Management of dyspepsia symptoms on dabigatran during RELY-ABLE: long-term follow up study after RE-LY
Bibliographic record
Abstract
Purpose: Data from the RE-LY trial showed that dabigatran etexilate (DE) was associated with more dyspepsia-like symptoms (DE 110 mg twice daily [bid] 11.8% total rate; 150 mg bid 11.3% total rate; dose independent) compared to well controlled warfarin (5.8% total rate). Almost 50% of the patients originally randomized to DE in the RE-LY trial were enrolled in the long-term follow-up study RELY-ABLE, where they continued to receive the blinded DE dose assigned in the RE-LY trial. Investigators completed specific case report forms (CRFs) during the RELY-ABLE trial to assess dyspepsia symptoms occurring at any time on DE treatment and whether specific measures provided symptom relief. Methods: A questionnaire in the CRFs collected descriptive information on the occurrence of dyspepsia and related events, the duration of episodes, therapies and responses to treatment. A total of 5851 patients were enrolled into the RELY-ABLE study (2914 on DE 110 mg bid and 2937 on 150 mg bid) and data were available from 5081 patients (86.8%). Patients were asked to describe the presence of new or worsening dyspepsia during their participation in the RE-LY and RELY-ABLE trials. If dyspepsia or a related event was reported, additional information regarding symptom alleviation and duration of symptoms was to be collected. Results: During the course of DE treatment 9.6% of patients (DE 110 mg and 150 mg bid) reported a period with dyspeptic symptoms; 2% reported prevalent dyspepsia; 6.8% reported previous and current dyspeptic symptoms. Occurrence of dyspepsia or abdominal discomfort was similar between the two DE dosages. The mean duration of dyspepsia symptoms was 44.7 days with DE 110 mg bid and 57.4 days with DE 150 mg bid. Overall, 1071 patients used 1123 treatments. The only treatments that appeared to reduce symptoms were concomitant food intake, proton pump inhibitors or H2-blocking agents (success rates 88%, 90% and 87%, respectively). Conclusion: Dyspepsia and related symptoms associated with the use of DE can be transient. If symptoms persist, some patients appear to benefit from measures that reduce stomach acidity. In RELY-ABLE, symptom improvement was reported with concomitant food intake, H2-blockers or proton pump inhibitors.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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".