Nausea and Vomiting of Pregnancy and its Management with the Dual-Release Formulation of Doxylamine and Pyridoxine

Abstract

Nausea and vomiting of pregnancy (NVP) is among the most common conditions that pregnant women encounter in the early stages of pregnancy. It can affect up to 85% of pregnant women, thus representing a significant public health concern. NVP results in substantial negative physical, emotional, and financial consequences. Despite its prevalence, the pathogenesis remains elusive. Few guidelines have been published; however, several interventions exist for the symptomatic treatment of NVP.

The aim of this review is to provide an overview of modern treatment strategies of NVP with a special focus on the recently approved dual-release formulation of the doxylamine and pyridoxine combination. This combination was approved by the Food and Drug Administration (FDA) in November 2016 for the treatment of NVP when conservative management fails, and it has been introduced to the American market in April 2018.

The maximum plasma concentration (T_max) of doxylamine and pyridoxal-5-phosphate is reached 3.5 h and 15 h, respectively, after administration of one tablet twice daily, or 4.5 h and 0.5 h, respectively, when one tablet is administered just once daily.

In addition, the delayed-release combination allows sufficient levels of doxylamine and the active metabolite pyridoxal-5-phosphate in the systemic circulation, providing symptoms relief in the subsequent morning.

Hence, the dual-release formulation can improve the quality of life of pregnant women suffering from NVP. Additionally, large epidemiological trials have shown no increased risk of adverse effects to newborns, demonstrating that its use is not teratogenic.

Zusammenfassung

Übelkeit und Erbrechen in der Schwangerschaft (Nausea and Vomiting of Pregnancy, NVP) gehören zu den häufigsten Schwangerschaftsbeschwerden, mit denen schwangere Frauen in der Frühschwangerschaft zu kämpfen haben. Bis zu 85% aller schwangeren Frauen können davon betroffen sein; diese Beschwerden stellen somit ein wichtiges Gesundheitsproblem dar. NVP kann beträchtliche negative physische, emotionelle und finanzielle Konsequenzen haben. Trotz der weiten Verbreitung von NVP ist die Pathogenese immer noch unklar. Bislang wurden nur wenige Leitlinien dazu veröffentlicht; es gibt aber mehrere Interventionen zur Behandlung der Symptome von NVP.

Ziel dieser Übersichtsarbeit war es, einen Überblick der modernen Strategien zur Behandlung von NVP zu geben, mit einem besonderen Schwerpunkt auf die kürzlich zugelassene duale Wirkstoffkombination von Doxylamin und Pyridoxin. Diese Wirkstoffkombination wurde im November 2016 von der US-amerikanischen Zulassungsbehörde FDA (Food and Drug Administration) zur Behandlung von NVP bei Versagen von konservativen Managementstrategien zugelassen und kam im April 2018 auf den US-amerikanischen Markt.

Die maximale Plasmakonzentration (T_max) von Doxylamin und Pyridoxin stellt sich ca. 3,5 bzw. 15 Stunden nach Einnahme einer Tablette, die 2-mal am Tag verabreicht wird, ein und 4,5 bzw. 9 h Stunden nach Einnahme einer Tablette, wenn nur 1 Tablette am Tag eingenommen wird.

Die Verzögerung bei der Freisetzung der Wirkstoffe bedeutet, dass der Blutspiegel von Doxylamin und dem aktiven Metaboliten Pyridoxal-5-Phosphat in der systemischen Zirkulation ausreicht, um eine Symptomlinderung auch am nächsten Morgen zu gewährleisten.

Diese Wirkstoffkombination mit dualer Freisetzung kann folglich die Lebensqualität von schwangeren Frauen, die unter NVP leiden, verbessern. Hinzu kommt, dass große epidemiologische Studien kein erhöhtes Risiko für negative Auswirkungen auf Neugeborene feststellen konnten; dies zeigt, dass diese Wirkstoffkombination nicht teratogen ist.

Keywords

pregnancy - nausea and vomiting of pregnancy - emesis - doxylamine - pyridoxine

Schlüsselwörter

Schwangerschaft - Übelkeit und Erbrechen in der Schwangerschaft - Emesis - Doxylamin - Pyridoxin

Publication History

Received: 22 September 2023

Accepted after revision: 10 December 2023

Article published online:
08 February 2024

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