Long-acting injectable risperidone in partially adherent and nonadherent patients with schizophrenia

Abstract

Mário Rodrigues Louzã1, Helio Elkis1, Sandra Ruschel2, Irismar Reis de Oliveira3, Rodrigo Affonseca Bressan4, Paulo Belmonte-de-Abreu5, Hamilton Grabowski6, José Carlos Appolinário71Universidade de São Paulo, São Paulo; 2Hospital Mário Kroeff, Rio de Janeiro; 3Universidade Federal da Bahia, Salvador; 4Universidade Federal de São Paulo, São Paulo; 5Universidade Federal do Rio Grande do Sul, Porto Alegre; 6Hospital Bom Retiro, Curitiba; 7Janssen-Cilag Farmaceutica Ltda, São Paulo, BrazilBackground: Long-acting injectable antipsychotics may improve medication adherence, thereby improving overall treatment effectiveness. This study aimed to evaluate the effectiveness, safety, and tolerability of risperidone long-acting injection in schizophrenic patients switched from oral antipsychotic medication.Methods: In a 12-month, multicenter, open-label, noncomparative study, symptomatically stable patients on oral antipsychotic medication with poor treatment adherence during the previous 12 months received intramuscular injections of risperidone long-acting injection (25 mg starting dose) every 2 weeks. The primary endpoint was the change in Positive and Negative Syndrome Scale (PANSS) total score.Results: Of the 60 patients who were screened, 53 received at least one injection (safety population), and 51 provided at least one postbaseline assessment. Mean PANSS total scores improved significantly throughout the study and at endpoint. Significant improvements were also observed in Clinical Global Impression of Severity, Personal and Social Performance, and Drug Attitude Inventory scales. Risperidone long-acting injection was safe and well-tolerated. Severity of movement disorders on the Extrapyramidal Symptom Rating Scale was reduced significantly. The most frequently reported adverse events were insomnia (22.6%), increased prolactin (17.0%), and weight gain (13.2%).Conclusion: Risperidone long-acting injection was associated with significant symptomatic improvements in stable patients with schizophrenia following a switch from previous antipsychotic medications.Keywords: patient compliance, adherence, risperidone, delayed-action preparations, schizophrenia