Abstract 12896: Safety of Transition From Tafamidis Meglumine 20 Mg to Tafamidis Free Acid 61 Mg in Patients With Transthyretin Amyloid Cardiomyopathy
Bibliographic record
Abstract
Introduction: Tafamidis meglumine, available as 20 mg capsules, is approved in >40 countries for use in early stage, symptomatic transthyretin amyloidosis with polyneuropathy. It is also approved in a growing number of countries as an 80 mg daily dose (4 x 20 mg capsules) and as tafamidis free acid 61 mg (a single dose bioequivalent to tafamidis meglumine 80 mg) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). As some patients receiving tafamidis meglumine 20 mg may benefit from transition to tafamidis free acid 61 mg, we assessed the hypothesis that this transition is not associated with any new safety concerns. Methods: In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) patients with ATTR-CM were treated with tafamidis meglumine 20 mg, 80 mg, or placebo for up to 30 months. Patients completing the trial could enroll in a long-term extension study (LTE) with placebo-treated patients randomized to tafamidis meglumine 20 mg or 80 mg. All patients in the LTE were later transitioned to tafamidis free acid 61 mg. Adverse events (AEs) emerging during the LTE were assessed in patients treated with tafamidis meglumine 20 mg in the LTE who transitioned to tafamidis free acid 61 mg (median exposure 19.8 months). AEs were compared with those emerging during ATTR-ACT in patients treated with tafamidis meglumine 20 mg (median exposure 29.7 months). Results: The 87 patients treated with tafamidis meglumine 20 mg in the LTE who transitioned to tafamidis free acid 61 mg had a similar incidence of the most common AEs by system organ class, and of specific AEs, as those treated with tafamidis meglumine 20 mg in ATTR-ACT (see Table ). The safety profile of tafamidis meglumine 20 mg was previously shown to be similar to placebo. Conclusions: While the duration of exposure to tafamidis free acid 61 mg was shorter than for tafamidis meglumine 20 mg, these data demonstrate that the transition to tafamidis free acid 61 mg is not associated with any new safety concerns.
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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) | 0.001 | 0.001 |
| 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 | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".