1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcomes
8.2 Secondary Outcomes
9 Criticisms
10 Funding
11 Further Reading
Clinical Question
In patients at high risk for cardiovascular events but without diabetes, does intensive blood pressure control to a systolic blood pressure target of less than 120 mm Hg reduce cardiovascular morbidity and mortality compared to a standard target of less than 140 mm Hg?
Bottom Line
In high-risk patients without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as opposed to less than 140 mm Hg, resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause.
Major Points
Guidelines
Design
Population
Inclusion Criteria: Age ≥50 years, systolic blood pressure of 130 to 180 mm Hg, and increased cardiovascular risk defined by various criteria.
Exclusion Criteria: Diabetes mellitus or prior stroke.
Baseline Characteristics: Average age was 68 years, and 28% of participants were 75 years of age or older.
Interventions
After randomization, participants' baseline antihypertensive regimens were adjusted to meet their assigned blood pressure targets, with regular follow-ups and lifestyle modifications encouraged.
Outcomes
Primary Outcomes: The primary composite outcome was the occurrence of myocardial infarction, acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.
Secondary Outcomes: Individual components of the primary composite outcome, death from any cause, and progression of renal disease were also assessed.
Criticisms
The lack of generalizability to populations not included in the study, such as persons with diabetes, those with prior stroke, and those younger than 50 years of age, is a limitation. Also noted were increased adverse events in intensive-treatment group including hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure.
Funding
Supported by contracts from the NIH, including NHLBI, NIDDK, NIA, and NINDS. Takeda Pharmaceuticals International and Arbor Pharmaceuticals donated medications for the trial.
Further Reading
Additional information and related research can be found through the ClinicalTrials.gov number, NCT01206062, and the supplementary material provided with the original NEJM article.