Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.

A post-marketing study was performed on all patients who had started treatment with iguratimod, a conventional synthetic disease-modifying antirheumatic drug approved in Japan. During the study period, various safety measures were implemented to reduce risks. We investigated the frequency of adverse...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Kai Shibata, Akiko Yoshimura, Satoshi Ikeuchi, Mika Ishii
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/3a0911d7be8740fdbb701f6d214dc9fb
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:3a0911d7be8740fdbb701f6d214dc9fb
record_format	dspace
spelling	oai:doaj.org-article:3a0911d7be8740fdbb701f6d214dc9fb2021-12-02T20:08:53ZEffectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.1932-620310.1371/journal.pone.0253513https://doaj.org/article/3a0911d7be8740fdbb701f6d214dc9fb2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0253513https://doaj.org/toc/1932-6203A post-marketing study was performed on all patients who had started treatment with iguratimod, a conventional synthetic disease-modifying antirheumatic drug approved in Japan. During the study period, various safety measures were implemented to reduce risks. We investigated the frequency of adverse drug reactions before and after implementation of each safety measure to examine the preventive effect of these measures. Post-hoc analysis was performed using data from all-case surveillance of iguratimod. The subjects were all of the patients receiving iguratimod for whom safety information was obtained. To identify the time after starting administration when adverse drug reactions were most likely to occur, a generalized linear mixed-effect model was applied for the period from initiation of administration until occurrence of reactions in each patient. The mean incidence of adverse drug reactions per patient was compared before and after the implementation of safety measures by using generalized estimating equations based on a two-sided test, 95% confidence interval, and 5% significance level. The number of patients treated with iguratimod was not related to changes in the number of patients with adverse drug reactions. After implementing precautions regarding co-administration with warfarin and liver dysfunction, the estimated mean incidence rate of adverse drug reactions (95% confidence interval) decreased significantly to 0.73 (0.59-0.90) and 0.72 (0.55-0.94), respectively. Accordingly, some of the implementation of safety measures significantly reduced adverse drug reactions. The effectiveness of safety measures implemented during the all-case surveillance of iguratimod was evaluated, revealing that early implementation of safety measures decreased the incidence of adverse drug reactions.Kai ShibataAkiko YoshimuraSatoshi IkeuchiMika IshiiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 7, p e0253513 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Kai Shibata Akiko Yoshimura Satoshi Ikeuchi Mika Ishii Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.
description	A post-marketing study was performed on all patients who had started treatment with iguratimod, a conventional synthetic disease-modifying antirheumatic drug approved in Japan. During the study period, various safety measures were implemented to reduce risks. We investigated the frequency of adverse drug reactions before and after implementation of each safety measure to examine the preventive effect of these measures. Post-hoc analysis was performed using data from all-case surveillance of iguratimod. The subjects were all of the patients receiving iguratimod for whom safety information was obtained. To identify the time after starting administration when adverse drug reactions were most likely to occur, a generalized linear mixed-effect model was applied for the period from initiation of administration until occurrence of reactions in each patient. The mean incidence of adverse drug reactions per patient was compared before and after the implementation of safety measures by using generalized estimating equations based on a two-sided test, 95% confidence interval, and 5% significance level. The number of patients treated with iguratimod was not related to changes in the number of patients with adverse drug reactions. After implementing precautions regarding co-administration with warfarin and liver dysfunction, the estimated mean incidence rate of adverse drug reactions (95% confidence interval) decreased significantly to 0.73 (0.59-0.90) and 0.72 (0.55-0.94), respectively. Accordingly, some of the implementation of safety measures significantly reduced adverse drug reactions. The effectiveness of safety measures implemented during the all-case surveillance of iguratimod was evaluated, revealing that early implementation of safety measures decreased the incidence of adverse drug reactions.
format	article
author	Kai Shibata Akiko Yoshimura Satoshi Ikeuchi Mika Ishii
author_facet	Kai Shibata Akiko Yoshimura Satoshi Ikeuchi Mika Ishii
author_sort	Kai Shibata
title	Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.
title_short	Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.
title_full	Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.
title_fullStr	Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.
title_full_unstemmed	Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.
title_sort	effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/3a0911d7be8740fdbb701f6d214dc9fb
work_keys_str_mv	AT kaishibata effectivenessofdrugsafetymeasuresforreducingtheincidenceofadversedrugreactionsposthocanalysisofdatafromallcasesurveillanceofiguratimodusinggeneralizedestimatingequations AT akikoyoshimura effectivenessofdrugsafetymeasuresforreducingtheincidenceofadversedrugreactionsposthocanalysisofdatafromallcasesurveillanceofiguratimodusinggeneralizedestimatingequations AT satoshiikeuchi effectivenessofdrugsafetymeasuresforreducingtheincidenceofadversedrugreactionsposthocanalysisofdatafromallcasesurveillanceofiguratimodusinggeneralizedestimatingequations AT mikaishii effectivenessofdrugsafetymeasuresforreducingtheincidenceofadversedrugreactionsposthocanalysisofdatafromallcasesurveillanceofiguratimodusinggeneralizedestimatingequations
_version_	1718375117518536704

Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations.

Ejemplares similares