Heart failure & cardiomyopathies
Effect of Acoramidis on Heart Failure–Related Health Status: A Secondary Analysis of the ATTRibute-CM Randomized Clinical Trial
Primary result · KCCQ-OSResult — go to the resultLSM difference 9.9 95% CI 6.0–13.9Authors' conclusion
In this secondary analysis of the ATTRibute-CM randomized clinical trial, in patients with ATTR-CM, acoramidis significantly attenuated the decline in HF-related health status compared with placebo.
Study context
- Population
- Adults with transthyretin amyloid cardiomyopathy (ATTR-CM)611 in modified ITT
- Participants
- 632 adults
- Comparison
- Acoramidis vs placebo
- Acoramidisn = 409
- Placebon = 202reference
- Primary endpoint
- LSM difference in KCCQ-OS (prespecified secondary outcome of the trial)
- Follow-up
- Over 30 months
Methodological detailsphase 3, multicentre, international, placebo-controlled
- Phase 3
- Multicentre
- International
- Placebo-controlled
Primary result
KCCQ-OS · month 30
Least-squares mean (LSM) difference
9.9
95% CI 6.0–13.9
P < 0.001
Acoramidis vs Placebo
LSM difference 9.9 (95% CI 6.0–13.9); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Acoramidis | Placebo | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Alive and not worse (KCCQ-OS <5-point decrease; post hoc) · month 30 · NNT = 6 · post hoc | 47% | 30% | 2.1 (1.4–3.1) | P < 0.001 | |
| Alive and well (KCCQ-OS >60 and <10-point decrease; post hoc) · month 30 · NNT = 7 · post hoc | 46% | 31% | 1.9 (1.3–2.8) | P < 0.001 | |
| Alive and better (KCCQ-OS >5-point increase; post hoc) · month 30 · NNT = 9 · post hoc | 25% | 14% | 2.1 (1.3–3.4) | P = 0.002 | |
| 0.20.5125Odds ratio (log scale) |
- Alive and not worse (KCCQ-OS <5-point decrease; post hoc): at month 30: acoramidis 367, placebo 188
Original publication
Effect of Acoramidis on Heart Failure–Related Health Status: A Secondary Analysis of the ATTRibute-CM Randomized Clinical Trial. JAMA Cardiol. Published 1 September 2026. doi:10.
Summarised from the published abstract; every number is checked against it