paliperidone-palmitate and Sexual-Dysfunction--Physiological

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.

Topics: Adolescent; Adult; Antipsychotic Agents; Aripiprazole; Female; Humans; Male; Middle Aged; Paliperidone Palmitate; Prolactin; Quality of Life; Schizophrenia; Sexual Dysfunction, Physiological; Young Adult

Topics: Dopamine Agents; Dopamine D2 Receptor Antagonists; Female; Humans; Levodopa; Middle Aged; Orgasm; Paliperidone Palmitate; Parkinson Disease; Sexual Dysfunction, Physiological

Hyperprolactinaemia is a significant side effect of antipsychotic medications and may cause sexual dysfunction. The aim of our study was to assess the effect of switching from long-acting injectable (LAI) risperidone to paliperidone palmitate (PP) on sexual function and prolactin levels in patients with psychosis. We carried out a prospective observational study during a 3-month period that involved 11 patients with psychosis treated with risperidone-LAI who suffered from hyperprolactinaemia and who were then switched to PP. Two assessments were completed: the first one before the switch and the second one 3 months after the switch. These assessments measured sexual function using the Arizona Sexual Experience Scale and assessed prolactin levels. Our results showed a significant decrease in serum prolactin levels (P=0.041). We observed a four-fold reduction in clinically significant sexual dysfunction that is suggestive of benefit, although the sample size is too small to be sure. Our study suggests that prolactin levels seem to decrease after switching from risperidone-LAI to PP in patients with a psychotic disorder.

Topics: Adult; Age Factors; Antipsychotic Agents; Biomarkers; Drug Substitution; Female; Humans; Hyperprolactinemia; Injections; Isoxazoles; Male; Paliperidone Palmitate; Palmitates; Prolactin; Prospective Studies; Psychiatric Status Rating Scales; Psychotic Disorders; Recovery of Function; Risperidone; Sexual Behavior; Sexual Dysfunction, Physiological; Surveys and Questionnaires; Time Factors; Treatment Outcome; Young Adult

Topics: Adult; Antipsychotic Agents; Ejaculation; Humans; Isoxazoles; Male; Paliperidone Palmitate; Pyrimidines; Risperidone; Schizophrenia; Sexual Dysfunction, Physiological

The aim of this study was to investigate the long-term treatment effects of risperidone on prolactin levels and prolactin-related side effects in pubertal boys with autism spectrum disorders (ASD) and disruptive behavior disorders (DBD).. Physical healthy 10-20-year-old males with ASD (n=89) and/ or DBD (n=9) chronically treated (mean 52 months, range 16-126 months) with risperidone (group 1, n=51) or not treated with any antipsychotic (group 2, n=47) were recruited to this observational study from the child psychiatry outpatient clinic. Morning non-fasting serum prolactin levels were measured and prolactin-related side effects were assessed by means of questionnaires and physical examination. Group differences were tested with Student's t, χ(2), Fisher exact, and Mann-Whitney tests, and logistic regression analysis, according to the type and distribution of data.. Hyperprolactinemia was present in 47% of subjects in group 1 but only in 2% of subjects in group 2 (odds ratio 71.9; 95% CI, 7.7; 676.3). Forty-six percent of subjects in group 1 had asymptomatic hyperprolactinemia. Current risperidone dose and 9-OH risperidone plasma level were significant predictors of hyperprolactinemia (p=0.035 and p=0.03, respectively). Gynecomastia and sexual dysfunction were present in 43% and 14% of the subjects in group 1, respectively, compared with 21% and 0% of subjects in group 2 (p=0.05 and p=0.01). Gynecomastia was not significantly associated with hyperprolactinemia.. Hyperprolactinemia is a common side effect in young males treated over the long term with risperidone. Young males treated with risperidone are more likely to report diminished sexual functioning than are those not treated with antipsychotics.

Topics: Adolescent; Adult; Antipsychotic Agents; Attention Deficit and Disruptive Behavior Disorders; Child; Child Development Disorders, Pervasive; Cross-Sectional Studies; Dose-Response Relationship, Drug; Gynecomastia; Humans; Hyperprolactinemia; Isoxazoles; Logistic Models; Male; Paliperidone Palmitate; Prolactin; Pyrimidines; Risperidone; Sexual Dysfunction, Physiological; Statistics, Nonparametric; Surveys and Questionnaires; Time Factors; Young Adult