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Antibiotics 2017, 6(4), 36; https://doi.org/10.3390/antibiotics6040036

Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial

1
Discipline of General Practice, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland
2
Discipline of Bacteriology, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland
3
Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), Hasselt University, 3500 Hasselt, Belgium
4
Primary Care and Population Science, University of Southampton, Southampton SO17 1BJ, UK
5
Julius Center for Health Science and Primary Care, University Medical Center Utrecht, 3508 Utrecht, GA, The Netherlands
6
The Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK
7
School of Medicine, Cardiff University, Cardiff CF14 4XN, UK
8
Laboratory Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, 2610 Antwerp, Belgium
9
Centre for General Practice, Department of Primary and Interdisciplinary Care (ELIZA), University of Antwerp, 2610 Antwerp, Belgium
10
Department of Epidemiology and Social Medicine (ESOC), University of Antwerp, 2610 Antwerp, Belgium
*
Author to whom correspondence should be addressed.
Academic Editor: Jeffrey Lipman
Received: 30 October 2017 / Revised: 6 December 2017 / Accepted: 8 December 2017 / Published: 13 December 2017
(This article belongs to the Special Issue Top 35 of Antibiotics Travel Awards 2017)
View Full-Text   |   Download PDF [192 KB, uploaded 22 December 2017]

Abstract

A 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. View Full-Text
Keywords: adverse effects; antibiotics; respiratory infections; randomized controlled trial; primary care; subgroup analysis adverse effects; antibiotics; respiratory infections; randomized controlled trial; primary care; subgroup analysis
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).
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MDPI and ACS Style

Tandan, M.; Vellinga, A.; Bruyndonckx, R.; Little, P.; Verheij, T.; Butler, C.C.; Goossens, H.; Coenen, S. Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial. Antibiotics 2017, 6, 36.

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