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Paliperidone Palmitate 3-Month Formulation (Trevicta) – a new word for the longterm therapy of patients with schizophrenia

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

Summary:The article presents the most important results of clinical trials of a new paliperidone palmitate 3-month formulation in intramuscular injections (Trevicta), and formulates the basic practical recommendations for its application, designed to optimize its use for the treatment of patients with schizophrenia in terms of initiation of therapy and long-term maintenance treatment.

References: 
  • 1. Kein Dzh., Kishimoto T., Korrell K. Nesoblyudenie rezhima lecheniya patsientami s psikhoticheskimi rasstroistvami: epidemiologiya, predraspolagayushchie faktory i taktika / per. s angl. // Vsemirnaya psikhiatriya. – 2013. – T. 12, № 3. – S. 216–226.
  • 2. Keit S., Pani L., Nik B. Prakticheskoe primenenie prolongirovannogo risperidona dlya lecheniya patsientov s shizofreniei / per. s angl. // Sotsial'naya i klinicheskaya psikhiatriya. – 2005. – T. 15, № 1. – S. 44.
  • 3. 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.
  • 4. Mosolov S.N., Kuzavkova M.V. Konsta (risperidon – mikrosfery) – pervyi atipichnyi antipsikhotik prolongirovannogo deistviya (obzor literatury) // Psikhiatriya i psikhofarmakoterapiya. – 2004. – T. 6, № 5. – S. 228–232.
  • 5. Mosolov S.N. Nekotorye aktual'nye teoreticheskie problemy diagnostiki, klassifikatsii, neirobiologii i terapii shizofrenii: sravnenie zarubezhnogo i otechestvennogo podkhodov // Zhurnal nevrologii i psikhiatrii im. C.C. Korsakova – 2010 – T. 110, № 6. – S. 4–11.
  • 6. Neznanov N.G., Vid V.D. Problema komplaensa v klinicheskoi psikhiatrii // Psikhiatriya i psikhofarmakoterapiya. – 2004. – T. 6, № 4. – S. 159–162.
  • 7. Oleneva E.V., Kapiletti S.G., Ryvkin P.V., Ladyzhenskii M.Ya. Rispolept Konsta – 10 let primeneniya v Rossii: nekotorye itogi // Sovremennaya terapiya psikhicheskikh rasstroistv. – 2015 – № 1. – S. 10–24.
  • 8. Agid O., Foussias G., Remington G. Long-acting injectable antipsychotics in the treatment of schizophrenia: their role in relapse prevention. Expert Opin Pharmacother 2010; 11: 2301–17.
  • 9. 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. [Epub ahead of print]. DOI: 10.1001/jamapsychiatry.2015.0241
  • 10. Bloch Y., Mendlovic S., Strupinsky S., et al. Injections of depot antipsychotic medications in patients suffering from schizophrenia: do they hurt? J Clin Psychiatry. 2001; 62: 855–59.
  • 11. Buchanan A. A two-year prospective study of treatment compliance in patients with schizophrenia // Psychol Medicine. – 1992. – Vol. 22. – P. 787–797.
  • 12. Byerly M., Fisher R., Rush A.J. et al. Comparison of clinician vs electronic monitoring of antipsychotic adherence in schizophrenia (poster) // Presented at the 41st annual meeting of the American College of Neuropsychopharmacology. – Dec. 10, – 2002. – San Juan, Puerto Rico.
  • 13. Cañas F., Möller H.J. Long-acting atypical injectable antipsychotics in the treatment of schizophrenia: safety and tolerability review // Expert Opin Drug Saf. – 2010. – Vol. 9. – P. 683–697.
  • 14. Carman J., Wyatt E., Fleck R. et al. Neuroleptic compliance in schizophrenia outpatients // Psychiatric Hospital. – 1984. – Vol. 15. – P. 173–178.
  • 15. Citrome L. New second-generation long-acting injectable antipsychotics for the treatment of schizophrenia. Expert Rev Neurotherapeut 2013; 13: 767–83.
  • 16. Davis J., Metalon L., Watanabe M. et al. Depot antipsychotic drugs: place in therapy // Drugs. – 1994. – Vol. 47. – P. 741–773.
  • 17. Ereshefsky L., Saklad S.R., Tran-Johnson T. et al. Kinetics and clinical evaluation of haloperidol decanoate loading dose regimen // Psychopharmacol Bull. – 1990. – Vol. 26. – P. 108–114.
  • 18. Fleischhacker W., Arango C., Arteel P., Barnes T., Carpenter W., Duckworth K., Galderisi S., Halpern L., Knapp M., Marder S., Moller M., Sartorius N., Woodruff P. Schizophrenia – time to commit to policy change // Schizophr Bull. – 2014. – No. 40 (Suppl. 3). – P. 165–194.
  • 19. Fleischhacker W., Meise U., Guenther V. et al. Compliance with antipsychotic drug treatment: influence of side effects // Acta Psychiatr Scand. – 1994. – Vol. 89. – P. 11–15.
  • 20. Fleischhacker W., Gopal S., Lane R., et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol 2012; 15: 107–18.
  • 21. 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: 247–56.
  • 22. Gopal S., Vijapurkar U., Lim P., et al. A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. J Psychopharmacol 2011; 25: 685–97.
