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Potential of paliperidone palmitate in long-term preventing therapy of relapses in schizophrenia (review of evidence-based studies)

Oleneva E.V., Ryvkin P.V., Ladyzhensky M.Ya.
Federal Medical Research Centrefor Psychiatry and Narcology by the name of V.P.Serbsky Minzdrava RF

Summary: Nonadherence to medication in patients with schizophrenia is one of the main causes leading to an adverse outcome, while the use of prolonged forms of antipsychotics can significantly increase patients’ compliance and, accordingly, significantly affect the overall effectiveness of long-term anti-relapse therapy. This review is devoted to the analysis of the results of randomized clinical studies of two injection forms of paliperidone palmitate (monthly and three-month action). The scientific materials were obtained in the MEDLINE system as a result of a cross-check of references found at the request of paliperidone palmitate in order to obtain the most relevant data, and concerned both placebo-controlled studies and studies with active control, as well as retrospective observations. The considered compounds have been shown significantly superior to placebo and comparable with other modern antipsychotics efficiency, close to risperidone safety profile, as well as a number of advantages related to the possibility of varying the frequency of injections and the lack of need for collateral assignment oral dosage forms.

References: 
  • 1. Chong H., Teoh S., Wu D., Kotirum S., Chiou C., Chaiyakunapruk N. Global economic burden of schizophrenia: a systematic review // Neuropsychiatr Dis Treat. − 2016. − Vol. 12. − P. 357 −373.
  • 2. Dzhons P.B., Bakli P.F. Shizofreniya. Klinicheskoe rukovodstvo / per. s angl. pod obshch. red. S.N. Mosolova. − M., 2008.
  • 3. Andreasen N., Carpenter W. Jr., Kane J., Lasser R., Marder S., Weinberger D. Remission in schizophrenia: proposed criteria and rationale for consensus // Am J Psychiatry. − 2005. − Vol. 162, No. 3. − P. 441 −449.
  • 4. Mosolov S.N. Shkaly psikhometricheskoi otsenki simptomatiki shizofrenii i kontseptsiya pozitivnykh i negativnykh rasstroistv. − M.: Novyi tsvet, 2001.
  • 5. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition. Text Revision. − Washington, DC: American Psychiatric Association, 1994.
  • 6. Kane J., Aguglia E., Altamura A. et al. Guidelines for depot antipsychotic treatment in schizophrenia // European Neuropsychopharmacology. − 1998. − Vol. 8. − P. 55−66.
  • 7. Leucht S., Tardy M., Komossa K. et al. Antipsychotic drugs versus placebo for relapse prevention in schizophrenia: a systematic review and meta-analysis // Lancet. − 2012. − Vol. 379, No. 9831. − P. 2063−2071.
  • 8. Mosolov S.N., Tsukarzi E.E., Kapiletti S.G. Antipsikhoticheskaya farmakoterapiya shizofrenii: ot nauchnykh dannykh k klinicheskim rekomendatsiyam // Biologicheskie metody terapii psikhicheskikh rasstroistv. Dokazatel'naya meditsina – klinicheskoi praktike / pod red. S.N. Mosolova. − M., 2012. − S. 11−61.
  • 9. Carman J., Wyatt E., Fleck R. et al. Neuroleptic compliance in schizophrenia outpatients // Psychiatric Hospital. − 1984. − Vol. 15. − P. 173−178.
  • 10. Zipursky R.B., Menezes N.M., Streiner D.L. Risk of symptom recurrence with medication discontinuation in first-episode psychosis: a systematic review // Schizophr Res. − 2014. − Vol. 152, No. 2−3. − P. 408−414.
  • 11. Donohoe G. et al. Predictors of compliance with neuroleptic medication among inpatients with schizophrenia: a discriminant function analysis // Eur Psychiatry. − 2001. Vol. 5. − P. 293−298.
  • 12. Mutsatsa S. et al. Clinical correlates of early medication adherence: West London first episode schizophrenia study // Acta Psychiat Scand. − 2003. − Vol. 6. − P. 439–446.
  • 13. Phillips E. Patient compliance. − Bern: H. Huber, 1988.
