Treatment algorithm
Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups: see disclaimer
ursodiol
Treatment recommended for SOME patients in selected patient group
Ursodiol reduces the severity of pruritus (although to a small degree and inconsistently), alters the composition of the bile acid pool (enriching it with hydrophilic ursodiol and reducing hydrophobic bile acid concentrations), and reduces alanine aminotransferase concentrations.[91][92]
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In a large placebo-controlled trial, which included more than 600 women, ursodiol did not reduce the frequency of a composite of adverse pregnancy outcomes that included preterm birth, stillbirth, and neonatal unit admission, although it did reduce meconium-staining of the amniotic fluid.[93] Reassuringly, however, ursodiol use was not associated with adverse side effects compared with placebo.
A subsequent meta-analysis that included individual participant data from 6974 women in 34 studies showed that ursodiol protects against spontaneous preterm birth in singleton ICP pregnancy.[94]
Although the Royal College of Obstetricians and Gynaecologists recommends against routine use of ursodiol due to lack of evidence for maternal or fetal benefit, the more recent European and joint Australian and New Zealand guidelines cite the new data and suggest ursodiol may be considered for women with mild ICP (bile acids <40 micromol/L).[14][79][95]
Decisions about treatment should be individualized.
Primary options
ursodiol: consult specialist for guidance on dose
ursodiol
Treatment recommended for SOME patients in selected patient group
Ursodiol reduces the severity of pruritus (although to a small degree and inconsistently), alters the composition of the bile acid pool (enriching it with hydrophilic ursodiol and reducing hydrophobic bile acid concentrations), and reduces alanine aminotransferase concentrations.[91][92]
[ ]
In a large placebo-controlled trial, which included more than 600 women, ursodiol did not reduce the frequency of a composite of adverse pregnancy outcomes that included preterm birth, stillbirth, and neonatal unit admission, although it did reduce meconium-staining of the amniotic fluid.[93] Reassuringly, however, ursodiol use was not associated with adverse side effects compared with placebo.
A subsequent individual patient data meta-analysis found that treatment with ursodiol was associated with a reduction in preterm birth (most clearly, spontaneous preterm birth) in singleton pregnancies in women whose serum bile acid concentrations at diagnosis or randomization were ≥40 micromol/L.[94] Thus, ursodiol is recommended, in particular, for women with ICP before 37 gestational weeks who have bile acid concentrations ≥40 micromol/L.
Decisions about treatment should be individualized.
Primary options
ursodiol: consult specialist for guidance on dose
ursodiol
Treatment recommended for SOME patients in selected patient group
Ursodiol reduces the severity of pruritus (although to a small degree and inconsistently), alters the composition of the bile acid pool (enriching it with hydrophilic ursodiol and reducing hydrophobic bile acid concentrations), and reduces alanine aminotransferase concentrations.[91][92]
[ ]
In a large placebo-controlled trial, which included more than 600 women, ursodiol did not reduce the frequency of a composite of adverse pregnancy outcomes that included preterm birth, stillbirth, and neonatal unit admission, although it did reduce meconium-staining of the amniotic fluid.[93] Reassuringly, however, ursodiol use was not associated with adverse side effects compared with placebo. A subsequent individual patient data meta-analysis found that treatment with ursodiol was associated with a reduction in preterm birth (most clearly, spontaneous preterm birth) in singleton pregnancies in women whose serum bile acid concentrations at diagnosis or randomization were ≥40 micromol/L.[94] Thus, ursodiol is recommended, in particular, for women with ICP before 37 gestational weeks who have bile acid concentrations ≥40 micromol/L. Decisions about treatment should be individualized.
Primary options
ursodiol: consult specialist for guidance on dose
Choose a patient group to see our recommendations
Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups. See disclaimer
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