  • 23. 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.
  • 24. Gopal S., Gassmann-Mayer C., Palumbo J., et al. Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. Curr Med Res Opin 2010; 26: 377–87.
  • 25. Higashi K., Medic G., Littlewood K., Diez T., Granstrom O., De Hert M. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systematic literature review. Ther Adv Psychopharmacol 3: 200–218.
  • 26. Hough D., Gopal S., Vijapurkar U., et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophrenia Res 2010; 116: 107–17.
  • 27. Hough D., Lindenmayer JP, Gopal S., et al. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Progr Neuro Psychopharmacol Biol Psychiatry 2009;33:1022–31
  • 28. Keith S., Kane J. Partial compliance and patient consequences in schizophrenia: our patients can do better // J Clin Psychiatry. – 2003. – Vol. 64. – P. 1308–1315.
  • 29. Kramer M., Litman R., Hough D., et al. Paliperidone palmitate, a potential longacting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol 2010; 13: 635–47.
  • 30. Lacro J.P., Dunn L.B., Dolder C.R., et al. Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: a comprehensive review of the recent literature // J Clin Psychiatry. – 2002. – Vol. 63, No. 10. – P. 892–909.
  • 31. Lam Y.W., Alfaro C.L., Ereshefsky L. et al. Pharmacokinetic and pharmacodynamic interactions of oral midazolam with ketoconazole, fluoxetine, fluvoxamine, and nefazodone // J Clin Pharmacology. – 2003. – Vol. 43. – P. 1274–1282.
  • 32. Lambert T. Perception of depot antipsychotics by mental health professionals // J Psychiatric Practice. – 2003. – Vol. 9. – P. 252–260.
  • 33. Larsen T., Haahr U., Joa I. et al. Early detection and intervention in first-episode schizophrenia: a critical review // Acta Psychiatr Scand. – 2001. – Vol. 103. – P. 323–334.
  • 34. Li H, Rui Q, Ning X, et al. A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. Progr Neuro Psychopharmacol Biol Psychiatry 2011; 35: 1002–8.
  • 35. Lloyd K., Latif M., Simpson S., Shrestha K. Switching stable patients with schizophrenia from depot and oral antipsychotics to long-acting injectable risperidone: efficacy, quality of life and functional outcome. Hum Psychopharmacol 2010; 25: 243–52.
  • 36. Marder S. Overview of partial compliance // J Clin Psychiat. – 2003. – Vol. 64 (Suppl. 16). – P. 3–9.
  • 37. Markowitz M., Fu D.J., Levitan B., et al. Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies. Ann Gen Psychiatry 2013; 12:22.
  • 38. Nasrallah H., Gopal S., Gassmann-Mayer C., et al. A controlled, evidencebased trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology 2010; 35: 2072–82.
  • 39. NICE. Guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia. Available at www. nice.org.uk.
  • 40. Perkins D., Gu H., Weiden P. et al. Comparison of atypicals in first episode study group. Predictors of treatment discontinuation and medication nonadherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: a randomized, double-blind, flexible- dose, multicenter study. J Clin Psychiatry 2008; 69: 106–13.
  • 41. Ravenstijn P., Remmerie B., Savitz A., et al. Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: a phase-1, single-dose, randomized, open-label study. J Clin Pharmacol 2015. [Epub ahead of print]. DOI: 10.1002/jcph.597.
  • 42. Savitz A., Xu H., Gopal S., Nuamah I., Ravenstijn P., Janik A., Schotte A., Hough D., FleischhackerW. Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study // International Journal of Neuropsychopharmacology. – 2016. – Vol. 19, No. 7. – P. 1–14.
  • 43. Weiden P.J., Olfson M. Cost of relapse in schizophrenia // Schizophr Bull. – 1995. – Vol. 21, No. 3 – P. 419–429.
  • 44. Weiden P.G., Kozma C., Grogg A. et al. Partial compliance and risk of rehospitalizaton in among California Medicaid patients with schizophrenia // Psychiat Serv. – 2004. – Vol. 55. – P. 886–891.
  • 45. Weiden P., Aquila R., Standard J. Atypical antipsychotic drugs and long-term outcome in schizophrenia // J Clin Psychiatry. – 1996. – Vol. 57. – P. 53–60.
  • 46. Woodru K., Chirila C., Van Impe K., Nuamah I. Health Care Resource Use Of Paliperidone Palmitate 3 Month Injection vs. Paliperidone Palmitate 1-Month Injection: An Analisis of Fase 3 Clinical Trial Hospital Date (poster) // Presented at the 24th EPA. – 12–15 March 2016. – Madrid, Spain.
  • 47. Young J.L., Zonana H.V., Shepler L. Medication noncompliance in schizophrenia: codification and update // Bulletin of the American Academy of Psychiatry and the Law. – 1986. – Vol. 14. – P. 105–122, 173–178.