Efficacy and safety of long-term cabergoline treatment of antipsychotic-induced hyperprolactinemia (naturalistic study)

Abstract

Introduction

Antipsychotic-induced hyperpolactinemia (AIH) is associated with disturbing clinical symptoms, such as sexual dysfunctions, menstrual disorders and galactorrhea. Long-term studies of dopamine agonists in AIH are scarce.

Objectives

To assess efficacy and safety of cabergoline use in psychiatric patients with AIH, including impact on sexual function and quality of life(QoL).

Methods

It was an open-labeled non-randomized naturalistic prospective comparison of cabergoline vs nо treatment in 84 chronic psychiatric patients (F/M = 77/7) with AIH. Cabergoline treatment was started in 44 patients, the сontrol group included 40 patients who rejected the treatment with cabergoline. For assessment of QoL, sexual dysfunction and other hyperprolactinemia symptoms, UKU side effects rating scale (UKU) and SF-36 were used.

Results

The main and control groups were comparable on all main clinical and psychiatric characteristics. The effective cabergoline dose was 0,25-3 (median-0,5) mg weekly; total cabergoline exposure–534 patient-weeks. Normal prolactin levels were achieved after 4-44 (median-14) weeks in 95% of patients. At 3 months after cabergoline discontinuation, prolactin remained normal in 71%, and AIH recurred in 29% of patients. Prolactin normalization was associated with significant reduction of menstrual disorders, galactorrhea, improvement of UKU scores on sexual desire, orgastic dysfunction, total UKU score and SF-36 scores on subscales of social functioning (P = 0,006), role-emotional (P = 0,042), and mental health (P = 0,049). The rate of psychosis exacerbation in control group was higher than in the treatment group (37,5% vs 0%; P < 0,001).

Conclusions

Cabergoline is effective and safe in majority of AIH patients. Long-term cabergoline treatment is not associated with psychosis exacerbation. Beyond reversal of typical AIH symptoms, treatment with cabergolin improves sexual function and QoL.

Disclosure of interest

The authors have not supplied their declaration of competing interest.