TY - JOUR
T1 - Trend survey on adverse event profiles of antipsychotic long-acting injections and oral agents using the Japanese adverse drug event report database
AU - Hatano, Masakazu
AU - Kamei, Hiroyuki
AU - Shimato, Akane
AU - Yamada, Shigeki
AU - Iwata, Nakao
N1 - Funding Information:
Dr Hatano, Kamei, Yamada, Iwata and Ms Shimato declare that they have no direct conflicts of interest relevant to this study. No grant support or other sources of funding were used to conduct this study or prepare this manuscript. Dr Hatano has received speaker's honoraria from Otsuka. Dr Kamei has received speaker's honoraria from Otsuka, Meiji and Dainippon Sumitomo. Dr Yamada has received speaker's honoraria from AstraZeneca, Nippon Kayaku, Nipro, Dainippon Sumitomo, Towa Pharmaceutical, Eisai, Bayer, Japan Blood Products Organization, Aska Pharmaceutical, Mitsubishi Tanabe Pharma, Chugai Pharamaceutical, Merck Sharp and Dohme, Daiichi Sankyo Company. Dr Iwata has received speaker's honoraria from Astellas, Dainippon Sumitomo, Eli Lilly, GlaxoSmithKline, Janssen, Yoshitomi, Otsuka, Meiji, Shionogi, Novartis, and Pfizer and has had research grants from GlaxoSmithKline, Meiji, and Otsuka.
PY - 2020/9
Y1 - 2020/9
N2 - 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 β 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.
AB - 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 β 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.
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U2 - 10.1016/j.psychres.2020.113249
DO - 10.1016/j.psychres.2020.113249
M3 - Article
C2 - 32603929
AN - SCOPUS:85086917237
VL - 291
JO - Psychiatry Research
JF - Psychiatry Research
SN - 0165-1781
M1 - 113249
ER -