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Article: Adverse event monitoring in lamotrigine patients: A pharmacoepidemiologic study in the United Kingdom

TitleAdverse event monitoring in lamotrigine patients: A pharmacoepidemiologic study in the United Kingdom
Authors
KeywordsChronic epilepsy
Lamotrigine
Postmarketing surveillance
Sudden death
Issue Date2001
PublisherWiley-Blackwell Publishing, Inc.. The Journal's web site is located at http://www.epilepsia.com/
Citation
Epilepsia, 2001, v. 42 n. 2, p. 237-244 How to Cite?
AbstractPurpose: This postmarketing surveillance study of lamotrigine (LTG) was performed to provide complementary data to large-scale Prescription-Event Monitoring study with a retrospective case records survey in five tertiary referral epilepsy centres in the United Kingdom. Methods: Adverse events were recorded and compared with those of two other new antiepileptic drugs (AEDs), gabapentin (GBP) and vigabatrin (VGB). All deaths were followed up and standardised mortality ratios (SMRs) were calculated. Serious adverse events were assessed individually. Results: A total of 2.701 patients was identified as being exposed to LTG and/or the comparators. It was necessary to exclude 1,326 patients because LTG and/or comparators had been commenced outside the study centres. The adverse events with LTG reported by this study were similar to those reported in the literature. Skin rash was the major adverse event. Life-threatening hepatic failure, acute exacerbation of ulcerative colitis, disseminated intravascular coagulation, and renal failure were reported. No death could be directly attributed to the use of LTG. The SMR was slightly higher than that reported in the literature: this probably reflects severity of epilepsy in the study population. Conclusions: The safety profile of LTG was similar to that in the large-scale Prescription-Event Monitoring study and generally acceptable. Life-threatening adverse reactions were rare.
Persistent Identifierhttp://hdl.handle.net/10722/132910
ISSN
2015 Impact Factor: 4.706
2015 SCImago Journal Rankings: 2.579
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorWong, ICKen_HK
dc.contributor.authorMawer, GEen_HK
dc.contributor.authorSander, JWASen_HK
dc.date.accessioned2011-04-04T07:57:56Z-
dc.date.available2011-04-04T07:57:56Z-
dc.date.issued2001en_HK
dc.identifier.citationEpilepsia, 2001, v. 42 n. 2, p. 237-244en_HK
dc.identifier.issn0013-9580en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132910-
dc.description.abstractPurpose: This postmarketing surveillance study of lamotrigine (LTG) was performed to provide complementary data to large-scale Prescription-Event Monitoring study with a retrospective case records survey in five tertiary referral epilepsy centres in the United Kingdom. Methods: Adverse events were recorded and compared with those of two other new antiepileptic drugs (AEDs), gabapentin (GBP) and vigabatrin (VGB). All deaths were followed up and standardised mortality ratios (SMRs) were calculated. Serious adverse events were assessed individually. Results: A total of 2.701 patients was identified as being exposed to LTG and/or the comparators. It was necessary to exclude 1,326 patients because LTG and/or comparators had been commenced outside the study centres. The adverse events with LTG reported by this study were similar to those reported in the literature. Skin rash was the major adverse event. Life-threatening hepatic failure, acute exacerbation of ulcerative colitis, disseminated intravascular coagulation, and renal failure were reported. No death could be directly attributed to the use of LTG. The SMR was slightly higher than that reported in the literature: this probably reflects severity of epilepsy in the study population. Conclusions: The safety profile of LTG was similar to that in the large-scale Prescription-Event Monitoring study and generally acceptable. Life-threatening adverse reactions were rare.en_HK
dc.languageengen_US
dc.publisherWiley-Blackwell Publishing, Inc.. The Journal's web site is located at http://www.epilepsia.com/en_HK
dc.relation.ispartofEpilepsiaen_HK
dc.subjectChronic epilepsyen_HK
dc.subjectLamotrigineen_HK
dc.subjectPostmarketing surveillanceen_HK
dc.subjectSudden deathen_HK
dc.titleAdverse event monitoring in lamotrigine patients: A pharmacoepidemiologic study in the United Kingdomen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, ICK: wongick@hku.hken_HK
dc.identifier.authorityWong, ICK=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1046/j.1528-1157.2001.254001.xen_HK
dc.identifier.pmid11240596-
dc.identifier.scopuseid_2-s2.0-0035092187en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0035092187&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume42en_HK
dc.identifier.issue2en_HK
dc.identifier.spage237en_HK
dc.identifier.epage244en_HK
dc.identifier.isiWOS:000167296200012-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridWong, ICK=7102513915en_HK
dc.identifier.scopusauthoridMawer, GE=7004053826en_HK
dc.identifier.scopusauthoridSander, JWAS=7202898360en_HK

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