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Evaluation of a sustained-release theophylline product in children with asthma
Insights
This study found that most children with asthma maintained therapeutic theophylline levels with Somophyllin-12. However, younger children required higher doses, and some patients experienced significant fluctuations in theophylline levels.
Area of Science:
- Pharmacology
- Pediatric Pulmonology
- Clinical Pharmacy
Background:
- Asthma management in children requires careful monitoring of theophylline levels.
- Sustained-release theophylline formulations aim to simplify dosing regimens.
- Individualized dose titration is crucial for optimizing therapeutic outcomes.
Purpose of the Study:
- To determine optimal dose requirements and intervals for Somophyllin-12 in pediatric asthma patients.
- To assess the maintenance of therapeutic serum theophylline concentrations.
- To evaluate dose-weight relationships across different age groups.
Main Methods:
- A 4-week prospective study involving children aged 3-12 years on continuous Somophyllin-12 therapy.
- Dosage titration to achieve therapeutic theophylline levels (8-20 mg/L) prior to the study.
- Serial measurement of predose and peak serum theophylline levels at baseline, week 2, and week 4.
Main Results:
- The majority of pediatric patients maintained therapeutic theophylline levels throughout the study.
- No significant changes in mean peak, trough, or peak-trough theophylline differences were observed.
- Younger children (3-7 years) required significantly higher weight-standardized doses compared to older children (8-12 years).
- Most patients required 12-hourly dosing, with a minority needing 8-hourly administration.
Conclusions:
- Somophyllin-12 can effectively maintain therapeutic theophylline levels in most pediatric asthma patients.
- Age-related differences in theophylline dosage requirements necessitate individualized treatment approaches.
- While generally stable, some patients may exhibit considerable variability in serum theophylline concentrations, warranting close monitoring.
Abstract:
The purpose of this study was to determine the dose requirements and dose interval of a sustained-release theophylline sprinkle preparation (Somophyllin-12) necessary to maintain therapeutic serum theophylline concentrations in children with asthma. Eighteen patients aged 3-7 years (subgroup 1) and 21 patients aged 8-12 years (subgroup 2), who had been on continuous theophylline therapy with Somophyllin-12, completed the study. Prior to entry into the study, each patient's dosage of Somophyllin-12 was titrated to achieve predose and peak (4-hour postdose) theophylline levels in the therapeutic range (8-20 mg/L). The patients subsequently had predose and peak serum theophylline levels determined at baseline (week 0) and at weeks 2 and 4 of the study. The majority of children maintained theophylline levels in the therapeutic range throughout the 4-week trial, and t-tests showed no significant change from baseline in mean values of peak, trough, or peak-trough theophylline differences in either patient subgroup at weeks 2 and 4. Nevertheless, some individual patients had considerable variation from baseline in peak and trough theophylline levels at follow-up visits. Dosage requirements standardized for weight were significantly higher in patients in subgroup 1 than in subgroup 2 (21.3 +/- 4.5 mg/kg per day versus 17.5 +/- 4.7 mg/kg per day; p less than 0.05). The majority of the patients required 12-hourly administration of Somophyllin-12, but seven of 39 patients required 8-hour dosing.(ABSTRACT TRUNCATED AT 250 WORDS)