Patients with office systolic BP >140 mm Hg or diastolic BP >90 mm Hg despite treatment with at least 3 antihypertensive drugs, including a diuretic, were enrolled
117 patients were randomly assigned to receive spironolactone (n=59) or a placebo (n=58) as an add–on to their antihypertensive medication, by the method of simple randomization.
Analyses were done with 111 patients (55 in the spironolactone and 56 in the placebo groups).
At 8 weeks, the primary end points, a difference in mean fall of BP on daytime ambulatory BP monitoring (ABPM), between the groups was –5.4 mm Hg (95% CI –10.0; –0.8) for systolic BP (P=0.024) and –1.0 mm Hg (95% CI –4.0; 2.0) for diastolic BP (P=0.358).
The APBM nighttime systolic, 24–hour ABPM systolic, and office systolic BP values were significantly decreased by spironolactone (difference of –8.6, –9.8, and –6.5 mm Hg; P=0.011, 0.004, and 0.011), whereas the fall of the respective diastolic BP values was not significant (–3.0, –1.0, and –2.5 mm Hg; P=0.079, 0.405, and 0.079).
The adverse events in both groups were comparable.
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