Intensive Blood-Pressure Lowering in Patients with Type 2 Diabetes

BackgroundUncertainty persists regarding the effects of intensive blood-pressure lowering in patients with type 2 diabetes. MethodsIn this multicenter, open-label, randomized trial conducted in Brazil, patients with elevated blood pressure, type 2 diabetes, and high cardiovascular risk received intensive therapy targeting a systolic blood pressure of less than 120 mm Hg or standard therapy targeting a systolic blood pressure of less than 140 mm Hg. The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina or heart failure. ResultsOf the 9476 ethnically diverse patients who were enrolled, 4745 were assigned to receive intensive therapy and 4731 to receive standard therapy. The mean (±SD) age was 64.7±8.2 years, and 5871 of the patients (62.0%) were women. The mean systolic blood pressure during follow-up (with exclusion of the first 3 months) was 121.8±10.8 mm Hg in the intensive-therapy group and 135.4±8.2 mm Hg in the standard-therapy group. During a median follow-up of 4.0 years (interquartile range, 3.9 to 4.0), a primary-outcome event occurred in 286 patients (6.0%; 1.65 events per 100 person-years) in the intensive-therapy group and in 315 patients (6.7%; 1.83 events per 100 person-years) in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval, 0.77 to 1.06; P=0.20). Serious adverse events occurred in 706 patients (14.9%) with intensive therapy and in 693 patients (14.6%) with standard therapy. ConclusionsAmong patients with type 2 diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the occurrence of major cardiovascular events. (Funded by Hospital Israelita Albert Einstein and the Brazilian Ministry of Health; OPTIMAL-DIABETES ClinicalTrials.gov number, NCT04040634.)

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Journal
New England Journal of Medicine
Published
2026-11-07
DOI
https://doi.org/10.1056/nejmoa2612922
Primary Topic
Blood Pressure and Hypertension Studies
Type
article
Field-Weighted Citation Impact
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article

Intensive Blood-Pressure Lowering in Patients with Type 2 Diabetes

Marcelo Franken, Silvia Regina Lamas Assis, Luiz Aparecido Bortolotto, Mauro Esteves Hernandes et al.
1 links
New England Journal of Medicine
Blood Pressure and Hypertension Studies
article

Intensive Blood-Pressure Lowering in Patients with Type 2 Diabetes

Marcelo Franken, Silvia Regina Lamas Assis, Luiz Aparecido Bortolotto, Mauro Esteves Hernandes, Patrícia O. Guimarães, Bruno Geloneze, Audes D. M. Feitosa, Miguel Nasser Hissa, Anthony Rodgers, Karla Santo, Andréa Araújo Brandão, Flávio Danni Fuchs, Otavio B Berwanger, Luciano F. Drager, Eduardo Bello Martins, Marcos S. Silveira, Luiz Alberto Andreotti Turatti, Fábio Serra Silveira, Paul Kieran Whelton, João Soares Felício, João Brainer Clares de Andrade, Elizabeth do Espírito Santo Cestário, Raul Dias Santos, Ricardo Reinaldo Bergo, Juan Carlos Yugar‐Toledo, Pedro A. Lemos, Nelson Rassi, Frederico Monfardini, Sandra Cristina Pereira Costa Fuchs, José Fernando Vilela-Martin, Dário Celestino Sobral Filho, Weimar Kunz Sebba Barroso, Andrei Carvalho Sposito, Marcelo Cidade Batista, Josué Nieri, Caio A.M. Tavares, Gisele Sampaio Silva, Lilia Nigro-Maia, Marco A.M. Gomes, José G. Mill, Marcio Gonçalves Sousa
article en

Abstract

BackgroundUncertainty persists regarding the effects of intensive blood-pressure lowering in patients with type 2 diabetes. MethodsIn this multicenter, open-label, randomized trial conducted in Brazil, patients with elevated blood pressure, type 2 diabetes, and high cardiovascular risk received intensive therapy targeting a systolic blood pressure of less than 120 mm Hg or standard therapy targeting a systolic blood pressure of less than 140 mm Hg. The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina or heart failure. ResultsOf the 9476 ethnically diverse patients who were enrolled, 4745 were assigned to receive intensive therapy and 4731 to receive standard therapy. The mean (±SD) age was 64.7±8.2 years, and 5871 of the patients (62.0%) were women. The mean systolic blood pressure during follow-up (with exclusion of the first 3 months) was 121.8±10.8 mm Hg in the intensive-therapy group and 135.4±8.2 mm Hg in the standard-therapy group. During a median follow-up of 4.0 years (interquartile range, 3.9 to 4.0), a primary-outcome event occurred in 286 patients (6.0%; 1.65 events per 100 person-years) in the intensive-therapy group and in 315 patients (6.7%; 1.83 events per 100 person-years) in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval, 0.77 to 1.06; P=0.20). Serious adverse events occurred in 706 patients (14.9%) with intensive therapy and in 693 patients (14.6%) with standard therapy. ConclusionsAmong patients with type 2 diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the occurrence of major cardiovascular events. (Funded by Hospital Israelita Albert Einstein and the Brazilian Ministry of Health; OPTIMAL-DIABETES ClinicalTrials.gov number, NCT04040634.)

New England Journal of Medicine
Tulane University (US), Universidade Federal do Rio Grande do Sul (BR), Faculdade de Medicina de São José do Rio Preto (BR), Universidade de São Paulo (BR), Universidade Estadual de Campinas (UNICAMP) (BR), The George Institute for Global Health (GB), Hospital Israelita Albert Einstein (BR), Universidad Autónoma de Chile (CL), Universidade do Estado do Rio de Janeiro (BR), Hospital de Clínicas de Porto Alegre (BR), The George Institute for Global Health (AU), Centro Universitário de Votuporanga (BR), Santa Casa de Votuporanga (BR), Centro Universitário Cesmac (BR), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR), Instituto Dante Pazzanese de Cardiologia (BR), Hospital de Base (BR), Instituto do Coração - HCFMUSP (BR), Imperial College London (GB), Universidade Federal do Pará (BR), Universidade Federal de Goiás (BR), Universidade de Pernambuco (BR), Universidade Federal de São Paulo (BR)
Ministério da Saúde
Good health and well-being
Openalex Percentile: Top 13%
Blood Pressure and Hypertension Studies
DOISourceOpenAlex
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