DALLAS -- Torsemide (Demadex) treatment did not reduce the frequency of post-partum hypertension among women who had preeclampsia during pregnancy, researchers said here.
While the rate of persistent post-partum hypertension was lower among women treated with the diuretic compared with placebo following delivery, the difference did not reach statistical significance (44% vs 58%, RR 0.76, 95% CI 0.53-1.10), reported Oscar A. Viteri, MD, of McGovern Medical School at UTHealth in Houston.
Post-partum hypertension complicated 3% to 28% of pregnancies, and severe post-partum hypertension can affect up to 14% of women, he said in a at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting.
Viteri cited the American College of Obstetricians and Gynecologists (ACOG) task force on hypertension in pregnancy, which more study is needed of diuretics to treat preeclampsia in pregnancy. To their knowledge, no studies had specifically evaluated torsemide for post-partum hypertension, according to the ACOG task force.
Viteri added that when compared with furosemide (Lasix), torsemide is the only pregnancy category B drug, while furosemide is category C. But he also noted there is no data on torsemide and lactation.
The researchers examined women, ages ≥18, with preeclampsia with or without severe features or superimposed preeclampsia up to 24 hours post-partum. The primary outcome was post-partum hypertension that met criteria for antihypertensive therapy: systolic blood pressure ≥150 and/or diastolic blood pressure ≥100 mmHg for at least two occasions ≥4 hours apart from randomization to discharge or day 5.
Women were randomized within 24 hours post-partum to receive torsemide 20 mg PO daily for 5 days or the same dose of placebo. Overall, 59 women each were randomized to receive torsemide or placebo. Mean age ranged from 27-28s, and 56%-59% of women were African American.
There was no significance between groups at baseline, but Viteri pointed out that "remarkably, women with preeclampsia with severe features and those with superimposed preeclampsia comprised three-quarters of our [participants]."
While the primary outcome did not reach statistical significance, a Bayesian analysis indicated the probability that torsemide reduced post-partum hypertension compared with placebo was 92%.
"It was disappointing that there was no identified benefit, since post-partum hypertension is an area of significant importance, and the optimal approach to management is still not known," David Hackney, MD, of University Hospitals Cleveland Medical Center in Cleveland, told 鶹ý. Hackney was not involved in the study.
There was no difference in secondary outcomes, including length of stay, hypertension at 7-10 days, and readmission for hypertension. There were also instances of severe maternal morbidity or death.
The authors suggested that longer duration of treatment may be warranted. Viteri added that a planned ancillary study of 19 patients will examine breast milk and serum samples in torsemide and placebo to look at concentration ratios by high-performance liquid chromatography.
Hackney agreed that it is possible that a benefit could be identified in future studies. "There were few adverse events, and thus there were no findings that would preclude future research," he said.
Disclosures
Viteri and co-authors disclosed no relevant relationships with industry.
Primary Source
Society for Maternal-Fetal Medicine
Viteri OA, et al "Torsemide for prevention of persistent post-partum hypertension in preeclampsia: A randomized, placebo-controlled trial" SMFM 2018; Abstract 42.