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Meta-Analysis
. 2008 Apr 16;2008(2):CD006369.
doi: 10.1002/14651858.CD006369.pub2.

Paliperidone for schizophrenia

A Nussbaum  1 , T S Stroup
Affiliations
Meta-Analysis

Paliperidone for schizophrenia

A Nussbaum et al. Cochrane Database Syst Rev. .

Abstract

Background: Paliperidone, risperidone's active metabolite, is now available in an oral formulation for daily use, and an intramuscular formulation for monthly administration may follow shortly.

Objectives: To compare effects of oral paliperidone with any other treatment for people with schizophrenia and schizophrenia-like illnesses.

Search strategy: We searched the Cochrane Schizophrenia Group's Register (December 2006), and inspected references of identified studies for further trials. We contacted the manufacturers of paliperidone, the Food and Drug Administration, and authors of relevant trials for additional material.

Selection criteria: We included all relevant randomised trials.

Data collection and analysis: We independently selected and critically appraised studies, extracted data and analysed on an intention-to-treat basis. Where possible and appropriate, we calculated risk ratios (RR) and their 95% confidence intervals (CI) with the number needed to treat (NNT). We calculated Weighted Mean Differences (WMD) for continuous data.

Main results: Five studies compared paliperidone with placebo. Fewer people left the studies early if they were randomized to paliperidone (n=1647, 5 RCTs, RR 0.68 CI 0.61 to 0.76, NNT 7 CI 6 to 9) and those receiving any dose of paliperidone were significantly more likely to have an improvement in global state (n=1420, 4RCTs, 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 (n=1638, 5 RCTs, RR 0.45 CI 0.31 to 0.66, NNT 16 CI 13 to 26) than those allocated to placebo. Adverse effect data were not well reported but paliperidone does seem to produce a greater incidence of tachycardia than placebo (n=1638, 5 RCTs, RR1.88 CI 1.28 to 2.76, NNH 21 CI 11 to 90) and a consistent, significant elevation in serum prolactin was found for both men (n=413, 3 RCTs, WMD 27.68 CI 23.66 to 31.69) and women (n=252, 3 RCTs, WMD 87.39 CI 74.27 to 100.51). People receiving paliperidone were more likely to experience extrapyramidal disorders (n=1638, 5 RCTs, RR 2.21 CI 1.26 to 3.88, NNH 28 CI 12 to 129) and weight gain (n=769, 4 RCTs, WMD 1.07 CI 0.65 to 1.49, I-squared 78%) compared with those allocated to placebo. When compared with 10 mg/day olanzapine we found no differences between paliperidone and olanzapine for leaving in the short term (n=1332, 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=1327, 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. There are no clear data relating to social functioning, services use, quality of life, satisfaction and cost.

Authors' conclusions: In short-term studies, oral paliperidone is an antipsychotic that is more efficacious than placebo. We found its adverse effects to be similar to those of its parent compound, risperidone, with movement disorders, weight gain, and tachycardia all more common with paliperidone than placebo. In addition, paliperidone is associated with substantial increases in serum prolactin that may be associated with sexual dysfunction, although sexual functioning outcomes were not reported. At doses greater than 3 mg per day, oral paliperidone appears comparable in efficacy to oral olanzapine 10 mg per day. Regarding the critical comparison of oral paliperidone to risperidone, we have no information and are thus unable to determine if paliperidone has any advantages or disadvantages compared to its well-known parent compound.

PubMed Disclaimer

Conflict of interest statement

The authors received no financial consideration from any parties for the preparation of this review. Dr. Stroup has been a consultant for AstraZeneca, Janssen, Lilly, and Pfizer, and has spoken at events sponsored by Lilly, Lundbeck, and Pfizer.

