Table 1.
Resistant Hypertension (+) | Resistant Hypertension (−) | |||||
---|---|---|---|---|---|---|
Placebo | Spironolactone | P Value | Placebo | Spironolactone | P Value | |
n=499 | n=505 | n=1221 | n=1216 | |||
Age, y | ||||||
Median (interquartile range) | 69 (61–75) | 69 (61–76) | 0.43 | 69 (61–76) | 69 (61–76) | 0.68 |
Female sex, % | 50.9 | 52.9 | 0.53 | 51.8 | 51.1 | 0.73 |
Race and ethnicity, % | 0.56 | 0.54 | ||||
White | 83.3 | 84.7 | 91.2 | 89.9 | ||
Black | 14.1 | 12.1 | 6.5 | 7.5 | ||
Asian | 0.4 | 1.0 | 0.6 | 0.4 | ||
Others | 2.2 | 2.2 | 1.7 | 2.2 | ||
Region of enrollment, % | 0.71 | 0.91 | ||||
United States | 38.3 | 34.5 | 31.7 | 32.7 | ||
Russia | 24.1 | 26.1 | 34.1 | 32.6 | ||
Georgia | 19.0 | 20.4 | 17.2 | 16.8 | ||
Canada | 11.2 | 12.9 | 8.5 | 8.3 | ||
Brazil | 5.6 | 4.8 | 4.3 | 5.0 | ||
Argentina | 1.8 | 1.4 | 4.2 | 4.6 | ||
Current smoking, % | 9.6 | 8.1 | 0.40 | 11.2 | 11.1 | 0.97 |
Alcohol drinks/wk, % | 0.32 | 0.71 | ||||
0 | 78.9 | 79.8 | 76.6 | 78.2 | ||
1–5 | 16.1 | 17.2 | 17.8 | 16.1 | ||
6–10 | 3.4 | 2.4 | 3.9 | 4.1 | ||
11– | 1.6 | 0.6 | 1.7 | 1.6 | ||
NYHA functional classification, % | 0.97 | 0.59 | ||||
I/II | 64.9 | 65.0 | 68.3 | 67.3 | ||
III/IV | 35.1 | 35.0 | 31.7 | 32.7 | ||
Body mass index † , kg/m2, % | 0.98 | 0.42 | ||||
<18.5 | 0.2 | 0.2 | 0.7 | 0.4 | ||
18.5–24.9 | 10.1 | 9.3 | 12.6 | 14.4 | ||
25.0–29.9 | 25.9 | 26.2 | 35.1 | 33.1 | ||
≥30.0 | 63.8 | 64.2 | 51.6 | 52.1 | ||
Diabetes mellitus, % | 40.7 | 42.8 | 0.50 | 28.7 | 28.7 | 0.99 |
Hypertension, % | 100 | 100 | … | 88.5 | 87.3 | 0.36 |
Dyslipidemia, % | 69.5 | 70.3 | 0.79 | 68.0 | 65.1 | 0.12 |
History of cardiovascular events, % | ||||||
Myocardial infarction | 26.3 | 24.8 | 0.58 | 26.1 | 26.2 | 0.92 |
Angina pectoris | 50.9 | 47.5 | 0.28 | 47.2 | 44.7 | 0.20 |
Stroke | 9.4 | 9.7 | 0.87 | 7.4 | 6.5 | 0.39 |
Peripheral arterial disease | 11.2 | 10.7 | 0.78 | 7.7 | 9.5 | 0.12 |
Atrial fibrillation | 28.1 | 33.5 | 0.06 | 38.0 | 36.3 | 0.39 |
Percutaneous coronary intervention | 14.6 | 15.5 | 0.71 | 14.7 | 14.0 | 0.62 |
CABG surgery | 13.6 | 12.9 | 0.72 | 12.8 | 12.7 | 0.92 |
Implanted cardioverter defibrillator | 1.0 | 0.6 | 0.46 | 1.2 | 1.7 | 0.30 |
Pacemaker | 6.8 | 5.4 | 0.33 | 8.0 | 9.1 | 0.29 |
COPD, % | 14.8 | 13.5 | 0.53 | 9.8 | 11.5 | 0.18 |
Asthma, % | 8.4 | 7.3 | 0.52 | 6.0 | 5.8 | 0.88 |
Medications, % | ||||||
ACEIs/ARBs | 98.0 | 97.8 | 0.84 | 78.5 | 78.8 | 0.88 |
Calcium‐channel blockers | 87.0 | 84.6 | 0.27 | 19.3 | 16.3 | 0.06 |
Diuretics | 99.0 | 98.6 | 0.57 | 75.5 | 74.2 | 0.44 |
Beta blockers | 77.4 | 76.0 | 0.62 | 77.3 | 79.1 | 0.28 |
Other antihypertensive medications | 32.7 | 36.4 | 0.20 | 4.8 | 5.4 | 0.50 |
Aspirin | 72.6 | 67.7 | 0.09 | 62.7 | 64.1 | 0.47 |
Statin | 54.1 | 57.4 | 0.37 | 51.2 | 51.0 | 0.92 |
Estimated GFR, mL/min per 1.73 m2 | 66.0 (19.2) | 66.0 (20.1) | 0.99 | 68.2 (20.6) | 68.5 (20.1) | 0.64 |
Blood pressure | ||||||
Systolic blood pressure, mm Hg | 135.0 (13.9) | 133.4 (12.6) | 0.06 | 127.1 (13.7) | 127.2 (13.8) | 0.93 |
Diastolic blood pressure, mm Hg | 76.4 (11.7) | 76.3 (10.8) | 0.87 | 75.5 (10.5) | 75.6 (10.3) | 0.75 |
<130/80 mm Hg, % | 19.5 | 19.8 | 0.89 | 33.6 | 34.1 | 0.80 |
Heart rate (beats per minute) | 68.3 (10.3) | 67.5 (11.0) | 0.23 | 69.5 (10.1) | 69.5 (10.7) | 0.96 |
ACEIs indicates angiotensin‐converting enzyme inhibitors; ARBs, angiotensin receptor blockers; CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; GFR, glomerular filtration rate; HFpEF, heart failure with preserved ejection fraction; and NYHA, New York Heart Association.
Data are presented as number of participants, percent, or mean (standard deviation).
Body mass index was calculated as weight in kilograms divided by the square of height in meters.