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Blood Pressure Control and the Association With Diabetes Mellitus Incidence: Results From SPRINT Randomized Trial.

ABSTRACT: The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated reduced cardiovascular outcomes. We evaluated diabetes mellitus incidence in this randomized trial that compared intensive blood pressure strategy (systolic blood pressure <120 mm Hg) versus standard strategy (<140 mm Hg). Participants were ?50 years of age, with systolic 130 to 180 mm Hg and increased cardiovascular risk. Participants were excluded if they had diabetes mellitus, polycystic kidney disease, proteinuria >1 g/d, heart failure, dementia, or stroke. Postrandomization exclusions included participants missing blood glucose or ?126 mg/dL (6.99 mmol/L) or on hypoglycemics. The outcome was incident diabetes mellitus: fasting blood glucose ?126 mg/dL (6.99 mmol/L), diabetes mellitus self-report, or new use of hypoglycemics. The secondary outcome was impaired fasting glucose (100-125 mg/dL [5.55-6.94 mmol/L]) among those with normoglycemia (<100 mg/dL [5.55 mmol/L]). There were 9361 participants randomized and 981 excluded, yielding 4187 and 4193 participants assigned to intensive and standard strategies. There were 299 incident diabetes mellitus events (2.3% per year) for intensive and 251 events (1.9% per year) for standard, rates of 22.6 (20.2-25.3) versus 19.0 (16.8-21.5) events per 1000 person-years of treatment, respectively (adjusted hazard ratio, 1.19 [95% CI, 0.95-1.49]). Impaired fasting glucose rates were 26.4 (24.9-28.0) and 22.5 (21.1-24.1) per 100 person-years for intensive and standard strategies (adjusted hazard ratio, 1.17 [1.06-1.30]). Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose. The risks and benefits of intensive blood pressure targets should be factored into individualized patient treatment goals. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.

SUBMITTER: Roumie CL

PROVIDER: S-EPMC7015147 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Blood Pressure Control and the Association With Diabetes Mellitus Incidence: Results From SPRINT Randomized Trial.

Roumie Christianne L CL Hung Adriana M AM Russell Gregory B GB Basile Jan J Kreider Kathryn Evans KE Nord John J Ramsey Thomas M TM Rastogi Anjay A Sweeney Mary Ellen ME Tamariz Leonardo L Kostis William J WJ Williams Jonathan S JS Zias Athena A Cushman William C WC

Hypertension (Dallas, Tex. : 1979) 20191223 2

The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated reduced cardiovascular outcomes. We evaluated diabetes mellitus incidence in this randomized trial that compared intensive blood pressure strategy (systolic blood pressure <120 mm Hg) versus standard strategy (<140 mm Hg). Participants were ≥50 years of age, with systolic 130 to 180 mm Hg and increased cardiovascular risk. Participants were excluded if they had diabetes mellitus, polycystic kidney disease, proteinuria >1 g/d, h ...[more]