Figures

1
1
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 1 Leaving the study early.
1.2
1.2. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 2 Death.
1.3
1.3. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 3 Global state: 1. No clinically important change.
1.4
1.4. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 4 Global state: 2. Relapse: recurrence of psychotic symptoms.
1.5
1.5. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 5 Global state: 3. Use of additional benzodiazepine.
1.6
1.6. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 6 Mental state: Average change score (PANSS total, decline=good).
1.7
1.7. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 7 Social functioning: Average change score (PSP total, increase=good).
1.8
1.8. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 8 Schizophrenia Quality of life: Average change score (SQLS total, decrease=good).
1.9
1.9. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 9 Adverse effect: 1. Anticholinergic events.
1.10
1.10. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 10 Adverse effect: 2a. Cardiovascular events.
1.11
1.11. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 11 Adverse effect: 2b.Cardiovascular ‐ average change in QTC LD (msec).
1.12
1.12. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 12 Adverse effect: 2c. Cardiovascular ‐ average change in serum level.
1.13
1.13. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 13 Adverse effect: 3. Central nervous system ‐ levels of arousal.
1.14
1.14. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 14 Adverse effect: 4. Endocrine: average change in serum level.
1.15
1.15. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 15 Adverse effect: 5. Gastrointestinal events.
1.16
1.16. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 16 Adverse effect: 6a. Metabolic ‐ average change in weight (kg).
1.17
1.17. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 17 Adverse effect: 6b. Metabolic ‐ average change in BMI.
1.18
1.18. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 18 Adverse effect: 6c. Metabolic ‐ average change in serum level.
1.19
1.19. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 19 Adverse effect: 7a. Movement disorder ‐ various events.
1.20
1.20. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 20 Adverse effect: 7b. Movement disorder ‐ akathisia (BARS).
1.21
1.21. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 21 Adverse effect: 7c. Movement disorder ‐ Average change score (BARS total, decline=good).
1.22
1.22. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 22 Adverse effect: 7d. Movement disorder ‐ Average change score (AIMS total, decline=good).
1.23
1.23. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 23 Adverse effect: 8. Other events.
1.24
1.24. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 24 Adverse effect: 9.Potentially prolactin‐related events.
1.25
1.25. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 25 Adverse effect: 10. Psychiatric event, serious.
1.26
1.26. Analysis
Comparison 1 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus PLACEBO (all short term), Outcome 26 Adverse effect: 11. Renal: average change in serum level.
2.1
2.1. Analysis
Comparison 2 SENSITIVITY ANALYSIS: 1. INCREASING DOSES OF PALPERIDONE versus PLACEBO (primary outcomes only), Outcome 1 Leaving the study early: any reason.
2.2
2.2. Analysis
Comparison 2 SENSITIVITY ANALYSIS: 1. INCREASING DOSES OF PALPERIDONE versus PLACEBO (primary outcomes only), Outcome 2 Global state: 1. No clinically important change.
2.3
2.3. Analysis
Comparison 2 SENSITIVITY ANALYSIS: 1. INCREASING DOSES OF PALPERIDONE versus PLACEBO (primary outcomes only), Outcome 3 Global state: 2. Recurrence of psychotic symptoms.
3.1
3.1. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 1 Leaving the study early.
3.2
3.2. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 2 Death.
3.3
3.3. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 3 Global state: 1. No clinically important change.
3.4
3.4. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 4 Global state: 2. Relapse: recurrence of psychotic symptoms.
3.5
3.5. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 5 Global state: 3. Use of additional benzodiazepine.
3.6
3.6. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 6 Mental state: Average change score (PANSS total, decline=good).
3.7
3.7. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 7 Social functioning: Average change score (PSP total, increase=good).
3.8
3.8. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 8 Adverse effect: 1. Anticholinergic events.
3.9
3.9. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 9 Adverse effect: 2a. Cardiovascular events.
3.10
3.10. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 10 Adverse effect: 2b.Cardiovascular ‐ Average change in QTC LD (msec) from baseline to end of trial.
3.11
3.11. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 11 Adverse effect: 2c. Cardiovascular ‐ average change in serum level.
3.12
3.12. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 12 Adverse effect: 3. Central nervous system ‐ levels of arousal.
3.13
3.13. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 13 Adverse effect: 4. Endocrine: average change in serum level.
3.14
3.14. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 14 Adverse effect: 5. Gastrointestinal events.
3.15
3.15. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 15 Adverse effect: 6a. Metabolic ‐ average change in weight (kg).
3.16
3.16. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 16 Adverse effect: 6b. Metabolic ‐ average change in BMI.
