Reduced sexual dysfunction with aripiprazole once-monthly versus paliperidone palmitate: results from QUALIFY

被引:18
作者
Potkin, Steven G. [1 ]
Loze, Jean-Yves [5 ]
Forray, Carlos [2 ]
Baker, Ross A. [3 ]
Sapin, Christophe [6 ]
Peters-Strickland, Timothy [3 ]
Beillat, Maud [6 ]
Nylander, Anna-Greta [7 ]
Hertel, Peter [7 ]
Andersen, Henrik Steen [7 ]
Eramo, Anna [4 ]
Hansen, Karina [6 ]
Naber, Dieter [8 ]
机构
[1] Univ Calif Irvine, Dept Psychiat & Human Behav, 5251 Calif Ave,Suite 240, Irvine, CA 92617 USA
[2] Lundbeck LLC, Paramus, NJ USA
[3] Otsuka Pharmaceut Dev & Commercializat Inc, Princeton, NJ USA
[4] Lundbeck LLC, Deerfield, IL USA
[5] Otsuka Pharmaceut Europe Ltd, Wexham, England
[6] Lundbeck SAS Issy Les Moulineaux, Paris, France
[7] H Lundbeck & Co AS, Valby, Denmark
[8] Univ Med Ctr Hamburg Eppendorf, Dept Psychiat & Psychotherapy, Hamburg, Germany
关键词
antipsychotic agents; aripiprazole; dopamine; long-acting injectable; paliperidone palmitate; patient-reported outcomes; prolactin; quality of life; schizophrenia; sexual dysfunction; SERUM PROLACTIN LEVELS; SCHIZOPHRENIA; ANTIPSYCHOTICS; PREVALENCE; MANAGEMENT; SCALE; LIFE;
D O I
10.1097/YIC.0000000000000168
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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 400mg (AOM 400), a dopamine D-2 receptor partial agonist, showed noninferiority and subsequent superiority versus paliperidone palmitate (PP), a dopamine D-2 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.
引用
收藏
页码:147 / 154
页数:8
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