A Cochrane review [Abstract] 1 included 8 RCTs with a total of 2567 subjects. All participants were over 18 and diagnosed with DSM-IV schizophrenia. Their Positive and Negative Syndrome Scale (PANSS) score ranged between 70 and 120. All trials included both males and females, but the majority (about 60%) were male. The daily oral dose of paliperidone varied between 3 and 15 mg. With the exception of one study, the included studies were designed to last only six weeks, yet only 46 - 81% of people randomised to paliperidone completed these studies.
When compared with 10 mg/day olanzapine no differences were found between paliperidone and olanzapine for leaving in the short term (n=1 332, 3 RCTs, RR 1.04 CI 0.89 to 1.21; 40% in both groups left by six weeks). Those receiving any dose of paliperidone were no more likely to have a recurrence of psychotic symptoms than those receiving 10 mg/day olanzapine (n=1 327, 3 RCTs, RR 0.1.07 CI 0.64 to 1.76). Data from all three studies found paliperidone was less likely to produce a weight change than olanzapine (n=660, 3 RCTs, WMD -0.88 CI -1.38 to -0.37). Results for various movement disorders all favoured olanzapine.
In comparisons paliperidone vs. placebo, fewer people left the studies early if they were randomized to paliperidone (n=1 647, 5 RCTs, RR 0.68 CI 0.61 to 0.75, NNT 7 CI 6 to 9; 7 RCTs, n=1926) and those receiving any dose of paliperidone were significantly more likely to have an improvement in global state (n=1 420, 4 RCTs, RR 0.69 CI 0.63 to 0.75, NNT 5 CI 4 to 6). People randomised to paliperidone were less likely to experience a recurrence of psychosis (RR 0.47 CI 0.34 to 0.66, NNT 17 CI 14 to 26; 7 RCTs, n=1918) than those allocated to placebo. Paliperidone seemed to produce a greater incidence of tachycardia than placebo (RR1.88 CI 1.28 to 2.76, NNH 21 CI 11 to 90; 5 RCTs, n=1 638) and a consistent, significant elevation in serum prolactin was found for both men (WMD 22.12, CI 21.34 to 22.89; 4 RCTs, n=568) and women (WMD 82.50, CI 78.88 to 86.12; 4 RCTs, n=335). People receiving paliperidone were more likely to experience extrapyramidal disorders (RR 2.27, CI 1.31 to 3.95, NNH 28 CI 12 to 111; 6 RCTs, n=1680) and weight gain (WMD 0.13, CI 0.05 to 0.20; 5 RCTs, n=1007) compared with those allocated to placebo.
Comment: The quality of evidence is downgraded by study quality (more than 20% loss to follow up) and indirectness (inadequate duration of follow up).
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