OBJECTIVE: There are relatively few reports in the world comparing the beneficial and adverse effects of bromocriptine and cabergoline in the treatment of hyperprolactinemic patients and there is also lack of such studies in Iraq. Therefore, this study sets out to compare the efficacy and safety of cabergoline with those of bromocriptine in women with hyperprolactinemic amenorrhea in Mosul city. DESIGN: Randomized, 8 - week period comparative trial. Setting: Al-Batool Teaching Hospital for Obstetric and Gynecology and the department of pharmacology, college of medicine in Mosul city. MATERIALS AND METHODS: One hundred and thirty women with hyperprolactinemic amenorrhea participated in the study. Women were treated with either cabergoline (0.5 mg weekly) or bromocriptine (2.5 mg twice daily) administered randomly for 8 weeks. Amenorrhea and galactorrhea and serum prolactin levels were assessed at baseline and at the end of the trial. MAIN OUTCOME MEASURES: The efficacy of both treatments was assessed with the occurrence of menses, absence of galactorrhea and normalization of serum prolactin levels. RESULTS: Amenorrhea persisted in 9 women of the cabergoline-treated women and 20 of the bromocriptine-treated women. Galactorrhea disappeared in the cabergoline group and persisted in 12 of the bromocriptine group. Normoprolactinemia was achieved in 87.7% women treated with cabergoline and in 67.7% of women treated with bromocriptine. CONCLUSIONS: Cabergoline and bromocriptine are effective in the treatment of hyperprolactinemic amenorrhea .Cabergoline has the advantage over bromocriptine in terms of both efficacy and tolerability and therefore it is preferred in the treatment of hyperprolactinemic amenorrhea.
OBJECTIVE: It is well known that bromocriptine has a suppressive effect on the prolactin release in hyperprolactinemic patients. But it also has some adverse effects. The new, long-acting dopaminergic drug, cabergoline, has been reported to be an effective agent in these patients. However, there are relatively few reports comparing the beneficial and adverse effects of these drugs in the treatment of hyperprolactinemic patients. Therefore, here we studied and compared the efficacy and tolerability of cabergoline with bromocriptine in hyperprolactinemic patients.
PATIENTS: Seventeen patients (7 with microprolactinoma, 4 with macroprolactinoma, 6 with idiopathic hyperprolactinemia) were given bromocriptine at a dose of 2.5 mg (or 5 mg for macroprolactinomas) twice daily, and 17 patients (8 with microprolactinoma, 4 with macroprolactinoma, 5 with idiopathic hyperprolactinemia) were given cabergoline at a dose of 0.5 mg twice weekly for 12 weeks.
RESULTS: At the end of the study, the prolactin reduction was significantly greater in the cabergoline group than in the bromocriptine group (-93 vs. -87.5 %, respectively, p < 0.05). Normalization of prolactin levels was achieved in 10 of 17 patients (59%) in the bromocriptine group, and in 14 of 17 patients (82%) in the cabergoline group (p = 0.13). Two patients (50%) with macroprolactinoma in the bromocriptine group and three patients (75%) with macroprolactinoma in the cabergoline group demonstrated a normalization of their serum prolactin levels. Adverse events were noted in 53% of bromocriptine patients and in 12% of cabergoline patients (p < 0.01).
CONCLUSION: These data indicate that cabergoline is a very effective agent for lowering the prolactin levels in hyperprolactinemic patients and that it appears to offer considerable advantage over bromocriptine in terms of efficacy and tolerability.
OBJECTIVES:
Cabergoline is a new, long-acting D2 agonist, highly effective in suppressing prolactin and restoring gonadal function in hyperprolactinaemic amenorrhoea. This study compares its efficacity and safety with that of the reference compound, bromocriptine.
METHODS:
A prospective study involved 21 French Centres and 120 women, with hyperprolactinaemic amenorrhoea, randomized to either cabergoline (CAB 0.5-1 mg twice weekly) or bromocriptine (BRC 2.5-5 mg twice daily). Treatment is given under double-blind conditions for the first 8 weeks, and subsequently in open conditions in further 16 weeks with dose adjustments according to response. Patients were assessed for biochemical and clinical efficacy and drug safety (adverse symptoms and biology).
