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
OMEPRAZOLE IMMEDIATE-RELEASE ORAL SUSPENSION IS MORE EFFECTIVE THAN PANTOPRAZOLE DELAYED-RELEASE CAPSULES IN REDUCING NIGHTTIME GASTRIC ACIDITY IN GERD PATIENTS
Donald Castell, M.D., et al.Am J Gastro 2004:99 Suppl; A117.
Note: Omeprazole immediate-release is Zegerid®
Evidence-based info : Prospective, cross-over trial
Type of Study : Marketing study Santarus
Sample size : n = 32
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)
Protonix® is the only PPI approved for reduction in the rate nighttime heartburn symptoms.
This is a prospective cross-over study where each patient serves as their own control.
P = Protonix® |
Z = Zegerid® |
Day 1 |
Days 2 thru 6 |
Day 7 |
P 40mg @ bedtime |
P 40mg before supper |
P 40mg 1hr before breakfast and @ hs |
Z 40mg @ bedtime |
Z 40mg @ bedtime |
Z 40mg 1hr before breakfast and @ hs |
Nocturnal Acid breakthrough [NAB] was defined as > 1 hr of continuous pH < 4 from 2200 to 0600hrs ( a standard definition ).
Primary finding :
DAY 6 NIGHTTIME MEDIAN GASTRIC pH (i.e. QD PPI 40mg)
| (% time pH > 4) | Protonix® 27% | vs. | Zegerid® 55% | p<0.001 |
| (median pH) | Protonix® 2.0 | vs. | Zegerid® 4.7 | p<0.001 |
| (NAB) | Protonix® 78% | vs. | Zegerid® 53% | p<0.005 |
DAY 7 NIGHTTIME MEDIAN GASTRIC pH (i.e. BID PPI)
| (% time pH > 4) | P 40mg 31% | vs. | Z 20mg 79% | p<0.001 |
| P 40mg 37% | vs. | Z 40mg 92% | p<0.001 | |
| (median pH) | P 40mg 1.9 | vs. | Z 20mg 5.8 | p<0.001 |
| P 40mg 1.5 | vs. | Z 40mg 6.5 | p<0.001 | |
| (NAB) | P 40mg 80% | vs. | Z 20mg 47% | p<0.025 |
| P 40mg 71% | vs. | Z 40mg 12% | p<0.025 |
Score of Study (TOES): = 85 out of 100
Is it consistent with what we already know? – Yes
SEE PREVIOUS STUDY ABSTRACT 116
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, previous 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®).
Additional Information:
See related graphs