A Prospective, Randomized, Open-Label Study to Evaluate Two Management Strategies for Gastrointestinal Symptoms in Patients Newly on Treatment with Dabigatran
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
INTRODUCTION: In the pivotal RE-LY trial, dabigatran etexilate (DE) at the dose of 150-mg twice daily (BID), significantly reduced total stroke and ischemic stroke compared with warfarin in patients with non-valvular atrial fibrillation (NVAF), while the 110-mg BID dose had efficacy equivalent to warfarin, and major bleeds were significantly reduced. Both DE regimens were generally well tolerated; however, approximately 4% of the patients discontinued treatment with DE due to gastrointestinal (GI) discomfort. METHODS: Clinical trial NCT01493557 was a multicenter, randomized, active control, open-label study to assess the efficacy of two simple GI symptom (GIS) management strategies in DE-treated patients who developed GIS: (1) concurrent treatment with the proton pump inhibitor pantoprazole (DE-P), or (2) ingestion of DE after a meal (DE-M). Patients were initially randomized to either GIS management strategy. If the first did not resolve their GIS, patients had the option to "add on" the alternative strategy. RESULTS: A total of 1067 patients with NVAF received DE therapy BID for 3 months (United States, 150-mg or 75-mg; Canada, 150-mg or 110-mg). Of these, 117 (11%) patients reported GIS and were randomized to one of two GIS management strategies. At 4 weeks, a significantly higher rate of complete or partial effectiveness was observed in patients on DE-P than in those receiving DE-M, [50/58 (86.2%) versus 40/59 (67.8%), respectively; p = 0.0273]. Patients with ongoing GIS were asked to "add on" the alternate strategy for an additional 4 weeks. Overall, 92/117 (78.6%) of randomized patients experienced complete or partial effectiveness using either the initial strategy or a combination of the two strategies: DE-P, 47 (81.0%); and DE-M, 45 (76.3%, no significant difference) (by initial strategy). CONCLUSION: The majority of patients enrolled either did not experience GIS at all, or their GIS resolved using either one individually, or a combination of the two strategies described. TRIAL REGISTRATION: http://www.ClinicalTrials.gov identifier: NCT01493557.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it