Ibuprofen provides superior antipyretic efficacy vs acetaminophen in childhood fever: Pooled analysis of 2 randomised trials
Canadian Pharmacists Conference ePoster Library. Kellstein D. Jun 25, 2016; 132126
Disclosure(s): David Kellstein, PhD is an employee of Pfizer Consumer Healthcare, Madison, NJ.
Dr. David Kellstein
Dr. David Kellstein
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Abstract
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OBJECTIVES: Compare antipyretic efficacy and safety of IBU vs APAP in children with fever from a pooled analysis of 2 studies.,METHODS: Two IRB-approved, randomised, double-blind studies enrolled children 0.5 - 11 y, 13 - 95 lb with fever (101.5 - 104.9°F, rectally, ages 0.5 - 3 y; 101.0 - 103.9°F, orally, ages 4 - 11 y) for >2-h duration to single-dose IBU suspension (Children's Advil® Suspension 7.5mg/kg) or APAP suspension (Children's Tylenol® Suspension 10 - 15mg/kg) based on labelled dose/age. Temperatures (temp; avg of 2 readings) were assessed at baseline (predose) and after single dose of study medication at 15, 30 and 45 min and hourly from 1 - 8 h thereafter. Primary efficacy: time-weighted sum of temp difference from baseline over 8 h evaluated via analysis of variance. Secondary efficacy endpoints included time to onset and duration of temp control (temp: <100°F orally or <101°F rectally) via Cox proportional hazards; percentage with temp control (Cochran-Mantel-Haenszel); safety was monitored throughout.,RESULTS: In total, 319 children (144 male, 175 female; 94% white; mean age 4.6 y; mean weight 42 lb) were evaluable for efficacy; 333 comprised the safety set. On primary efficacy, IBU 7.5mg/kg was significantly better in terms of time-weighted sum of temp differences vs APAP 10 - 15mg/kg: mean (SD) -11.1 (8.5) vs -7.6 (8.0); P<.001. Onset of temp control occurred significantly earlier (median: 94.5 vs 111.6 min; P<.001), lasted significantly longer (median: 191.3 vs 122.7 min; P=.042) and occurred in a significantly higher percentage of children (89.6 vs 66.7%; P<.001) with IBU suspension vs APAP suspension. Fifteen AEs occurred in each group; none severe. Most common AE was vomiting (4.6%: IBU; 6.3%: APAP; P>.05).,CONCLUSIONS: IBU paediatric suspension (7.5mg/kg) is superior to APAP suspension (10 - 15mg/kg) in treating paediatric fever, with better temperature reduction that was faster and of longer duration compared with APAP. Both products were well tolerated.
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