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

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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.


Galina Afanas'evna Melnichenko

Endocrinology Research Centre

Email: melnich@endocrincentr.ru

Russian Federation MD, Ph.D. Academician of the Russian Academy of Sciences, Director of the  Clinical EndocrinologyInstitute

Larisa Konstantinovna Dzeranova

Endocrinology Research Centre

Email: dzeranovalk@ya.ru

Russian Federation MD, Ph.D. chief researcher at the Neuroendocrinology and osteopathies department

Ekaterina Aleksandrovna Pigarova

Endocrinology Research Centre

Email: kpigarova@gmail.com

Russian Federation Ph.D., Senior research fellow at the Neuroendocrinology and osteopathies department

Svetlana Yur'evna Vorotnikova

Endocrinology Research Centre

Author for correspondence.
Email: vorotnikova.s.y@gmail.com

Russian Federation MD, postgraduate student at the Neuroendocrinology and osteopathies department

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