Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study

Folquitto, Jefferson Cunha; Barros, Sérgio Barbosa de; Pinto Junior, Jony Arrais; Bottino, Cássio M.C.

doi:10.1590/S1980-57642010DN40100012

Abstract

To compare the efficacy and tolerability of brand-risperidone against similar-risperidone in elderly outpatients. Method: The medical files of 16 elderly outpatients from the IPq-HCFMUSP treated with two formulations of risperidone (brand and similar) between July/1999 and February/2000 were reviewed. Two independent raters, using the Clinical Global Impression scale, evaluated the efficacy of the treatment with risperidone and the frequency of adverse effects. Results: Comparing October/1999 to November/1999, Rater 1 observed a trend (p=0.059) and Rater 2 found a statistically significant difference, in favor of the brand-risperidone group (p=0.014). Comparing October/1999 to February/2000, Rater 1 observed no statistically significant difference (p=0.190), but the Rater 2 found a statistically significant difference in favor of the brand-risperidone group (p=0.029). Comparing November/1999 to February/2000, both raters found no statistically significant differences between both risperidone formulations. Regarding adverse effects, a statistically significant difference (p=0.046) was found in favor of the patients treated with brand-risperidone. Conclusions: The risperidone-reference, compared to similar-risperidone, showed a trend toward greater efficacy and tolerability.

Key words:
risperidone; elderly; treatment; efficacy; side effects

Resumo

Comparar a eficácia e a tolerabilidade da risperidona-referência versus a risperidona-similar em pacientes idosos. Métodos: Os prontuários de 16 pacientes do IPq-HCFMUSP tratados com duas formulações de risperidona (referência e similar) entre julho/1999 e fevereiro/2000 foram revisados. Dois examinadores independentes, utilizando a escala de Impressão Clínica Global, avaliaram a eficácia do tratamento com risperidona e a freqüência de efeitos colaterais. Resultados: Comparando outubro/1999 e novembro/1999, o avaliador 1 observou uma tendência (p=0,059) e o examinador 2 encontrou uma diferença estatisticamente significativa a favor da risperidona-referência (p=0,014). Comparando outubro/99 com fevereiro/2000, o avaliador 1 não encontrou diferença estatisticamente significativa (p=0,190), mas o examinador 2 encontrou uma diferença estatisticamente significativa a favor da risperidona-referência (p=0,029). Entre novembro/1999 e fevereiro/2000, ambos examinadores não encontraram diferença significativas entre as formulações. Quanto aos efeitos colaterais, houve diferença significativa (p=0,046) a favor do grupo risperidona-referência. Conclusões: A risperidona-referência, quando comparada à risperidona-similar, mostrou tendência a maior eficácia e tolerabilidade.

