Intensive blood-pressure control for the prevention of major cardiovascular events in patients with type 2 diabetes: Rationale, design and baseline characteristics of the OPTIMAL-DIABETES randomized trial.

BACKGROUND

Evidence on the beneficial effects of intensive blood pressure (BP) control is still uncertain in patients with type 2 diabetes (T2D), particularly in an ethnically diverse population.

OBJECTIVES

To assess whether a target of systolic BP (SBP) < 120 mm Hg reduces major cardiovascular (CV) events compared with a target of SBP < 140 mm Hg in patients with T2D and high CV risk.

DESIGN

This is a multicentre, 2-arm, open-label, randomized clinical trial, in which individuals aged ≥50 years, with a SBP between 130 and 180 mm Hg, T2D and high CV risk are randomly assigned to a target SBP of <120 or <140 mm Hg. The primary endpoint is a composite of CV mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or hospitalization for heart failure. Maximum follow-up duration is 48 months. Main analysis will follow the intention-to-treat principle.

RESULTS

From August 2019 through October 2021, 9,476 participants from 33 sites in Brazil were enrolled. The overall mean age was 64.74 years (standard deviation [SD], 8.16), and 5,871 (62.0%) were women. Race distribution was diverse with 4,025/9,467 (42.5%) self-described as mixed-race, 3,971/9,467 (41.9%) as White, and 1,374/9,467 (14.5%) as Black. Overall, 2,697/9,475 (28.5%) and 371 (3.9%) had established and subclinical CV disease, respectively. Antihypertensive medication was prescribed to 9,104/9,473 (96.1%) of the participants. Mean SBP is 145.89 mm Hg (SD, 12.13) and mean diastolic BP is 79.48 mm Hg (SD, 10.61).

CONCLUSION

The OPTIMAL-DIABETES trial results will provide valuable evidence regarding the benefits and risks of antihypertensive treatment to an SBP < 120 vs <140 mm Hg in a diverse population of patients with T2D, elevated BP, and high CV risk.

TRIAL REGISTRATION: The trial is registered at the ClinicalTrials.gov (NCT04040634).