Context: The Action to Control Cardiovascular Risk in Type 2 Diabetes (ACCORD) was a double factorial randomized clinical trial comparing intensive vs. standard glycemic control, intensive versus standard blood pressure control and fenofibrate versus placebo against a background of statin treatment.
Evidence: The primary outcome of cardiovascular disease (CVD), a composite of CVD death, non-fatal myocardial infarction and non-fatal stroke was not reduced by either of the intensive strategies or by addition of fenofibrate; moreover, total mortality was increased by the intensive glycemic strategy. Some secondary CVD outcomes were benefited as were some secondary microvascular outcomes by the more aggressive treatments. Epidemiological analyses were perplexing: for example, earlier severe hypoglycemic episodes were a risk factor for mortality and occurred three times as often in the intensive glycemic treatment group, but the excess of deaths in that group was not accounted for by those subjects who had suffered earlier episodes of severe hypoglycemia.
Conclusions: Despite such perplexing results, some clinical implications that can be drawn from the kaleidoscope of ACCORD findings are offered here. Cases are suggested where intensive blood pressure treatment or addition of fenofibrate to statin therapy may be warranted, whereas intensive glycemic therapy is rarely, if ever, justified in ACCORD type patients.
Trial registration: ClinicalTrials.gov NCT00000620.