Proton pump inhibitors such as
lansoprazole are used in the treatment of
gastroesophageal reflux disease (
GERD), but dosing guidelines for infants have not been determined. The objective of this study was to assess the clinical efficacy of 2 dosing regimens of
lansoprazole in infants with
GERD using the revised infant
gastroesophageal reflux questionnaire scores (I-GERQ-R). Thirty consecutive infants (3-7 months) with
GERD, whose conditions were diagnosed by I-GERQ-R scores of > or =16, were randomly assigned to receive 1 of 2
lansoprazole dosing regimens: 15 mg given once per day (group A) or approximately 7.5 mg given 2 times per day (group B). Matched infants in a control group were treated with an extensively hydrolyzed formula (group C). Daily I-GERQ-R scores were gathered, and the scores after 1 and 2 weeks of treatment were used for analysis. The mean pretreatment scores were similar in groups A, B, and C (26.6, 26.9, and 25.9, respectively).
After treatment there was a similar drop in the mean scores in groups A and B (20.6 and 20.0, respectively), but not in group C (25.8). At the end of the first week of treatment, in group A, 5 of 15 infants (33%) had a significant reduction in their I-GERQ-R scores, whereas in group B, 10 of 15 infants (67%) had a significant reduction in their I-GERQ-R scores (P < 0.05). At the end of the second week of treatment, groups A and B had similar numbers of patients with significant improvement (60% and 67%), which was higher than in group C (3/15, 20%). Overall, there was no difference in the symptom response, as measured by I-GERQ-R scores, between 15 mg of
lansoprazole given once per day and 7.5 mg given twice per day in infants with
GERD, but the twice-daily regimen produced a faster symptom response. Both regimens were significantly better than treatment of infants with an extensively hydrolyzed formula.