PMID- 18218293 OWN - NLM STAT- MEDLINE DCOM- 20080229 LR - 20190608 IS - 0946-1965 (Print) IS - 0946-1965 (Linking) VI - 46 IP - 1 DP - 2008 Jan TI - Long-term remission in schizophrenia and related psychoses with long-acting risperidone: results obtained in an open-label study with an observation period of 18 months. PG - 14-22 AB - OBJECTIVE: To monitor long-term symptomatic tolerability and remission in patients with stable but suboptimally treated psychoses after switching to risperidone long-acting injectable (RLAI). METHOD: This subgroup analysis of the Switch to Risperidone Microspheres (StoRMi) open-label trial followed up patients with psychoses who were converted to RLAI for a period of 18 months or until RLAI became commercially available in their country of residence. It included patients from seven European countries. Dosage adjustments were performed as clinically necessary. The efficacy endpoint was achieving and maintaining remission, defined as absent to mild core schizophrenia symptoms for > or = 6 months. A schizophrenia assessment was also completed and patients were monitored for the development of adverse events (AEs). Discontinuation rates were calculated based on Kaplan-Meier estimates where patients switching to commercial RLAI were used as censored observations. RESULTS: A total of 529 patients were followed for up to 18 months. At 18 months, the discontinuation rate was 55.7% based on Kaplan-Meier estimates. The median time to discontinuation was 15.7 months (95% CI (14.0; 17.5)). RLAI was generally well tolerated with most AEs mild-to-moderate in severity. 13% of patients discontinued treatment because of an AE. Body weight of patients increased by a mean A+/- SD of 1.0 A+/- 6.1 kg from treatment initiation to endpoint (p = 0.0001). Glucose-related AEs occurred in four patients (0.8%). Among those patients not meeting severity remission criteria at baseline, 44.8% were in remission at endpoint. Among those patients meeting severity criteria for remission at baseline, 84.2% were in remission at endpoint. A total of 93.7% of the patients who achieved or maintained remission at 6 months were in remission at endpoint. CONCLUSIONS: RLAI is safe during long-term treatment up to 18 months in adults requiring antipsychotics. Conversion to RLAI resulted in improved symptom control. Most patients achieved and maintained a sustained remission (> or = 6 months) after conversion to RLAI. FAU - Llorca, P-M AU - Llorca PM AD - CMP B, CHU Clermont-Ferrand, Clermont-Ferrand, France. FAU - Sacchetti, E AU - Sacchetti E FAU - Lloyd, K AU - Lloyd K FAU - Kissling, W AU - Kissling W FAU - Medori, R AU - Medori R LA - eng PT - Journal Article PT - Multicenter Study PL - Germany TA - Int J Clin Pharmacol Ther JT - International journal of clinical pharmacology and therapeutics JID - 9423309 RN - 0 (Antipsychotic Agents) RN - 0 (Delayed-Action Preparations) RN - L6UH7ZF8HC (Risperidone) SB - IM MH - Adult MH - Antipsychotic Agents/administration & dosage/adverse effects/*therapeutic use MH - Delayed-Action Preparations MH - Female MH - Humans MH - Injections, Intramuscular MH - Male MH - Psychiatric Status Rating Scales MH - Psychotic Disorders/*drug therapy MH - Risperidone/administration & dosage/adverse effects/*therapeutic use MH - Schizophrenia/*drug therapy MH - Treatment Outcome EDAT- 2008/01/26 09:00 MHDA- 2008/03/01 09:00 CRDT- 2008/01/26 09:00 PHST- 2008/01/26 09:00 [pubmed] PHST- 2008/03/01 09:00 [medline] PHST- 2008/01/26 09:00 [entrez] AID - 10.5414/cpp46014 [doi] PST - ppublish SO - Int J Clin Pharmacol Ther. 2008 Jan;46(1):14-22. doi: 10.5414/cpp46014.