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dc.contributor.authorPisano, Umberto
dc.contributor.authorDeosaran, Jordanna
dc.contributor.authorLeslie, Stephen James
dc.contributor.authorRushworth, Gordon F.
dc.contributor.authorStewart, Derek C.
dc.contributor.authorFord, Ian
dc.contributor.authorWatson, Angus
dc.date.accessioned2016-09-19T08:28:55Z
dc.date.available2016-09-19T08:28:55Z
dc.date.issued2016-02-09en
dc.identifier.citationPISANO, U., DEOSARAN, J., LESLIE, S.J., RUSHWORTH, G.F., STEWART, D., FORD, I. and WATSON, A.J.M. 2016. Nicorandil, gastrointestinal adverse drug reactions and ulcerations: a systematic review. Advances in therapy [online], 33(3), pages 320-344. Available from: http://dx.doi.org/10.1007/s12325-016-0294-9en
dc.identifier.issn0741-238Xen
dc.identifier.issn1865-8652en
dc.identifier.urihttp://hdl.handle.net/10059/1746
dc.description.abstractIntroduction - Nicorandil is a popular anti-anginal drug in Europe and Japan. Apart from some common adverse drug reactions (ADR), its safety is satisfactory. Several reports have suggested a link between nicorandil, gastrointestinal (GI) ulceration and fistulas. The review aims to critically appraise, synthesize and present the available evidence of all known GI ADR per anatomical location. Methods - The study complied with the PRISMA statement. Literature and pharmacovigilance databases were used to provide rate and/or calculate parameters (median age, median dose, history of symptoms, length of therapy and healing time after withdrawal of the drug). Differences in distribution of quantitative variables were analyzed via Mann-Whitney test. Correlation between quantitative variables was assessed with a Spearman's correlation coefficient. A p value <0.05 was significant. Results - Oral ulcerations occur in 0.2% of the subjects, anal ulcerations are present between 0.07% and 0.37% of patients. Oral and distal GI involvements are the most common ADR (28-29% and 27-31% of all GI ADR, respectively). The hepatobiliary system, the pancreas and salivary glands are not affected by nicorandil exposure. The time to develop oral ulcerations is 74 weeks among people on <30 mg/day compared to only 7.5 weeks in individuals on higher regimens (p = 0.47). There is a significant correlation between dose and ulcer healing time (Spearman's 0.525, p < 0.001). Conclusions - Ulcerative disease is a very commonly reported GI ADR. A delayed ulcerative tendency supports the hypothesis of an ulcerogenic metabolite. Nicorandil seems to act as a cause of the ulcerations, but appears to also work in synergy with other promoting factors. Whether the action of the metabolites relies on a specific mechanism or a simple chemical ulceration is still to be established.en
dc.description.sponsorshipNHS Highland Research and Developmenten
dc.language.isoengen
dc.publisherSpringeren
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/4.0en
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectCardiologyen
dc.subjectFamily medicineen
dc.subjectGastroenterologyen
dc.subjectPharmacologyen
dc.subjectSurgeryen
dc.titleNicorandil, gastrointestinal adverse drug reactions and ulcerations: a systematic review.en
dc.typeJournal articlesen
dc.publisher.urihttp://dx.doi.org/10.1007/s12325-016-0294-9en
dcterms.dateAccepted2015-12-07en
dcterms.publicationdate2016-03-01en
refterms.accessExceptionNAen
refterms.dateDeposit2016-09-19en
refterms.dateEmbargoEnd2017-02-09en
refterms.dateFCA2017-02-09en
refterms.dateFCD2016-09-19en
refterms.dateFreeToDownload2017-02-09en
refterms.dateFreeToRead2017-02-09en
refterms.dateToSearch2017-02-09en
refterms.depositExceptionNAen
refterms.panelAen
refterms.technicalExceptionNAen
refterms.versionAMen
rioxxterms.publicationdate2016-02-09en
rioxxterms.typeJournal Article/Reviewen
rioxxterms.versionAMen


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