Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

Patients eligible for the study and randomized to the HIGH CAB arm will start oral CAB, 1 pill of 0.5mg, once a week. The dose will be increased by 0.5mg every week until the target dose of 3.5 mg/w. This initial low-dose-escalating regimen of 7 weeks will be used to prevent symptoms of intolerance. When 3.5 mg/w (1 pill every day) is reached, the patient must maintain this dose for 6 months. After this period, a 1-month de-escalation regime is implemented, reducing the dose by 1 mg/w (2 pills per week) until discontinuation.

The standard dosage group will receive conventional treatment as recommended by current guidelines: a low dose of CAB enough to achieve normoPRL for 2 years. All patients will start CAB with 1 pill (0.5mg) once a week. The CAB dose can be adjusted during visits if hyperPRL is not resolved (maximum dose 2mg/w to prevent inclusion of resistant cases). The expected dose used for this arm during follow-up is between 0.5 and 1 mg/w. After completion of 2 years of treatment, all patients will have CAB withdrawn, irrespective of tumor reduction, PRL levels or last CAB dose used.