Long-term treatment of bromocriptine-intolerant prolactinoma patients with CV 205-502.

Prolactin-secreting pituitary adenomas are an importance cause of male and female infertility. Dopaminergic drug therapy is the cornerstone of treatment. However, the currently available drugs, particularly bromocriptine, are associated with frequent adverse effects. In this study we evaluated the efficacy and safety of long-term treatment with a new dopaminergic agent, CV 205-502 (CV) in prolactinoma patients previously intolerant of bromocriptine. Nine patients (five male, four female) were treated for up to 39 months. Six had macroprolactinomas, and three had microprolactinomas; four had had previous transphenoidal surgery. Prolactin levels, tumor size and pituitary function were determined before treatment. These parameters and indices of drug toxicity were monitored at regular intervals. Prolactin decreased from 546 +/- 381 (SE) to 19.3 +/- 9.4 micrograms/L on CV doses ranging from 75 to 600 micrograms orally, given at bedtime (percent decrease, 37-99; mean +/- SE, 87 +/- 6.5%). Levels were normalized in six patients. Twenty-four-hour prolactin profiles documented adequate suppression with a single daily dose. All clinical symptoms related to hyperprolactinemia subsided. One accidental pregnancy occurred, and two other women had normalization of menstrual function. One man regained a normal sperm count. Of the four patients who presented with arrested puberty, only the one without previous surgery completed normal puberty during CV treatment. Mild drug-related adverse effects were reported by three patients. Dose reduction eliminated the adverse effects with adequate prolactin suppression in two; the third stopped treatment. Tumor size decreased in three of six macroprolactinoma patients. Liver and kidney function, hematocrit, WBC and platelet counts, EKG and urinalysis remained normal in all.(ABSTRACT TRUNCATED AT 250 WORDS)