Heart failure & cardiomyopathies
Vutrisiran in Transthyretin Amyloidosis: A Pooled Safety Analysis of HELIOS-A and HELIOS-B
Authors' conclusion
In a broad population of patients with ATTR who were treated for up to 58 months, vutrisiran was well tolerated and had an acceptable safety profile, consistent with that previously reported for the HELIOS-A and HELIOS-B studies.
Study context
- Population
- Patients with hereditary ATTR and wild-type ATTR who received at least one dose of vutrisiran during the HELIOS-A or HELIOS-B studiescombined vutrisiran group · HELIOS-A vutrisiran group 160 · HELIOS-B vutrisiran group 547
- Participants
- 707 patients
- Comparison
- Vutrisiran vs placebo reference groups
- Combined vutrisiran groupn = 707
Further findings
Baseline characteristics and exposure of the combined vutrisiran group
- Mean age at symptom onset
- 68.5 years
- Hereditary ATTR
- 30.3%
- Median (range) treatment duration
- 33.4 months (0.0-57.8)
- Cumulative exposure
- 1,518.9 patient-years
Safety
Adverse event rates (AERs) and serious AERs for specific adverse events
- Comparable to those reported in either of the placebo reference groups and those previously reported during the initial randomized treatment periods
- AERs for cardiac failure lower in the HELIOS-A and HELIOS-B vutrisiran groups than in the corresponding placebo groups
- Injection-site reactions infrequent and mild or moderate in severity
- No ocular, hepatic, or renal safety concerns
- Exposure-adjusted rates per 100 patient-years
Original publication
Vutrisiran in Transthyretin Amyloidosis: A Pooled Safety Analysis of HELIOS-A and HELIOS-B. JACC Adv. Published 22 August 2025. doi:10.
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