Related Experiment Videos
Intensive blood-pressure control for the prevention of major cardiovascular events in patients with type 2 diabetes:
Karla Santo1, Eduardo Martins1, Gisele S Silva2
1Hospital Israelita Albert Einstein, São Paulo, Brazil.
Background:
Evidence on the beneficial effects of intensive blood pressure (BP) control is still uncertain in patients with type 2 diabetes (T2D), particularly in an ethnically diverse population.
Objectives:
To assess whether a target of systolic BP (SBP) < 120 mm Hg reduces major cardiovascular (CV) events compared with a target of SBP < 140 mm Hg in patients with T2D and high CV risk.
Design:
This is a multicentre, 2-arm, open-label, randomized clinical trial, in which individuals aged ≥50 years, with a SBP between 130 and 180 mm Hg, T2D and high CV risk are randomly assigned to a target SBP of <120 or <140 mm Hg. The primary endpoint is a composite of CV mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or hospitalization for heart failure. Maximum follow-up duration is 48 months. Main analysis will follow the intention-to-treat principle.
Results:
From August 2019 through October 2021, 9,476 participants from 33 sites in Brazil were enrolled. The overall mean age was 64.74 years (standard deviation [SD], 8.16), and 5,871 (62.0%) were women. Race distribution was diverse with 4,025/9,467 (42.5%) self-described as mixed-race, 3,971/9,467 (41.9%) as White, and 1,374/9,467 (14.5%) as Black. Overall, 2,697/9,475 (28.5%) and 371 (3.9%) had established and subclinical CV disease, respectively. Antihypertensive medication was prescribed to 9,104/9,473 (96.1%) of the participants. Mean SBP is 145.89 mm Hg (SD, 12.13) and mean diastolic BP is 79.48 mm Hg (SD, 10.61).
Conclusion:
The OPTIMAL-DIABETES trial results will provide valuable evidence regarding the benefits and risks of antihypertensive treatment to an SBP < 120 vs <140 mm Hg in a diverse population of patients with T2D, elevated BP, and high CV risk.
Trial Registration:
The trial is registered at the ClinicalTrials.gov (NCT04040634).
Insights
This study investigates intensive blood pressure (BP) control in type 2 diabetes (T2D). Lowering systolic BP to <120 mmHg may reduce cardiovascular events compared to <140 mmHg in high-risk T2D patients.
Area of Science:
- Cardiology
- Endocrinology
- Clinical Trials
Background:
- Uncertainty exists regarding the benefits of intensive blood pressure (BP) control in type 2 diabetes (T2D) patients.
- This is particularly relevant in ethnically diverse populations with high cardiovascular (CV) risk.
- The OPTIMAL-DIABETES trial addresses this gap in evidence.
Purpose of the Study:
- To compare the efficacy of a target systolic BP (SBP) of <120 mmHg versus <140 mmHg.
- To assess the reduction in major cardiovascular events in patients with T2D and high CV risk.
Main Methods:
- Multicenter, 2-arm, open-label, randomized clinical trial.
- Inclusion criteria: age ≥ 50 years, SBP 130-180 mmHg, T2D, high CV risk.
- Primary endpoint: composite of CV mortality, myocardial infarction, stroke, and heart-related hospitalizations.
Main Results:
- 9476 participants enrolled from 33 sites in Brazil (August 2019 - October 2021).
- Diverse population: 62.0% women, 42.5% Mixed-race, 41.9% White, 14.5% Black.
- Mean SBP 145.89 mmHg, mean DBP 79.48 mmHg; 96.1% on anti-hypertensive medication.
Conclusions:
- The OPTIMAL-DIABETES trial will provide crucial evidence on intensive BP management in T2D.
- Results will inform benefits and risks of targeting SBP <120 mmHg versus <140 mmHg.
- Findings will be valuable for a diverse T2D population with elevated BP and high CV risk.
Related Concept Videos
Diabetes: Management and Pharmacotherapy
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
Diabetes Mellitus: Type 2 and Gestational
Diabetes Mellitus: Overview and Type I Subtype
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
Type II Diabetes Mellitus III: Clinical Manifestations and Diagnosis
Type II Diabetes I: Introduction
Diabetes: Symptoms, Diagnosis, and Complications