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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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