Deaths force NIH to alter diabetes trial, ACC responds

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NHBLI halts type 2 diabetes trial due to deaths. Source: ABC News  

The National Heart, Lung and Blood Institute has stopped the intensive glucose-lowering arm of the ACCORD trial, a cardiovascular-endpoint study of type 2 diabetes, due to an unexpected increase in the number of deaths.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study had enrolled 10,251 participants. Participants, who had diabetes for a 10-year average at enrollment, were assigned to either standard (5,123) or intensive (5,128) blood sugar treatment goals.

Of these patients, 257 in the intensive treatment group have died, compared with 203 in the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment, the NHBLI said. The death rates in both groups were lower than seen in similar populations in other studies.

“The NHBLI made the prudent decision to halt the trial, especially because the monitoring committee followed the typical response when patients are feared to be in harm” ACC President-Elect W. Douglas Weaver, MD, told CVB News.
Weaver is the chair of cardiology and co-director at the Henry Ford Heart & Vascular Institute in Detroit.

Patients in both treatment groups used a variety of medications, including Avandia, a drug that has been linked to adverse events in studies over the past year, according to William T. Friedewald, MD, ACCORD steering committee chair and clinical professor of medicine and public health at Columbia University in New York City.

“Because of the recent concerns with rosiglitazone [Avandia], our extensive analysis included a specific review to determine whether there was any link between this particular medication and the increased deaths. We found no link,” Friedewald said in a statement from the NHLBI.

GlaxoSmithKline released a statement saying that “none of the medicines in the study appear to be the cause of the increased risk. The study is continuing, and patients will continue to receive Avandia and all other diabetes medicines; however, the goal for glucose control will be adjusted.”

NHBLI said that the ACCORD participants will continue to receive blood sugar treatment from their study clinicians until the planned trial conclusion in June 2009. The participants in the intensive treatment group will now be treated to the same A1C goals as those in the standard treatment group.

Despite extensive analyses, the ACCORD researchers have yet to determine a specific cause for the increased deaths among the intensive treatment group. The researchers said they will continue to monitor participants and conduct additional analyses to try and explain the findings. Investigators said they are preparing a report of the findings for a peer-reviewed publication.

For Weaver, these results point to the importance of personalized medicine.

“One important message for physicians is that the better we treat these patients in terms of their biochemical abnormalities, the better they are going to be,” he said.

Weaver also said that these results could lead to immediate changes in the way physicians manage patients.

In addition, the ACCORD outcomes will influence any future ACC guidelines, which are often times reflected in the American Diabetes Association, he said.