Intensive blood pressure-lowering treatment aimed at reducing systolic pressure below 120 mm Hg did not significantly reduce the incidence of cardiovascular death, stroke, heart attack or other cardiovascular events in adults with Type 2 diabetes at increased cardiovascular risk, according to late-breaking research presented at the American Heart Association’s Scientific Sessions 2026. The OPTIMAL-DIABETES trial, which enrolled more than 9,000 middle-aged adults in Brazil, compared intensive therapy targeting systolic blood pressure below 120 mm Hg with standard treatment targeting below 140 mm Hg.
The findings carry significant implications for clinical practice because they challenge the assumption that lower is always better for this high-risk population. People with Type 2 diabetes and high blood pressure face elevated risks of heart attack and stroke. Current guidance from the American Heart Association and American College of Cardiology, detailed in the 2025 Joint Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults, encourages achieving systolic pressure below 120 mm Hg for people at increased risk of cardiovascular disease. The new trial suggests that for adults with Type 2 diabetes, the benefits of intensive treatment may be smaller than previously thought.
During a median follow-up of four years, participants in the intensive-treatment group had about a 10% lower risk of a major cardiovascular event compared with the standard-treatment group, but the difference was not statistically significant. Major cardiovascular events occurred in 6.0% of the intensive group versus 6.7% of the standard group. However, kidney-related events were about 55% higher in the intensive group (5.7% vs 3.7%), primarily declines in kidney function, though end-stage renal disease rates were similar.
“These findings should not be interpreted as evidence that more intensive blood pressure lowering is ineffective for people with Type 2 diabetes,” said Otavio Berwanger, M.D., Ph.D., chair of the trial Steering Committee. “Rather, they suggest that any cardiovascular benefit may be smaller than that observed in individuals without Type 2 diabetes.” He emphasized that blood pressure management should remain individualized, balancing cardiovascular benefits, kidney effects and patient preferences. “A target below 120 mm Hg should not necessarily be applied universally to all patients,” he said.
The trial’s limitation to an open-label design and a Brazilian population means results may not be fully generalizable. Still, the study adds crucial evidence to the ongoing debate over optimal blood pressure targets. As Berwanger noted, “our study adds an important piece to the overall evidence base and highlights the need to consider the totality of evidence, rather than any single trial alone.” For patients and clinicians, the message is clear: intensive blood pressure control in Type 2 diabetes requires careful consideration of trade-offs, and a one-size-fits-all approach may not be appropriate.
