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.

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.

All reported SD-TEAEs were mild or moderate in severity.

Short-term and long-term studies, including ≤22-month open-label extension studies of lurasidone with no controls

erectile dysfunction, amenorrhoea, irregular menstruation, sexual dysfunction

decreased libido, erectile dysfunction, amenorrhoea, galactorrhoea

erectile dysfunction, delayed menstruation

breast pain

irregular menstruation

galactorrhoea.

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.