Minimal Effects of Cariprazine on Prolactin Levels in Bipolar Disorder and Schizophrenia.

Background

Many medications used to treat schizophrenia and bipolar I disorder are linked to hyperprolactinemia. The effects of cariprazine, a dopamine D

Methods

Effects on prolactin were evaluated using pooled data from randomized, double-blind, placebo-controlled studies in patients with schizophrenia (4 studies; 6-week duration; cariprazine 1.5-3 mg/d, 4.5-6 mg/d, and 9-12 mg/d), bipolar mania (3 studies; 3-week duration; cariprazine 3-6 and 9-12 mg/d), and bipolar depression (3 studies; 6- to 8-week duration; cariprazine 1.5 and 3 mg/d). Long-term effects were analyzed using open-label studies in patients with schizophrenia (2 studies; 48-week duration) and patients with bipolar mania (1 study; 16-week duration). Change in prolactin levels (ng/mL) from baseline to study endpoint was evaluated in subsets of sex and prior medication use.

Results

In patients with schizophrenia (male, n = 1377; female, n = 558), median prolactin changes were -1.2 for males and -7.4 for females on placebo, and ranged from -4.2 to -3.6 for males and -12.4 to +0.2 for females in the cariprazine-treatment groups. In patients with bipolar mania (male, n = 570; female, n = 395), median prolactin changes were -0.2 for males and -1.1 for females on placebo and ranged from -2.1 to -3.0 for males and 0 to +1.8 for females in the cariprazine-treatment groups. Median decreases were also seen in the long-term studies of schizophrenia (range, -14.6 to -2.0) and bipolar mania (range, -0.8 to +1.9). In patients with bipolar depression (male, n = 485; female, n = 780), median prolactin changes were +0.3 for males and +0.7 for females on placebo and ranged from +0.4 to +0.5 for males and +3.0 to +3.1 for females in the cariprazine-treatment groups.

Conclusion

Treatment with cariprazine for schizophrenia or bipolar I disorder was associated with minimal effects on prolactin levels.

Informations de copyright

© 2022 Culpepper et al.

Déclaration de conflit d'intérêts

L. Culpepper has served as an advisor or consultant for Acadia Pharmaceuticals, Allergan Pharmaceuticals, Eisai Pharmaceuticals, Merck & Co., Takeda, Supernus Pharmaceuticals; owns stock in M-3 Information, LLC, and has received royalties from UpToDate and Oxford University Press in addition to receiving payment from Physicians Postgraduate Press as Editor-in-Chief of the Primary Care Companion for CNS Diseases. E. Vieta has received grants and served as consultant, advisor, or speaker for: AB Biotics, Abbott, Alexza, Almirall, Allergan, Angelini, AstraZeneca, Bristol Myers Squibb, Casen Recordati, Cephalon, Dainippon Sumitomo Pharma, Elan, Eli Lilly, Ferrer, Forest Research Institute, Galenica, Gedeon Richter, GH Research, GlaxoSmithKline, Janssen Cilag, Jazz, Johnson and Johnson, Lundbeck, Merck, Novartis, Organon, Otsuka, Pfizer, Raffo, Roche, Sage, Sanofi Aventis, Servier, Schering Plough, Shire, the Spanish Ministry of Science and Innovation, the Seventh European Framework Programme, the Stanley Medical Research Institute, Sunovion, Takeda, Teva, United BioSource Corporation, and Wyeth. D.L. Kelly serves as a consultant to Alkermes, Sunovion, and Lyndra Therapeutics. B. Szatmári is an employee of Gedeon Richter Plc. and has a patent EP 2925324 B1 issued to Gedeon Richter Plc. A. Hankinson and W.R. Earley were employees of AbbVie at the time of the study and may hold stock. W.R. Earley is also a shareholder of AstraZeneca and Eli Lilly. M.D. Patel was an employee of AbbVie at the time of the study and may hold stock. The authors report no other conflicts of interest in this work.