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Emerg Med J. 2017 Oct;34(10):637-642. doi: 10.1136/emermed-2016-206353. Epub 2017 Jul 5.

Ibuprofen versus placebo effect on acute kidney injury in ultramarathons: a randomised controlled trial.

Author information

1
Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California, USA.
2
Department of Computational Sciences, University of Colorado at Boulder, Boulder, Colorado, USA.
3
Emergency Medicine Residency, University of Washington, Seattle, USA.
4
Stanford-Kaiser Emergency Medicine Residency, Stanford, USA.
5
Harvard Affiliated Emergency Medicine Residency, Harvard Medical School, Boston, USA.
6
Washington University in St. Louis Emergency Medicine Residency, St. Louis, USA.
7
Department of Orthopedics and Sports Medicine, University of Washington, Seattle, USA.

Abstract

BACKGROUND:

Despite concerns that non-steroidal anti-inflammatory drugs (NSAIDs) contribute to acute kidney injury (AKI), up to 75% of ultramarathon runners ingest these during competition. The effect of NSAID on AKI incidence in ultramarathon runners is unclear.

METHODS:

Multisite randomised double-blind placebo-controlled trial in the Gobi, Atacama, Ecuador and Sri Lankan deserts to determine whether ibuprofen (400 mg every 4 hours) would be non-inferior to placebo during a 50-mile (80 km) foot race. The primary outcome was incidence of AKI defined as severity categories of 'risk' of injury of 1.5× baseline creatinine (Cr) or 'injury' as 2× Cr, combined to calculate total incidence at the finish line. Non-inferiority margin for difference in AKI rates was defined as 15%.

RESULTS:

Eighty-nine participants (47% ibuprofen and 53% placebo) were enrolled with similar demographics between groups. The overall incidence of AKI was 44%. Intent-to-treat analysis found 22 (52%) ibuprofen versus 16 (34%) placebo users developed AKI (18% difference, 95% CI -4% to 41%; OR 2.1, 95% CI 0.9 to 5.1) with a number needed to harm of 5.5. Greater severity of AKI was seen with ibuprofen compared with placebo (risk=38% vs 26%; 95% CI -9% to 34%; injury=14% vs 9%; 95% CI -10% to 21%). Slower finishers were less likely to encounter AKI (OR 0.67, 95% CI 0.47 to 0.98) and greater weight loss (-1.3%) increased AKI (OR 1.24, 95% CI 1.00 to 1.63).

CONCLUSION:

There were increased rates of AKI in those who took ibuprofen, and although not statistically inferior to placebo by a small margin, there was a number needed to harm of 5.5 people to cause 1 case of AKI. Consideration should therefore be taken before ingesting NSAID during endurance running as it could exacerbate renal injury.

TRIAL REGISTRATION NUMBER:

NCT02272725.

KEYWORDS:

environmental medicine, wilderness medicine; renal; wilderness medicine

PMID:
28679502
DOI:
10.1136/emermed-2016-206353
[Indexed for MEDLINE]

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