期刊
KIDNEY INTERNATIONAL
卷 95, 期 4, 页码 973-982出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.kint.2018.08.034
关键词
hemodialysis; mineralocorticoid blockade; multiple dosage; randomized controlled trial
资金
- National Institute of Diabetes and Digestive and Kidney Diseases [U01 DK096189, U01 DK099923, U01 DK099914, U01 DK099919]
- Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award) [UL1 TR001102]
- Harvard University
- CSRD [I01CX000982]
The safety and efficacy of spironolactone is uncertain in end-stage renal disease. We randomized 129 maintenance hemodialysis patients to placebo (n = 51) or spironolactone 12.5 mg (n = 27), 25 mg (n = 26), or 50 mg (n = 25) daily for 36 weeks in a double-blind, placebo-controlled, multiple dosage trial to assess safety, tolerability and feasibility and to explore cardiovascular efficacy. The primary safety endpoints were hyperkalemia (potassium > 6.5 mEq/L) and hypotension requiring emergency department visit or hospitalization. Diastolic function was assessed by Doppler echocardiography. 125 participants (97%) completed dose escalation, with no significant difference in permanent study drug discontinuation between the groups (27.5% in placebo versus 16.7% in the combined spironolactone groups and 28% in the 50 mg group). Hyperkalemia frequency was similar between spironolactone and placebo (0.49 versus 0.50 events per patient-year) but demonstrated a significant linear trend due primarily to an increased event rate at the 50 mg dose (0.89 events per patient-year). The primary hypotension outcome was infrequent and similar with spironolactone and placebo (0.11 versus 0 events per patient-year). Gynecomastia was rare and did not differ significantly between groups. Change in diastolic function was similar with spironolactone and placebo. Spironolactone appears safe in carefully monitored maintenance hemodialysis patients, but did not affect cardiovascular parameters in this small study. Hyperkalemia occurs more frequently as dosage increases to 50 mg daily.
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