A cross-over study with the two novel dopaminergic drugs cabergoline and quinagolide in hyperprolactinemic patients

Abstract

Cabergoline and quinagolide, two new dopamine agonist drugs with long-lasting activity, are currently under investigation for the treatment of hyperprolactinemia. At present, studies comparing these drugs for tolerability and efficacy in the same patients are lacking. It was our aim to make such a comparison in an open randomized cross-over trial. Cabergoline (0.5 mg twice weekly) and quinagolide (75 micrograms once daily) were given orally. Each drug was administered for 12 weeks. Treatment with the second drug was started after the recurrence of hyperprolactinemia. Twelve women with hyperprolactinemia due to idiopathic disease (n = 6), microprolactinoma (n = 5) or postsurgical empty sella (n = 1) were evaluated. Six women were amenorrheic and 6 were oligomenorrheic. Ten had spontaneous or provoked galactorrhea. Baseline characteristics (age, clinical signs and PRL levels) of patients initially allocated to the two treatment groups were similar. Nine patients completed both treatment cycles and PRL levels were lower under cabergoline (10.7 +/- 3.7 micrograms/L) than under quinagolide (25.0 +/- 7.7 micrograms/L; p < 0.05). One patient discontinued cabergoline because of dryness of the eyes after having completed the quinagolide cycle and 2 patients initially treated with cabergoline discontinued quinagolide because of gastrointestinal symptoms. After completion of the first treatment cycle, the time of recurrence of hyperprolactinemia was significantly longer after cabergoline (14 +/- 7 weeks) than after quinagolide (5 +/- 1 weeks; p < 0.05). At week 12, normal PRL levels (< 20 micrograms/L) were observed in 10 and 6 women during cabergoline and quinagolide, respectively. Only one case was resistant to both drugs. The clinical effects of the two treatments were similar.(ABSTRACT TRUNCATED AT 250 WORDS)

Advances in the Treatment of Prolactinomas

“…Giusti et al (233) compared once-daily quinagolide (0.075 mg) with twice-weekly cabergoline (0.5 mg) in 12 patients enrolled in a randomized cross-over study where treatment with the second dopamine agonist was initiated after the recurrence of hyperprolactinemia. Nine patients completed both treatment cycles; the clinical effects were similar with the two drugs and, interestingly, only one patient remained resistant to both dopamine agonists.…”

Quinagolide – a valuable treatment option for hyperprolactinaemia

“…Treatment with the second dopamine agonist was initiated after the recurrence of hyperprolactinaemia; nine patients completed both treatment cycles. In this study, the clinical effects were similar with both cabergoline and quinagolide and, interestingly, only one patient remained resistant to both dopamine agonists (53). In a study of 26 children or adolescents with prolactinomas, 16 were considered resistant or intolerant to bromocriptine (52).…”

“…Therefore, in this study, quinagolide and cabergoline normalised prolactin levels in the majority of patients after 12 months of treatment, but recurrence of hyperprolactinaemia was observed in all patients with macroprolactinomas withdrawn from cabergoline and quinagolide (21). In another randomized cross-over study, 12 patients received either once-daily quinagolide (0.075 mg) or twice-weekly cabergoline (0.5 mg) for 12 weeks (53). Treatment with the second dopamine agonist was initiated after the recurrence of hyperprolactinaemia; nine patients completed both treatment cycles.…”

Late Development of Resistance to Bromocriptine in a Patient with Macroprolactinoma

“…There are not many data comparing these two novel dopaminergic drugs. In a cross-over trial including 12 hyperprolactinemic women, Giusti et al [14] observed a normalization of serum PRL levels in 10 patients during CAB therapy (0.5 mg twice weekly) and in 6 during CV treatment (75 µg once daily.) In a recent study by Colao et al [5], 13 of the 20 patients resistant to 600 µg CV daily responded to low doses of CAB (0.5–1 mg weekly).…”