Body Mass Index, Intensive Blood Pressure Management, and Cardiovascular Events in the SPRINT Trial

ABSTRACT Background It is unclear whether intensive blood pressure management is well-tolerated and affects risk uniformly across the body mass index (BMI) spectrum. Methods The randomized, controlled Systolic Blood Pressure Intervention Trial (SPRINT) included 9,361 individuals ≥50 years at high cardiovascular risk, without diabetes mellitus, and a systolic blood pressure 130-180 mmHg. Participants were randomized to intensive versus standard antihypertensive treatment and evaluated for the primary composite efficacy endpoint of acute coronary syndromes, stroke, heart failure, or cardiovascular death. The primary safety endpoint was serious adverse events. We used restricted cubic splines to determine the relationship between BMI, response to intensive blood pressure lowering, and clinical outcomes in SPRINT. Results BMI measurements could be calculated for 9,284 (99.2%) individuals. Mean BMI was similar between the two treatment groups (intensive group 29.9±5.8 kg/m 2 vs. standard group 29.8± 5.7 kg/m 2 ; P=0.39). Median follow-up was 3.3 years (range 0-4.8 years). BMI had a significant, J-shaped association with risk of all-cause mortality, stroke, and serious adverse events (P 0.05 for all). Intensive blood pressure lowering reduced the primary efficacy endpoint and increased the primary safety endpoint compared with standard targets, consistently across the BMI spectrum (P interaction >0.05). Conclusion The overall efficacy and safety of intensive blood pressure lowering did not appear to be modified by baseline BMI among high-risk older adults. Trial Registration SPRINT (Systolic Blood Pressure Intervention Trial); ClinicalTrials.gov Identifier: NCT01206062, https://clinicaltrials.gov/ct2/show/NCT01206062