Clinical outcomes with olanzapine long-acting injection: impact of the 3-hour observation period on patient satisfaction and well-being

Abstract

BackgroundThe objective of the present analysis is to determine the impact of the 3-hour observation period for olanzapine long-acting injection (LAI) on patient satisfaction and well-being by comparing data collected before and after its implementation.MethodsThis is a post hoc analysis of patients treated with olanzapine LAI in 1) a 6-month fixed-dose randomized controlled trial and/or 2) a 6-year open-label safety study. This analysis was limited to patients with schizophrenia who were treated with olanzapine LAI consistent with the approved indication and dosing recommendations of the European Union Summary of Product Characteristics (N=966). Of the 966 patients, the analysis further focused only on those patients who received both 1) at least one injection before the implementation of the 3-hour observation period and 2) at least one injection after implementation of the 3-hour observation period (N=487). Patient satisfaction was assessed with the three-item Patient Satisfaction with Medication Questionnaire-Modified. Responses were averaged across all postbaseline visits occurring before (ie, without) the implementation of the 3-hour observation period and across all postbaseline visits occurring after (ie, with) the implementation of the 3-hour observation period. In addition, the rate of postinjection delirium/sedation syndrome events was calculated.ResultsThere was no meaningful change after implementation of the 3-hour observation period in satisfaction (before: mean [SD] =4.0 [1.02] and after: mean [SD] =4.1 [0.82]), preference for olanzapine LAI over oral medication (before: mean [SD] =4.0 [0.90] and after: mean [SD] =4.1 [0.77]), or ratings of satisfaction regarding side effects (before: mean [SD] =1.9 [0.79] and after: mean [SD] =1.8 [0.60]). For the total population (N=966), postinjection delirium/sedation syndrome occurred in 26 (0.07%) of 38,010 injections.ConclusionFor patients with schizophrenia receiving treatment with olanzapine LAI, the 3-hour observation period had no impact on their satisfaction with the medication or on their subjective well-being.

Postinjection delirium/sedation syndrome in patients with schizophrenia receiving olanzapine long-acting injection: Results from a large observational study

“…Results from this large, multinational, prospective and observational study of olanzapine LAI indicate that the risk of PDSS at each injection was 0.044% and 1.17% in each patient. This rate, the most accurate and precise estimate of the per-injection rate of PDSS in the European Union real-world clinical setting to date, is lower than the per-injection rate (0.07%) 4 , 7 , 8 , 10 and per-patient rate (1.85%) 10 previously observed in clinical trials. These clinical trials were the basis for the current prescribing information text, which states that PDSS occurs in <0.1% of injections and in approximately 2% of patients.…”

“…Other signs and symptoms observed include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension or convulsion. In multiple clinical trials, the incidence of PDSS events was determined to be 0.07% 4 , 7 , 8 , 10 of olanzapine LAI injections (1.85% 10 of patients).…”

Consideration of Long-Acting Injectable Antipsychotics for Polypharmacy Regimen in the Treatment of Schizophrenia: Put It on the Table or Not?

“…Based on data with approximately 45,000 OP given to 2,054 patients, onset of PDSS ranged from immediate to 3 to 5 hours after injection (median onset time = 25 minutes after injection) and the recovery time ranged from 1.5 to 72 hours [ 78 ]. However, it should be notable that 3-hour close monitoring time did not significantly impacted on patients’ satisfaction with continued long-term treatment with OP based on the results from post-hoc analysis for a 6-month fixed dose RCT and a 6-year open-label safety study [ 79 ]. Intramuscular/intravenous olanzapine has been successfully and commonly utilized to treat schizophrenia patients with acute agitation in emergency department or acute admission situation [ 80 , 81 ].…”