Cardiopulmonary Risk Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate Triple Therapy: A Number Needed to Treat Post Hoc Analysis of the ETHOS Trial
Bibliographic record
Abstract
Abstract Rationale: The number needed to treat (NNT) describes the absolute effect of an intervention over a period of time and can aid clinical decision making. The relative benefits of a triple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) therapy budesonide/glycopyrrolate/formoterol fumarate (BGF) over the dual LAMA/LABA therapy of glycopyrrolate/formoterol fumarate (GFF) for a range of cardiopulmonary endpoints have been reported. In the current analyses, we estimate the NNTs for these endpoints. Methods: In the ETHOS randomized controlled trial, patients with moderate-to-very severe COPD and a history of exacerbations were randomly allocated to one of four treatment arms including twice-daily BGF 320/18/9.6μg, and GFF 18/9.6µg administered via a metered dose inhaler. The annualized NNT for the comparison of BGF with GFF for time to first cardiac AE (which included any adverse event (AE) within the cardiac disorders System Organ Class [SOC]), time to major adverse cardiac event (MACE), and time to a composite endpoint of severe cardiopulmonary events (MACE, severe COPD exacerbation leading to hospitalization, or death due to a respiratory cause) were calculated using a Kaplan-Meier approach. Endpoints were not adjusted for multiplicity and the analyses are considered exploratory in nature. Results: Over 8500 patients received treatment and were included in the analyses. Approximately 70% of patients in each treatment group had at least one cardiovascular risk factor at baseline. BGF had beneficial effects on time to first events for all endpoints considered in the analyses. The annualized NNTs for BGF versus GFF were NNT = 27 [95% CIs: 21-45] for cardiac AE, NNT = 118 [95% CIs: 70-NC] for MACE, and NNT = 37 [95% CIs: 22-148] for severe cardiopulmonary events, respectively. Conclusion: In the ETHOS trial of patients with moderate/very severe COPD, estimated annualized NNTs for a range of cardiopulmonary events comparing BGF with LAMA/LABA treatment suggest that triple therapy with BGF improves outcomes beyond the respiratory system alone.
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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 | 0.021 | 0.019 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.006 | 0.008 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 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".