Due to safety concerns part of diabetes study halted; SE Idaho participants notified

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data, although the study will continue.

Southeast Idaho residents who have been participating in this study have been contacted and informed of the new findings.

In this trial of adults with type 2 diabetes who are at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose  (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy. Study participants receiving intensive blood glucose lowering treatment will now receive the less-intensive standard treatment.

The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or three per 1,000 participants each year, over an average of almost four years of treatment. The death rates in both groups were lower than seen in similar populations in other studies.

ISU is one of 80 sites for this study, which started in 2001 and will run through 2009.  More than 140 people from southeast Idaho have been participating in the study.

“A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes,” said Elizabeth G. Nabel, M.D., director, NHLBI.

“Though we have stopped this part of the trial,” continued Nabel, “we will continue to care for these participants, who now will receive the less-intensive standard treatment. In addition, we will continue to monitor the health of all participants, seek the underlying causes for this finding, and carry on with other important research within ACCORD.”

Rex Force, Pharm.D., professor in the ISU Family Medicine Residency Program and principal investigator of the ACCORD study in southeast Idaho, said that the risks publicized about the study should be viewed in context.

“We’ve contacted everyone in southeast Idaho who has volunteered to participate in the study. Our concern is that they are informed of the results and understand what it means for their care,” Force said. “Many are participating in the study because of the altruism involved. They know that the knowledge gained in the project will help many other patients struggling with diabetes. Our study volunteers have been very engaged and committed to the project over the years.”

That altruism is yielding substantial return for the medical understanding of some facets of diabetes and some study findings have been surprising to researchers, Force said.

”Basically we’ve been doing this work to see whether there are differences in outcomes using aggressive treatments,” Force said. “There is a tendency to think ‘lower is better’ with regard to cholesterol and heart disease or, blood sugar and diabetes in this instance, but going aggressively lower with blood sugar did not prove beneficial in this patient population. This flies in the face of what might be expected and is a very important new finding.”

In stopping this part of the trial, Nabel accepted the recommendation of the 10-member Data and Safety Monitoring Board (DSMB) – an independent advisory group of experts in diabetes, cardiovascular disease, epidemiology, patient care, biostatistics, medical ethics, and clinical trial design that has been monitoring ACCORD since it began. A specific charge of any DSMB is to monitor participant safety.

ACCORD participants will continue to receive blood sugar treatment from their study clinicians. Those participants in the intensive treatment group will now be treated to the same A1C goals as those already in the standard treatment group.

“The ACCORD findings are important, but will not change therapy for most patients with type 2 diabetes. Few patients with high cardiovascular risk like those studied in ACCORD are treated to blood sugar levels as low as those tested in this study,” said Judith Fradkin, M.D., director, Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases. “People with diabetes should never adjust their treatment plan or goals without consulting their health-care providers.”

Please Note: This is a shortened version of an NHLBI press release, which includes information pertaining to southeast Idaho. To view the NHLBI release in its entirety, visit http://www.nhlbi.nih.gov/health/prof/heart/other/accord/.

Visit http://www.accordtrial.org/web/public/index.cfm for more information on the ACCORD study.

ISU Contact: Dr. Rex Force, (208) 282-4508

National Contacts: National Heart, Lung, and Blood Institute Communications Office, (301) 496-4236 or nhlbi_news@nhlbi.nih.gov; National Institute of Diabetes and Digestive and Kidney Diseases Office of Communications and Public Liaison, (301) 496-3583 or niddkmedia@mail.nih.gov