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Psych Congress  

Analysis of Sexual Function in a Study With Aripiprazole Once-Monthly Versus Paliperidone Palmitate Once-Monthly

Authors  

Jessica Madera, MD – Otsuka Pharmaceutical Development & Commercialization, Inc.; pedro Such, MD – H. Lundbeck A/S, Valby, Denmark; Louise Rosenberg Christ, PhD – H. Lundbeck A/S, Valby, Denmark; heather Fitzgerald, PharmD, BCPS – Lundbeck LLC; Ross Baker, PhD – Otsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor  
Otsuka Pharmaceutical Development & Commercialization, Inc and H. Lundbeck A/S.

Introduction: Sexual dysfunction is a common side effect of antipsychotic treatment and may contribute to non-adherence. In the QUALIFY study (NCT01795547) the effectiveness of aripiprazole once-monthly 400 mg (AOM 400) was compared to paliperidone palmitate once-monthly intramuscular injection (PP1M) in a 28-week, open-label, rater-blinded setting in adult patients with schizophrenia. A smaller proportion of patients in the study reported sexual dysfunction with AOM 400 versus PP1M at week 28. Here, the results for sexual function are further analyzed.

Methods: Sexual function was evaluated as a secondary objective using the Arizona Sexual Experiences Scale (ASEX). The ASEX is a patient-reported five-item scale measuring sexual experiences over the last week. Each item is rated from 1 to 6; higher scores indicate greater sexual dysfunction.

Results: At week 28, younger patients ( < 35 years) in the AOM 400 group showed numerical improvements, as changes from baseline ranged from 0.5-0.8; lubrication (women) worsened by 0.7. In the PP1M group, sex drive, erection (men), lubrication (women), orgasm, and satisfaction improved; changes from baseline ranged from 0.1-0.7. At week 28, older patients (>35 years) in the AOM 400 group showed similar, yet less robust improvements in all items except lubrication (women); changes from baseline ranged from 0.1-0.6. In the PP1M group, sex drive, arousal, erection (men), and orgasm numerically improved; changes from baseline ranged from 0.1-0.3. These post-hoc results show how details of a side effect can be presented to support discussions with patients about specific medication concerns.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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