Key result
OPTIMAL-DIABETES trial design details intensive versus standard blood pressure control in type 2 diabetes.
Why the study?
Evidence on the beneficial effects of intensive blood pressure control is still uncertain in patients with type 2 diabetes, particularly in an ethnically diverse population.
Does intensive blood pressure control targeting a systolic blood pressure <120 mm Hg reduce major cardiovascular events compared with a target <140 mm Hg in patients with type 2 diabetes and high cardiovascular risk?
RCT (n=9,476)
Open-label
2-arm randomized
Yes
Does intensive blood pressure control targeting a systolic blood pressure <120 mm Hg reduce major cardiovascular events compared with a target <140 mm Hg in patients with type 2 diabetes and high cardiovascular risk?
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This paper outlines the rationale, design, and baseline characteristics of the OPTIMAL-DIABETES trial, which will evaluate intensive (<120 mm Hg) versus standard (<140 mm Hg) systolic blood pressure targets in an ethnically diverse Brazilian cohort of 9,476 patients with type 2 diabetes and high cardiovascular risk.
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).
Santo et al. (2026) conducted an RCT in Type 2 diabetes with elevated blood pressure and high cardiovascular risk (n=9,476). Intensive blood pressure control (target SBP < 120 mm Hg) vs. Standard blood pressure control (target SBP < 140 mm Hg) was evaluated on Composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or hospitalization for heart failure. Intensive BP control (SBP <120 vs <140 mm Hg) is being tested in 9,476 patients with T2D (mean age 64.74 years, mean baseline SBP 145.89 mm Hg); outcome results are not yet reported.
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