Ursodeoxycholic acid therapy in intrahepatic cholestasis of pregnancy: Results in real-world conditions and factors predictive of response to treatment.
BACKGROUND
Ursodeoxycholic acid (UDCA) therapy is commonly used in intrahepatic cholestasis of pregnancy (ICP).


OBJECTIVE
To evaluate the efficacy and tolerance of UDCA in real-world conditions and to search for factors predictive of response to treatment.


METHODS
This observational study included 98 consecutive patients suffering from pruritus during pregnancy associated with increased ALT levels or total bile acid (TBA) concentrations, without other causes of cholestasis. The entire ABCB4 gene coding sequence was analyzed by DNA sequencing.


RESULTS
UDCA was prescribed until delivery in all patients (mean dose 14.0mg/kg/day; mean duration 30.4 days). Pruritus improved in 75/98 (76.5%) patients, and totally disappeared before delivery in 25/98 (25.5%). After 2-3 weeks of treatment, ALT levels decreased by more than 50% of base line in 67/86 (77.9%) patients and normalized in 34/86 (39.5%), and TBA concentrations decreased in 28/81 (34.6%). Only one patient stopped the treatment before delivery. On multivariate analysis, ALT >175IU/l before treatment was associated with improvement of pruritus (OR 2.97, 95% CI 1.12-7.89, P=0.029) and with decreased ALT (OR 18.61, 95% CI 3.94-87.99, P=0.0002). ABCB4 gene mutation was not associated with response to treatment.


CONCLUSIONS
This study supports the use of UDCA as first line therapy in ICP.
Department of Hepatology and Gastroenterology, University Hospital of Tours, Tours, France. Electronic address: bacq@med.univ-tours.fr.
Yannick
Y
Bacq
Department of Hepatology and Gastroenterology, University Hospital of Tours, Tours, France.
Matthieu
M
le Besco
Department of Public Health and Medical Information, University Hospital of Tours, Tours, France.
Anne-Isabelle
AI
Lecuyer
Laboratory of Biochemistry and Molecular Biology, University Hospital of Tours, Tours, France.
Chantal
C
Gendrot
Department of Obstetrics and Gynecology, University Hospital of Tours, Tours, France.
Jérôme
J
Potin
Laboratory of Biochemistry and Molecular Biology, University Hospital of Tours, Tours, France.
Christian R
CR
Andres
Department of Hepatology and Gastroenterology, University Hospital of Tours, Tours, France.
Alexandre
A
Aubourg
D018435:ATP Binding Cassette Transporter, Subfamily B / Q000235:genetics; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001647:Bile Acids and Salts / Q000097:blood; D002756:Cholagogues and Choleretics / Q000009:adverse effects / Q000627:therapeutic use*; D002780:Cholestasis, Intrahepatic / Q000188:drug therapy* / Q000235:genetics; D005260:Female; D005602:France; D006801:Humans; D008111:Liver Function Tests; D016015:Logistic Models; D015999:Multivariate Analysis; D009154:Mutation; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000235:genetics; D011537:Pruritus / Q000188:drug therapy; D014580:Ursodeoxycholic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D018435:ATP Binding Cassette Transporter, Subfamily B; D001647:Bile Acids and Salts; D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid; C095122:multidrug resistance protein 3; D000410:Alanine Transaminase
ABCB4 gene; Bile acids; Liver disease; Pharmacology