Neonatal Reflux Disease Not Improved With Esomeprazole

Troy Brown

July 01, 2013

Neonates given esomeprazole once daily had no significant changes in the number of gastroesophageal reflux disease (GERD)-related signs and symptoms or the total number of reflux episodes compared with neonates who were given placebo. They did have a significant reduction in the number of acidic reflux episodes, with an increase in weakly acidic reflux episodes, according to a randomized, double-blind, placebo-controlled, multicenter study.

Geoffrey Davidson, MBBS, MD, from the Women's and Children's Hospital, Children, Youth and Women's Health Service in North Adelaide and the School of Pediatrics and Reproductive Health at the University of Adelaide in Australia, and colleagues report their findings in an article published online June 24 in the Journal of Pediatrics.

A total of 52 patients aged from premature to 1 month corrected age were enrolled in the study: 26 received esomeprazole 0.5 mg/kg and 26 received placebo once daily for up to 14 days. The researchers assessed change in the total number of GERD symptoms and GERD-related signs with simultaneous esophageal pH, impedance, cardiorespiratory, and 8-hour video monitoring. The study was stopped early because of poor enrollment.

No significant difference was found between the treatment groups in the percentage of change from baseline after 14 days in the total number of GERD-related signs and symptoms seen on video and cardiorespiratory monitoring (−14.7% vs −14.1%, respectively; 95% confidence interval, −14.2% to 14.9%; P = .92).

From baseline, the mean change in total number of acidic reflux episodes, measured by 24-hour esophageal pH monitoring, fell in the esomeprazole group and increased in the placebo group, but the difference between the 2 groups was not significant (−19.5 vs 6.4; P = .0737).

The mean change from baseline in the number of acidic reflux events longer than 5 minutes in duration, however, did decrease significantly in the esomeprazole group compared with the placebo group (−5.5 vs 1.0; P = .0009).

The mean change from baseline in the percentage of time that pH was lower than 4.0 also fell significantly in the esomeprazole group compared with the placebo group (−10.7 vs 2.2; P = .0017). Similarly, the mean percentage of time that pH was between 4.0 and 6.9 in the esomeprazole group rose significantly from baseline compared with placebo (9.8 vs −2.6; P = .0022).

Significantly fewer (P < .0001) GERD-related signs and symptoms were temporally associated with acidic reflux (pH < 4.0) in the esomeprazole receivers compared with the placebo receivers, with similar results at all 3 times (baseline, final study day, 14 days after final study dose).

From baseline, a significant reduction was seen for all neurobehavioral events (P < .0001), back arching (P = .005), and irritability/crying/fussing events (P < .0001) temporally associated with acid reflux in the esomeprazole group vs the placebo group. Gagging did not differ between the 2 groups. Again, similar results were observed at all 3 times.

There were few adverse events (AEs), with similar results between the 2 groups: A total of 6 (23.1%) of the patients receiving esomeprazole experienced a total of 10 AEs, and 9 (34.6%) patients receiving placebo experienced a total of 14 AEs. There were no deaths.

Thomas J. Sferra, MD, the Martin and Betty Rosskamm Chair in Pediatric Gastroenterology and chief of pediatric gastroenterology and nutrition at University Hospitals Rainbow Babies & Children's Hospital, and an associate professor in the Department of Pediatrics at Case Western Reserve University School of Medicine in Cleveland, Ohio, commented on the study in a telephone interview with Medscape Medical News. "Clinicians should not reflexively prescribe proton pump inhibitors to treat neonates or young infants who they believe may have symptoms due to gastroesophageal reflux. Further investigation should be done to confirm that they might be an indicated treatment," said Dr. Sferra, who was not involved in the study.

"Many of these symptoms that have...been attributed to reflux are really not due to gastroesophageal reflux events. It may be not the acid coming up into the esophagus...it may be any bolus. Nonacid reflux may be contributing to these symptoms," Dr. Sferra explained.

The study was supported by AstraZeneca LP. Dr. Davidson and his coauthors have financial relationships with AstraZeneca LP and/or Sandhill Scientific in the form of research grants, advisory board appointments, consultancy, employment, and/or stock ownership. Dr. Sferra has disclosed no relevant financial relationships.

J Peds. Published online June 24, 2013. Abstract

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