Intensive Blood-Pressure Lowering in Patients with Type 2 Diabetes

Uncertainty persists regarding the effects of intensive blood-pressure lowering in patients with type 2 diabetes.

In this multicenter, open-label, randomized trial conducted in Brazil, patients with elevated blood pressure, type 2 diabetes, and high cardiovascular risk received intensive therapy targeting a systolic blood pressure of less than 120 mm Hg or standard therapy targeting a systolic blood pressure of less than 140 mm Hg. The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina or heart failure.

Of the 9476 ethnically diverse patients who were enrolled, 4745 were assigned to receive intensive therapy and 4731 to receive standard therapy. The mean (±SD) age was 64.7±8.2 years, and 5871 of the patients (62.0%) were women. The mean systolic blood pressure during follow-up (with exclusion of the first 3 months) was 121.8±10.8 mm Hg in the intensive-therapy group and 135.4±8.2 mm Hg in the standard-therapy group. During a median follow-up of 4.0 years (interquartile range, 3.9 to 4.0), a primary-outcome event occurred in 286 patients (6.0%; 1.65 events per 100 person-years) in the intensive-therapy group and in 315 patients (6.7%; 1.83 events per 100 person-years) in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval, 0.77 to 1.06; P = 0.20). Serious adverse events occurred in 706 patients (14.9%) with intensive therapy and in 693 patients (14.6%) with standard therapy.

Among patients with type 2 diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the occurrence of major cardiovascular events. (Funded by Hospital Israelita Albert Einstein and the Brazilian Ministry of Health; OPTIMAL-DIABETES ClinicalTrials.gov number, NCT04040634.).