PMID- 29236038 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201001 IS - 2079-6382 (Print) IS - 2079-6382 (Electronic) IS - 2079-6382 (Linking) VI - 6 IP - 4 DP - 2017 Dec 13 TI - Adverse Effects of Amoxicillin for Acute Lower Respiratory Tract Infection in Primary Care: Secondary and Subgroup Analysis of a Randomised Clinical Trial. LID - 10.3390/antibiotics6040036 [doi] LID - 36 AB - 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. FAU - Tandan, Meera AU - Tandan M AUID- ORCID: 0000-0002-7742-7980 AD - Discipline of General Practice, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland. m.tandan1@nuigalway.ie. FAU - Vellinga, Akke AU - Vellinga A AUID- ORCID: 0000-0002-6583-4300 AD - Discipline of General Practice, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland. akke.vellinga@nuigalway.ie. AD - Discipline of Bacteriology, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland. akke.vellinga@nuigalway.ie. FAU - Bruyndonckx, Robin AU - Bruyndonckx R AD - Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), Hasselt University, 3500 Hasselt, Belgium. robin.bruyndonckx@uhasselt.be. AD - Laboratory Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, 2610 Antwerp, Belgium. robin.bruyndonckx@uhasselt.be. FAU - Little, Paul AU - Little P AD - Primary Care and Population Science, University of Southampton, Southampton SO17 1BJ, UK. p.little@soton.ac.uk. FAU - Verheij, Theo AU - Verheij T AD - Julius Center for Health Science and Primary Care, University Medical Center Utrecht, 3508 Utrecht, GA, The Netherlands. t.j.m.verheij@umcutrecht.nl. FAU - Butler, Chris C AU - Butler CC AD - The Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK. christopher.butler@phc.ox.ac.uk. AD - School of Medicine, Cardiff University, Cardiff CF14 4XN, UK. christopher.butler@phc.ox.ac.uk. FAU - Goossens, Herman AU - Goossens H AD - Laboratory Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, 2610 Antwerp, Belgium. Herman.Goossens@uza.be. FAU - Coenen, Samuel AU - Coenen S AUID- ORCID: 0000-0002-1238-8052 AD - Laboratory Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, 2610 Antwerp, Belgium. samuel.coenen@uantwerpen.be. AD - Centre for General Practice, Department of Primary and Interdisciplinary Care (ELIZA), University of Antwerp, 2610 Antwerp, Belgium. samuel.coenen@uantwerpen.be. AD - Department of Epidemiology and Social Medicine (ESOC), University of Antwerp, 2610 Antwerp, Belgium. samuel.coenen@uantwerpen.be. LA - eng PT - Journal Article DEP - 20171213 PL - Switzerland TA - Antibiotics (Basel) JT - Antibiotics (Basel, Switzerland) JID - 101637404 PMC - PMC5745479 OTO - NOTNLM OT - adverse effects OT - antibiotics OT - primary care OT - randomized controlled trial OT - respiratory infections OT - subgroup analysis COIS- All authors declare no conflict of interests. EDAT- 2017/12/14 06:00 MHDA- 2017/12/14 06:01 PMCR- 2017/12/13 CRDT- 2017/12/14 06:00 PHST- 2017/10/30 00:00 [received] PHST- 2017/12/06 00:00 [revised] PHST- 2017/12/08 00:00 [accepted] PHST- 2017/12/14 06:00 [entrez] PHST- 2017/12/14 06:00 [pubmed] PHST- 2017/12/14 06:01 [medline] PHST- 2017/12/13 00:00 [pmc-release] AID - antibiotics6040036 [pii] AID - antibiotics-06-00036 [pii] AID - 10.3390/antibiotics6040036 [doi] PST - epublish SO - Antibiotics (Basel). 2017 Dec 13;6(4):36. doi: 10.3390/antibiotics6040036.