Cargando…
Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial
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...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5745479/ https://www.ncbi.nlm.nih.gov/pubmed/29236038 http://dx.doi.org/10.3390/antibiotics6040036 |
_version_ | 1783288911931375616 |
---|---|
author | Tandan, Meera Vellinga, Akke Bruyndonckx, Robin Little, Paul Verheij, Theo Butler, Chris C Goossens, Herman Coenen, Samuel |
author_facet | Tandan, Meera Vellinga, Akke Bruyndonckx, Robin Little, Paul Verheij, Theo Butler, Chris C Goossens, Herman Coenen, Samuel |
author_sort | Tandan, Meera |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5745479 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-57454792018-01-02 Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial Tandan, Meera Vellinga, Akke Bruyndonckx, Robin Little, Paul Verheij, Theo Butler, Chris C Goossens, Herman Coenen, Samuel Antibiotics (Basel) Article 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. MDPI 2017-12-13 /pmc/articles/PMC5745479/ /pubmed/29236038 http://dx.doi.org/10.3390/antibiotics6040036 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Tandan, Meera Vellinga, Akke Bruyndonckx, Robin Little, Paul Verheij, Theo Butler, Chris C Goossens, Herman Coenen, Samuel Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial |
title | Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial |
title_full | Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial |
title_fullStr | Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial |
title_full_unstemmed | Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial |
title_short | Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial |
title_sort | adverse effects of amoxicillin for acute lower respiratory tract infection in primary care: secondary and subgroup analysis of a randomised clinical trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5745479/ https://www.ncbi.nlm.nih.gov/pubmed/29236038 http://dx.doi.org/10.3390/antibiotics6040036 |
work_keys_str_mv | AT tandanmeera adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial AT vellingaakke adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial AT bruyndonckxrobin adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial AT littlepaul adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial AT verheijtheo adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial AT butlerchrisc adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial AT goossensherman adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial AT coenensamuel adverseeffectsofamoxicillinforacutelowerrespiratorytractinfectioninprimarycaresecondaryandsubgroupanalysisofarandomisedclinicaltrial |