To test the efficacy of achieving target SBP less than 120 mmHg, or less than 140 mmHg, for lowering the risk of major adverse cardiovascular events (MACE) in persons with diabetes mellitus.Method:
The study comprised 4732 [mean ± SD age: 63 ± 7 years; 2258 (48%) women] persons with advanced diabetes mellitus. Participants randomly assigned to achieve intensive (<120 mmHg) or standard (<140 mmHg) SBP control were grouped according to whether or not they achieved their respective SBP goal. MACE consisted of nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular causes.Results:
During a median 5.0 (interquartile range: 4.2–5.7) years, 1939 (82%) and 2038 (86%) persons achieved SBP targets less than 120 and less than 140 mmHg in each treatment arm, respectively. Overall, 208 (9%) and 237 (10%) persons in the intensive and standard treatment arms experienced MACE. In the intensive treatment arm, multivariable Cox regression revealed no significant reduction in risk of MACE for those who achieved a target SBP less than 120 mmHg. In the standard treatment arm, those who achieved a target SBP less than 140 mmHg displayed a substantial reduction in risk of MACE (hazard ratio = 0.65, P = 0.005), all-cause death (hazard ratio = 0.64, P = 0.02), and nonfatal stroke (hazard ratio = 0.47, P = 0.02) as compared with those whose achieved SBP was 140 mmHg or higher.Conclusion:
Achieving a standard SBP goal between 120 and 140 mmHg may prove useful for lowering cardiovascular risk in persons with diabetes mellitus. Achieving a target SBP less than 120 mmHg does not appear to mitigate risk.Clinical trial registration:
ClinicalTrials.gov # NCT00000620 (https://clinicaltrials.gov/ct2/results?term=NCT00000620&Search=Search).