Further information: Hypertension (see p1833) and Endocrine Disorders and the Heart (see p2295) from Cardiovascular Medicine, 3rd Edn*

This review features two studies focusing on patients with diabetes mellitus that were recently presented at the American College of Cardiology Scientific Sessions in Atlanta. Both segments of the ACCORD trial are summarized here.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) [1] was conducted in diabetic patients who were at high-risk of cardiovascular (CV) events to determine if a combination therapy that included a fibrate to raise HDL cholesterol and to lower triglyceride levels and a statin to lower LDL cholesterol was more effective than treatment with statin therapy alone. Between January 11, 2001 and October 29, 2005, 5518 patients in 77 clinical sites who were already being treated with open-label simvastatin were randomized to also receive either masked fenofibrate or placebo. Prespecified primary outcome was the first occurrence of a major CV event, including nonfatal myocardial infarction (MI), nonfatal stroke, or death from CV causes. Secondary outcomes were a combination of the primary outcome plus revascularization or hospitalization for congestive heart failure (HF), a combination of a fatal CV event, nonfatal MI, or unstable angina; nonfatal MI; fatal or nonfatal stroke; death from any cause or from CV causes; and CV death due to HF. The average follow-up for patients who did not have an event was 5.6 years. There were no significant differences in the primary outcome for either the fenofibrate group (annual rate, 2.2%) or the placebo group (annual rate, 2.4%), with hazard ratio (HR) in fenofibrate group, 0.92; 95% confidence interval (CI), 0.79–1.08; P=0.32. There were also no significant differences in secondary outcomes. Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (HR, 0.91; 95% CI, 0.75–1.10; P=0.33). ACCORD investigators concluded that combination therapy did not reduce CV risk in high-risk patients with type 2 diabetes.

This study [2] draws from the same cohort of patients with type 2 diabetes mellitus as the previous paper; however, the focus of this study was to determine if lowering the systolic blood pressure (BP) to less than 120 mm Hg was more effective in reducing CV events than the current target strategy of lowering systolic BP to below 135–140 mmHg. The 4733 patients with type 2 diabetes were randomly assigned to receive intensive therapy that would target a systolic pressure of less than 120 mmHg, or a standard therapy of pressure less than 140 mmHg. The same primary and secondary outcomes were in effect for both ACCORD trials. In the intensive therapy group after one year, the mean systolic BP was 119.3 mm Hg, and in the standard therapy group, mean systolic BP was 133.5 mmHg. In the intensive therapy group, the annual rate of outcome was 1.87%, and it was 2.09% in the standard therapy group (HR with intensive therapy, 0.88; .95% CI, 0.73–1.06; P=0.20). There were no significant differences in annual rates of death. The annual rates of stroke were 0.32% in intensive therapy patients and 0.53% in the standard therapy patients. Of the 2362 patients in the intensive therapy group, 77 had serious adverse events related to antihypertensive treatment (3.3%), as did 30 of 2371 patients in the standard therapy group (1.3%). Investigators concluded that targeting a systolic BP of less than 120 mmHg did not reduce risk of CV events in patients with type 2 diabetes.

[1] The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010 (10.1056/NEJMoa1001282)

[2] The ACCORD Study Group. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010 (10.1056/NEJMoa1001286)

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