The objective of the study was to assess the hypotensive effect and safety of add-on therapy with aldosterone inhibitor – eplerenone – in patients with resistant arterial hypertension.Design and method:
50 patients with office systolic (SBP) and diastolic blood pressure (DBP) still exceeding 140 mmHg and 90 mmHg respectively, despite being treated with at least 3 hypotensive drugs, including diuretic and who did not have history of aldosterone inhibitors treatment in last 3 months were enrolled to this study. 28 patients with mean blood pressure during daytime greater than 135/85 mmHg, with potassium levels of no more than 5,1 mmol/l and serum creatinine concentration less than 115 umol/l had eplerenone 25 mg or 50 mg daily added to their therapy. Each patient had office blood pressure measurement, ambulatory 24-hour blood pressure monitoring (ABPM) and laboratory tests carried out at the beginning and at the end of the study. Observation time was 6 weeks. 6 patients were excluded from the analysis due to non-compliance.Results:
After 6 weeks of follow-up 18 patients (82%) had reduction of office blood pressure and 17 patients (77%) of ambulatory blood pressure. Mean decrease in office SBP and DBP was 15 and 8 mmHg respectively (95% Cls: 8 to 22 and 4 to 12, p < 0,001). Mean decrease in ABPM during daytime was 9 in SBP and 5 mmHg in DBP (95% Cls: 3 to 15 and 1 to 8, p < 0,01). Mean decrease in ABPM during nighttime was 7 in SBP and 4 mmHg in DBP, but was not statistically significant. There were no statistically significant changes in electrolytes and serum creatinine levels. No patient reached potassium level greater than 5,1 mmol/l or creatinine greater than 115 umol/l.Conclusions:
This study shows that eplerenon is safe and efficient drug when added to the therapy of resistant arterial hypertension.