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

Abstract

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

Aldosterone, Drospirenone, Potassium