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 studies1
	N	SD-TEAEs (%)	N	SD-TEAEs (%)	N	SD-TEAEs (%)
Lurasidone	1508	0.52	624	2.23	3202	1.2
Placebo	708	0.64	N/A		N/A
Haloperidol	72	0
Olanzapine	122	0.85
Quetiapine XR	119	0.86	85	0
Risperidone	65	1.57	199	6.53

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.