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Conference Paper: Neuropsychiatric Events Associated with the Use of Helicobacter Pylori Eradication Therapy Containing-Clarithromycin: Self-Controlled Case Series

TitleNeuropsychiatric Events Associated with the Use of Helicobacter Pylori Eradication Therapy Containing-Clarithromycin: Self-Controlled Case Series
Authors
Issue Date2016
PublisherJohn Wiley & Sons Ltd. The Journal's web site is located at http://www3.interscience.wiley.com/cgi-bin/jhome/5669
Citation
The 32nd International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2016), Dublin, Ireland, 25-28 August 2016. In Pharmacoepidemiology and Drug Safety, 2016, v. 25 n. Suppl. 3, p. 434-435, abstract no. 747 How to Cite?
AbstractBackground: There have been concerns that clarithromycin might be associated with neuropsychiatric events in many case reports and spontaneous reports from the World Health Organization and the Food and Drug Administration. Nevertheless, no observational study has been conducted to examine this association. Objectives: To investigate the association between the use of Helicobacter pylori therapy containing‐clarithromycin and acute neuropsychiatric events. Methods: Using the Clinical Data Analysis and Reporting System database in Hong Kong, we identified patients who had both exposure of at least one out‐patient H. pylori therapy containing‐clarithromycin and outcomes of interest during the study period from 2003‐2012 in a self‐controlled case series study. The primary outcome was composite neuropsychiatric events while secondary outcomes were psychotic events and cognitive impairment. The observation period started from one year after patients entered the database and was censored at the earliest of end of study, death, date of receiving clarithromycin script or in‐patient H. pylori therapy containing‐clarithromycin. Several risk periods were defined as 14 day pre‐exposure, day 1‐14 and day 15‐30 since prescription start date. Age adjusted incidence rate ratios were estimated using the conditional Poisson regression. Results: The preliminary findings showed that 1824, 354 and 726 patients were identified with a first recorded composite neuropsychiatric event, psychotic event and cognitive impairment respectively within the study period. The increased incidence rate ratios of 4.12 (95% confidence interval 2.94 to 5.76), 5.42 (2.77‐10.60) and 2.63 (1.36‐5.09) were found during current use for outcomes of composite neuropsychiatric events, psychotic events and cognitive impairment respectively. However, no increased risk was found during all other risk periods for all outcomes. Conclusions: This study showed a short‐term increased risk of neuropsychiatric events associated with H. pylori therapy containing‐clarithromycin among Hong Kong population. There was no evidence of a long‐term increased risk of neuropsychiatric events.
Persistent Identifierhttp://hdl.handle.net/10722/242841
ISSN
2017 Impact Factor: 2.314
2015 SCImago Journal Rankings: 1.804
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorWong, AYS-
dc.contributor.authorWong, ICK-
dc.contributor.authorChui, SLC-
dc.contributor.authorLee, EHM-
dc.contributor.authorChang, WC-
dc.contributor.authorChen, EYH-
dc.contributor.authorLeung, WK-
dc.contributor.authorChan, EWY-
dc.date.accessioned2017-08-25T02:46:06Z-
dc.date.available2017-08-25T02:46:06Z-
dc.date.issued2016-
dc.identifier.citationThe 32nd International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2016), Dublin, Ireland, 25-28 August 2016. In Pharmacoepidemiology and Drug Safety, 2016, v. 25 n. Suppl. 3, p. 434-435, abstract no. 747-
dc.identifier.issn1053-8569-
dc.identifier.urihttp://hdl.handle.net/10722/242841-
dc.description.abstractBackground: There have been concerns that clarithromycin might be associated with neuropsychiatric events in many case reports and spontaneous reports from the World Health Organization and the Food and Drug Administration. Nevertheless, no observational study has been conducted to examine this association. Objectives: To investigate the association between the use of Helicobacter pylori therapy containing‐clarithromycin and acute neuropsychiatric events. Methods: Using the Clinical Data Analysis and Reporting System database in Hong Kong, we identified patients who had both exposure of at least one out‐patient H. pylori therapy containing‐clarithromycin and outcomes of interest during the study period from 2003‐2012 in a self‐controlled case series study. The primary outcome was composite neuropsychiatric events while secondary outcomes were psychotic events and cognitive impairment. The observation period started from one year after patients entered the database and was censored at the earliest of end of study, death, date of receiving clarithromycin script or in‐patient H. pylori therapy containing‐clarithromycin. Several risk periods were defined as 14 day pre‐exposure, day 1‐14 and day 15‐30 since prescription start date. Age adjusted incidence rate ratios were estimated using the conditional Poisson regression. Results: The preliminary findings showed that 1824, 354 and 726 patients were identified with a first recorded composite neuropsychiatric event, psychotic event and cognitive impairment respectively within the study period. The increased incidence rate ratios of 4.12 (95% confidence interval 2.94 to 5.76), 5.42 (2.77‐10.60) and 2.63 (1.36‐5.09) were found during current use for outcomes of composite neuropsychiatric events, psychotic events and cognitive impairment respectively. However, no increased risk was found during all other risk periods for all outcomes. Conclusions: This study showed a short‐term increased risk of neuropsychiatric events associated with H. pylori therapy containing‐clarithromycin among Hong Kong population. There was no evidence of a long‐term increased risk of neuropsychiatric events.-
dc.languageeng-
dc.publisherJohn Wiley & Sons Ltd. The Journal's web site is located at http://www3.interscience.wiley.com/cgi-bin/jhome/5669-
dc.relation.ispartofPharmacoepidemiology and Drug Safety-
dc.rightsPharmacoepidemiology and Drug Safety. Copyright © John Wiley & Sons Ltd.-
dc.titleNeuropsychiatric Events Associated with the Use of Helicobacter Pylori Eradication Therapy Containing-Clarithromycin: Self-Controlled Case Series-
dc.typeConference_Paper-
dc.identifier.emailWong, ICK: wongick@hku.hk-
dc.identifier.emailChui, SLC: cslchui@hku.hk-
dc.identifier.emailLee, EHM: edwinlhm@hku.hk-
dc.identifier.emailChang, WC: changwc@hku.hk-
dc.identifier.emailChen, EYH: eyhchen@hku.hk-
dc.identifier.emailLeung, WK: waikleung@hku.hk-
dc.identifier.emailChan, EWY: ewchan@hku.hk-
dc.identifier.authorityWong, ICK=rp01480-
dc.identifier.authorityChui, SLC=rp02527-
dc.identifier.authorityLee, EHM=rp01575-
dc.identifier.authorityChang, WC=rp01465-
dc.identifier.authorityChen, EYH=rp00392-
dc.identifier.authorityLeung, WK=rp01479-
dc.identifier.authorityChan, EWY=rp01587-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1002/pds.4070-
dc.identifier.hkuros274986-
dc.identifier.volume25-
dc.identifier.issueSuppl. 3-
dc.identifier.spage434, abstract no. 747-
dc.identifier.epage435, abstract no. 747-
dc.identifier.isiWOS:000385483503013-
dc.publisher.placeUnited Kingdom-

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