Appendix Table 1. Randomized, Controlled Trials of Hypertension Treatment in Diabetic Populationsa
Study, Year (Reference) |
Intervention |
Sample Size (Diabetes Subgroup/Total), n/n |
Baseline Cardiovascular Risk Factors b |
Achieved Blood Pressure, mm Hg |
Outcome: Relative Risk (95% CI) |
Quality Rating |
Comment |
ALLHAT, 200250, 200551, 2001155 |
Chlorthalidone vs. lisinopril vs. amlodipinec |
13,101/31,512 |
HTN: 100/100 History of CVD: 36%/62% Smoking: 13%/28% Hyperlipidemia: NR |
Mean SBP (SD) in DM subgroup: Chlorthalidone: 135.0 (15.6) Amlodipine: 136.3 (15.9)d Lisinopril: 137.9 (19.0)d.
Mean SBP (SD) in normoglycemia subgroup: Chlorthalidone: 133.4 (14.9) Amlodipine: 133.5 (14.1) Lisinopril: 134.8 (17.3). |
Fatal CVD or nonfatal MI in the DM subgroup: Amlodipine–chlorthalidone: 0.97 (0.86–1.10); P = 0.64 Lisinopril–chlorthalidone: 0.97 (0.85–1.10); P = 0.59.
Fatal CVD or nonfatal MI in the normoglycemia subgroup: Amlodipine–chlorthalidone: 0.94 (0.82–1.07); P = 0.36 Lisinopril–chlorthalidone: 1.02 (0.89–1.16); P = 0.79.
Difference between DM and normoglycemia subgroups: P = NRe |
Fair |
Significantly higher rate of attrition in the lisinopril group. |
CONVINCE, 2003 52 |
Verapamil vs. atenolol or HCTZ |
3,239/16,476 |
HTN: 100% Hyperlipidemia: 31.2% Previous MI: 7.6% Established vascular disease: 16.7% Stroke: 4.6% |
Mean SBP/DBP in total study sample (DM subgroup NR):
Verapamil: 136.5/79.0 Atenolol or HCTZ: 136.6/79.5 |
Fatal CVD, stroke, or MI: DM subgroup: 0.86 (0.66–1.12); P = NR Normoglycemia subgroup: 1.10 (0.92–1.31); P = NR Difference between DM and normoglycemia subgroups: P = 0.16e |
Fair |
— |
a ALLHAT = Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; CONVINCE = Controlled Onset Verapamil Investigation of Cardiovascular End Points; CVD = cardiovascular disease; DBP = diastolic blood pressure; DM = diabetes mellitus; HCTZ = hydrochlorothiazide; HTN = hypertension; MI = myocardial infarction; NR = not reported; SBP = systolic blood pressure.
b Data reported as percentages for the DM/non-DM groups in ALLHAT and for the total study sample for the CONVINCE study (data for the DM subgroup alone NR).
c Doxazosin treatment was prematurely discontinued because of an excess of heart failure events.
d P < 0.5 compared with chlorthalidone.
e P value for interaction between DM and normoglycemia subgroups for primary outcome.
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