Dose‐dependent suppression of serum prolactin by cabergoline in hyperprolactinaemia: a placebo controlled, double blind, multicentre study

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Abstract
OBJECTIVE Dopamine agonists have a well established place in the treatment of hyperprolactinaemic disorders but their use is associated with a high incidence of adverse effects. We have investigated the biochemical efficacy and side‐effect profile of a range of doses of the novel, long‐acting dopamine agonist, cabergoline, in suppressing prolactin (PRL) in hyperprolactinaemic women. DESIGN Multicentre, prospective, randomized, placebo controlled and double blind. PATIENTS One hundred and eighty‐eight women with hyperprolactinaemia secondary to microprolactinoma (n= 113), idiopathic disease (n= 67), empty sella syndrome (n= 7) or following failed surgery for a macroprolactinoma (n= 1). MEASUREMENTS Weekly assessment of adverse symptoms, blood pressure and pulse, serum PRL, blood count, liver and renal function. RESULTS Patients received either placebo (n= 20) or cabergoline 0.125 (n= 43), 0.5 (n= 42), 0 75 (n= 42) or 10 mg (n= 41) twice weekly for 4 weeks. The five treatment groups were comparable in age (mean 31.8, range 16– 46 years), diagnosis, previous therapy, and pretreatment serum PRL. PRL was suppressed to below half the pretreatment level in 5,60,90,95 and 98% and normalized in 0, 30, 74, 74 and 95% of patients taking placebo or cabergoline 0.125, 0.5, 0.75 or 1.0 mg twice weekly respectively (Armitage's test, χ2= 39.3, P < 0.01). Cabergoline therapy (all doses) restored menses in 82% of the amenorrhoeic women not previously treated with dopamine agonists. Adverse events were recorded in 45% of patients in the placebo group and in 44, 50, 50 and 58% of those taking 0.125, 0.5, 0.75 and 1.0 mg cabergoline twice weekly (Armitage's test, P < 0.05). Over 95% of reported symptoms were relatively trivial, most frequently transient nausea, headache, dizziness, fatigue and constipation. More severe adverse events, interfering significantly with the patients’ lifestyle, occurred in 13 (7.7%) patients taking cabergoline; treatment withdrawal was necessary in only one case. No adverse effects were detected on blood pressure or haematological or biochemical parameters. CONCLUSIONS We have shown a linear dose‐response relationship for cabergoline in the treatment of hyperprolactinaemia in the range 0.125– 1.0 mg twice weekly, with normalization of PRL in up to 95% of cases and acceptable tolerability throughout the dose range.

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