Comparative efficacy and safety of generic (Bergolak) vs. brand cabergoline in the treatment of patients with prolactin-secreting tumors

Abstract

Objective: To evaluate the effectiveness and safety of cabergoline drug Bergolak («Veropharm», Russia) in the treatment of patients with prolactin-secreting tumors.Materials and methods: The study included 14 patients (14 women, mean age 46±12) diagnosed with prolactinoma. The patients were switched to Bergolak after 1 month of treatment by original cabergoline. Dose of cabergoline varied from 0,125 mg to 3,25 mg per week. Prolactin level, symptoms of hyperprolactinemic hypogonadism, side-effects were evaluated at the baseline, after 1 month of original cabergoline treatment and 1 and 2 months of Bergolak therapy.Results: Statistical differences in the level of prolactin (p> 0.05), and the incidence of side-effects (p> 0.43) during Bergolak therapy in comparison with the original drug was not registered.Conclusions: Bergolak showed to be effective drug for treatment of patients with prolactin-secreting tumors. The incidence of side-effects during Bergolak therapy is equal to the original cabergoline treatment.

Keywords

• hyperprolactinemia
• prolactinoma
• dopamine agonists
• cabergoline