TOES Evaluations of Abstracts Submitted for the 69th Annual Scientific Meeting of the American College of Gastroenterology
American Journal of Gastroenterology, Vol. 99, No. 10, Suppl., 2004, ©2004 by Am. Coll. of Gastroenterology, ISSN 0002-9270/04/xx.xx, Published by Blackwell Publishing
October 29–November 3, 2004, Orlando, Florida
NIGHTTIME DOSING OF OMEPRAZOLE IMMEDIATE-RELEASE ORAL SUSPENSION RAPIDLY DECREASES NOCTURNAL GASTRIC ACIDITY
Barry Goldlust, Ph.D, et al. Santarus, Inc. Am J Gastro 2004:99 Suppl; A116.
Evidence-based info : Prospective open-label trial
Type of Study : Marketing study
Sample size : n = 17
Background : This is a study of a new dosage form of omeprazole. NOT DELAYED RELEASE. It is commonly thought that PPIs must be given as enteric-coated products (or intravenously- thereby bypassing the acidic stomach). Patients received Q am omeprazole immediate release 20mg suspension for 7 days. Then on Day 8 the patients received 20mg in am and at 10pm (bedtime) BID. 24hr pH was assessed for nighttime and for 24 hrs at the end of Day 7 and Day 8.
Nocturnal Acid breakthrough [NAB] was defined as > 1 hr of continuous pH < 4 (a standard definition).
Primary finding :- Q am 20mg omeprazole immediate release suspension
- pH > 4 (% time out of 24 hrs) 39%
- NAB occurred 76% of patients
- BID 20mg omeprazole immediate release suspension
- pH > 4 (% time out of 24 hrs) 87%
- NAB occurred 29% of patients
Score of Study (TOES): = 30 out of 100
Is it consistent with what we already know? – Yes
PPIs need active pumps to get their maximal effect. Sodium bicarbonate is a known parietal cell stimulator.
How should this affect your practice?
- This is dramatic pH control for nighttime. Hard to believe. However, next abstract confirms this excellent pH control. This could change the way PPIs are used.
- This is a unique new way to take advantage of PPIs. The sodium bicarbonate can produce a local effect on esophageal acidity also.
- According to the FDA approved package label, (see Zegerid®), the absorption is very rapid. The AUC is similar to enteric-coated, delayed release omeprazole (Prilosec®).