A multicentre, long-term evaluation of the safety and efficacy of ibuprofen syrup in children with juvenile chronic arthritis.

The safety, efficacy and acceptability of ibuprofen syrup were assessed in a multicentre controlled open study in children with juvenile chronic arthritis. Forty-six children aged 18 months to 13 years (mean 6.8 years) were studied. Dosage commenced at 10 mg/kg/day and increased to a maximum of 40 mg/kg/day depending on condition and individual disease control. Follow-up assessments of disease severity, active joint count and any side effects were made at each clinic visit, usually monthly or as often as deemed necessary by the physician. Thirty-nine children completed the minimum eight weeks treatment period, with average duration of treatment being eight months. Seven children did not complete the minimum required treatment period, of which four were lost to follow-up or non-complaint, two had suspected adverse reactions, and one had a taste complaint and nausea. Adverse reactions were predominantly gastrointestinal, but only one was severe enough for discontinuation from the study before the end of the protocol period. Two children had minimal benefit from treatment and were changed to other medication, 10 went into remission during the study period and four were lost to follow-up. Twenty-three children continued on ibuprofen syrup or tablets after the study period. This study demonstrates that ibuprofen is a well tolerated anti-inflammatory agent for children with juvenile chronic arthritis, and that the syrup form is particularly useful for small children who may not be able to swallow tablets.