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dc.contributor.authorTandan, Meera
dc.contributor.authorVellinga, Akke
dc.contributor.authorBruyndonckx, Robin
dc.contributor.authorLittle, Paul
dc.contributor.authorVerheij, Theo
dc.contributor.authorButler, Chris C.
dc.contributor.authorGoossens, Herman
dc.contributor.authorCoenen, Samuel
dc.identifier.citationTandan, M., Vellinga, A., Bruyndonckx, R., Little, P., Verheij, T., Butler, C., Goossens, H., Coenen, S. (2017). Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial. Antibiotics, 6(4), 36. doi: 10.3390/antibiotics6040036en_IE
dc.description.abstractA European placebo-controlled trial of antibiotic treatment for lower respiratory tract infection (LRTI) conducted in 16 primary care practices networks recruited participants between November 2007 and April 2010, and found adverse events (AEs) occurred more often in patients prescribed amoxicillin compared to placebo. This secondary analysis explores the causal relationship and estimates specific AEs (diarrhoea, nausea, rash) due to amoxicillin treatment for LRTI, and if any subgroup is at increased risk of any or a specific AE. A total of 2061 patients were randomly assigned to amoxicillin (1038) and placebo (1023); 595 (28%) were 60 and older. A significantly higher proportion of any AEs (diarrhoea or nausea or rash) (OR = 1.31, 95% CI 1.05-1.64, number needed to harm (NNH) = 24) and of diarrhoea (OR 1.43 95% CI 1.08-1.90, NNH = 29) was reported in the amoxicillin group during the first week after randomisation. Subgroup analysis showed rash was significantly more often reported in males prescribed amoxicillin (interaction term 3.72 95% CI 1.22-11.36; OR of amoxicillin in males 2.79 (95% CI 1.08-7.22). No other subgroup at higher risk was identified. Although the study was not powered for subgroup analysis, this analysis suggests that most patients are likely to be equally harmed when prescribed antibiotics.en_IE
dc.description.sponsorshipWe are thankful to GRACE team for providing us with their data and the TRACE project for funding MT’s work visit to the Department of Primary Care and Interdisciplinary Care of the University of Antwerp. We would like to acknowledge the dedication, expertise and enthusiasm of entire GRACE team and active participation of all patients.en_IE
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 Ireland
dc.subjectAdverse effectsen_IE
dc.subjectRespiratory infectionsen_IE
dc.subjectRandomized controlled trialen_IE
dc.subjectPrimary careen_IE
dc.subjectSubgroup analysisen_IE
dc.titleAdverse effects of amoxicillin for acute lower respiratory tract infection in primary care: Secondary and subgroup analysis of a randomised clinical trialen_IE
dc.local.contactMeera Tandan, 1 Distillery Road,, Newcastle, , Galway. - Email:

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