LATEST STUDY SHOWS NO LINK BETWEEN DIABETES DRUG ROSIGLITAZONE AND HEART RISKS

Two Large, Independent Outcomes Trials Offer New Important Safety Information on Cardiovascular Effects of Rosiglitazone Maleate

Two long-term, large-scale and independent studies evaluating cardiovascular (CV) outcomes in people with type 2 diabetes enrolled more than 9,300 patients taking GlaxoSmithKline’s (GSK) diabetes medication rosiglitazone maleate and provided an additional 20,000 patient years of experience with the drug. The Veteran Affairs Diabetes Trial (VADT), through two separate analyses, found that rosiglitazone maleate was not associated with increased risk for heart attacks and CV death while a second trial, The Action to Control Cardiovascular Risk in Diabetes Study Group (ACCORD), found that rosiglitazone maleate was not associated with any increased risk of death. These studies were presented during the recently concluded 68th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, CA. These findings display a safety profile consistent with results from other long-term studies (DREAM, ADOPT and RECORD) with rosiglitazone maleate, which show no statistically significant difference between the drug and other medications used in the trials with regard to major CV endpoints .

"The findings on rosiglitazone maleate should be reassuring to physicians who prescribe the medication for their type 2 diabetes patients," added Paul Aftring, MD, PhD, GSK Clinical Lead. "The safety findings from these two trials add substantial patient experience to the large body of existing evidence on the safety profile of the medication."

Findings from VADT

VADT evaluated whether intense glycemic control in patients with type 2 diabetes would reduce major CV events. The study had been ongoing for 7.5 years. In total, 1,704 patients enrolled in VADT took rosiglitazone maleate.

Study Design

The primary result of VADT did not show that intensive blood sugar control (HbA1c levels below 7%) had a statistically significant effect on reducing major CV events associated with diabetes. However, it was found that there was a favorable trend in reducing all CV events, except CV death and inoperable heart disease, among the patients in the intensive arm. There were significantly fewer CV events in the trial than predicted.

In the trial, investigators said that they were “more aggressive” with rosiglitazone maleate and other medications in the intensive arm to achieve and maintain tight glycemic targets. The investigators found that in VADT, there were no increased deaths associated with any of the medications used in the trial, including rosiglitazone maleate.

Findings from ACCORD

ACCORD, which investigated whether or not intensive glycemic control would reduce CV events in patients with type 2 diabetes who had either established cardiovascular disease or additional CV risk factors, was presented at a press conference at the ADA Scientific Sessions and published simultaneously in the New England Journal of Medicine. The study had a mean follow-up of 3.5 years. In total, 7,623 patients enrolled in the ACCORD trial took rosiglitazone maleate, representing more than 19,200 patient years of experience with the medication.

The investigators found that, as compared with standard therapy, the use of intensive therapy to reach the study’s A1C goal for 3.5 years did not significantly reduce major CV events. Although they found an increase in CV deaths among these high-risk patients who were in the intensive arm, the death rates from ACCORD were substantially lower than investigators predicted at the outset of the trial.

Additionally, an accompanying editorial in the New England Journal of Medicine states, ”…the ACCORD trial investigators concluded that patients in the standard-control group and those in the intensive-control group had similar risks and rates of death, whether or not they were prescribed rosiglitazone.”

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. Controlling blood sugar may help prevent the serious complications of diabetes such as heart attack, stroke, blindness, amputation and kidney failure. Patients are advised to consult their physicians to learn more about effectively controlling blood sugar and managing diabetes.

Rosiglitazone maleate is backed by one of the largest programs to study the safety and effectiveness of the drug (52,000 patients) ever undertaken for any medicine, and the largest for any oral anti-diabetic medicine to date. Clinical trial data demonstrate that rosiglitazone is the only drug in its class to have been proven to control blood sugar for up to five years.

As one of the world’s leading research-based pharmaceutical and healthcare companies, GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer.