Pantoprazole Relieves Gastro-Oesophageal Reflux Symptoms in Infants: Presented at ACG

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Title: Pantoprazole Relieves Gastro-Oesophageal Reflux Symptoms in Infants: Presented at ACG
URL: http://www.pslgroup.com/dg/22E892.htm
Doctor's Guide
October 10, 2008

By Deborah Brauser

ORLANDO, Fla -- October 10, 2008 -- Four weeks of the proton-pump inhibitor (PPI) pantoprazole significantly improved symptoms of gastro-oesophageal reflux disease (GERD) in infants 1 through 11 months old, according to results presented here at the American College of Gastroenterology (ACG) 73rd Annual Scientific Meeting.

Gail Comer, MD, Wyeth Research, Collegeville, Pennsylvania, reported the findings of this multicentre treatment-withdrawal study in a poster session here on October 6. According to her poster, GERD is common in infants and may predispose them to poor weight gain and respiratory disorders.

"I think [this study] is important because there's really a paucity of data in infants under 1 year. And there's no PPI currently approved for [them]," said Dr. Comer. "I think this is important data for the medical community."

In this trial, all infants with GERD symptoms received 2 weeks of standardised conservative treatment. Then, 128 infants who remained symptomatic entered into a 4-week, open-label phase with a daily dose of pantoprazole 1.2 mg/kg. Infants with 80% compliance or better at the end of this open-label phase were entered in the double-blind treatment-withdrawal phase. During this part of the study, these patients were randomised to receive a daily dose of pantoprazole 1.2 mg/kg again or placebo for an additional 4 weeks.

Site visits were conducted every 2 weeks up to week 8, and telephone interviews with parents were conducted on the alternating weeks. In addition, parents completed daily electronic diaries assessing 5 key GERD symptoms. Mean weekly GERD symptom scores (WGSS) based on the daily diary assessments were compared with baseline scores using a 2-sided paired t-test. Investigators used an analysis of variance model to perform group comparisons.

The study's primary endpoint was withdrawal rate due to lack of efficacy in the double-blind phase. Of the 128 patients who entered the open-label treatment phase, 106 made up the modified intent-to-treat population for the withdrawal phase. This group was a mean of 5.1 months old.

At the end of the trial, results showed no significant difference between the active-treatment and placebo groups in rates of withdrawal due to efficacy (as measured by WGSS at baseline and at week 4).

However, significant reductions in weekly GERD symptom scores were observed each week in all patients during the open-label treatment phase (P < .001 for both groups), with greater changes in patients older than 6 months (P < .005) and in those with a higher baseline WGSS score (P < .0001).

The greatest difference between groups in WGSS change occurred at week 5, with slightly worse scores for placebo (P = .09). Investigators note that this was mainly due to a greater decrease in episodes of arching back with pantoprazole than placebo (P = .028). No other significant differences in WGSS were noted in any other week.

No differences were noted between groups in frequency of adverse events.

Dr. Comer said, "We really didn't expect to see a durable response after 4 weeks of treatment. We really expected rebound acid secretion, based upon the literature. And we really didn't see that. We saw up to almost 70% healing at 4 weeks along with, we think, a durable response. So, these babies only needed about 4 weeks of treatment."

"I think the number 1 take-away is that prolonged treatment is probably not necessary in infants under 1 year," she added.

Funding for this trial was provided by Wyeth Pharmaceuticals Inc.

[Presentation title: Efficacy and Tolerability of Pantoprazole Delayed-Release Granules for Oral Suspension in a Placebo-Controlled Treatment-Withdrawal Study in Infants 1 Through 11 Months of Age With Symptomatic GERD. Abstract P-734]

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