Aiming for Systolic Pressure Below 120 Did Not Significantly Cut Heart Events in Adults With Type 2 Diabetes, Trial Finds

Lowering systolic blood pressure below 120 mm Hg did not significantly reduce heart attacks, strokes and other cardiovascular events in adults with Type 2 diabetes, researchers reported Saturday, Nov. 7. The OPTIMAL-DIABETES trial was presented at the American Heart Association’s Scientific Sessions in Chicago and published in the New England Journal of Medicine, the association said.

Related: CPR and 911 Training Across 31 North Carolina Counties Did Not Raise Cardiac Arrest Survival, Trial Finds.

What the trial found

Researchers randomly assigned participants to a systolic goal below 120 mm Hg or a standard goal below 140 mm Hg, according to the association. Systolic pressure is the top number in a reading.

In the intensive group, 286 participants, or 6.0%, had a major cardiovascular event during a median follow-up of four years, the association said. In the standard group, 315 participants, or 6.7%, had one. The intensive group’s risk was about 10% lower, but the result was not statistically significant.

Major events included cardiovascular death, stroke, heart attack and hospitalization for heart failure or unstable angina, according to the release.

Kidney effects

Kidney-related events occurred in 270 participants, or 5.7%, in the intensive group, the association said. They occurred in 175 participants, or 3.7%, in the standard group. That was about 55% higher with intensive treatment.

Those events were primarily declines in kidney function, according to the release. End-stage renal disease occurred at similar rates in both groups, and serious adverse events were similar, the association said.

Who was in the study

The trial enrolled 9,476 adults ages 50 and older at 33 sites in Brazil, from August 2019 to October 2021, the association said. Average age was 65, and 62% of participants identified as women. Participants began with an average systolic pressure of 146 mm Hg.

Average systolic pressure during follow-up was 122 mm Hg in the intensive group and 135 mm Hg in the standard group, according to the release.

The trial was open-label, meaning participants and investigators knew which treatment each person received, the association said. The results may not apply to populations outside Brazil, according to the release.

What the researchers said

Dr. Karla Santo, the lead author, said more intensive treatment may still have modest yet meaningful health benefits for adults with Type 2 diabetes. Santo works at Einstein Hospital Israelita in São Paulo.

“A target below 120 mm Hg should not necessarily be applied universally to all patients,” said Dr. Otavio Berwanger, chair of the trial’s steering committee. Berwanger is executive director at The George Institute for Global Health at Imperial College London. Treatment decisions should balance cardiovascular benefits, kidney effects, treatment burden and patient preferences, he said.

Dr. Shawna Nesbitt of UT Southwestern Medical Center said the trial supports earlier findings on treating hypertension more aggressively in patients with diabetes, STAT reported.

A different result after stroke

A related Brazilian trial, OPTIMAL-STROKE, reached a different conclusion at the same meeting, STAT reported. People who had a stroke and took medication to reach the lower goal were significantly less likely to die or have cardiovascular events within four years, according to STAT. That trial was also published in the New England Journal of Medicine.

The 2025 American Heart Association and American College of Cardiology guideline recommends systolic pressure below 130 mm Hg, the association said. It encourages reaching below 120 mm Hg for people at increased cardiovascular risk, according to the release.

Berwanger said blood pressure management for people with Type 2 diabetes should remain individualized. For more coverage, see Health and Science.

Sources

• American Heart Association: Intensive blood pressure therapy did not cut cardiovascular events in adults with diabetes
• STAT: Lowering blood pressure after stroke or with diabetes poses challenges, in research and practice

About the reporter: Theo Lin is an AI reporter covering AI, technology and science for The Boston Report. This article was produced with AI under our editorial policy. Read our AI and media disclosure.