Number needed to treat and number needed to harm with paliperidone palmitate relative to long-acting haloperidol, bromperidol, and fluphenazine decanoate for treatment of patients with schizophrenia

Neuropsychiatric Disease and Treatment

Volumn 7, Issue 1, 2011, Pages 93-101

  Gopal, Srihari ^a   Berwaerts, Joris ^a   Nuamah, Isaac ^a   Akhras, Kasem ^a   Coppola, Danielle ^a   Daly, Ella ^a   Hough, David ^a   Palumbo, Joseph ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

First generation antipsychotics; Long acting injectables; Number needed to harm; Number needed to treat; Paliperidone palmitate; Randomized; Second generation antipsychotics

Indexed keywords

BROMPERIDOL DECANOATE; CHOLINERGIC RECEPTOR BLOCKING AGENT; FLUPHENAZINE DECANOATE; HALOPERIDOL DECANOATE; LONG ACTING DRUG; NEUROLEPTIC AGENT; PALIPERIDONE; PLACEBO;

AKATHISIA; ARTICLE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DRUG EFFECT; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG USE; EXTRAPYRAMIDAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; RANDOMIZED CONTROLLED TRIAL; RELAPSE; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SCHIZOPHRENIA; SIDE EFFECT; SURVIVAL RATE; TARDIVE DYSKINESIA; TREATMENT DURATION; TREMOR; WEIGHT GAIN;

EID: 80053632328     PISSN: 11766328     EISSN: 11782021     Source Type: Journal    
DOI: 10.2147/NDT.S17177     Document Type: Article

References (44)

