A tighter blood-pressure target did not cut events in type 2 diabetes

How low to push blood pressure in someone with type 2 diabetes has been argued over for years. A landmark trial a decade ago, SPRINT, found that aiming for a systolic pressure below 120 rather than below 140 reduced cardiovascular events — but SPRINT deliberately excluded people with diabetes, leaving the question open for exactly the group in which it is asked most often. A trial presented at the American Heart Association's 2026 Scientific Sessions and published in the New England Journal of Medicine on 7 November set out to answer it directly [s1].

The question

The uncertainty is real and specific: do people with type 2 diabetes get the same protection from an aggressive blood-pressure target that non-diabetic patients appeared to get in SPRINT, or does the balance of benefit and harm shift [s1]? OPTIMAL-DIABETES, registered as NCT04040634, was designed to find out [s1][s2].

How the trial was built

This was a multicentre, open-label, randomised trial conducted in Brazil [s1]. It enrolled patients who had elevated blood pressure, type 2 diabetes and high cardiovascular risk, and assigned them to one of two strategies: intensive therapy targeting a systolic blood pressure below 120 mmHg, or standard therapy targeting below 140 mmHg [s1].

The primary endpoint was a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for unstable angina or heart failure [s1].

Of the 9,476 ethnically diverse patients enrolled, 4,745 were assigned to intensive therapy and 4,731 to standard therapy [s1]. Their mean age was 64.7 years, and 5,871 (62.0%) were women — an unusually high proportion of women for a cardiovascular trial [s1].

What it found

The two targets produced a clear separation in achieved blood pressure, so the strategies genuinely differed. Excluding the first three months, the mean systolic pressure during follow-up was 121.8 mmHg in the intensive group and 135.4 mmHg in the standard group [s1] — a gap of roughly 14 mmHg.

That separation did not translate into fewer events. Over a median follow-up of 4.0 years, a primary-outcome event occurred in 286 patients (6.0%, or 1.65 events per 100 person-years) in the intensive group and in 315 patients (6.7%, or 1.83 per 100 person-years) in the standard group [s1]. The hazard ratio was 0.90, with a 95% confidence interval of 0.77 to 1.06 and a P value of 0.20 — the confidence interval crosses 1, so the difference is not statistically significant [s1].

Harms, often the counterweight to intensive blood-pressure lowering, were similar between groups: serious adverse events occurred in 706 patients (14.9%) with intensive therapy and 693 (14.6%) with standard therapy [s1].

What is, and is not, established

OPTIMAL-DIABETES found that, among patients with type 2 diabetes, targeting a systolic pressure below 120 rather than below 140 did not reduce major cardiovascular events, even though it lowered pressure substantially [s1]. The authors state that conclusion plainly [s1].

Several caveats shape how far that travels. The event rate was low — about 6% over four years — and a low event rate makes it harder for a trial to detect a modest benefit if one exists, so this is not proof that the tighter target is useless, only that it did not show an advantage here [s1]. The trial was open-label, meaning patients and clinicians knew the assignment, which can influence the handling of softer endpoints. And it was conducted in one country; whether the result generalises everywhere is a fair question [s1]. What the trial does counter is any assumption that SPRINT's finding automatically carries over to diabetes — in this trial, it did not [s1].

Blood-pressure targets and medicines are individual clinical decisions, and nothing here is a reason to change treatment. This article describes research and is not medical advice.