P-670: Effects of novel hormone therapy with aldosterone antagonist activity drospirenone/estradiol on blood pressure, renal function, and potassium in high risk subgoups of hypertensive postmenopausal women

• Published in: American journal of hypertension Vol. 18; no. S4; p. 252A
• Main Authors: Preston, Richard A., White, William B., Pitt, Bertram, Norris, Paul M., Hanes, Vladimir
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.05.2005
• Subjects: Aldosterone; Drospirenone; Potassium
• ISSN: 0895-7061; 1941-7225; 1879-1905
• DOI: 10.1016/j.amjhyper.2005.03.687

Purpose: The novel hormone therapy Drospirenone/17-β-estradiol (DRSP/E2) has aldosterone antagonist activity and has been shown to lower both systolic and diastolic blood pressures (SBP/DBP) in hypertensive postmenopausal (PM) women. We assessed its effects on creatinine clearance (Ccr) and potassium (K) in high risk subgroups of hypertensive PM women. Methods: Multicenter, randomized trial of DRSP/E2 versus placebo in PM women aged 45-70 years, with (n=82) or without (n=148) diabetes mellitus treated with an ACE inhibitor (ACEI) or ARB. Changes from baseline in Ccr (ml/min) and K (mEq/L) were analyzed overall and for subjects with renal impairment and age>60. Results: Overall, DRSP/E2 reduced SBP/DBP -8.8/-5.8 versus placebo −3.7/−2.9 mmHg (p=0.0001/0.003). There was no deterioration in creatinine clearance. There were small and clinically insignificant differences in change from baseline K only on day 15 in the overall group and age>60 group. There were no differences in K in subjects with renal impairment. Conclusions: DRSP/E2 lowered both SBP and DBP when added to an ACEI or ARB and was not associated with significant changes in renal function or K compared to placebo in high risk PM women. See Table 1. Change from baseline in K (mEq/L) Day 15 Day 17 Day 25 Study End DRSP/E2 Overall (N = 112) 0.099 0.123 0.121 0.097 Placebo Overall (N = 118) 0.005 0.080 0.105 0.073 P-value 0.004 0.340 0.800 0.650 DRSP/E2 renal impaired (n = 28) 0.161 0.243 0.284 0.197 Placebo renal impaired (n = 28) 0.019 0.106 0.056 0.122 P-value 0.20 0.25 0.15 0.45 DRSP/E2 age >60 (n = 47) 0.138 0.158 0.123 0.164 Placebo age >60 (n = 47) −0.01 0.059 −0.013 0.033 P-value 0.03 0.18 0.10 0.07