OPTIMAL-DIABETES

Presented in LBS.03 at AHA 2026 (Saturday 7 November, Karla Santo, Hospital Israelita Albert Einstein, Sao Paulo) and published simultaneously in NEJM. OPTIMAL-DIABETES randomised 9,476 adults aged 50 or over (mean 65, 62 percent women) with type 2 diabetes, systolic 130 to 180 mmHg (baseline 146/80) and established cardiovascular disease (28.5 percent), subclinical disease (3.9 percent), chronic kidney disease (22.6 percent) or other risk factors, at 33 Brazilian sites between August 2019 and October 2021, to a systolic target below 120 or below 140 mmHg, open label. Achieved systolic pressure after the first 3 months: 122 versus 135 mmHg. Over a median 4 years the primary endpoint (cardiovascular death, stroke, MI, hospitalisation for heart failure or unstable angina) occurred in 286 patients (6.0 percent) versus 315 (6.7 percent), about 10 percent lower and not statistically significant (the AHA release gives no hazard ratio; it is in the NEJM paper). Renal events 270 (5.7 percent) versus 175 (3.7 percent), about 55 percent higher, mainly eGFR declines; end-stage kidney disease similar; serious adverse events similar. Berwanger: any benefit in type 2 diabetes may be smaller than in people without diabetes, so even this large trial may have missed a modest effect; individualise. Sits between ACCORD BP (neutral) and BPROAD (positive); the sister trial OPTIMAL-Stroke, same evening, was positive.