Intensive blood pressure therapy did not cut cardiovascular events in adults with diabetes

Research Highlights:

• Compared to standard treatment, using antihypertensive medications to lower systolic blood pressure (the top number in a reading) below 120 mm Hg in middle-aged adults with Type 2 diabetes did not significantly reduce the incidence of cardiovascular death, stroke, heart attack and other cardiovascular events.
• There is still a chance of a modest but clinically relevant benefit from more intensive blood pressure-lowering treatment, and high blood pressure management in people with Type 2 diabetes should remain individualized, researchers said.
• In the OPTIMAL-DIABETES trial, more than 9,000 middle-aged adults with Type 2 diabetes and other risk factors including elevated blood pressure between 130 and 180 mm Hg were randomly assigned to receive either intensive therapy to lower systolic blood pressure to less than 120 mm Hg or standard treatment to reduce systolic pressure to less than 140 mm Hg.
• Note: This trial is simultaneously published today as a full manuscript in the peer-reviewed scientific journal New England Journal of Medicine.

Embargoed until 3:30 p.m. CT, 4:30 p.m. ET, Saturday, Nov. 7, 2026

CHICAGO, Nov. 7, 2026 - Intensive blood pressure-lowering treatment to reduce systolic pressure below 120 mm Hg in adults with Type 2 diabetes, who are at increased risk of cardiovascular events, did not significantly reduce the incidence of cardiovascular death, stroke, heart attack or other cardiovascular events, compared to standard treatment targeting a systolic blood pressure of less than 140 mm Hg. These were the results of new, independent, preliminary late-breaking science presented today at the American Heart Association's Scientific Sessions 2026. The meeting on Nov. 6-9 in Chicago is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science.

People with Type 2 diabetes and high blood pressure are at increased risk of heart attacks and strokes. The American Heart Association/American College of Cardiology's 2025 Joint Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults notes that high blood pressure (≥130/80 mm Hg) is the #1 preventable risk factor for cardiovascular disease, including heart attack, stroke and heart failure, as well as kidney disease, cognitive decline and dementia. The guideline recommends keeping systolic blood pressure lower than 130 mm Hg and diastolic blood pressure less than 80 mm Hg; and encourages reaching less than 120 mm Hg for people with increased risk of cardiovascular disease.

"These findings add important evidence about optimal blood pressure targets for adults with Type 2 diabetes," said lead study author Karla Santo, M.D., Ph.D., head of Decentralized Clinical Studies and Innovative Trial Models at the Academic Research Organization of Einstein Hospital Israelita in São Paulo, Brazil.

"While this trial did not find a statistically significant reduction in major cardiovascular events, more intensive blood pressure treatment may still have modest yet meaningful health benefits for adults with Type 2 diabetes," she said.

Researchers analyzed data from the OPTIMAL-DIABETES trial, which enrolled more than 9,000 men and women, ages 50 and older, at 33 sites in Brazil. Participants had elevated blood pressure (systolic blood pressure between 130 and 180 mm Hg), Type 2 diabetes, and a history of cardiovascular disease, subclinical cardiovascular disease (early heart or blood vessel disease that has not yet caused symptoms), chronic kidney disease or other cardiovascular risk factors. Participants were randomly assigned to receive either intensive treatment to lower systolic blood pressure to below 120 mm Hg or standard treatment targeting a systolic level below 140 mm Hg. Researchers sought to determine if more intensive blood pressure management could reduce incidence of cardiovascular death, stroke, heart attack or other cardiovascular events, including hospitalization due to heart failure or unstable angina (chest pain), compared to standard treatment.

What are the key findings of the study?