  • 14. Neznanov N.G., Vid V.D. Problema komplaensa v klinicheskoi psikhiatrii // Psikhiatriya i psikhofarmakoterapiya. − 2004. − T. 6, № 4. − S. 159−162.
  • 15. Ahn J., McCombs J., Jung C., Croudace T., McDonnell D., Ascher-Svanum H, Edgell E., Shi L. Classifying patients by antipsychotic adherence patterns using latent class analysis: characteristics of nonadherent groups in the California Medicaid (Medi-Cal) program // Value Health. − 2008. − Vol. 11. − P. 48−56.
  • 16. Sellwood W., Tarrier N. Demographic factors associated with extreme non-compliance in schizophrenia // Soc Psychiatry Psychiatr Epidemiol. − 1994. − Vol. 29. − P. 172−177.
  • 17. Fenton W., Blyler C., Heinssen R. Determinants of medication compliance in schizophrenia: empirical and clinical findings // Schizophr Bull. − 1997. − Vol. 23. − P. 637−651.
  • 18. Perkins D. Predictors of noncompliance in patients with schizophrenia // J Clin Psychiatry. − 2002. − Vol. 63. − P. 1121−1128.
  • 19. Krasnov V.N., Gurovich I.Ya., Mosolov S.N., Shmukler A.B. Psikhiatricheskaya pomoshch' bol'nym shizofreniei. Klinicheskoe rukovodstvo. − M.: Medpraktika, 2007.
  • 20. Tandon R., Nasrallah H., Keshavan M.S. Schizophrenia. “Just the facts”: 5. Treatment and prevention, Past, present and future // Schizophr Res. − 2010. − Vol. 122. − R. 1−23.
  • 21. Mosolov S.N., Tsukarzi E.E., Alfimov P.V. Algoritmy biologicheskoi terapii shizofrenii // Sovremennaya terapiya psikhicheskikh rasstroistv. − 2014. − № 1. − S. 27−36.
  • 22. Mosolov S.N. Novye dostizheniya v terapii psikhicheskikh zabolevanii. − M., 2002.− S. 622.
  • 23. Mosolov S.N. Nekotorye aktual'nye teoreticheskie problemy diagnostiki, klassifikatsii, neirobiologii i terapii shizofrenii: sravnenie zarubezhnogo i otechestvennogo podkhodov // Zhurnal nevrologii i psikhiatrii imeni C.C. Korsakova. − 2010. − T. 110, № 6. − S. 4−11.
  • 24. Leucht C., Heres S., Kane J.M. et al. Oral versus depot antipsychotic drugs for schizophrenia: a critical systematic review and meta-analysis of randomized long-term trials // Schizophr Res. − 2011. − Vol. 127, No 1−3. − P. 83−92.
  • 25. Keith S., Pani L., Nick B. et al. Practical application of pharmacotherapy with long-acting risperidone for patients with schizophrenia // Psychiatr Serv. − 2004. − Vol. 55, No 9. − P. 997−1005.
  • 26. Emsley R., Chiliza B., Asmal L., Mashile M., Fusar-Poli P. Long-acting injectable antipsychotics in early psychosis: a literature review // Early Interv Psychiatry. − 2013. − Vol. 7, No 3. − P. 247−254.
  • 27. Mosolov S.N., Potapov A.V., Ryvkin P.V. Strategii perevoda bol'nykh na dlitel'nuyu ambulatornuyu terapiyu antipsikhoticheskimi preparatami prolongirovannogo deistviya (na primere in"ektsionnogo risperidona v mikrosferakh) // Sovremennaya terapiya psikhicheskikh rasstroistv. − 2014. − № 1. − S. 11−18.
  • 28. Morozova M.A. Paliperidona Pal'mitat (Kseplion) v povsednevnoi klinicheskoi praktike v usloviyakh psikhiatricheskogo statsionara (rezul'taty rossiiskoi mnogotsentrovoi nablyudatel'noi programmy) // Sotsial'naya i klinicheskaya psikhiatriya. − 2014. − T. 24, № 4. − C. 37−40.
