MedStar Authors catalog › Details for: Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial.
Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. Journal: BMC pregnancy and childbirth.ISSN: 1471-2393.UI/PMID: 25884778.Subject(s): 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] | *Dicyclomine | Double-Blind Method | Doxylamine/ad [Administration & Dosage] | Doxylamine/ae [Adverse Effects] | *Doxylamine | 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] | *Nausea | Pregnancy | *Pregnancy Complications/dt [Drug Therapy] | Pyridoxine/ad [Administration & Dosage] | Pyridoxine/ae [Adverse Effects] | *Pyridoxine | Treatment Outcome | Vitamin B Complex | Vomiting/dt [Drug Therapy] | Vomiting/et [Etiology] | *VomitingInstitution(s): MedStar Health Research InstituteActivity type: Journal Article.Medline article type(s): Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tOnline resources: Click here to access online Digital Object Identifier: http://dx.doi.org/10.1186/s12884-015-0488-1 (Click here) Abbreviated citation: BMC Pregnancy Childbirth. 15:59, 2015.Local Holdings: Available online from MWHC library: 2001 - present.Abstract: 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; 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; 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; TRIAL REGISTRATION: Clinical Trial Registration No: NCT00614445.