In Reply.—
Dr Twarog and colleagues raise a number of questions about our report of the adverse effects of theophylline. We appreciate their concerns and we hope the following satisfies them.
The study was double blinded and randomized; the investigators, the children, the teachers, and the parents had no way of knowing which child was receiving theophylline or placebo, and there was no prior experience with theophylline titration. A "designated'tant' physician monitored the theophylline levels.
Adult and adolescent asthmatics have responded favorably on transfer from more frequent dosing to once-a-day theophylline (Uniphyl; UN). Young children, being rapid theophylline metabolizers, are thought not to be candidates for such therapy. We conducted a sequential crossover, nonblinded, nonrandomized evaluation of UN in 24 children (6-12 years of age) with chronic asthma clinically controlled while receiving bid Theo-dur tablets (TD). Subjects continued on TD for 2 weeks and then were transferred to evening UN at dinner time (mg for mg) for 2 weeks. Response variables included day and night cough, wheeze, dyspnea, chest tightness, medication side effects, thrice daily PEFR, and need for extra medications. Patients were seen weekly for compliance check, diary review, am spirometry, and theophylline levels. Eighteen of 24 subjects preferred UN, 5 preferred TD, and 1 had no preference (Chi-square < 0.01). Twenty-two of 24 patients were transferred to UN while maintaining the same asthma control. Paired /-test analysis showed none of the measured response variables to be significantly different (p > 0.05), except for chest tightness at night, which was significantly less severe (p < 0.05) while the subjects received UN. No significant adverse reaction differences were reported between the two treatments. This pilot study has demonstrated that many young children with chronic asthma requiring daily theophylline can be controlled as well on once-a-day Uniphyl as they were on bid Theo-Dur without adverse effects.'
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