Lurasidone and Sexual Dysfunction: Post-HOC Analysis of Pooled Data

Abstract

Introduction/Objectives/Aims Antipsychotic-induced hyperprolactinaemia is associated with sexual dysfunction. 1 In pivotal schizophrenia studies, lurasidone was associated with limited elevation of prolactin. 2 This post-hoc analysis substantiates the clinical relevance by evaluating the incidence of treatment-emergent adverse events related to sexual dysfunction (SD-TEAEs) in patients with schizophrenia treated with lurasidone compared with active controls or placebo. Methods 22 clinical studies were stratified into short-term, long-term and all Phase 2/3 lurasidone study pools. SD-TEAEs were defined as any adverse events related to sexual dysfunction starting on/after the first dose date and within 7 days of treatment discontinuation. Results All reported SD-TEAEs were mild or moderate in severity. Short-term controlled studies Long-term controlled studies All Phase 2/3 lurasidone studies a N SD-TEAEs (%) N SD-TEAEs (%) N SD-TEAEs (%) Lurasidone 1508 0.5 b 624 2.2 c 3202 1.2 Placebo 708 0.6 d N/A N/A Haloperidol 72 0 Olanzapine 122 0.8 e Quetiapine XR 119 0.8 f 85 0 Risperidone 65 1.5 g 199 6.5 c a Short-term and long-term studies, including ≤22-month open-label extension studies of lurasidone with no controls b erectile dysfunction, amenorrhoea, irregular menstruation, sexual dysfunction c decreased libido, erectile dysfunction, amenorrhoea, galactorrhoea d erectile dysfunction, delayed menstruation e breast pain f irregular menstruation g galactorrhoea. Conclusion The incidence of SD-TEAEs with lurasidone treatment was comparable to placebo in short-term studies and lower than for risperidone in both short-term and long-term trials. Future studies utilising formal sexual functioning rating scales on a prospective basis should be considered to further examine this issue.