Effects of Intensive Blood-Pressure Control in Type 2 Diabetes Mellitus

Abstract

BACKGROUND There is no evidence from randomized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (i.e., <120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes at high risk for cardiovascular events. METHODS A total of 4733 participants with type 2 diabetes were randomly assigned to intensive therapy, targeting a systolic pressure of less than 120 mm Hg, or standard therapy, targeting a systolic pressure of less than 140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years. RESULTS After 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. The annual rate of the primary outcome was 1.87% in the intensive-therapy group and 2.09% in the standard-therapy group (hazard ratio with intensive therapy, 0.88; 95% confidence interval [CI], 0.73 to 1.06; P = 0.20). The annual rates of death from any cause were 1.28% and 1.19% in the two groups, respectively (hazard ratio, 1.07; 95% CI, 0.85 to 1.35; P = 0.55). The annual rates of stroke, a prespecified secondary outcome, were 0.32% and 0.53% in the two groups, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group (3.3%) and 30 of the 2371 participants in the standard-therapy group (1.3%) (P <0.001). CONCLUSIONS In patients with type 2 diabetes at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events. (ClinicalTrials.gov number, NCT00000620.)

Implications of Blood Pressure Measurement Technique for Implementation of Systolic Blood Pressure Intervention Trial (SPRINT)

“…The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study randomized patients with diabetes mellitus who were hypertensive to the same systolic BP targets as those used in SPRINT 18. The sample size of ACCORD was less than half that of SPRINT, and a factorial design included interventions to test lipid lowering with fenofibrate and intensive or standard glucose lowering.…”

“…Furthermore, there was 48% reduction in relative risk for stroke. Although the ACCORD study used the same automated device as SPRINT (Omron HEM 907) and measured BP in triplicate at each visit, it is less clear whether ACCORD required and enforced a mandatory period of 5 minutes of rest and whether the readings were observed or unobserved (supplementary appendix 2 of Cushman et al18). The overall results of the ACCORD trial for intensive BP lowering, providing little additional benefit for cardiovascular end points, could be partly related to the cointerventions of lipid and glucose lowering, which may have diluted the results of aggressive BP lowering.…”

Treatment Intensification for Hypertension in US Ambulatory Medical Care

“…In contrast, for people with diabetes mellitus, a goal SBP/DBP of 130/80 mm Hg was recommended in 2003,12 and yet treatment intensification from 2005 to 2012 among diabetic adults remained low even compared to those without diabetes mellitus. This appears concerning because diabetic patients commonly require at least 2 or 3 hypertension medications to achieve the recommended blood pressure,30, 31, 32 even though the specific level of goal blood pressure in this population remains a focus of discussion 4, 15, 33, 34…”

Prevalence of Eligibility Criteria for the Systolic Blood Pressure Intervention Trial in US Adults Among Excluded Groups: Age <50 Years, Diabetes Mellitus, or a History of Stroke

“…Some of the risks associated with a SBP target goal of <120 mm Hg in SPRINT and ACCORD BP include falls, renal dysfunction, bradyarrhythmias, and electrolyte abnormalties 1, 5. These risks may be more pronounced in some subgroups such as those with a history of stroke or older individuals, and potential adverse effects should be considered when deciding SBP target goals for individual patients.…”

“…Also, SPRINT excluded patients with diabetes mellitus or a history of stroke. At the time SPRINT was being designed, other National Institutes of Health–funded trials including the Action to Control Cardiovascular Risk in Diabetes blood pressure trial (ACCORD BP) and the Secondary Prevention of Small Subcortical Strokes trial were evaluating the benefits and harms of lower versus conventional SBP target goals in these populations 4, 5, 6. In a recent meta‐analysis of large‐scale blood pressure–lowering trials, which included ACCORD BP and Secondary Prevention of Small Subcortical Strokes, greater SBP reductions achieved were associated with statistically significant lower risk for CVD events among adults with diabetes mellitus or with a history of stroke 7.…”