Table 5 Treatment-emergent adverse events in ≥5% in any active-treatment or placebo groups
From: Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis
Placebo-Adjusted Difference* ≥2% | |||||||
|---|---|---|---|---|---|---|---|
Paliperidone ER 6-12 mg/day n = 179 n (%) | Placebo (PALI) n = 95 n (%) | Risperidone 2-4 mg/day n = 113 n (%) | Risperidone 4-6 mg/day n = 129 n (%) | Placebo (RIS) n = 122 n (%) | Paliperidone ER 6-12 mg/day vs Risperidone 2-4 mg/day | Paliperidone ER 6-12 mg/day vs Risperidone 4-6 mg/day | |
Placebo-Adjusted AEs More Common With Paliperidone ER Than Risperidone | |||||||
Insomnia | 26 (14.5) | 9 (9.5) | 25 (22.1) | 22 (17.1) | 23 (18.9) | NA† | 5.0 |
Sinus tachycardia | 14 (7.8) | 4 (4.2) | 1 (0.9) | 2 (1.6) | 0 (0.0) | 2.7 | 2.0 |
Tachycardia | 12 (6.7) | 3 (3.2) | 1 (0.9) | 3 (2.3) | 0 (0.0) | 2.6 | NA† |
Placebo-Adjusted AEs More Common With Risperidone Than Paliperidone ER | |||||||
Somnolence | 7 (3.9) | 5 (5.3) | 10 (8.9) | 9 (7.0) | 2 (1.6) | 7.3 | 5.4 |
Restlessness | 0 (0.0) | 0 (0.0) | 9 (8.0) | 7 (5.4) | 1 (0.8) | 7.2 | 4.6 |
Nausea | 4 (2.2) | 4 (4.2) | 9 (8.0) | 11 (8.5) | 4 (3.3) | 4.7 | 5.2 |
Anxiety | 3 (1.7) | 2 (2.1) | 11 (9.7) | 14 (10.9) | 7 (5.7) | 4.0 | 5.2 |
Salivary hypersecretion | 3 (1.7) | 0 (0.0) | 6 (5.3) | 5 (3.9) | 0 (0.0) | 3.6 | 2.2 |
Akathisia | 8 (4.5) | 3 (3.2) | 5 (4.4) | 6 (4.7) | 1 (0.8) | 2.3 | 2.6 |
Dizziness | 8 (4.5) | 3 (3.2) | 5 (4.4) | 8 (6.2) | 3 (2.5) | NA† | 2.4 |
Nasal congestion | 1 (0.6) | 0 (0.0) | 4 (3.5) | 7 (5.4) | 3 (2.5) | NA† | 2.3 |