In patients with hyperprolactinaemia:
77% of DOSTINEX patients* saw restored menses following hyperprolactinaemic amenorrhoea.1
*In DOSTINEX patients with a baseline prolactin level <100μg/L.1
72% of DOSTINEX patients had ovulatory cycles or became pregnant.1
Study design: A randomised, multicenter, 24-week trial was conducted to compare cabergoline (0.5-1.0 mg twice weekly; n=223) with bromocriptine (2.5-5.0 mg twice daily; n=236) in the treatment of patients with hyperprolactinaemic amenorrhoea. The 8-week double-blind trial was followed by a 16-week open-label period, depending on dose response. The study comprised 459 patients aged 16 to 45 years who had amenorrhoea for at least 3 months and serum prolactin concentrations at least twice the upper limit of normal values for each center on 2 occasions at least 4 weeks after the discontinuation of any previous therapy. Serum prolactin concentrations of this magnitude were obtained in all but 9 of the 313 patients who had been previously treated. Complete clinical success was defined as the occurrence of at least 2 consecutive menses with biochemical evidence of ovulation on at least one occasion (plasma progesterone concentration above 7.9 ng/mL [25 nmol/L] in samples obtained during the midluteal phase or above 3.2 ng/mL [10 nmol/L] in samples not taken during the midluteal phase) or pregnancy.
In postpartum (≤6 weeks after delivery) women who wish to inhibit lactation:3
78% of DOSTINEX patients had no breast signs or symptoms of lactation at 15 days.3
Study design: A prospective, randomised, double-blind, parallel-group, multicenter study was conducted to compare the efficacy and safety of a single 1-mg dose of cabergoline with that of bromocriptine 2.5 mg twice daily for 14 days in the inhibition of puerperal lactation. Subjects included 272 puerperal patients not wishing to lactate. Patients randomised to cabergoline (n=136) received two 0.5 mg tablets of cabergoline and 1 placebo tablet within 27 hours after delivery and then placebo twice daily for 14 days. Those randomised to bromocriptine (n=136) received 2.5 mg of bromocriptine and 2 placebo tablets within 27 hours and then 2.5 mg of bromocriptine twice daily for 14 days. Complete success was defined as the absence of breast signs and symptoms except for mild spontaneous milk secretion, which was regarded as physiological because the breasts had already produced some milk at the end of pregnancy. Partial success was defined as the presence of any moderate milk secretion or mild to moderate breast pain, or both, or breast engorgement at any time.
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PP-PFE-GBR-3863. November 2021