RESULTS:
Normoprolactinaemia was achieved in 56/60 (93.3%) taking CAB and 27/58 (48.2%) taking BRC (p < 0.0001). Ovulatory cycles or pregnancy were recorded in 71.6% and 48.2% of patients (p = 0.001). Prolactin suppression to below 50% of the baseline value was observed in 1.6% and 15.5% (p = 0.007). Adverse symptoms were recorded in 31/60 (51.6%) and 40/58 (69.2%) patients respectively in the double-blind period, and 53.3% versus 65.5% for the full course of the study. There were significantly fewer gastro-intestinal symptoms in the CAB group, 36.6% versus 84.5% (p < 0.0001).
CONCLUSION:
Cabergoline is a new prolactin-lowering drug, more effective and better tolerated with fewer gastrointestinal symptoms than the reference compound, bromocriptine.
BACKGROUND: Cabergoline is a long-acting dopamine-agonist drug that suppresses prolactin secretion and restores gonadal function in women with hyperprolactinemic amenorrhea. We designed a study to compare its safety and efficacy with those of bromocriptine, which has been the standard therapy.
METHODS: A total of 459 women with hyperprolactinemic amenorrhea were treated with either cabergoline (0.5 to 1.0 mg twice weekly) or bromocriptine (2.5 to 5.0 mg twice daily), administered in a double-blind fashion for 8 weeks and subsequently in an open fashion for 16 weeks, during which adjustments in the dose were made according to the response. Of the 459 women, 279 had microprolactinomas, 3 had macroprolactinomas, 1 had a craniopharyngioma, 167 had idiopathic hyperprolactinemia, and the remainder had an empty sella. Clinical and biochemical status was assessed at 2-week intervals for 8 weeks and monthly thereafter for a total of 6 months, with an additional assessment at 14 weeks.
RESULTS: Stable normoprolactinemia was achieved in 186 of the 223 women treated with cabergoline (83 percent) and 138 of the 236 women treated with bromocriptine (59 percent, P < 0.001). Seventy-two percent of the women treated with cabergoline and 52 percent of those treated with bromocriptine had ovulatory cycles or became pregnant during treatment (P < 0.001). Amenorrhea persisted in 7 percent of the cabergoline-treated women and 16 percent of the bromocriptine-treated women. Adverse effects were recorded in 68 percent of the women taking cabergoline and 78 percent of those taking bromocriptine (P = 0.03); 3 percent discontinued taking cabergoline, and 12 percent stopped taking bromocriptine (P < 0.001) because of drug intolerance. Gastrointestinal symptoms were significantly less frequent, less severe, and shorter-lived in the women treated with cabergoline.
CONCLUSIONS: Cabergoline is more effective and better tolerated than bromocriptine in women with hyperprolactinemic amenorrhea.
There are relatively few reports in the world comparing the beneficial and adverse effects of bromocriptine and cabergoline in the treatment of hyperprolactinemic patients and there is also lack of such studies in Iraq. Therefore, this study sets out to compare the efficacy and safety of cabergoline with those of bromocriptine in women with hyperprolactinemic amenorrhea in Mosul city.
DESIGN:
Randomized, 8 - week period comparative trial. Setting: Al-Batool Teaching Hospital for Obstetric and Gynecology and the department of pharmacology, college of medicine in Mosul city.
MATERIALS AND METHODS:
One hundred and thirty women with hyperprolactinemic amenorrhea participated in the study. Women were treated with either cabergoline (0.5 mg weekly) or bromocriptine (2.5 mg twice daily) administered randomly for 8 weeks. Amenorrhea and galactorrhea and serum prolactin levels were assessed at baseline and at the end of the trial.
MAIN OUTCOME MEASURES:
The efficacy of both treatments was assessed with the occurrence of menses, absence of galactorrhea and normalization of serum prolactin levels.
RESULTS:
Amenorrhea persisted in 9 women of the cabergoline-treated women and 20 of the bromocriptine-treated women. Galactorrhea disappeared in the cabergoline group and persisted in 12 of the bromocriptine group. Normoprolactinemia was achieved in 87.7% women treated with cabergoline and in 67.7% of women treated with bromocriptine.
CONCLUSIONS:
Cabergoline and bromocriptine are effective in the treatment of hyperprolactinemic amenorrhea .Cabergoline has the advantage over bromocriptine in terms of both efficacy and tolerability and therefore it is preferred in the treatment of hyperprolactinemic amenorrhea.
