A European placebo-controlled trial of antibiotic treatment for lower respiratory tract\ninfection (LRTI) conducted in 16 primary care practices networks recruited participants between\nNovember 2007 and April 2010, and found adverse events (AEs) occurred more often in patients\nprescribed amoxicillin compared to placebo. This secondary analysis explores the causal relationship\nand estimates specific AEs (diarrhoea, nausea, rash) due to amoxicillin treatment for LRTI, and if\nany subgroup is at increased risk of any or a specific AE. A total of 2061 patients were randomly\nassigned to amoxicillin (1038) and placebo (1023); 595 (28%) were 60 and older. A significantly\nhigher proportion of any AEs (diarrhoea or nausea or rash) (OR = 1.31, 95% CI 1.05ââ?¬â??1.64, number\nneeded to harm (NNH) = 24) and of diarrhoea (OR 1.43 95% CI 1.08ââ?¬â??1.90, NNH = 29) was reported\nin the amoxicillin group during the first week after randomisation. Subgroup analysis showed rash\nwas significantly more often reported in males prescribed amoxicillin (interaction term 3.72 95%\nCI 1.22ââ?¬â??11.36; OR of amoxicillin in males 2.79 (95% CI 1.08ââ?¬â??7.22). No other subgroup at higher risk\nwas identified. Although the study was not powered for subgroup analysis, this analysis suggests\nthat most patients are likely to be equally harmed when prescribed antibiotics.
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