Effect of Spironolactone in Resistant Arterial Hypertension

This study was designed to assess the effect of the addition of low-dose spironolactone on blood pressure (BP) in patients with resistant arterial hypertension. Patients with office systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP)>90 mm Hg despite treatment with at least 3 antihypertensive drugs, including a diuretic, were enrolled in this double-blind, placebo-controlled, multicentre trial. One hundred sixtyone patients in outpatient internal medicine departments of 6 hospitals in the Czech Republic were randomly assigned to receive 25 mg of spironolactone (N1⁄4 81) or a placebo (N1⁄4 80) once daily as an add-on to their antihypertensive medication, using simple randomization. This study was registered with ClinicalTrials.gov, number NCT00524615. Analyses were done with 150 patients who finished the follow-up (74 in the spironolactone and 76 in the placebo group). At 8 weeks, BP values were decreased more by spironolactone, with differences in mean fall of SBP of 9.8, 13.0, 10.5, and 9.9 mm Hg (P< 0.001 for all) in daytime, nighttime, and 24-hour ambulatory BP monitoring and in the office. The respective DBP differences were 3.2, 6.4, 3.5, and 3.0 mm Hg (P1⁄4 0.013, P< 0.001, P1⁄4 0.005, and P1⁄4 0.003). Adverse events in both groups were comparable. The office SBP goal <140 mm Hg at 8 weeks was reached in 73% of patients using spironolactone and 41% using placebo (P1⁄4 0.001). dlák, MD, Jiřı́ Jar iloš Táborský, MD, PhD (Medicine 93(27):e162) Abbreviations: ABPM = ambulatory blood pressure monitoring, ARR = aldosterone/renin ratio, ASPIRANT = Addition of Spironolactone in Patients with Resistant Arterial Hypertension, BP = blood pressure, DBP = diastolic blood pressure, PRA = plasma renin activity, SBP = systolic blood pressure, SD = standard