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DOI: 10.1055/s-2006-946703
A Comparative Efficacy and Safety Study of Long-Acting Risperidone Injection and Risperidone Oral Tablets Among Hospitalized Patients: 12-Week Randomized, Single-Blind Study
Publication History
Received: 12.12.2005
Revised: 27.3.2006
Accepted: 29.3.2006
Publication Date:
27 July 2006 (online)
Objective: The superiority of risperidone long-acting injection (RLAI) over oral typical and atypical antipsychotics demonstrated in previous studies may be related to the improved drug compliance. The aim of the 12-week randomized, single-blind study was to test whether the superiority of RLAI remained among hospitalized patients that drug compliance could be optimally controlled. Methods: Fifty hospitalized stable schizophrenic patients, who had maintained on oral risperidone for more than 3 months, were randomized to the RLAI and oral risperidone group. Finally 49 patients (98 %) completed the study, and no dose change of oral risperidone, or RLAI was noted among all patients. Results: The RLAI group showed significantly increased positive score of Positive and Negative Syndrome Scale (PANSS) than the risperidone group (0.72 ± 3.52 vs. –1.24 ± 3.81, p = 0.022), but without significance difference for the PANSS total, negative and general psychopathology scores. The RLAI group also showed a significantly improved Udvalg for Kliniske Undersogelser (UKU) Scale (p = 0.037), social life domains of Short-From Health Survey (SF-36) (p = 0.011), and reduced prolactin level (p = 0.001). Conclusion: The results indicated that with optimal controlling of drug compliance among hospitalized patients, RLAI showed no benefit of efficacy over oral risperidone, but with advantages of improved side-effect profiles, social life ratings, and reduced prolactin levels.
References
- 1 Allison D B, Mentore J L, Heo M, Chandler L P, Cappelleri J C, Infante M C, Weiden P J. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999; 156 1686-1696
- 2 Andreasen N C, Carpenter WT J r, Kane J M, Lasser R A, Marder S R, Weinberger D R. Remission in schizophrenia: proposed criteria and rationale for consensus. . 2005; 162 441-449
- 3 Baptista T, Kin N M, Beaulieu S, de Baptista E A. Obesity and related metabolic abnormalities during antipsychotic drug administration: mechanisms, management and research perspectives. . 2002; 35 205-219
- 4 Bhanji N H, Chouinard G, Margolese H C. A review of compliance, depot intramuscular antipsychotics and the new long-acting injectable atypical antipsychotic risperidone in schizophrenia. Eur Neuropsychopharmacol. 2004; 14 87-92
- 5 Bloch Y, Mendlovic S, Strupinsky S, Altshuler A, Fennig S, Ratzoni G. Injections of depot antipsychotic medications in patients suffering from schizophrenia: do they hurt?. J Clin Psychiatry. 2001; 62 855-859
- 6 Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, Pretorius H, David A S. Comparative efficacy and safety of long-acting risperidone and risperidone oral tablets. Eur Neuropsychopharmacol. 2005; 15 111-117
- 7 Eerdekens M, Van H I, Remmerie B, Mannaert E. Pharmacokinetics and tolerability of long-acting risperidone in schizophrenia. Schizophr Res. 2004; 70 91-100
- 8 Fleischhacker W W, Eerdekens M, Karcher K, Remington G, Llorca P M, Chrzanowski W, Martin S, Gefvert O. Treatment of schizophrenia with long-acting injectable risperidone: a 12-month open-label trial of the first long-acting second-generation antipsychotic. J Clin Psychiatry. 2003; 64 1250-1257
- 9 Fleischhacker W W, Rabinowitz J, Kemmler G, Eerdekens M, Mehnert A. Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year. Br J Psychiatry 2005. Aug ; 187 131-136
- 10 Hay J. Complications at site of injection of depot neuroleptics. BMJ. 1995; 311 421
- 11 Hosalli P, Davis J M. Depot risperidone for schizophrenia. Cochrane Database Syst Rev 2003: CD004161
- 12 Kane J M, Eerdekens M, Lindenmayer J P, Keith S J, Lesem M, Karcher K. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am J Psychiatry. 2003; 160 1125-1132
- 13 Keith S J, Kane J M, Turner M, Conley R R, N asrallahHA. Academic highlights: guidelines for the use of long-acting injectable atypical antipsychotics. . 2004; 65 120-131
- 14 Kropp S, Ziegenbein M, Grohmann R, Engel R R, Degner D. Galactorrhea due to psychotropic drugs. . 2004; 37 (Suppl 1) S84-88
- 15 Lane H Y, Chang Y C, Chiu C C, Lee S H, Lin C Y, Chang W H. Fine-tuning risperidone dosage for acutely exacerbated schizophrenia: clinical determinants. Psychopharmacology (Berl). 2004; 172 393-399
- 16 Lasser R A, Bossie C A, Gharabawi G M, Kane J M. Remission in schizophrenia: Results from a 1-year study of long-acting risperidone injection. Schizophr Res. 2005 Sep 15; 77 (2 – 3) 215-227
- 17 Leal A, Rosillon D, Mehnert A, Jarema M, Remington G. Healthcare resource utilization during 1-year treatment with long-acting, injectable risperidone. Pharmacoepidemiol Drug Saf. 2004; 13 811-816
- 18 Lindenmayer J P, Eerdekens E, Berry S A, Eerdekens M. Safety and efficacy of long-acting risperidone in schizophrenia: a 12-week, multicenter, open-label study in stable patients switched from typical and atypical oral antipsychotics. J Clin Psychiatry. 2004; 65 1084-1089
- 19 Liu C Y, Chiu N Y, Wu C K, Yuan L M, Hsiao M C, Liao O. Optimal dose of risperidone and olanzapine for patients with schizophrenia in Taiwan. Int Clin Psychopharmacol. 2003; 18 49-51
- 20 Masand P S, Gupta S. Long-acting injectable antipsychotics in the elderly: guidelines for effective use. Drugs Aging. 2003; 20 1099-1110
- 21 Mendhekar D N, Jiloha R C, Srivastava P K. Effect of risperidone on prolactinoma--a case report. . 2004; 37 41-42
- 22 Nasrallah H A, Duchesne I, Mehnert A, Janagap C, Eerdekens M. Health-related quality of life in patients with schizophrenia during treatment with long-acting, injectable risperidone. J Clin Psychiatry. 2004; 65 531-536
- 23 Parellada E, Andrezina R, Milanova V, Glue P, Masiak M, Turner M S, Medori R, Gaebel W. Patients in the early phases of schizophrenia and schizoaffective disorders effectively treated with risperidone long-acting injectable. . 2005; 19 (Suppl 5) 5-14
- 24 Sim K, Su A, Leong J Y, Yip K, Chong M Y, Fujii S, Yang S, Ungvari G S, Si T, Chung E K, Tsang H Y, Shinfuku N, Kua E H, Tan C H. High dose antipsychotic use in schizophrenia: findings of the REAP (research on east Asia psychotropic prescriptions) study. Pharmacopsychiatry. 2004; 37 175-179
- 25 van Os J, Bossie C A, Lasser R A. Improvements in stable patients with psychotic disorders switched from oral conventional antipsychotics therapy to long-acting risperidone. Int Clin Psychopharmacol. 2004; 19 229-232
Pesus Chou Dr. P. H.
Community Medicine Research Center & Institute of Public Health
National Yang-Ming University
155, Li-Nong St., Sec.2
Shihpai
Taipei 112
Taiwan
Phone: +886 2 28229695
Fax: +886 2 28201461
Email: pschou@ym.edu.tw