Pregnancy outcome after first trimester exposure to bisoprolol: an observational cohort study. Issue 10 (October 2018)

• Record Type: Journal Article
• Authors: Hoeltzenbein, Maria; Fietz, Anne-Katrin; Kayser, Angela; Zinke, Sandra; Meister, Reinhard; Weber-Schoendorfer, Corinna; Schaefer, Christof
• Is Part Of: Journal of hypertension. Volume 36:Issue 10(2018:Oct.)
• Publication Date: 2018-10
• Subjects: birth defects -- bisoprolol -- chronic hypertension -- congenital abnormalities -- pregnancy outcome -- spontaneous abortion -- ACEI -- angiotensin-converting enzyme inhibitor -- ARB -- angiotensin receptor blocker -- CI -- confidence interval -- C-section -- Cesarean-section -- CYP -- cytochrome P450 -- ESC -- European Society of Cardiology -- ETOP -- elective termination of pregnancy -- EUROCAT -- European register of congenital anomalies and twins -- IPTW -- inverse probability of treatment weighting -- OR -- odds ratio -- SDS -- standard deviation score; Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/HJH.0000000000001818
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objectives: Beta-blockers are frequently used during pregnancy, with labetalol and metoprolol being considered as drugs of choice. As there are no prospective pregnancy studies for bisoprolol yet, our aim was to analyze pregnancy outcomes after bisoprolol exposure. Methods: Pregnancies exposed to bisoprolol during the first trimester were retrieved from the German Embryotox pharmacovigilance database. Pregnancy outcomes of prospectively ascertained pregnancies were compared with women neither exposed to beta-blockers nor other antihypertensives. In addition, retrospective reports on adverse drug reactions were screened for patterns of birth defects. Results: Inclusion criteria for the prospective study were met by 339 bisoprolol-treated women and 678 patients in the comparison cohort. Neither the risk for spontaneous abortions [adjusted hazard ratio (HRadj. ) 1.06; 95% confidence interval (CI) 0.66–1.70] nor for major congenital malformations [adjusted odds ratio (ORadj. ) 0.77; 95% CI 0.34–1.75] was increased after first trimester bisoprolol treatment. However, higher rates of preterm births [ORadj. 1.90; 95% CI 1.17–3.11] and reduced birthweights in singleton pregnancies (adjusted standard deviation score difference −0.48; 95% CI −0.62 to −0.34) were noted. Continued treatment with beta-blockers until birth was found to be associated with a higher risk for growth restriction than first trimester exposure only. A sensitivity analysis did not suggest higher rates of adverse pregnancy outcomes in hypertensive women on bisoprolol compared with nonhypertensive bisoprolol-exposed women. Conclusion: Our study supports the hypothesis that first trimester bisoprolol treatment does not increase the risk for spontaneous abortions or major birth defects. However, an influence of prolonged bisoprolol exposure on fetal growth cannot be ruled out. Abstract : Supplemental Digital Content is available in the text