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Randomized Controlled Trial
. 2017 Nov;70(5):907-914.
doi: 10.1161/HYPERTENSIONAHA.117.09482. Epub 2017 Aug 28.

Hypertension Control in Adults With Diabetes Mellitus and Recurrent Cardiovascular Events: Global Results From the Trial Evaluating Cardiovascular Outcomes With Sitagliptin

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Free PMC article
Randomized Controlled Trial

Hypertension Control in Adults With Diabetes Mellitus and Recurrent Cardiovascular Events: Global Results From the Trial Evaluating Cardiovascular Outcomes With Sitagliptin

Ann Marie Navar et al. Hypertension. .
Free PMC article

Abstract

Systolic blood pressure (SBP) treatment targets for adults with diabetes mellitus remain unclear. SBP levels among 12 275 adults with diabetes mellitus, prior cardiovascular disease, and treated hypertension were evaluated in the TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) randomized trial of sitagliptin versus placebo. The association between baseline SBP and recurrent cardiovascular disease was evaluated using multivariable Cox proportional hazards modeling with restricted cubic splines, adjusting for clinical characteristics. Kaplan-Meier curves by baseline SBP were created to assess time to cardiovascular disease and 2 potential hypotension-related adverse events: worsening kidney function and fractures. The association between time-updated SBP and outcomes was examined using multivariable Cox proportional hazards models. Overall, 42.2% of adults with diabetes mellitus, cardiovascular disease, and hypertension had an SBP ≥140 mm Hg. The association between SBP and cardiovascular disease risk was U shaped, with a nadir ≈130 mm Hg. When the analysis was restricted to those with baseline SBP of 110 to 150 mm Hg, the adjusted association between SBP and cardiovascular disease risk was flat (hazard ratio per 10-mm Hg increase, 0.96; 95% confidence interval, 0.91-1.02). There was no association between SBP and risk of fracture. Above 150 mm Hg, higher SBP was associated with increasing risk of worsening kidney function (hazard ratio per 10-mm Hg increase, 1.10; 95% confidence interval, 1.02-1.18). Many patients with diabetes mellitus have uncontrolled hypertension. The U-shaped association between SBP and cardiovascular disease events was largely driven by those with very high or low SBP, with no difference in cardiovascular disease risk between 110 and 150 mm Hg. Lower SBP was not associated with higher risks of fractures or worsening kidney function.

Keywords: blood pressure; cardiovascular disease; diabetes mellitus; hypertension; hypotension.

Figures

Figure 1
Figure 1
SBP at baseline and time to CVD in adults with diabetes, treated hypertension, and prior CVD in TECOS. Unadjusted Kaplan-Meier CVD event rates for adults with prior CVD, hypertension, and on blood pressure treatment. Numbers below the x-axis are the number at risk at the time point, stratified by SBP group of interest.
Figure 2
Figure 2
Multivariable adjusted predicted CVD event rates at 48 months in adults with diabetes, hypertension, and prior CVD by SBP at baseline: (a) SBP 70–200 mmHg, (b) SBP 110–150 mmHg. Predicted CVD event rates by baseline SBP adjusting for sex, age, race (white, black, Asian, other), history of coronary disease, history of stroke/TIA, history of peripheral artery disease, history of COPD, history of congestive heart failure, history of atrial fibrillation/flutter, eGFR, baseline hemoglobin A1c, albumin:creatinine ratio, creatinine, hemoglobin, HDL-cholesterol, LDL-cholesterol, smoking status (never, current, former), statin use, BMI, eGFR, and randomized treatment. Predicted event rates represent predicted rates from an average subject and are calculated from the Cox model based on an individual with mean values for each variable in the equation.
Figure 3
Figure 3
SBP at baseline and time to worsening kidney function in adults with diabetes, treated hypertension, and prior CVD in TECOS. Unadjusted Kaplan-Meier event rates of worsening kidney function by baseline SBP category. Numbers below the x-axis are the number at risk at the time point, stratified by SBP group of interest.
Figure 4
Figure 4
Multivariable adjusted predicted rates of worsening kidney function at 48 months in adults with diabetes, hypertension, and prior CVD by SBP at baseline: (a) SBP 70–200 mmHg, (b) SBP 110–150 mmHg. Predicted event rates for worsening kidney function at 48 months by baseline SBP adjusting for sex, age, race (white, black, Asian, other), history of coronary disease, history of stroke/TIA, history of peripheral artery disease, history of COPD, history of congestive heart failure, history of atrial fibrillation/flutter, eGFR, baseline hemoglobin A1c, albumin:creatinine ratio, creatinine, hemoglobin, HDL-cholesterol, LDL-cholesterol, smoking status (never, current, former), statin use, BMI, and randomized treatment. Predicted event rates represent predicted rates from an average subject and are calculated from the Cox model based on an individual with mean values for each variable in the equation.

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