  • 29. 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 effi cacy and safety study // Int J Neuropsychopharmacol. − 2010. − Vol. 13, No 5. − P. 635−647.
  • 30. Nasrallah H., Gopal S., Gassmann-Mayer C. et al. A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia // Neuropsychopharmacology. − 2010. − Vol. 35, No 10. − P. 2072−2082.
  • 31. 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. − Vol. 25, No 5. − P. 247−256.
  • 32. Pandina G., Lindenmayer J., Lull J. et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia // J Clin Psychopharmacol. − 2010. − Vol 30, No 3. − P. 235−244.
  • 33. 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. − 2011. − Vol. 25, No 5. − P. 685−697.
  • 34. 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, placebo-controlled study // Schizophr Res. − 2010. − Vol. 116, No 2−3. − P. 107−117.
  • 35. Attard A., Olofinjana O., Cornelius V., Curtis V., Taylor D. Paliperidone palmitate long-acting injection – prospective year-long follow-up of use in clinical practice // Acta Psychiatr Scand. − 2014. − Vol. 130, No 1. − P. 46−51.
  • 36. Hargarter L., Cherubin P., Bergmans P. et al. Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics // Prog Neuropsychopharmacol Biol Psychiatry. − 2015. − Vol. 58. − P. 1−7.
  • 37. Baser O., Xie L., Pesa J., Durkin M. Healthcare utilization and costs of veterans health administration patients with schizophrenia treated with paliperidone palmitate long-acting injection or oral atypical antipsychotics // J Med Econ. − 2015. − Vol. 18, No 5. − P. 357−365.
  • 38. Bressington D., Stock J., Hulbert S., MacInnes D. A retrospective observational study of the effectiveness of paliperidone palmitate on acute inpatient hospitalization rates // Int Clin Psychopharmacol. − 2015. − Vol. 30, No 4. − P. 230−236.
  • 39. Doshi J., Pettit A., Stoddard J., Zummo J., Marcus S. Concurrent oral antipsychotic drug use among schizophrenia patients initiated on long-acting injectable antipsychotics post-hospital discharge // J Clin Psychopharmacol. − 2015. − Vol. 35, No 4. − P. 442−446.
  • 40. Emsley R., Kilian S. Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review // Neuropsychiatric Disease and Treatment. − 2018. − Vol. 14. − P. 205−223.
  • 41. Fleischhacker W.W., Gopal S., Lane R. et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia // Int J Neuropsychopharmacol. − 2012. − Vol. 15, No 1. − P. 107−118.
  • 42. Pandina G., Lane R., Gopal S. et al. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia // Prog Neuropsychopharmacol Biol Psychiatry. − 2011. − Vol. 35, No 1. − P. 218−226.
  • 43. Fu D.J., Bossie C.A., Kern S.J., Ma Y.W., Alphs L. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens // Clin Schizophr Relat Psychoses. − 2014. − Vol. 8, No 2. − P. 101−109, 109A.
  • 44. Fu D.J., Bossie C.A., Sliwa J.K., Ma Y.W., Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison // Int Clin Psychopharmacol. − 2014. − Vol. 29, No 1. − P. 45−55.
  • 45. Li H., Rui Q., Ning X., Xu H., Gu N. A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia // Prog Neuropsychopharmacol Biol Psychiatry. − 2011. − Vol. 35, No 4. − P. 1002−1008.
  • 46. Koshikawa Y., Takekita Y., Kato M. et al. The comparative effects of risperidone long-acting injection and paliperidone palmitate on social functioning in schizophrenia: a 6-month, open-label, randomized controlled pilot trial. // Neuropsychobiology. − 2016. − Vol. 73, No 1. − P. 35−42.
  • 47. Takekita Y., Koshikawa Y., Fabbri C. et al. Cognitive function and risperidone long-acting injection vs. paliperidone palmitate in schizophrenia: a 6-month, open-label, randomized, pilot trial // BMC Psychiatry. − 2016. − Vol. 16. − P. 172.
  • 48. McEvoy J., Byerly M., Hamer R. et al. Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial // JAMA. − 2014. − Vol. 311, No 19. − P. 1978−1987.