Palavras-chave:
risperidona; idosos; tratamento; eficácia; efeitos colaterais

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References

¹
American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. 2nd ed. American Psychiatric Association; 2004.
²
Davis JM, Chen N, Glick ID. A meta-analysis of the efficacy of second-generation antipsychotics. Arch Gen Psychiatry. 2003; 60:553-564.
³
Hunter RH, Joy CB, Kennedy E, Gilbody SM, Song F. Risperidone versus typical antipsychotic medication for schizophrenia. Cochrane Database Syst Ver 2000;2:CD000440.
⁴
Zhang XY, Zhou DF, Cão LY, Zhang PY, Wu GY, Shen,YC. Risperidone versus haloperidol in the treatment of acute exacerbations of chronic inpatients with schizophrenia: a randomized double-blind study. Int Clin Psychopharmacol 2001; 16:325-330.
⁵
Claus A, Bollen J, De Cuyper H, et al. Risperidone versus haloperidol in the treatment of chronic schizophrenic inpatients: a multicentre double-blind comparative study. Acta Psychiatr Scand 1992;85:295-305.
⁶
Borison RL, Pathiraja AP, Diamond BI, Meibach RC. Risperidone: clinical safety and efficacy in schizophrenia. Psychopharmacol Bull 1992;28:213-218.
⁷
Castelao JF, Ferreira L, Gelders YG, Heylen SL. The efficacy of the D2 and 5-HT2 antagonist risperidone (R 64,766) in the treatment of chronic psychosis. An open dose-finding study. Schizophr Res 1989;2:411-415.
⁸
Grant S, Fitton A. Risperidone. A review of its pharmacology and therapeutic potential in the treatment of schizophrenia. Drugs 1994;48:253-273.
⁹
Conley RR. Risperidone side effects. J Clin Psychiatry 2000; 61(Suppl 8):20-23.
¹⁰
Willians R. Optimal dosing with risperidone: updated recommendations. J Clin Psychiatry 2001;62:282-289.
¹¹
Ghaemi SN, Sachs GS. Long-term risperidone treatment in bipolar disorder: 6-month follow up. Int Clin Psychopharmacol 1997;12:333-338.
¹²
Tohen M, Zarate CA Jr. Antipsychotic agents and bipolar disorder. J Clin Psychiatry 1998;59(Suppl. 1):38-48.
¹³
Perlis RH, Welge JA, Vornik LA, Hirschfeld RM, Keck PE Jr. Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry 2006;67:509-516.
¹⁴
Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial - Risperidone Study Group. J Clin Psychiatry 1999;60:107-115.
¹⁵
De Deyn PP, Rabheru K, Rasmussen A, et al. A randomized trial of risperidone, placebo, and haloperidol for behavioral sumptons of dementia. Neurology 1999;53:946-955.
¹⁶
Brodaty H, Ames D, Snowdon J, et al. A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. J Clin Psychiatry 2003; 64:134-143.
¹⁷
Alexopoulos GS, Streim J, Carpenter D, Docherty JP. Expert consensus panel for using antipsychotic drugs in older patients: using antipsychotic agents in older patients. J Clin Psychiatry 2004;65(Suppl. 2):5-99.
¹⁸
Laks J, Engelhardt E, Marinho V, Rozenthal M, Souza FC, Bacalchuk J. Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly. Arq Neuropsiquiatr 2001;59:859-864.
¹⁹
Grau-Veciana JM. Tratamiento de los síntomas no cognitivos de la enfermedad de Alzheimer. Rev Neurol 2006;42:482-488.
²⁰
Ballard C, Waite J. The effectiveness of atypical antipsychotics for the treatment of aggression and psychosis in Alzheimer's disease. Cochrane Database Syst Rev 2006;25:CD003476.
²¹
Guy W. CGI Clinical Global Impressions: ECDEU Assessment Manual. Rev ed. Rockville, Md: US Dept of Health, Education, and Welfare; 1976.
²²
Organização Mundial de Saúde. Classificação de Transtornos Mentais de Comportamento da CID-10: Descrições Clínicas e Diretrizes Diagnósticas. Porto Alegre: Editora Artes Médicas; 1993.
²³
Agência Nacional de Vigilância Sanitária (ANVISA). Resolução - RDC N° 133 de 29 de maio de 2003. Diário Oficial da União (D.O.U.), 02 de junho de 2003.
²⁴
Agência Nacional de Vigilância Sanitária (ANVISA). Resolução - RDC N° 135 de 29 de maio de 2003. Diário Oficial da União (D.O.U.) , 02 de junho de 2003.
²⁵
Borgherini G. The bioequivalenceand therapeutic efficacy of generic versus brand-name psychotropic drugs. Clin Ther 2003:25:1578-1592.
²⁶
van Os S, Relleke M, Piniella PM. Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets.Int J Clin Pharmacol Ther 2007;45:293-299.
²⁷
Gaete LE, Solis J, Venegas P, Carrillo MJ, Schatloff O, Saavedra I. Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno. Rev Méd Chile 2003;131:527-534.
²⁸
Crawford P, Hall WW, Chapell B, Collings J, Stewart A. Generic prescribing for epilepsy: is it safe? Seizure 1996;5:1-5.
²⁹
Vadney VJ, Kraushaar KW. Effects of switching from Depakene to generic valproic acid on individuals with mental retardation. Ment Retard 1997;35:468-472.
³⁰
Aldenkamp AP, Rentmeester T, Hulsman J, Majoie M, Doelman J, Diepman L, Schellekens A, Franken M, Olling M. Pharmacokinetics and cognitive effects of carbamazepine formulations with different dissolution rates. Eur J Clin Pharmacol 1998;54:185-192.

Publication Dates

Publication in this collection
Jan-Mar 2010

History

Received
22 Oct 2009
Accepted
08 Jan 2010

This is an open-access article distributed under the terms of the Creative Commons Attribution License

[1] ¹
American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. 2nd ed. American Psychiatric Association; 2004.

[2] ²
Davis JM, Chen N, Glick ID. A meta-analysis of the efficacy of second-generation antipsychotics. Arch Gen Psychiatry. 2003; 60:553-564.

[3] ³
Hunter RH, Joy CB, Kennedy E, Gilbody SM, Song F. Risperidone versus typical antipsychotic medication for schizophrenia. Cochrane Database Syst Ver 2000;2:CD000440.

[4] ⁴
Zhang XY, Zhou DF, Cão LY, Zhang PY, Wu GY, Shen,YC. Risperidone versus haloperidol in the treatment of acute exacerbations of chronic inpatients with schizophrenia: a randomized double-blind study. Int Clin Psychopharmacol 2001; 16:325-330.

[5] ⁵
Claus A, Bollen J, De Cuyper H, et al. Risperidone versus haloperidol in the treatment of chronic schizophrenic inpatients: a multicentre double-blind comparative study. Acta Psychiatr Scand 1992;85:295-305.

