A common treatment for intrahepatic cholestasis of pregnancy decreased certain adverse outcomes in pregnant women, a systematic review and meta-analysis found.
Patients who received ursodeoxycholic acid had lower rates of preterm birth and lower rates of the composite outcome of stillbirth and preterm birth compared with untreated patients, reported Catherine Williamson, MD, of King's College London in England, and colleagues.
Additionally, the benefit of treatment on reducing spontaneous preterm birth was statistically significant for women with bile acid concentrations of 40 μmol/L or higher, they noted in Lancet Gastroenterology & Hepatology.
The group previously identified an increased risk of preterm birth and other adverse pregnancy outcomes when peak bile acid concentrations reached 40 µmol/L or higher.
Ursodeoxycholic acid improves biliary flow, enhances the protective bicarbonate environment on the surface of cholangiocytes, and protects the liver from bile acid-induced apoptosis, they explained. It also has anti-inflammatory actions, and can reduce the elevation of serum bile acid concentration in the fetus.
"This study suggests that ursodeoxycholic acid should be offered as part of antenatal treatment for intrahepatic cholestasis of pregnancy, and, particularly, to women with a disease onset before 37 gestational weeks and serum bile acid concentrations of 40 μmol/L or more," Williamson and co-authors wrote.
The group's earlier PITCHES trial, a randomized trial that tested ursodeoxycholic acid against placebo, found no statistically significant improvement in perinatal outcomes with the therapy.
For the current analysis, Williamson and team included individual participant data on 6,974 women in 34 studies, of whom 4,726 (67.8%) took ursodeoxycholic acid. The overall event rate was low, the authors said, with stillbirth occurring in 35 (0.7%) of 5,097 fetuses among treated women with intrahepatic cholestasis of pregnancy and in 12 (0.6%) of 2,038 fetuses among untreated women (adjusted OR 1.04, 95% CI 0.35-3.07, P=0.95).
In other findings, ursodeoxycholic acid, also commonly used to treat gallstones and primary biliary cirrhosis, had no effect on the prevalence of stillbirth when only randomized controlled trials were considered (adjusted OR 0.29, 95% CI 0.04-2.42, P=0.25), and similarly no effect on the prevalence of the composite outcome in all studies (adjusted OR 1.28, 95% CI 0.86-1.91, P=0.22). However, treatment was associated with a reduced composite outcome when only randomized controlled trials were evaluated (adjusted OR 0.60, 95% CI 0.39-0.91, P=0.016).
In terms of maternal outcomes, 5.7% of treated mothers had preeclampsia compared with 7.7% of untreated mothers. Unassisted vaginal birth was achieved in 50.1% of treated mothers versus 61.8% of their untreated counterparts.
Treated women also had lower odds of meconium-stained amniotic fluid and higher odds of large-for-gestational-age babies than untreated women. There were no differences between the groups in neonatal unit admission, umbilical cord arterial pH of less than 7.0, Apgar score of less than 7 at 5 minutes, small-for-gestational-age babies, and perinatal death.
However, there were significantly higher prevalences of neonatal unit admission and meconium-stained amniotic fluid in patients with baseline bile acid concentrations of 40 µmol/L or higher and those with baseline bile acid concentrations of 100 µmol/L or higher. Of note, baseline bile acid concentrations of 100 µmol/L or higher were associated with a higher prevalence of neonatal death.
Although the current study found that treatment did not reduce the odds of early preterm birth before 34 gestational weeks, the prevention of late preterm birth before 37 gestational weeks was beneficial. And while the number needed to treat was just 15, the authors conceded that the analysis was underpowered to show a statistically significant reduction in the overall prevalence of stillbirth with use of ursodeoxycholic acid.
Williamson and colleagues also acknowledged that the low overall event rate was likely a limitation of the analysis.
This meta-analysis "has potentially important clinical implications," wrote Mairead Black, PhD, MBchB, of the University of Aberdeen in Scotland, and colleagues in an accompanying commentary. Although it has not been established whether ursodeoxycholic acid protects against stillbirth, "the number needed to treat of only 15 to reduce a composite of stillbirth and preterm birth suggests that ursodeoxycholic acid could have a substantial health and cost benefit through the reduction of preterm birth alone," they wrote.
Additionally, "although there remains little justification to expedite birth in women with low bile acid concentrations, those units that stopped using ursodeoxycholic acid in patients with intrahepatic cholestasis of pregnancy might now want to consider its reintroduction in light of findings from this new study," Black and co-authors concluded.
Disclosures
This study was funded by Tommy's, the Wellcome Trust, ICP Support, and the National Institute for Health Research.
Williamson had no competing interests to disclose.
Other co-authors disclosed ties to Mirum Pharmaceuticals, GlaxoSmithKline, and Myriad Pharmaceuticals.
Black declared no competing interests. Mol reported ties to Guerbet, Merck, and ObsEva.
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