  • 49. Rosenheck R., Leslie D., Sint K. et al. Cost-effectiveness of longacting injectable paliperidone palmitate versus haloperidol decanoate in maintenance treatment of schizophrenia // Psychiatr Serv. − 2016. − Vol. 67, No 10. − P. 1124−1130.
  • 50. Naber D., Hansen K., Forray C. et al. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia // Schizophr Res. − 2015. − Vol. 168, No 1−2. − P. 498−504.
  • 51. Alphs L., Mao L., Lynn S.H., Benson C. A pragmatic analysis comparing once-monthly paliperidone palmitate versus daily oral antipsychotic treatment in patients with schizophrenia // Schizophr Res. − 2016. − Vol. 170, No 2−3. − P. 259−264.
  • 52. Kwon J.S., Kim S.N., Han J. et al. Satisfaction of immediate or delayed switch to paliperidone palmitate in patients unsatisfied with current oral atypical antipsychotics // Int Clin Psychopharmacol. − 2015. − Vol. 30, No 6. − P. 320−328.
  • 53. Schreiner A., Aadamsoo K., Altamura A.C. et al. Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia // Schizophr Res. − 2015. − Vol. 169, No 1−3. − P. 393−399.
  • 54. Pesa J.A., Doshi D., Wang L., Yuce H., Baser O. Health care resource utilization and costs of California Medicaid patients with schizophrenia treated with paliperidone palmitate once monthly or atypical oral antipsychotic treatment // Curr Med Res Opin. − 2017. − Vol. 33, No 4. − P. 723−731.
  • 55. Oleneva E.V., Ryvkin P.V., Ladyzhenskii M.Ya. Populyatsionnoe farmakokineticheskoe modelirovanie kak obosnovanie osobennostei prakticheskogo primeneniya in"ektsii paliperidona pal'mitata trekhmesyachnogo deistviya // Sovremennaya terapiya psikhicheskikh rasstroistv. − 2017. − № 2. − S. 15−23.
  • 56. Gopal S., Vermeulen A., Nandy P., Ravenstijn P. at al. Rekomendatsii po primeneniyu PP3M u vzroslykh patsientov, stradayushchikh shizofreniei (per. s angl.) // Currenent Medical Research & Opinion. − 2013. − P. 1−9.
  • 57. Oleneva E.V., Ryvkin P.V., Ladyzhenskii M.Ya. In"ektsionnyi paliperidona pal'mitat trekhmesyachnogo deistviya (trevikta) − novoe slovo v dlitel'noi terapii bol'nykh shizofreniei. //Sovremennaya terapiya psikhicheskikh rasstroistv. − 2017. − № 1. − S. 35−43.
  • 58. Berwaerts J., Liu Y., Gopal S. et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial // JAMA Psychiatry. − 2015. − Vol. 72, No 8. − P. 830−839.
  • 59. Savitz A.J., Xu H., Gopal S. et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: a randomized, multicenter, double-blind, noninferiority study // Int J Neuropsychopharmacol. − 2016. − Vol. 19, No 7. − pyw018.
  • 60. Savitz A.J., Xu H., Gopal S., Nuamah I., Hough D., Mathews M. Paliperidone palmitate 3-month treatment results in symptomatic remission in patients with schizophrenia: a randomized, multicenter, double-blind, and noninferiority study // Int Clin Psychopharmacol. − 2017. − Vol. 32, No 6. − P. 329−336.
  • 61. Savitz A.J., Xu H., Gopal S. et al. Efficacy and safety of paliperidone palmitate three-monthly formulation in East Asian patients with schizophrenia: subgroup analysis of a global, randomized, double-blind, Phase III, noninferiority study // Neuropsychiatr Dis Treat. − 2017. − Vol. 13. − P. 2193−2207.
  • 62. Weiden P.J., Kim E., Bermak J., Turkoz I., Gopal S., Berwaerts J. Does half-life matter after antipsychotic discontinuation? A relapse comparison in schizophrenia with 3 different formulations of paliperidone // J Clin Psychiatry. − 2017. − Vol. 78, No 7. − P. e813−e820.