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Pharmacokinetics of Hydroxyprogesterone Caproate and its Primary Metabolites during Pregnancy.

ABSTRACT: Objective ?To measure pharmacokinetics of hydroxyprogesterone caproate (OHPC) and its major metabolites throughout pregnancy. Study Design ?Thirty women were prescribed OHPC for recurrent preterm birth prevention. Three cohorts of subjects had blood drawn for 7 consecutive days at one of three times: cohort 1 ( n? =?6) after the first dose (weeks 16-20), cohort 2 ( n? =?8) between weeks 24 and 28, and cohort 3 ( n? =?16) between weeks 32 and 36. We measured serum trough levels after week 1 in cohort 1 or after two consecutive weekly doses in cohorts 2 and 3. In 10 subjects, we estimated OHPC terminal half-life at 28 days after their last dose. Results ?In cohorts 1, 2, and 3, the areas under curve (ng?×?h/mL) for OHPC were 571.4?±?195.2, 1,269.6?±?285.0, and 1,268.0?±?511.6, respectively. Maximum OHPC levels (ng/mL) were 5.0?±?1.5, 12.5?±?3.9, and 12.3?±?4.9, respectively. The areas under the curve for mono-hydroxylated metabolites were 208.5?±?92.4, 157.1?±?64.6, and 211.2?±?113.1, and maximum concentrations were 1.9?±?0.7, 1.5?±?0.7, and 1.8?±?1.0, respectively. Di-hydroxylated metabolite levels were significantly lower than mono-hydroxylated metabolites. Estimated terminal half-life of OHPC was 16.3?±?3.6 days and 19.7?±?6.2 days for the mono-hydroxylated metabolites. Conclusion ?After the first injection, OHPC maximum serum level was approximately half steady-state level. Measurable metabolites of unknown activity were detected.

SUBMITTER: Boggess KA

PROVIDER: S-EPMC5951785 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Pharmacokinetics of Hydroxyprogesterone Caproate and its Primary Metabolites during Pregnancy.

Boggess Kim A KA Baker Jeffrey B JB Murtha Amy P AP Peaceman Alan M AM Shah Dinesh M DM Siegfried Sylvia L SL Birch Robert R

AJP reports 20180401 2

Objective To measure pharmacokinetics of hydroxyprogesterone caproate (OHPC) and its major metabolites throughout pregnancy. Study Design Thirty women were prescribed OHPC for recurrent preterm birth prevention. Three cohorts of subjects had blood drawn for 7 consecutive days at one of three times: cohort 1 ( n = 6) after the first dose (weeks 16-20), cohort 2 ( n = 8) between weeks 24 and 28, and cohort 3 ( n = 16) between weeks 32 and 36. We measured ser ...[more]

PMID: 29765789

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Project description:ObjectiveTo evaluate whether 17α-hydroxyprogesterone caproate use in preventing preterm birth increases the risk of gestational diabetes mellitus (GDM).Data sourcesElectronic databases (MEDLINE, Scopus, ClinicalTrials.gov, PROSPERO, EMBASE, Scielo and the Cochrane Central Register of Controlled Trials) were searched for studies published before October 2018. Keywords included "gestational diabetes," "preterm birth," "pregnancy," and "17-hydroxyprogesterone caproate."Methods of study selectionStudies comparing 17α-hydroxyprogesterone caproate with unexposed control groups in women with singleton gestation and a history of a prior spontaneous preterm birth were included. The primary outcome was the development of GDM. Secondary outcomes included abnormal 1-hour, 50-g glucose screen results and mean venous blood glucose levels. Summary estimates were reported as mean differences and 95% CI for continuous variables or relative risk (RR) with 95% CI for dichotomous outcomes. Meta-analysis was performed using the random effects model of DerSimonian and Laird.Tabulation, integration and resultsSix studies, four of which were cohort studies, met inclusion criteria and were included in the final meta-analysis. Of the 5,053 women, 1,538 (30.4%) received 17α-hydroxyprogesterone caproate and 3,515 (69.6%) were in unexposed control groups. The overall rate of GDM in women exposed to 17α-hydroxyprogesterone caproate was 10.9% vs 6.1% in women who were not exposed (RR 1.77, 95% CI 1.22-2.55). After exclusion of the cohort studies, the summary estimate of effect was nonsignificant among women who had been randomly allocated to 17α-hydroxyprogesterone caproate (RR 1.21, 95% CI 0.63-2.36).ConclusionWomen with singleton gestations receiving weekly 17α-hydroxyprogesterone caproate for recurrent preterm birth prevention had a significantly higher incidence of abnormal glucose test results and GDM compared with those in unexposed control groups, a finding that did not hold among women who had been randomly allocated to 17α-hydroxyprogesterone caproate.Systematic review registrationPROSPERO, CRD42016041694.

Dataset Information

Pharmacokinetics of Hydroxyprogesterone Caproate and its Primary Metabolites during Pregnancy.

Publications

Pharmacokinetics of Hydroxyprogesterone Caproate and its Primary Metabolites during Pregnancy.

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