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Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care

  • Pharmacoepidemiology and Prescription
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Abstract

Purpose

To determine whether treatment with nitrofurantoin in women with urinary tract infection (UTI) and renal impairment in primary care is associated with a higher risk of ineffectiveness and/or serious adverse events than in women without renal impairment.

Methods

A cohort of 21,317 women treated with nitrofurantoin and a cohort of 7,926 women treated with trimethoprim, identified from the Pharmo Record Linkage System, were analysed. The primary outcome was ineffectiveness of treatment of nitrofurantoin defined as the start of a second antibacterial within 1 month after the start of nitrofurantoin. The secondary outcome was the occurrence of serious adverse events of nitrofurantoin leading to hospitalization within 90 days. A cohort of trimethoprim users was used to determine if the associations found for nitrofurantoin were mainly related to nitrofurantoin itself. The association between renal impairment and the risk of these outcomes was determined with Cox regression and expressed as hazard ratios (HRs).

Results

Overall, the incidence density for ineffectiveness was 5.4 per 1,000 person-days, and moderate renal impairment was not associated with ineffective treatment [HR 1.1, 95 % confidence interval (CI) 0.74–1.51]. The overall incidence density for adverse events was 0.02 per 1,000 person-days. In patients with renal impairment (<50 ml/min/1.73 m2) the risk of pulmonary adverse events leading to hospitalization was significantly increased (HR 4.1, 95 % CI 1.31–13.09)

Conclusions

Nitrofurantoin treatment was not associated with a higher risk of ineffectiveness in women with UTI and moderate renal impairment (30–50 ml/min/1.73m2). However, we did find a significant association between renal impairment (<50 ml/min/1.73 m2) and pulmonary adverse events leading to hospitalization.

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Authors and Affiliations

  1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80 082, 3508 TB, Utrecht, The Netherlands

    Arjen F. J. Geerts, Rob Heerdink, Hieronymus J. Derijks & Toine C. G. Egberts

  2. Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

    Willemijn L. Eppenga, Michel J. P. Wensing & Peter A. G. M. De Smet

  3. Hospital Pharmacy ‘ZANOB’, ‘s-Hertogenbosch, The Netherlands

    Willemijn L. Eppenga & Hieronymus J. Derijks

  4. Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands

    Toine C. G. Egberts

  5. Department of Pharmacy, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

    Peter A. G. M. De Smet

Authors
  1. Arjen F. J. Geerts
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  2. Willemijn L. Eppenga
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  3. Rob Heerdink
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  4. Hieronymus J. Derijks
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  5. Michel J. P. Wensing
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  6. Toine C. G. Egberts
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  7. Peter A. G. M. De Smet
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Corresponding author

Correspondence to Arjen F. J. Geerts.

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Geerts, A.F.J., Eppenga, W.L., Heerdink, R. et al. Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care. Eur J Clin Pharmacol 69, 1701–1707 (2013). https://doi.org/10.1007/s00228-013-1520-x

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  • DOI: https://doi.org/10.1007/s00228-013-1520-x

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