude that rosiglitazone carries no increased risk of overall cardiovascular death or hospitalization compared to the most commonly used diabetes medicines, metformin and sulfonylurea, which have been used for decades," said Dr. Philip D. Home, chairman of the RECORD Steering Committee and a professor at Newcastle University. "Millions of patients with diabetes do not achieve good blood sugar control, even with combination therapy, making a wide range of therapeutic options critical for the management of this growing and deadly disease."

Commenting on the RECORD study, Dr. V Mohan, Chairman & Chief Diabetologist, Dr. Mohan's Diabetes Specialities Centre, said,"The RECORD trial puts to rest the fears regarding rosiglitazone and provides clear evidence that rosiglitazone carries no increased risk of overall cardiovascular death or hospitalization compared to metformin and sulphonylurea."

Glycaemic control, as measured by mean HbA1c, was statistically significantly better in the patient group randomized to Rosiglitazone after the average of 5.5 years of treatment in the trial. This result is consistent with the superior long term glycaemic control (for nearly 5 years) previously demonstrated by Rosiglitazone versus metformin and sulfonylurea in the ADOPT (A Diabetes Outcome Progression Trial) study.

Congestive heart failure (CHF) is a known effect of thiazolidinedione (TZD) class (Rosiglitazone and Pioglitazone) and is mentioned in the prescribing information of both these drugs. As anticipated, rates of CHF in the RECORD study were statistically significantly higher in the group randomized to Rosiglitazone (61 events, 2.7 %) compared to the control group (29 events, 1.3 %).

"RECORD study provides reassuring information on GSK's Rosiglitazone. This data is very relevant in the Indian context, given that India has over 42 million diabetics and every fifth diabetic in the world is a native Asian Indian" said Dr. Sadhna Joglekar, GlaxoSmithKline's VP Medical, Regulatory & Clinical Research, India. Avandia is marketed in India by GSK as Windia. "Clinical outcomes trials like this offer the highest standard of evidence when considering the benefits and risks of medicines. We believe that Rosiglitazone remains an important diabetes medicine for the appropriate patients." said Dr. Ellen Strahlman, GlaxoSmithKline's Chief Medical Officer.

About 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 further information please visit www.gsk.com/ www.gsk-india.com.


CONTACT DETAILS
Sunaina Baghla, Assistant Manager- Corporate Communications, GlaxoSmithKline Pharmaceuticals Limited, +91 9819995850, sunaina.b.baghla@gsk.com

KEYWORDS
CONSUMER, BUSINESS SERVICES, HEALTHCARE, HEALTHCARE

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