1. Nayak RK, Doose DR, Nair NP. The bioavailability and pharmacokinetics of oral and depot intramuscular haloperidol in schizophrenic patients. J Clin Pharmacol. 1987;27(2):144-150.
2. Olivares JM, Rodriguez-Morales A, Diels J, et al. Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: Results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR). Eur Psychiatry. 2009;24(5):287-296.
3. Bransgrove LL, Kelly MW. Movement disorders in patients treated with long-acting injectable antipsychotic drugs. Am J Hosp Pharm. 1994;51(7):895-899.
4. Correll CU, Leucht S, Kane JM. Lower risk for tardive dyskinesia associated with second-generation antipsychotics: A systematic review of 1-year studies. Am J Psychiatry. 2004;161(3):414-425.
5. Gharabawi GM, Bossie CA, Zhu Y, et al. An assessment of emergent tardive dyskinesia and existing dyskinesia in patients receiving longacting, injectable risperidone: Results from a long-term study. Schizophr Res. 2005;77(2-3):129-139.
6. Kraemer HC, Kupfer DJ. Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry. 2006;59(11):990-996.
7. Citrome L, Kantrowitz J. Antipsychotics for the treatment of schizophrenia: Likelihood to be helped or harmed, understanding proximal and distal benefits and risks. Expert Rev Neurother. 2008;8(7):1079-1091.
8. Citrome L. Compelling or irrelevant? Using number needed to treat can help decide. Acta Psychiatr Scand. 2008;117(6):412-429.
9. Straus SE. Individualizing treatment decisions. The likelihood of being helped or harmed. Eval Health Prof. 2002;25(2):210-224.
10. Citrome L. Show me the evidence: Using number needed to treat. South Med J. 2007;100(9):881-884.
11. Martinez-Aran A, Vieta E, Chengappa KN, Gershon S, Mullen J, Paulsson B. Reporting outcomes in clinical trials for bipolar disorder: A commentary and suggestions for change. Bipolar Disord. 2008;10(5): 566-579.
12. Dotti A, Bersani G, Rubino IA, Elliseo C. Double blind trial of fluphenazine decanoate against placebo in ambulant maintenance treatment of chronic schizophrenics. Rivista di Psichiatria. 1979;14(5):374-383.
13. David A, Adams CE, Eisenbruch M, et al. Depot fluphenazine decanoate and enanthate for schizophrenia. Cochrane Database Syst Rev. 2005;1: CD000307.
14. Adams CE, David A, Quraishi SN. Depot bromperidol decanoate for schizophrenia. Cochrane Database Syst Rev. 2004;3:CD001719.
15. Quraishi SN, David A, Brasil MA, Alheira FV. Depot haloperidol decanoate for schizophrenia. Cochrane Database Syst Rev. 1999;1: CD001361.
16. Hough D, Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M. Paliperidone palmitate maintenance treatment in delaying the time- to-relapse in patients with schizophrenia: A randomized, double-blind, placebocontrolled study. Schizophr Res. 2010;116(2-3):107-117.
17. Pandina G, Lindenmayer J-P, Lull J, et al. Randomized, placebo-controlled study to assess the efficacy and safety of three doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010;30(3):235-244.
18. Eklund K, Forsman A. Minimal effective dose and relapse-doubleblind trial: Haloperidol decanoate vs. placebo. Clin Neuropharmacol. 1991;14(Suppl 2):S7-S12.
19. Hirsch SR, Gaind R, Rohde PD, Stevens BC, Wing JK. Outpatient maintenance of chronic schizophrenic patients with long-acting fluphenazine: Double-blind placebo trial. Report to the Medical Research Council committee on clinical trials in psychiatry. BMJ. 1973;1(5854): 633-637.
20. Jolley AG, Hirsch SR, Morrison E, McRink A, Wilson L. Trial of brief intermittent neuroleptic prophylaxis for selected schizophrenic outpatients: Clinical and social outcome at two years. BMJ. 1990; 301(6756):837-842.
21. Odejide OA, Aderounmu AF. Double-blind placebo substitution: Withdrawal of fluphenazine decanoate in schizophrenic patients. J Clin Psychiatry. 1982;43(5):195-196.
22. Smeraldi EB, Bellini L, Rochi P, Volonte MV, Virzi A, Aguglia E. Bromperidol decanoate versus placebo in treating schizophrenia in the residual phase. New Trends Exp Clin Psychiatry. 1990;6:187-198.
23. Kramer M, Litman R, Hough D, et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol. 2010;13(5):635-647.
24. Nasrallah HA, Gopal S, Gassmann-Mayer C, et al. A controlled, evidencebased trial of paliperidone palmitate, an investigational long-acting injectable antipsychotic in schizophrenia. Neuropsychopharmacology. 2010;35(10):2072-2082.
25. Gopal S, Hough D, Xu H, et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: A randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010;25(5):245-256.
26. Altman DG, Andersen PK. Calculating the number needed to treat for trials where the outcome is time to an event. BMJ. 1999;319(7223): 1492-1495.
27. Bender R. Calculating confidence intervals for the number needed to treat. Control Clin Trials. 2001;22(2):102-110.
28. Newcombe RG. Interval estimation for the difference between independent proportions: Comparison of eleven methods. Stat Med. 1998;17(8): 873-890.
29. Wilson EB. Probable inference, the law of succession, and statistical inference. J Am Stat Assoc.1927;22(158):209-212.
30. Schlectman E. Odds ratio, relative risk, absolute risk reduction, and the number needed to treat - which of these should we use? Value Health. 2002;5(5):431-436.
31. Citrome L, Stroup TS. Schizophrenia, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and number needed to treat: How can CATIE inform clinicians? Int J Clin Pract. 2006;60(8):933-940.
32. Karagianis J, Rosenbluth M, Tohen M, et al. Reviewing CATIE for clinicians: Balancing benefit and risk using evidence-based medicine tools. Curr Med Res Opin. 2007;23(10):2551-2557.
33. Stauffer V, Karagianis J, Sutton V, et al. Number needed to treat (NNT) and number needed to harm (NNH) in randomized, blinded trials comparing olanzapine to other atypical antipsychotics for treatment of schizophrenia. Clin Schizophr Relat Psychoses. 2008;2(2):136-146.
34. Leucht S, Corves C, Arbter D, Engel RR, Li C, John M. Secondgeneration versus first-generation antipsychotic drugs for schizophrenia: A meta-analysis. Lancet. 2009;373(657):31-41.
35. Tepper SJ, Haas JF. Prevalence of tardive dyskinesia. J Clin Psychiatry. 1979;40(12):508-516.
36. Kane JM. Tardive dyskinesisa rate with atypical antipsychotics in adults: Prevalence and incidence. J Clin Psychiatry. 2004;65(Suppl 9): 16-20.
37. Correll CU, Schenk EM. Tardive dyskinesia and new antipsychotics. Curr Opin Psychiatry. 2008;21(2):151-156.
38. Taylor D. Psychopharmacology and adverse effects of antipsychotic long-acting injections: A review. Br J Psychiatry Suppl. 2009;195: S13-S19.
39. Coppola D, Liu Y, Gopal S, et al. Long-term safety, tolerability and pharmacokinetics of highest available dose of paliperidone palmitate: A one-year open-label study in patients with schizophrenia (submitted).
40. Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M, Hough D. A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. J Psychopharmacol. July 8, 2010. [Epub ahead of print].
41. De Hert M, Schreurs V, Sweers K, et al. Typical and atypical antipsychotics differentially affect long-term incidence rates of the metabolic syndrome in first-episode patients with schizophrenia: A retrospective chart review. Schizophr Res. 2008;101(1-3):295-303.
42. Lee E, Chow LY, Leung CM. Metabolic profile of first and second generation antipsychotics among Chinese patients. Psychiatry Res. 2011;185(3):456-458.
43. Tarricone I, Casoria M, Gozzi BF, et al. Metabolic risk factor profile associated with use of second generation antipsychotics: A cross sectional study in a community mental health centre. BMC Psychiatry. 2006;6:11.
44. Citrome L. Paliperidone palmitate - review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Int J Clin Pract. 2010(2):216-239.