Safety and efficacy of long‐acting injectable risperidone in patients with schizophrenia spectrum disorders: A 6‐month open‐label trial in Asian patients

Abstract

The study aimed to evaluate the efficacy of long-acting injectable risperidone (LAR) in Asian patients with schizophrenia spectrum disorders. Twenty-five patients enrolled in this 6-month open labelled study. They were switched from their current antipsychotic to LAR without a prior oral risperidone run-in phase. Efficacy was assessed by the positive and negative syndrome scale (PANSS) and clinical global impression (CGI) scales. Extra-pyramidal side effects (EPSE) was assessed using the Simpson Angus Scale (SAS), and weight and plasma levels of fasting blood glucose, lipids and prolactin were measured. Baseline and last visits differences were tested by paired t-test and Wilcoxon signed-rank test; ratings measured over time were analysed using repeated measures ANOVA. Participants' mean age was 30.3 (+/-6.6) years. Principal reason for switching to LAR was non-compliance (40.0%). Thirteen (52%) patients completed the trial. Over 6 months, there were significant reductions in total PANSS (p = 0.008) and CGI (p = 0.001) scores. There were significant increases in weight (p < 0.001), levels of plasma cholesterol and fasting glucose. LAR was effective in improving symptom severity within the first month of starting treatment. However, significant increases in weight and plasma levels of fasting glucose and cholesterol raise concern about metabolic side effects.

Long‐acting injectable antipsychotics in early psychosis: a literature review

“…Three studies assessed conventional LAIAs, two studies included several LAIAs, nine studies involved long‐acting risperidone injection (RLAI), one study assessed olanzapine long‐acting injection (LAI) and two studies involved paliperidone palmitate (PP). Nine of the 17 included studies reported data on relapse, the primary outcome measure …”

“…There was a significant increase in body mass index ( P < 0.001) as well as increase in plasma cholesterol and fasting glucose. The authors concluded that RLAI was effective in first‐episode patients, and that it is not necessary to have a run‐in phase with oral risperidone before switching to RLAI, but were concerned about the observed metabolic side‐effects …”

“…Nine of the 17 included studies reported data on relapse, the primary outcome measure. [22][23][24][25][26][27][28][29][30]…”

“…The authors concluded that RLAI was effective in first-episode patients, and that it is not necessary to have a run-in phase with oral risperidone before switching to RLAI, but were concerned about the observed metabolic sideeffects. 24 A post hoc analysis was conducted of a randomized, double-blind international 52-week trial of 25 mg versus 50 g of RLAI every two weeks in stable patients with schizophrenia or schizo-affective disorder by comparing the recently diagnosed patients (defined as those diagnosed within 3 years of study entry) with the rest of the sample. Although results need to be interpreted with caution because of the retrospective nature of the study, they do provide some suggestion to improve outcomes for patients with more recently diagnosed illness.…”

Mapping the Positive and Negative Syndrome Scale scores to EQ-5D-5L and SF-6D utility scores in patients with schizophrenia

“…From a clinical perspective, PANSS, age and gender are the most commonly used data to measure symptoms severity and characteristics of patients with schizophrenia either in trials or intervention programs in Singapore. For example, in Singapore’s Early Psychosis Intervention Programme’s (EPIP) [ 33 ] long-acting injectable risperidone (LAR) trial [ 34 ], information on symptom severity was routinely captured by case managers to monitor patients as well as to assess the efficacy of the antipsychotic medication but the trial lacked a cost-effectiveness component. The availability of this algorithm will make cost–utility analysis among patients with schizophrenia who are monitored only for symptom severity possible in future trials and program evaluation.…”