Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial.

MedStar author(s):
Citation: BMC Pregnancy & Childbirth. 15:59, 2015.PMID: 25884778Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Dicyclomine | *Doxylamine | *Nausea | *Pregnancy Complications/dt [Drug Therapy] | *Pyridoxine | *Vomiting | Adult | Antiemetics/ad [Administration & Dosage] | Antiemetics/ae [Adverse Effects] | Delayed-Action Preparations/ad [Administration & Dosage] | Delayed-Action Preparations/ae [Adverse Effects] | Dicyclomine/ad [Administration & Dosage] | Dicyclomine/ae [Adverse Effects] | Double-Blind Method | Doxylamine/ad [Administration & Dosage] | Doxylamine/ae [Adverse Effects] | Drug Combinations | Drug Monitoring/mt [Methods] | Female | Histamine H1 Antagonists/ad [Administration & Dosage] | Histamine H1 Antagonists/ae [Adverse Effects] | Humans | Nausea/dt [Drug Therapy] | Nausea/et [Etiology] | Pregnancy | Pyridoxine/ad [Administration & Dosage] | Pyridoxine/ae [Adverse Effects] | Treatment Outcome | Vitamin B Complex | Vomiting/dt [Drug Therapy] | Vomiting/et [Etiology]Year: 2015Local holdings: Available online from MWHC library: 2001 - presentISSN:
  • 1471-2393
Name of journal: BMC pregnancy and childbirthAbstract: BACKGROUND: Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question. The Objective is to evaluate the maternal safety of doxylamine succinate -pyridoxine hydrochloride delayed-release preparation (Diclegis as compared to placebo.CONCLUSIONS: Doxylamine succinate-pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy.METHODS: We randomized women suffering from NVP to receive Diclegis (n=131) or placebo (n=125) for 14 days at doses ranging from 2-4 tablets a day, based on a pre-specified titration protocol response to symptoms. Adverse events were collected through patient diaries, clinical examination and laboratory testing.RESULTS: Doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg use was not associated with an increased rate of any adverse event over placebo, including CNS depression, gastrointestinal or cardiovascular involvement.TRIAL REGISTRATION: Clinical Trial Registration No: NCT00614445 .All authors: Caritis SN, Clark S, Hankins GD, Koren G, Matok I, Mattison DR, Miodovnik M, Umans JGFiscal year: FY2016Digital Object Identifier: Date added to catalog: 2016-05-24
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 25884778 Available 25884778

Available online from MWHC library: 2001 - present

BACKGROUND: Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question. The Objective is to evaluate the maternal safety of doxylamine succinate -pyridoxine hydrochloride delayed-release preparation (Diclegis as compared to placebo.

CONCLUSIONS: Doxylamine succinate-pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy.

METHODS: We randomized women suffering from NVP to receive Diclegis (n=131) or placebo (n=125) for 14 days at doses ranging from 2-4 tablets a day, based on a pre-specified titration protocol response to symptoms. Adverse events were collected through patient diaries, clinical examination and laboratory testing.

RESULTS: Doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg use was not associated with an increased rate of any adverse event over placebo, including CNS depression, gastrointestinal or cardiovascular involvement.

TRIAL REGISTRATION: Clinical Trial Registration No: NCT00614445 .

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