Efficacy of PPIs for Infants

Lansoprazole was no more effective than placebo for treating GER symptoms.

During the past decade, use of proton-pump inhibitors (PPIs) has grown dramatically in infants with gastroesophageal reflux (GER), despite little evidence that PPIs are effective. In an industry-supported, international, double-blind trial, 162 infants (age range, 28 days to 12 months) with symptoms consistent with GER were randomized to receive 4 weeks of once-daily lansoprazole or placebo. In all infants, symptoms had persisted despite at least 7 days of nonpharmacologic treatment. Parents tracked GER symptoms with daily diaries.

At 4 weeks, no difference was found between groups in the primary outcome, which was the percentage of patients with ≥50% reduction from baseline in feeding-related crying (54% in both groups). Likewise, secondary…

Reviewing Author

Howard Bauchner, MD

Disclosures

Grant / research supportHuman Resources and Services Administration; NIH; NIH-NHLBI; USDA; GlaxoSmithKline

Editorial boardsArchives of Disease in Childhood (Editor-in-Chief)

Howard Bauchner, MD

Disclosures

Grant / research supportHuman Resources and Services Administration; NIH; NIH-NHLBI; USDA; GlaxoSmithKline

Editorial boardsArchives of Disease in Childhood (Editor-in-Chief)