Efficacy and safety of spironolactone in mono-therapy versus low dose spironolactone in combined-therapy for the treatment of idiopathic hyperaldosteronism / 中华内分泌代谢杂志

ABSTRACT

Objective The aim of this study was to compare the efficacy and safety of spironolactone in mono-therapy versus low dose spironolactone in combined-therapy for the treatment of idiopathic hyperaldosteronism (IHA). Methods This was a prospective and randomized study. After 2 weeks wash out period, 48 patients confirmed IHA were assigned to either spironolactone mono-therapy or low dose spironolactone combined-therapy groups. All patients underwent adrenal venous sampling and showed no lateralization. The primary outcome was the percentage of patients with blood pressure<140/90 mmHg(1 mmHg＝0.133 kPa) at 16 weeks. The other observatory parameters were the occurrence of gynecomastia, renal insufficiency, and hyperkalemia. Results At the end of 16 weeks, the patients′blood pressure were normalized in 17 out of 24 patients(70.8%) in mono-therapy group and in 23 out of 24 patients ( 95. 8%) in combined-therapy group ( P<0. 05). There was no hyperkalemia in both groups. 2 patients and 5 patients in mono-therapy group were observed renal insufficiency and gynecomastia respectively, while no patients in combined-therapy group presented with those side effects. Conclusion Low dose spironolactone combined-therapy group is more effective to control blood pressure and hypokalemia without increase the occurrence of renal insufficiency or gynecomastia.