Safety and Efficacy of Cabergoline on Pregnancy Outcome in Patients With Microprolactinoma

Abstract

BACKGROUND Cabergoline (CAB) has emerged as an effective and well-tolerated drug for the treatment of hyperprolactinemia. However, the drug was included in the pregnancy risk category B by US Food and drug administration. There is limited literature evidence on the use of CAB for treating microprolactinoma during pregnancy, especially among Indian population. The present study was conducted to evaluate the pregnancy outcomes in patients with microprolactinoma, who underwent CAB treatment. MATERIALS AND METHODS The prospective study was conducted in a clinical practice setting in India from Jan 2016 to Dec 2017. The study included female subjects with microprolactinoma, aged between 20-35 years, treated with CAB (0.5 mg to 1.5 mg per week) for a period of 4-12 months, prior to conception and during early weeks of gestation. Level of prolactin was measured at diagnosis, pregnancy confirmation and at the 3 rd month of gestation. Pregnancy, delivery and neonatal complications were the outcome measures considered. Statistical analysis involved descriptive analysis of the study variables. RESULTS The study included a total of 16 subjects with an average age of 26±3.15 years. The average level of prolactin decreased from 122.5±32 mcg/ltr. at diagnosis to 32 (28-54) mcg/ltr. at conception. Spontaneous abortion, pre-term delivery, and neonatal complications were observed in 37.5% (n=6) of the cases. CONCLUSION The current study findings corroborate the previous literature evidence suggesting CAB as an effective drug for the treatment of prolactinomas, specifically microprolactinoma. The study demonstrates that CAB administration, prior to conception and during early weeks of gestation, is not significantly associated with pregnancy-related complications.