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Postpartum hypertension (pHTN) in preeclampsia (PE) results, in part, from mobilization of extravascular fluid accumulated in pregnancy. Our objective was to determine whether the loop diuretic torsemide reduces the rate of persistent pHTN in women with PE.
Pragmatic, randomized, double-blind, placebo-controlled trial (RCT, NCT02813551) of women with PE or superimposed PE (with or without severe features) at a single center from August 2016 to July 2017. Those with chronic or gestational HTN, renal or cardiopulmonary failure were excluded. Within 24h of delivery, women were randomized to oral torsemide 20 mg/d or placebo, for 5d. Primary outcome was rate of persistent pHTN (sustained SBP≥150 or DBP≥100 mmHg) by postpartum day 5 or at hospital discharge, whichever occurred first. Secondary outcomes included: pHTN 7-10d after delivery, severe HTN (SBP≥160 or DBP≥110 mmHg), length of puerperal hospital stay, readmission for HTN, adverse events and severe composite morbidity (ICU admission, HELLP syndrome, eclampsia, stroke, renal/heart failure, pulmonary edema or death). A 50% rate of pHTN in the placebo arm was expected based on prior studies. Assuming a 25% rate with torsemide, 80% power and alpha-error of 0.05, a sample of 118 women was required. Bayesian analysis to calculate probability of treatment benefit or harm was planned a priori. Analyses were based on intention-to-treat.
59 women were allocated to torsemide and 59 to placebo. Baseline characteristics were similar. Overall, 43 (73%) women in the torsemide group and 45 (76%) in the placebo group had either PE with severe features or superimposed to chronic HTN. The rate of persistent pHTN was 44% in torsemide vs 57% in placebo group (RR 0.76, 95% CI 0.53-1.10). However, Bayesian analysis revealed that probability of torsemide reducing persistent pHTN compared to placebo was 92%. There were no differences in rate of pHTN 7-10d after delivery, severe HTN, length of stay, readmission for HTN or adverse events (Table). There were no cases of severe composite morbidity or deaths.