title: Reduced sexual dysfunction with aripiprazole once-monthly versus paliperidone palmitate: results from QUALIFY.
abstract: Sexual dysfunction, a common side effect of antipsychotic medications, may be partly caused by dopamine antagonism and elevation of prolactin. In QUALIFY, a randomized study, aripiprazole once-monthly 400 mg (AOM 400), a dopamine D2 receptor partial agonist, showed noninferiority and subsequent superiority versus paliperidone palmitate (PP), a dopamine D2 receptor antagonist, on the Heinrichs-Carpenter Quality-of-Life Scale (QLS) in patients with schizophrenia aged 18-60 years. Sexual dysfunction (Arizona Sexual Experience Scale) and serum prolactin levels were also assessed. Odds for sexual dysfunction were lower with AOM 400 versus PP [week 28 adjusted odds ratio (95% confidence interval), 0.29 (0.14-0.61); P=0.0012] in men [0.33 (0.13-0.86); P=0.023], women [0.14 (0.03-0.62); P=0.0099], and patients aged 18-35 years [0.04 (<0.01-0.34); P=0.003]. Among patients shifting from sexual dysfunction at baseline to none at week 28, there was a trend toward greater improvement in the QLS total score. The mean (SD) prolactin concentrations decreased with AOM 400 [-150.6 (274.4) mIU/l] and increased with PP [464.7 (867.5) mIU/l] in both men and women. Six PP-treated patients experienced prolactin-related adverse events. In addition to greater improvement on QLS, patients had a lower risk for sexual dysfunction and prolactin elevation with AOM 400 versus PP in QUALIFY.
authors.affiliation: aDepartment of Psychiatry and Human Behavior, University of California, Irvine, California bLundbeck LLC, Paramus, New Jersey cOtsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey dLundbeck LLC, Deerfield, Illinois, USA eOtsuka Pharmaceutical Europe Ltd., Wexham, UK fLundbeck SAS Issy-les-Moulineaux, Paris, France gH. Lundbeck A/S, Valby, Denmark hDepartment for Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Potkin
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Loze
authors.forename: Carlos
authors.initials: C
authors.lastname: Forray
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.forename: Christophe
authors.initials: C
authors.lastname: Sapin
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
authors.forename: Maud
authors.initials: M
authors.lastname: Beillat
authors.forename: Anna-Greta
authors.initials: AG
authors.lastname: Nylander
authors.forename: Peter
authors.initials: P
authors.lastname: Hertel
authors.forename: Henrik
authors.initials: H
authors.lastname: Steen Andersen
authors.forename: Anna
authors.initials: A
authors.lastname: Eramo
authors.forename: Karina
authors.initials: K
authors.lastname: Hansen
authors.forename: Dieter
authors.initials: D
authors.lastname: Naber
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000068180:Aripiprazole / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate / Q000009:adverse effects* / Q000627:therapeutic use; D011388:Prolactin / Q000097:blood; D011788:Quality of Life; D012559:Schizophrenia / Q000097:blood / Q000188:drug therapy*; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced*; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole; D011388:Prolactin; D000068882:Paliperidone Palmitate