Treatment of intrahepatic cholestasis of pregnancy with ursodeoxycholic acid appears promising, but data are limited so far.
Dr Kondrackiene's team evaluated the efficacy and safety of ursodeoxycholic acid in comparison with cholestyramine.
The team reported that 84 symptomatic patients with intrahepatic cholestasis of pregnancy were randomized to 2 groups.
Group 1 included 42 patients and were randomized to receive ursodeoxycholic acid 8 to10 mg/kg body weight daily.
| Serum alanine was reduced by 79% after ursodeoxycholic acid|
Group 2 had 42 patients that received cholestyramine, 8 g daily for 14 days.
The primary end point was a reduction of pruritus by more than 50% after 14 days of treatment as evaluated by a pruritus score.
Secondary end points were outcome of pregnancy, reduction of serum aminotransferase activities and serum bile acid levels, and drug safety.
The researchers applied intention-to-treat analysis.
The research team found that pruritus was more effectively reduced by ursodeoxycholic acid than cholestyramine.
The team noted that babies were delivered significantly closer to term by patients treated with ursodeoxycholic acid than those treated with cholestyramine.
Serum alanine and aspartate aminotransferase activities were markedly reduced by 79% and 74%, respectively, after ursodeoxycholic acid.
However, the team observed that after cholestyramine therapy, serum alanine and aspartate aminotransferase activities were reduced by 21%.
Endogenous serum bile acid levels decreased by 60% and 19%, respectively.
The researchers found that ursodeoxycholic acid, but not cholestyramine was free of adverse effects.
Dr Kondrackiene's team commented, “Ursodeoxycholic acid is safe and more effective than cholestyramine in intrahepatic cholestasis of pregnancy.”