NHLBI-sponsored researchers recently announced the results of two major clinical trials that looked for new ways to help adults with type 2 diabetes reduce their risk of cardiovascular disease. Both trials were part of the landmark Action to Control Cardiovascular Risk in Diabetes (ACCORD) study of over 10,000 North American adults with type 2 diabetes who had or were at especially high risk of developing cardiovascular disease. The papers appeared online in The New England Journal of Medicine on March 14. The results were also presented as late-breaking clinical trials at the American College of Cardiology’s 59th annual scientific session in Atlanta, GA.
One of the papers reported that providing intensive therapy to lower systolic blood pressure to below normal levels (less than 120 mmHg) did not reduce participants' overall risk of cardiovascular disease more than lowering systolic blood pressure below 140 mmHg. The other paper reported that taking a drug called a fibrate in addition to a statin to improve multiple blood lipids (LDL and HDL cholesterol and triglycerides) had no more overall benefit on cardiovascular disease than just taking a statin to improve LDL cholesterol. "Overall benefit" refers to the combined rate of non-fatal heart attacks and strokes as well as deaths from cardiovascular disease. The researchers treated and followed both sets of participants for about five years. All participants maintained good blood sugar control as part of another ACCORD trial.
These findings are important. They do not support the general use of intensive therapy to lower blood pressure to normal levels or the use of combination therapy to improve blood lipids in patients similar to the ACCORD study participants. Learning that certain treatment approaches do not work better than others can be just as valuable as discovering a new treatment.
Some of the findings suggest that certain subgroups of patients might benefit from the tested treatments, but more research is needed. The NHLBI will continue to seek new treatment options for patients who, like the ones enrolled in the ACCORD study, are at especially high risk of having cardiovascular problems.
There is still much to be learned from the bounty of data ACCORD has provided. You can expect to see many more papers published from the ACCORD trials in the coming months. Researchers should continue to conduct large-scale clinical trials comparing different treatment approaches to gather the evidence needed to inform good medical practices and weed out potentially harmful or less effective treatment methods.
The NHLBI was the primary sponsor of ACCORD, with support from the National Institute of Diabetes and Digestive and Kidney Disorders, the National Institute of Aging, the National Eye Institute, and the Centers for Disease Control and Prevention. Pharmaceutical and device companies donated medications, matching placebo, device, and supplies.