アブストラクト | This study aims to assess the differences in adverse event profiles of long-acting injectable antipsychotics (LAIs) and oral antipsychotics (OAPs) using real-world data in the Japanese Adverse Drug Event Report database. Reporting odds ratios were determined using disproportionality analysis to estimate the risk of adverse events for LAIs and OAPs. Differences in adverse event profiles between formulations were determined after propensity score matching. Time-to-onset of adverse events was compared between LAIs and OAPs using the Weibull shape parameter. Signals were detected for approximately 50% of the adverse events (12 of 22) with LAIs and for the majority of adverse events (19 of 22) with OAPs. LAIs was associated with significantly lower reporting rate than OAPs for extrapyramidal symptom, neuroleptic malignant syndrome, and dystonia. For QT prolongation, convulsions, and hyperglycemia associated with LAIs, the 95% Confidence Interval of beta included 1 in time-to-onset analysis. Real-world data suggest that LAIs tend to reduce the occurrence of extrapyramidal symptom and neuroleptic malignant syndrome, but a number of other adverse events have potential risks as well as OAPs. In addition, onset of adverse events with LAIs have been shown to be slightly delayed, requiring more careful long-term monitoring. |
組織名 | Department of Psychiatry, Fujita Health University School of Medicine, Toyoake,;Aichi, Japan; Department of Clinical Pharmacy, Fujita Health University School of;Medicine, Toyoake, Aichi, Japan; Office of Clinical Pharmacy Practice and Health;Care Management, Faculty of Pharmacy, Meijo University, Nagoya, Aichi, Japan.;Electronic address: hatanomasakazu@yahoo.co.jp.;Aichi, Japan; Office of Clinical Pharmacy Practice and Health Care Management,;Faculty of Pharmacy, Meijo University, Nagoya, Aichi, Japan.;Department of Clinical Pharmacy, Fujita Health University School of Medicine,;Toyoake, Aichi, Japan.;Aichi, Japan. |