[6] ⁶
Borison RL, Pathiraja AP, Diamond BI, Meibach RC. Risperidone: clinical safety and efficacy in schizophrenia. Psychopharmacol Bull 1992;28:213-218.

[7] ⁷
Castelao JF, Ferreira L, Gelders YG, Heylen SL. The efficacy of the D2 and 5-HT2 antagonist risperidone (R 64,766) in the treatment of chronic psychosis. An open dose-finding study. Schizophr Res 1989;2:411-415.

[8] ⁸
Grant S, Fitton A. Risperidone. A review of its pharmacology and therapeutic potential in the treatment of schizophrenia. Drugs 1994;48:253-273.

[9] ⁹
Conley RR. Risperidone side effects. J Clin Psychiatry 2000; 61(Suppl 8):20-23.

[10] ¹⁰
Willians R. Optimal dosing with risperidone: updated recommendations. J Clin Psychiatry 2001;62:282-289.

[11] ¹¹
Ghaemi SN, Sachs GS. Long-term risperidone treatment in bipolar disorder: 6-month follow up. Int Clin Psychopharmacol 1997;12:333-338.

[12] ¹²
Tohen M, Zarate CA Jr. Antipsychotic agents and bipolar disorder. J Clin Psychiatry 1998;59(Suppl. 1):38-48.

[13] ¹³
Perlis RH, Welge JA, Vornik LA, Hirschfeld RM, Keck PE Jr. Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry 2006;67:509-516.

[14] ¹⁴
Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial - Risperidone Study Group. J Clin Psychiatry 1999;60:107-115.

[15] ¹⁵
De Deyn PP, Rabheru K, Rasmussen A, et al. A randomized trial of risperidone, placebo, and haloperidol for behavioral sumptons of dementia. Neurology 1999;53:946-955.

[16] ¹⁶
Brodaty H, Ames D, Snowdon J, et al. A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. J Clin Psychiatry 2003; 64:134-143.

[17] ¹⁷
Alexopoulos GS, Streim J, Carpenter D, Docherty JP. Expert consensus panel for using antipsychotic drugs in older patients: using antipsychotic agents in older patients. J Clin Psychiatry 2004;65(Suppl. 2):5-99.

[18] ¹⁸
Laks J, Engelhardt E, Marinho V, Rozenthal M, Souza FC, Bacalchuk J. Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly. Arq Neuropsiquiatr 2001;59:859-864.

[19] ¹⁹
Grau-Veciana JM. Tratamiento de los síntomas no cognitivos de la enfermedad de Alzheimer. Rev Neurol 2006;42:482-488.

[20] ²⁰
Ballard C, Waite J. The effectiveness of atypical antipsychotics for the treatment of aggression and psychosis in Alzheimer's disease. Cochrane Database Syst Rev 2006;25:CD003476.

[21] ²¹
Guy W. CGI Clinical Global Impressions: ECDEU Assessment Manual. Rev ed. Rockville, Md: US Dept of Health, Education, and Welfare; 1976.

[22] ²²
Organização Mundial de Saúde. Classificação de Transtornos Mentais de Comportamento da CID-10: Descrições Clínicas e Diretrizes Diagnósticas. Porto Alegre: Editora Artes Médicas; 1993.

[23] ²³
Agência Nacional de Vigilância Sanitária (ANVISA). Resolução - RDC N° 133 de 29 de maio de 2003. Diário Oficial da União (D.O.U.), 02 de junho de 2003.

[24] ²⁴
Agência Nacional de Vigilância Sanitária (ANVISA). Resolução - RDC N° 135 de 29 de maio de 2003. Diário Oficial da União (D.O.U.) , 02 de junho de 2003.

[25] ²⁵
Borgherini G. The bioequivalenceand therapeutic efficacy of generic versus brand-name psychotropic drugs. Clin Ther 2003:25:1578-1592.

[26] ²⁶
van Os S, Relleke M, Piniella PM. Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets.Int J Clin Pharmacol Ther 2007;45:293-299.

[27] ²⁷
Gaete LE, Solis J, Venegas P, Carrillo MJ, Schatloff O, Saavedra I. Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno. Rev Méd Chile 2003;131:527-534.

[28] ²⁸
Crawford P, Hall WW, Chapell B, Collings J, Stewart A. Generic prescribing for epilepsy: is it safe? Seizure 1996;5:1-5.

[29] ²⁹
Vadney VJ, Kraushaar KW. Effects of switching from Depakene to generic valproic acid on individuals with mental retardation. Ment Retard 1997;35:468-472.

[30] ³⁰
Aldenkamp AP, Rentmeester T, Hulsman J, Majoie M, Doelman J, Diepman L, Schellekens A, Franken M, Olling M. Pharmacokinetics and cognitive effects of carbamazepine formulations with different dissolution rates. Eur J Clin Pharmacol 1998;54:185-192.

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