Cabergoline in the long-term therapy of hyperprolactinemic disorders

Abstract

in the longterm therapy of hyperprolactinemic disorders. Acta Endocrinol 1992:126:489-94. The efficacy and safety of the new long-acting dopamine agonist cabergoline were evaluated in 127 hyperprolactinemic patients (124F and 3M; 71 with microprolactinoma, 14 with macroprolactinoma, 5 with operated macroprolactinoma and 37 with idiopathic disorder) who were treated with the drug for from 3 to 52 months (median, 14 months). Cabergoline was administered orally at dose levels ranging between 0.2 and 3.5mg per week, given once weekly in 92 patients, twice weekly in 22, thrice weekly in 9 and daily in 4. Serum prolactin and progesterone levels, hematology, blood chemistry and electrocardiograms were frequently evaluated throughout treatment. CT or MR imaging of the pituitary was repeated during treatment in patients with macroprolactinoma and in 38 with microprolactinoma. After drug discontinuation, serum prolactin and gonadal function were evaluated monthly for three months in 65 patients and for up to two years in 12. Serum prolactin levels were normalized in 114 patients (90%). Of 56 women with amenorrhea, 52 resumed menses (with presumptive evidence of ovulation in 49); 17 women became pregnant; and sexual potency was restored in the 3 men. Evidence of tumor shrinkage was obtained in 13 of the 14 patients with macroprolactinoma and in 28 of 38 with microprolactinoma; complete disappearance of the tumor image was achieved in 2 macro and 14 microprolactinomas. A total of 48 adverse events was reported by 29 patients (2 3%), almost all typical of the pharmacological class and mild to moderate; no patient withdrew from treatment due to adverse events. Safety parameters did not change. Following cabergoline discontinuation, prolactin levels increased slowly, being still markedly lower than pretreatment values after three months; 10 patients out of 32 had persistently normal prolactin levels during one year of follow-up. Of 28 previously amenorrheic women who resumed menses during treatment and were followed for at least six months after cabergoline withdrawal, 23 continued to have cyclic ovulatory menses. These efficacy and safety data, including those obtained on drug withdrawal, compare favorably with those reported for bromocriptine and other prolactin-lowering drugs. Because of its very simple administration schedule, which should increase patient compliance, cabergoline may become the drug of choice for hyperprolactinemic disorders. Carlo Ferrari, Endocrine Unit, Ospedale Fatebenefratelli e Oftálmico, 23 Corso di Porta Nuova, 1-20121 Milano, Italy Since its introduction to clinical medicine in the early seventies, bromocriptine has became the first choice treatment for hyperprolactinemic disorders (1). It is very effective in normalizing serum prolactin (PRL) levels (approximately 80% of patients), restoring gonadal function (approximately 85% of patients) and shrinking prolactinomas (about 70% of cases with macroprolacti¬ noma) (2), but it has quite a high rate of adverse events (69% of patients according to the...

Long term follow-up of patients with prolactinomas and outcome of dopamine agonist withdrawal: a single center experience

“…These outcomes are better than usually been reported (mean 29%, ranging from 7 to 69% [5][6][7][8][9][10][11][12][13][14][15][16][17][18].…”

“…In general, most studies have reported remission rates of 17-35%, with variable follow-up times of 12-60 months [7,8,[12][13][14][15][16]. A prospective study by Colao et al [18] including 200 hyperprolactinemic patients reported recurrence rates of 31% in those with micro-and 36% in those with macroprolactinomas at 2-5 years of follow-up after cabergoline withdrawal.…”

Comparison of the Effects of Cabergoline and Bromocriptine on Prolactin Levels in Hyperprolactinemic Patients.

“…These success rates are similar to those of other studies (73-90 vs. 59%) evaluating micro-and macroprolactinomas together (15)(16)(17)(18). When the patients were analyzed after being divided into two groups (idiopathic + microprolactinoma, and macroprolactinoma), the success rate in the bromocriptine-treated idiopathic + microprolactinoma subgroup was 62%, similar to the 70%rate observed by van der Heijden et al (19), and higher than the 48% rate reported by Pascal-Vigneron et al (20).…”

Therapeutic Options in Patients with Microprolactinoma

“…1,11 Although a direct trial comparing bromocriptine with cabergoline is lacking, the results obtained with the latter drug seem even better. In one study, 31% of patients with microprolactinoma had normal PRL levels one year after discontinuation of therapy, 12 whereas in another large study, 69% of 105 patients with microprolactinoma had no recurrence of hyperprolactinaemia two years after stopping cabergoline. 10 These excellent results were obtained in a selected group of highly responsive patients who also had favourable tumour characteristics on magnetic resonance imaging (MRI).…”