Abstract
BackgroundOur previous research showed that uric acid lowering therapy (ULT) for gout and hyperuricemia is being prescribed for pediatric patients even though these drugs have not been approved for use in children. However, the actual clinical situation has not been clearly elucidated. In this paper, we provide an in-depth look at the details of actual clinical practice.MethodsThis retrospective cross-sectional study accessed health insurance data for 696,277 children from April 2016 through March 2017 to identify pediatric patients with gout or asymptomatic hyperuricemia, calculate the proportion of patients prescribed ULTs, and analyze population characteristics. Adherence and mean dose for febuxostat and allopurinol, the most commonly prescribed drugs, were also analyzed.ResultsAmong children with gout or asymptomatic hyperuricemia, we found that 35.1% (97/276) were prescribed ULT. This proportion increased with age, especially among males. By comorbidity, ULT was prescribed to 47.9% (46/96) of patients with kidney disease, 41.3% (26/63) for cardiovascular disease, 40.0% (6/15) for Down syndrome, and 27.1% (32/118) for metabolic syndrome. In patients with kidney disease, febuxostat was prescribed more than twice as frequently as allopurinol (28 vs. 12). Median values for the medication possession ratio (MPR) of febuxostat and allopurinol were 70.1 and 76.7%, respectively, and prescriptions were continued for a relatively long period for both drugs. Both drugs were prescribed at about half the adult dose for patients 6–11 years old and about the same as the adult dose for patients 12–18 years old.ConclusionsThis study showed that the continuous management of serum uric acid is being explored using off-label use of ULT in pediatric patients with gout or asymptomatic hyperuricemia in Japan. Drug selection is based on patient characteristics such as sex, age, and comorbidities, and pediatric dosage is based on usage experience in adults. To develop appropriate pediatric ULT, clinical trials are needed on the efficacy and safety of ULT in the pediatric population.Trial registrationUMIN000036029.
Highlights
Our previous research showed that uric acid lowering therapy (ULT) for gout and hyperuricemia is being prescribed for pediatric patients even though these drugs have not been approved for use in children
276 patients identified as having gout or asymptomatic hyperuricemia were included in analysis (Fig. 1)
Proportion of patients diagnosed with gout or asymptomatic hyperuricemia who received ULT Overall, ULT was prescribed for 35.1% (97/276) and that number trended higher with age [16]
Summary
Our previous research showed that uric acid lowering therapy (ULT) for gout and hyperuricemia is being prescribed for pediatric patients even though these drugs have not been approved for use in children. The causes of hyperuricemia in adult patients are more often related to lifestyle, while hyperuricemia in pediatric patients is usually due to underlying chronic disease, including cardiovascular and kidney disease, and to inborn errors of metabolism [4,5,6,7,8,9,10,11,12,13,14,15]. Our findings showed that a certain number of pediatric patients had gout or asymptomatic hyperuricemia and that the prevalence of these conditions increased with age. We noted an increase in the number of patients with comorbid metabolic syndrome associated with lifestyle-related diseases [16]
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