Pregnancy outcome after cabergoline treatment in early weeks of gestation
Introduction
Hyperprolactinemia involves high levels of prolactin in the blood outside of physiologic conditions such as pregnancy and breastfeeding. Treatments of choice are dopamine agonists, mainly bromocriptine and cabergoline. In comparison with bromocriptine, cabergoline has a longer action and fewer adverse effects and is effective in patients with bromocriptine intolerance or resistance [1], [2].
Women with infertility secondary to hyperprolactinemia take dopamine agonists until pregnancy occurs. The safety profile of bromocriptine was investigated in a surveillance study [3]. Cabergoline showed no teratogenic or embryotoxic effects on rabbits [4], but data on safety in women are scanty. The only published study, based on 204 pregnancies in women treated with cabergoline, gave reassuring results [5], with no increase in miscarriage rate or abortions induced because of malformations. In the 148 liveborns, the frequency of congenital malformations did not differ from that in the general population. We here report addition experience with pregnancy outcome in women treated with this drug.
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Materials and methods
We included in this study all pregnant women who conceived during treatment with cabergoline and self-referred during the period 1990–2001 for clinical counseling or treatment to the Centro Regionale per l’ Informazione sul Farmaco (CRIF) of the Mario Negri Institute or to six obstetrics or endocrinology centers participating in the study (Prima Clinica Ostetrico Ginecologica, Università di Milano; Divisione di Medicina Generale e Servizio di Endocrinologia, Clinica S. Pio X, Milano; Istituto
Results
Sixty-one pregnancies were observed in 50 women (mean age 30.4 years, range 21–45). Hyperprolactinemia was due to microadenoma in 25 women, macroadenoma in 12, was idiopathic in 5, and due to empty sella syndrome in 2 (six cases unknown). Duration of therapy before pregnancy ranged from 1 to 236 weeks (median 42.5). The mean dose was 1.1 mg per week near conception (range 0.25–7.0 mg per week).
Sixty pregnancies began during treatment and one immediately after stopping treatment. Fetal exposure
Discussion
In this study, the rate of induced abortions in women treated with cabergoline was similar to that in the same time period in the general population of Lombardy (the region of origin of most of the patients): 8.2% (95% CI 7.5–8.9) in our sample and 8.5% in the resident population [6]. Of five terminations, four were at the patient’s request and one was because of fetal malformations suspected by ultrasound examination. Likewise, the proportion of spontaneous abortions (9.8%, 95% CI 9.0–10.6) in
References (10)
- et al.
Reproductive toxicity of cabergoline in mice, rats, and rabbits
Reprod. Toxicol.
(1996) - et al.
Pregnancy outcome after treatment with the ergot derivative, cabergoline
Reprod. Toxicol.
(1996) - et al.
Frequency of hydatidiform mole in Lombardy, Northern Italy
Gynecol. Oncol.
(1986) - et al.
A comparison of cabergoline and bromocriptine in the treatment of hyperprolactinemic amenorrhea. Cabergoline Comparative Study Group
New Engl. J. Med.
(1994) - et al.
Cabergoline in the treatment of hyperprolactinemia: a study in 455 patients
J. Clin. Endocrinol. Metab.
(1999)