The study called ACCORD (Action to Control Cardiovascular Risk in Diabetes) is back in the news. The study, which included 10,251 patients with type 2 diabetes mellitus and who were at especially high risk of cardiovascular events (such as heart attacks, stroke, or death from cardiovascular disease). The study should not be extrapolated to patients with type 2 diabetes "who are younger, whose diagnosis is more recent, or who have a lower risk of CVD than participants studied in the ACCORD trials. It is not known what effect more intensive therapy might have on CVD in younger people with type 2 diabetes or in patients with a lower risk of CVD than were studied in ACCORD" (per a NIH Q&A about the study).
I have previously written (several times!) about earlier results from the ACCORD trial, which surprised experts when it was announced that patients in the tight-glucose-control part of the study (aiming for A1C below 6.0) had more deaths than patients in the standard-glucose-treatment group (aiming for A1C between 7 and 7.9). This unexpected finding generated a lively discussion amongst endocrinologists: were the problems in the intensive group actually due to hypoglycemia, and if not, to what? No clear reason has been identified to explain why there were excess deaths in the tight-glucose-control part of the ACCORD trial. Various experts are implicating weight gain, the use of multiple drug combinations and perhaps even getting blood sugar too low, too fast.
Now, more results from the ACCORD study have become available, and again, the results seem counterintuitive. (A summary of the study and the new findings is available at the NIH website [and are reproduced here]). This time, it was announced that lowering blood pressure of the participants to normal levels did not significantly decrease the risk of fatal or nonfatal cardiovascular disease events. Similarly, treating lipids (cholesterol, triglycerides, LDL and HDL) with a combination of a fibrate and a statin did not decrease the risk of cardiovascular disease events more than treatment with statin alone.
"ACCORD provides important evidence to help guide treatment recommendations for adults with type 2 diabetes who have had a heart attack or stroke or who are otherwise at especially high risk for cardiovascular disease," Susan B. Shurin, M.D., acting director of the NIH's National Heart, Lung, and Blood Institute, is quoted as saying. "This information provides guidance to avoid unnecessarily increasing treatment that provides limited benefit and potentially increases the risk of adverse effects."
I take the results differently. In fact, the NIH press release states that "Lowering blood pressure to below the standard level significantly cut the risk of stroke by about 40 percent. The intensive blood pressure group had 36 strokes, compared to 62 strokes in the standard group." You can't just ignore this and say that treatment is of "limited benefit."
I do agree with one conclusion, however: adding fibrates to statins seems to be overkill. But statins do have a place, and ACCORD did not attempt to establish whether statins alone (vs placebo) might be appropriate: they are well-established in the care of hyperlipidemia. The lead author agreed: "The lack of benefit from fibrates should not obscure the proven value of statins in preventing cardiovascular disease, which is well established from earlier studies," Henry N. Ginsberg, M.D. added. "Patients should discuss with their health care provider the implications of this research for their lipid therapy management." Yes they should! If your lipids are not at ideal levels despite statins or other antilipid medications, then either raising your dose, or adding a second agent, should be considered - but adding a fibrate to a statin may not be the best choice.
Back to the confusing discussion. As Denise G. Simons-Morton, M.D., Ph.D., one of the co-authors, said: "the findings in no way detract from the important point that controlling blood pressure and LDL cholesterol levels reduce cardiovascular risk - not only in patients with diabetes, but in all patients with elevated levels."
All patients and their caregivers should understand that whether you have type 2 diabetes (either with or without cardiovascular disease) or are a type 1 diabetes patient, or for that matter, anyone else, controlling blood glucose, blood pressure, and blood lipids are extremely important to prevent nasty complications. The ACCORD study merely reminds us that overtreating might not be much more helpful than treating.