Clinical Update

Study identifies no side effects of rosiglitazone to cardiac diseases

Our News Bureau - Mumbai

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 hospitalisation and cardiovascular death were similar in patients taking rosiglitazone compared to those receiving metformin and sulfonylurea.

RECORD is a large, prospective, randomised, 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 hospitalisation or cardiovascular death (which includes heart attack, congestive heart failure, and stroke) was not statistically different between the Rosiglitazone groups (321 events, 14.5 percent) compared to the patients receiving control medications [Metfomin and Sulfonyurea] (323 events, 14.5 percent).

"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 hospitalisation 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 and 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 hospitalisation compared to metformin and sulphonylurea."

Glycaemia 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 glycaemia control (for nearly five years) previously demonstrated by Rosiglitazone versus metformin and sulfonylurea in the ADOPT (A Diabetes Outcome Progression Trial) study. "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 Vice President Medical, Regulatory and 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.