Preview

Obesity and metabolism

Advanced search

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

https://doi.org/10.14341/omet2015140-44

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.

About the Authors

Galina Afanas'evna Melnichenko
Endocrinology Research Centre
Russian Federation
MD, Ph.D. Academician of the Russian Academy of Sciences, Director of the  Clinical EndocrinologyInstitute


Larisa Konstantinovna Dzeranova
Endocrinology Research Centre
Russian Federation
MD, Ph.D. chief researcher at the Neuroendocrinology and osteopathies department


Ekaterina Aleksandrovna Pigarova
Endocrinology Research Centre
Russian Federation
Ph.D., Senior research fellow at the Neuroendocrinology and osteopathies department


Svetlana Yur'evna Vorotnikova
Endocrinology Research Centre
Russian Federation
MD, postgraduate student at the Neuroendocrinology and osteopathies department


References

1. Shibli-Rahhal A, Schlechte J. The effects of hyperprolactinemia on bone and fat. Pituitary. 2008;12(2):96–104. PMID:18338266 doi: 10.1007/s11102-008-0097-3.

2. Melmed S, Casanueva FF, Hoffman AR, Kleinberg DL, Montori VM, Schlechte JA, et al. Diagnosis and Treatment of Hyperprolactinemia: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism. 2011;96(2):273–88. PMID:21296991 doi: 10.1210/jc.2010-1692.

3. Романцова Т.И. Репродукция и энергетический баланс: интегративная роль пролактина //Ожирение и метаболизм. – 2014. – №. 1. – С. 5–18. [Romantsova TI. Reproduction and energy balance: the integrative role of prolactin. Obesity and metabolism. 2014;(1):5–18.] doi: 10.14341/omet201415-18

4. Клиническая нейроэндокринология. Под ред. И.И. Дедова. М, 2011; 113–118. [Dedov II (editor). Klinicheskaya neyroendokrinologiya. Moscow, 2011.]

5. Мельниченко Г.А., Дзеранова Л.К., Пигарова Е.А., Воротникова С.Ю., Рожинская Л.Я., Дедов И.И. Федеральные клинические рекомендации по клинике, диагностике, дифференциальной диагностике и методам лечения гиперпролактинемии. // Проблемы эндокринологии. – 2013. – Т. 59. – №6. – С. 19–26. [Mel'nichenko GA, Dzeranova LK, Pigarova EA, Vorotnikova SYu, Rozhinskaya LYa, Dedov II. Federal'nye klinicheskie rekomendatsii po klinike, diagnostike, differentsial'noy diagnostike i metodam lecheniya giperprolaktinemii. Problemy endokrinologii. 2013; 59(6): 19–26.] doi: 10.14341 probl201359619 26.

6. Wang A., Mullan R., Lane M., Hazem A., Prasad C., Gathaiya N., Fernández-Balsells M., Bagatto A., Coto-Yglesias F., Carey J., Elraiyah T., Erwin P., Gandhi G., Montori V., Murad M. Treatment of hyperprolactinemia: a systematic review and meta-analysis. Syst. Rev. 2012; 24: 1–33.

7. Государственный регистр лекарственных средств Российской Федерации. Доступ по ссылке: http://grls.rosminzdrav.ru/default.aspx [State Register of medicines of the Russian Federation. Access on: http://grls.rosminzdrav.ru/default.aspx]

8. Ушкалова Е.А., Юргель Н.В., Хубиева М.Ю., Хубиева А.Ю., Малин А.А. Проблемы качества и терапевтической эквивалентности дженериков. // Здравоохранение. – 2010. – №11. – С.15–27. [Ushkalova EA, Yurgel' NV, Khubieva MYu, Khubieva AYu, Malin AA. Problemy kachestva i terapevticheskoy ekvivalentnosti dzhenerikov. Zdravookhranenie. 2010; (11): 15–27.]


Review

For citations:


Melnichenko G.A., Dzeranova L.K., Pigarova E.A., Vorotnikova S.Yu. Comparative efficacy and safety of generic (Bergolak) vs. brand cabergoline in the treatment of patients with prolactin-secreting tumors. Obesity and metabolism. 2015;12(1):40-44. (In Russ.) https://doi.org/10.14341/omet2015140-44

Views: 1864


ISSN 2071-8713 (Print)
ISSN 2306-5524 (Online)