Paliperidone

During paliperidone therapy, patients should be asked if they are experiencing abnormal movements, sexual dysfunction, breast enlargement, or irregular menstruation (women). If so, decrease the dosage by 3 mg and monitor for side effects and clinical efficacy.

Among other reported adverse effects in the efficacy studies:

• somnolence was less prevalent among patients receiving either paliperidone, 3 to 12 mg/d, or placebo (13%) than among those receiving olanzapine, 10 mg/d (25%)³
• tachycardia was more prevalent among the paliperidone and olanzapine groups (14% to 20%) compared with placebo (0%)^1-3
• headache prevalence (10% to 20%) was similar in all groups^1-3
• mean body weight changes after 6 weeks were more pronounced in the olanzapine group (1.3±2.8 kg) than among patients receiving placebo (–0.7±2.4 kg) or paliperidone at 6 mg/d (0.2±2.4 kg), 9 mg/d (0.6±2.7 kg), or 12 mg/d (0.6±2.6 kg).²

In the relapse prevention study,⁴ potential neuroleptic malignant syndrome was reported in 1 patient taking paliperidone 3 days after the patient withdrew from the study. The patient had received paliperidone for 19 days and was treated for EPS with an unknown medication during the run-in period. Medical status returned to normal at endpoint except for elevated creatine kinase.

Discontinuation rates in the relapse prevention study’s double-blind phase were greater among the paliperidone group (n=20, 19%) compared with placebo (n=8, 8%).⁴ The reasons paliperidone group patients withdrew consent were not available.

Related resources

• Karlsson P, Dencker E, Nyberg S, et al. Pharmacokinetics, dopamine D2 and serotonin 5-HT2A receptor occupancy and safety profile of paliperidone extended-release in healthy subjects. Poster presented at: Winter Workshop on Schizophrenia (WWS); February 5-11, 2006; Davos, Switzerland.

Drug brand names

• Olanzapine • Zyprexa
• Risperidone • Risperdal

Disclosures

Dr. Simpson receives grant support from AstraZeneca Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica, and Johnson & Johnson. He is a consultant to Janssen Pharmaceutica, Johnson & Johnson, Merck and Co., and Pfizer, and is a speaker for Janssen Pharmaceutica and Pfizer.