Abstract 4140424: Early Insights on Mavacamten Usage in Canada: A Retrospective Cohort Study of the Patient Support Program
Bibliographic record
Abstract
Introduction: Mavacamten is a first-in-class cardiac myosin inhibitor initially approved in the US for treating obstructive hypertrophic cardiomyopathy (oHCM) under the FDA-mandated Risk Evaluation Mitigation Strategy (REMS). Subsequently, mavacamten was approved in Canada with less restrictions. A patient support program (PSP) was implemented, offering a unique opportunity to generate data on mavacamten utilization in the Canadian population. Aims: The objective of the study was to obtain real-world insights into the demographic and clinical characteristics, including dosing and treatment duration of patients treated with mavacamten for oHCM in Canada. Methods: This was an observational retrospective study of 683 adult patients with symptomatic oHCM enrolled in the Canadian mavacamten PSP between January 4, 2023 to April 12, 2024. Baseline demographic and clinical data were collected for age, gender, NYHA class, vLVOT gradient, LVEF and change in mavacamten dose. Results: The baseline clinical characteristics of the 683 patients are summarized in Table 1. Patients were distributed across several provinces with a median age of 65 years and a similar distribution between the male and female populations. The majority (N=458: 67.1%) were classified as NYHA class II. Nearly all patients were initiated at 5 mg of mavacamten as per the Canadian product monograph. Most (63.7%) of patients were on β-blockers alone (Table 1). The median follow-up time was 27.4 weeks (range 1.6-70.1). Notably, at the time of data cut off, 13.2% of patients were receiving mavacamten alone compared to 10.5% at initiation. The median treatment duration was 24.6 weeks, censored at data cut-off, with a discontinuation rate of 7.9%, primarily due to adverse events (2.5%) and lack of efficacy (0.9%). Conclusions: Mavacamten has been widely adopted across Canada with low discontinuation rates indicating good tolerability. The current risk management strategies in Canada are sufficient and obviate the need for a stricter approach. These early results provide the largest dataset on mavacamten utilization in the Canadian HCM population, adding to the accruing evidence of its safe and effective use in the real world.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.005 |
| Science and technology studies | 0.002 | 0.001 |
| 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 | 0.000 |
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".