• During a median follow-up of four years, participants who received intensive blood pressure-lowering treatment had about a 10% lower risk of experiencing a major cardiovascular event (cardiovascular death, stroke, heart attack, hospitalization due to heart failure or unstable angina). The results were not statistically significant.
• In the intensive-treatment group, 286 participants (6.0%) experienced a major cardiovascular event, compared to 315 participants (6.7%) in the standard-treatment group.
• The occurrence rate for kidney-related events was about 55% higher in the intensive-treatment group (270 participants, or 5.7%) compared to the standard-treatment group (175 participants, or 3.7%). These were primarily declines in kidney function with only a small number of participants developing end-stage renal disease. Importantly, the occurrence of end-stage renal disease was similar between groups.
• Serious adverse events were similar between groups.

"These findings should not be interpreted as evidence that more intensive blood pressure lowering is ineffective for people with Type 2 diabetes. Rather, they suggest that any cardiovascular benefit may be smaller than that observed in individuals without Type 2 diabetes. As a result, even a large trial such as OPTIMAL-DIABETES may not have been able to definitively detect a modest treatment effect," said Otavio Berwanger, M.D., Ph.D., chair of the OPTIMAL-DIABETES trial Steering Committee and executive director at The George Institute for Global Health - Imperial College London in London, UK.

Berwanger said the broader, important message is that blood pressure management for people with Type 2 diabetes should remain individualized.

"A target below 120 mm Hg should not necessarily be applied universally to all patients, and treatment decisions should balance potential cardiovascular benefits, kidney effects, treatment burden and patient preferences," he said. "Ultimately, 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, when defining optimal blood pressure targets in patients with Type 2 diabetes."

Study design, background, details and limitations:

• The OPTIMAL-DIABETES trial enrolled 9,476 adults, ages 50 and older (average age 65) with elevated systolic blood pressure between 130-180 mm Hg; Type 2 diabetes; and established cardiovascular disease, subclinical cardiovascular disease, chronic kidney disease or cardiovascular risk factors, such as smoking, high cholesterol, or age 75 or older. Among the participants, 62% identified as women; 42.5% self-identified as mixed-race adults; 41.9% as white adults; and 14.5% as Black adults.
• Participants were enrolled in the study from August 2019 to October 2021 and followed up for 4 years at 33 sites in Brazil.
• The analysis found that 2,697 participants (28.5%) had cardiovascular disease; 371 (3.9%) had subclinical cardiovascular disease; and 2,113 (22.6%) had chronic kidney disease at baseline.
• At the beginning of the study, participants' average systolic blood pressure was 146 mm Hg, and diastolic blood pressure was 80 mm Hg. Participants were randomly assigned to either an intensive treatment group to lower systolic blood pressure below 120 mm Hg, or a standard treatment group targeting systolic blood pressure less than 140 mm Hg. Blood pressure medications were adjusted throughout the study to reach those targets. The average systolic blood pressure throughout follow-up (excluding the first 3 months) was 122 mm Hg in the intensive-treatment group and 135 mm Hg in the standard-treatment group.
• Researchers evaluated whether participants experienced cardiovascular death, heart attack, stroke, hospitalization for chest pain or heart failure during the 4-year study period. They also examined deaths from any cause, each of these cardiovascular outcomes individually and kidney-related outcomes.
• The main limitation of the study is that the trial was open-label, meaning participants and investigators knew which treatment strategy they were receiving. Additionally, the results may not be generalizable to populations outside Brazil.

Co-authors, disclosures and funding sources are listed in the abstract.

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Additional Resources:

• Multimedia is available on the right column of the release link
• View the abstract in the American Heart Association Scientific Sessions 2026 Online Program Planner
• American Heart Association news release: Managing high blood pressure could prevent >500K CVD deaths annually in 20 countries (Oct. 2026)
• American Heart Association news release: New high blood pressure guideline emphasizes prevention, early treatment to reduce CVD risk (Aug. 2025)
• American Heart Association health information: Understanding Blood Pressure Readings
• About Scientific Sessions 2026
• For more news at the American Heart Association's Scientific Sessions 2026, follow us on X @HeartNews, #ScientificSessions26

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