3.17
3.17. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 17 Adverse effect: 6c. Metabolic ‐ average change in serum level.
3.18
3.18. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 18 Adverse effect: 7a. Movement disorder ‐ various events.
3.19
3.19. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 19 Adverse effect: 7b. Movement disorder ‐ akathisia (BARS).
3.20
3.20. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 20 Adverse effect: 8. Other events.
3.21
3.21. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 21 Adverse effect: 9. Potentially prolactin‐related events.
3.22
3.22. Analysis
Comparison 3 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus OLANZAPINE (fixed dose 10 mg/day, all short term), Outcome 22 Adverse effect: 10. Psychiatric event, serious.
4.1
4.1. Analysis
Comparison 4 SENSITIVITY ANALYSIS: 2. INCREASING DOSES OF PALPERIDONE versus OLANZAPINE (primary outcomes only), Outcome 1 Leaving the study early: any reason.
4.2
4.2. Analysis
Comparison 4 SENSITIVITY ANALYSIS: 2. INCREASING DOSES OF PALPERIDONE versus OLANZAPINE (primary outcomes only), Outcome 2 Global state: 1. No clinically important change.
4.3
4.3. Analysis
Comparison 4 SENSITIVITY ANALYSIS: 2. INCREASING DOSES OF PALPERIDONE versus OLANZAPINE (primary outcomes only), Outcome 3 Global state: 2. Recurrence of psychotic symptoms.
5.1
5.1. Analysis
Comparison 5 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus RISPERIDONE (fixed dose, all short term), Outcome 1 Death.
5.2
5.2. Analysis
Comparison 5 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus RISPERIDONE (fixed dose, all short term), Outcome 2 Global state: Relapse: recurrence of psychotic symptoms.
5.3
5.3. Analysis
Comparison 5 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus RISPERIDONE (fixed dose, all short term), Outcome 3 Adverse effect: 1. Cardiovascular events.
5.4
5.4. Analysis
Comparison 5 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus RISPERIDONE (fixed dose, all short term), Outcome 4 Adverse effect: 2. Central nervous system ‐ levels of arousal.
5.5
5.5. Analysis
Comparison 5 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus RISPERIDONE (fixed dose, all short term), Outcome 5 Adverse effect: 3. Gastrointestinal events.
5.6
5.6. Analysis
Comparison 5 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus RISPERIDONE (fixed dose, all short term), Outcome 6 Adverse effect: 4. Movement disorder ‐ various events.
5.7
5.7. Analysis
Comparison 5 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus RISPERIDONE (fixed dose, all short term), Outcome 7 Adverse effect: 5. Other events.
6.1
6.1. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 1 Leaving the study early.
6.2
6.2. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 2 Death.
6.3
6.3. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 3 Global State: 1. No clinically important change.
6.4
6.4. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 4 Global State: 2. Recurrence of psychotic symptoms.
6.5
6.5. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 5 Global State: 3. Use of additional benzodiazepine.
6.6
6.6. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 6 Mental state: Average change score (PANSS total, decline=good).
6.7
6.7. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 7 Adverse effect: 1. Anticholinergic events.
6.8
6.8. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 8 Adverse effect: 2. Cardiovascular events.
6.9
6.9. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 9 Adverse effect: 3. Central nervous system ‐ levels of arousal.
6.10
6.10. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 10 Adverse effect: 4. Endocrine: average change in serum level.
6.11
6.11. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 11 Adverse effect 5: Gastrointestinal events.
6.12
6.12. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 12 Adverse effect: 6. Metabolic ‐ average change in weight (kg).
6.13
6.13. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 13 Adverse effect: 7. Movement disorder ‐ various events.
6.14
6.14. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 14 Adverse effect: 8. Other events.
6.15
6.15. Analysis
Comparison 6 PALIPERIDONE ‐ ANY DOSE OR FLEXIBLE DOSES versus QUETIAPINE (flexible dose, all short term), Outcome 15 Adverse effect: 9.Potentially prolactin‐related events.
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Comment in

References

References to studies included in this review

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Tzimos 2008 {published and unpublished data}
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    1. Tzimos A, Kramer M, Ford L, Gassmann‐Mayer C, Lim P, Eerdekens M. A 6‐week placebo‐controlled study on the safety and tolerability of flexible doses of oral paliperidone extended‐release tablets in the treatment of schizophrenia in elderly patients. Proceedings of the 159th Annual Meeting of the American Psychiatric Association; 2006 May 20‐25; Toronto, Canada. 2006.
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References to studies excluded from this review

Arakawa 2008 {published data only}
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Cleton 2006 {published data only}
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Cleton 2007b {published data only}
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References to ongoing studies

Armenteros 2001 {published data only}
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Rossenu 2008 {published data only (unpublished sought but not used)}
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