PMID: 31865790

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Project description:BackgroundPrevious studies indicated that intensive blood pressure (BP) control (systolic BP < 120 mm·Hg) compared with standard BP control (<140 mm·Hg) was associated with an increased risk of type 2 diabetes (T2D) and impaired fasting glucose (IFG) among hypertensive patients with normoglycemia. However, the impact of intensive BP control on the incidence of T2D for those with IFG is still unknown.MethodsThis was a secondary analysis of the SPRINT (Systolic Blood Pressure Intervention Trial) of the study. We included participants with IFG at randomization, which was defined as fasting blood glucose (FBG) between 100 and 125 mg/dL. The primary outcome was incident T2D, defined as events of reaching FBG ≥ 126 mg/dL, participant self-report T2D at annual examination, or a record of hypoglycemic medications at follow-up. The secondary outcome was incident IFG reversion (IFGR), defined as the time to first FBG back to normoglycemia (<100 mg/dl) among participants without incident T2D. Cox proportional hazards models were used to compare the cumulative incidence of outcomes between the two BP control groups. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated.ResultsA total of 3310 participants were included in our primary outcome analysis (median age 67 years, 29% female). There were 293 participants who developed T2D among the intensive BP control group and 256 participants who developed T2D among the standard BP control group, resulting in 56.87 (50.36-63.39) versus 49.33 (43.29-55.37) events per 1000 person-years of treatment (HR 1.18 [95% CI, 1.00-1.40], P=0.052). After excluding 549 participants who developed T2D, 2761 participants were included in our secondary outcome analysis with 559 participants who developed IFGR among the intensive BP control group and 632 participants who developed IFGR among the standard BP control group, resulting in 141.20 (129.50-152.91) versus 158.20 (145.86,170.53) events per 1000 person-years of treatment (HR 0.9 [95% CI, 0.8-1.01], P=0.067).ConclusionsOur study found that in comparison to the standard BP control for hypertensive patients with IFG, intensive BP control was associated with a small increased risk of new-onset T2D, though it did not reach statistical significance. This kind of impact should be considered when implementing the strategy, especially for those with high risks of developing T2D. This trial is registered with NCT01206062.

Project description:BackgroundThere 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.MethodsA 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.ResultsAfter 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).ConclusionsIn 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.)

Project description:ImportanceMeta-analyses of randomized clinical trials have indicated that improved hypertension control reduces the risk for cognitive impairment and dementia. However, it is unclear to what extent pathways reflective of Alzheimer disease (AD) pathology are affected by hypertension control.ObjectiveTo evaluate the association of intensive blood pressure control on AD-related brain biomarkers.Design, setting, and participantsThis is a substudy of the Systolic Blood Pressure Intervention Trial (SPRINT MIND), a multicenter randomized clinical trial that compared the efficacy of 2 different blood pressure-lowering strategies. Potential participants (n = 1267) 50 years or older with hypertension and without a history of diabetes or stroke were approached for a brain magnetic resonance imaging (MRI) study. Of these, 205 participants were deemed ineligible and 269 did not agree to participate; 673 and 454 participants completed brain MRI at baseline and at 4-year follow-up, respectively; the final follow-up date was July 1, 2016. Analysis began September 2019 and ended November 2020.InterventionsParticipants were randomized to either a systolic blood pressure goal of less than 120 mm Hg (intensive treatment: n = 356) or less than 140 mm Hg (standard treatment: n = 317).Main outcomes and measuresChanges in hippocampal volume, measures of AD regional atrophy, posterior cingulate cerebral blood flow, and mean fractional anisotropy in the cingulum bundle.ResultsAmong 673 recruited patients who had baseline MRI (mean [SD] age, 67.3 [8.2] years; 271 women [40.3%]), 454 completed the follow-up MRI at a median (interquartile range) of 3.98 (3.7-4.1) years after randomization. In the intensive treatment group, mean hippocampal volume decreased from 7.45 cm3 to 7.39 cm3 (difference, -0.06 cm3; 95% CI, -0.08 to -0.04) vs a decrease from 7.48 cm3 to 7.46 cm3 (difference, -0.02 cm3; 95% CI, -0.05 to -0.003) in the standard treatment group (between-group difference in change, -0.033 cm3; 95% CI, -0.062 to -0.003; P = .03). There were no significant treatment group differences for measures of AD regional atrophy, cerebral blood flow, or mean fractional anisotropy.Conclusions and relevanceIntensive treatment was associated with a small but statistically significant greater decrease in hippocampal volume compared with standard treatment, consistent with the observation that intensive treatment is associated with greater decreases in total brain volume. However, intensive treatment was not associated with changes in any of the other MRI biomarkers of AD compared with standard treatment.Trial registrationClinicalTrials.gov Identifier: NCT01206062.

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Blood Pressure Control and the Association With Diabetes Mellitus Incidence: Results From SPRINT Randomized Trial.

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Blood Pressure Control and the Association With Diabetes Mellitus Incidence: Results From SPRINT Randomized Trial.

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