EN | RU
EN | RU

Help Support

Back

Rectal omeprazole is effective to treat infants with pathological GERD

Rectal omeprazole is effective to treat infants with pathological GERD Rectal omeprazole is effective to treat infants with pathological GERD
Rectal omeprazole is effective to treat infants with pathological GERD Rectal omeprazole is effective to treat infants with pathological GERD

What's new?

A single rectal omeprazole dose (1 mg/kg) is effective to treat infants with esophageal atresia (EA) or congenital diaphragmatic hernia (CDH)-related gastroesophageal Reflux Disease (GERD).

A recent study depicted that in infants with GERD due to congenital malformations such as EA or CDH, single rectal omeprazole (proton pump inhibitor) dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH similar to an oral dose. A rapid exposure in the therapeutic range is attained with a 1 mg/kg rectally-administered omeprazole dose.

For infants with pathological GERD, rectally administered omeprazole presents as an innovative, potent alternative, considering the challenges with existing oral formulations. In the Netherlands, an open-label randomized pilot study was carried out to investigate the efficacy and pharmacokinetics of rectal omeprazole in infants (6–12 weeks postnatal and bodyweight >3 kg) with EA or CDH-related GERD and compare these with oral omeprazole.

The study recruited 17 infants (13 with CDH and 4 with EA). Infants were randomly assigned to  receive a 1 mg/kg omeprazole dose rectally or orally. Based on the predefined criteria for 24-h intraesophageal pH, the percentage of infants for whom omeprazole was effective was the primary endpoint ascertained. The pharmacokinetic parameters, and the percentages of time that gastric pH was <3 or <4 were the secondary endpoints ascertained.

Rectally-administered omeprazole was found to be effective in higher infants compared to orally-administered omeprazole, as depicted in the following table:


After both rectal and oral omeprazole administration, the total reflux time in minutes and percentages and the number of reflux episodes of pH<4 remarkably declined, as shown in the following table:


Both oral and rectal omeprazole administration resulted in similar serum exposure. During the study, no study-specific adverse events were witnessed.  Thus, in infants with GERD due to congenital malformations such as EA or CDH, rectally-administered omeprazole appears to yield satisfactory results.

 

Source:

European Journal of Drug Metabolism and Pharmacokinetics

Article:

Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial

Authors:

Petra Bestebreurtje et al.

Comments (0)

You want to delete this comment? Please mention comment Invalid Text Content Text Content cannot me more than 1000 Something Went Wrong Cancel Confirm Confirm Delete Hide Replies View Replies View Replies en ru
Try: