GlaxoSmithKline [NYSE:GSK] said that findings from an interim analysis of RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes), a prospective clinical trial designed specifically to determine cardiovascular outcomes in more than 4,400 patients with type 2 diabetes, adds further evidence to the overall cardiovascular safety profile of Avandia? (rosiglitazone maleate).
The study results, authored by Philip D. Home and colleagues on the RECORD Steering Committee, were published Tuesday in the online edition of The New England Journal of Medicine.
The study compares cardiovascular hospitalization and death in patients treated with Avandia dual therapy (Avandia plus metformin or sulfonylurea) and in patients treated with metformin and sulfonylurea in combination. After following patients for an average of 3.75 years, the interim analysis found a low number of events overall, and a similar number of events in each group. The study is scheduled to complete in late 2008.
Like all interim analyses, these data do not offer final conclusions. Based on the interim analysis, key findings include:
The interim data show no significant difference between the Avandia and control groups in the key outcomes of hospitalization or death due to cardiovascular events.
There was no difference between the groups in mortality, whether cardiovascular deaths or deaths from all causes.
The interim data show that Avandia was not significantly different than the control groups in several secondary outcomes, including heart attack.
A significant difference between the Avandia and control groups was seen only in the secondary outcome of congestive heart failure (CHF), where significantly more cases were seen in Avandia patients ? consistent with the well known association between fluid retention and TZDs, the class of medicine to which Avandia belongs. Fluid retention can worsen or lead to CHF. Importantly, despite the increase in CHF, there was no difference between the Avandia group and the control groups in the key outcome of cardiovascular hospitalizations and death.
?The interim findings do not show evidence of a significant difference in cardiovascular death and heart attack between Avandia and the control groups, and therefore do not confirm the hypothesis generated by the recently published meta-analysis in the New England Journal of Medicine that raised concerns about these events with Avandia,? said Moncef Slaoui, chairman, R&D for GSK. ?They addto the weight of evidence, from both previously published long-term clinical trials and other studies, that the overall ischemic cardiovascular safety profile of Avandia is comparable to the traditional anti-diabetes treatments. Patients and physicians should find these data reassuring.?
Because Avandia has been shown to control blood sugar for longer than other traditional oral anti-diabetic medicines, it is an important option for physicians who often need to prescribe a combination of diabetes medicines to help their patients maintain blood sugar levels.