OMEPRAZOLE IMMEDIATE-RELEASE ORAL SUSPENSION IS MORE EFFECTIVE THAN PANTOPRAZOLE DELAYED-RELEASE CAPSULES IN REDUCING NIGHTTIME GASTRIC ACIDITY IN GERD PATIENTS
Bibliographic record
Abstract
Purpose: The present trial was conducted to evaluate nighttime dosing of omeprazole imediate-release oral suspension (OME-IR[SUSP]) in once- and twice-daily regimens, comparing the effect of OME-IR on nocturnal gastric acidity to that of pantoprazole (P), the only PPI with FDA-approved labeling for reduction in rate of nighttime heartburn symptoms. Methods: Thirty-two patients with nocturnal GERD symptoms were enrolled in a crossover trial with 40-mg doses of P (Protonix®, Wyeth-Ayerst, Philadelphia) given at 2200 hrs (bedtime) on Day 1 and prior to dinner on Days 2–6 and 40-mg OME-IR(SUSP) (Santarus, San Diego) given at 2200 hrs on Days 1-6. On Day 7, both PPIs were given 1 hr prior to breakfast and at 2200 hrs: P 40 mg (n = 32); OME-IR 40 mg (n = 17) and 20 mg (n = 15). Continuous 24-hr gastric pH monitoring (Medtronic) was performed on Days 1, 6, and 7. Median gastric pH,% time pH was >4, and the proportion of patients with “nocturnal acid breakthrough” (NAB) (> 1 hr of continuous pH <4) were determined for the nighttime period (2200-0600 hrs). Results: Nighttime median gastric pH on Day 6 is shown below. For this 8-hr period, median % time pH was >4 was greater for OME-IR (5 5%) than for P (27%) (p <0.001); median pH was 4.7 for OME-IR and 2.0 for P (p <0.001); and NAB occurred in fewer OME-IR-treated patients (17/32) than P-treated patients. (25/32) (p = 0.005). For the 8-hr nighttime period after twice-daily dosing, median % time pH was >4 was greater for OME-IR (40 mg and 20 mg) than for P (92% vs. 37% and 79% vs. 31%, p <0.001 each); median pH was also higher (6.5 vs. 1.5 and 5.8 vs. 1.9, p <0.001 each). NAB occurred in fewer OME-IR-treated patients than P-treated patients (2/17 vs. 12/17 and 7/15 vs. 12/15, p<0.025 each). Conclusions: OME-IR(SUSP) is more effective in reducing nighttime gastric acidity than P. These results suggest that OME-IR may also be more effective than delayed-release PPIs in controlling nighttime symptoms of GERD when dosed at bedtime.[figure 1]Figure
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".