Heart failure & cardiomyopathies
Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM
Authors' conclusion
In FOREST-HCM, one-half of the patients with oHCM attempted downtitration and withdrawal of SoC medications while receiving aficamten treatment, with infrequent instances of resumption of SoC. Stopping and dose reduction of SoC medications were well tolerated with no adverse consequences in clinical measures of efficacy
Study context
- Population
- Patients with obstructive hypertrophic cardiomyopathy receiving aficamten and standard-of-care (SoC) therapy, followed ≥24 weeks136 receiving ≥1 SoC therapy
- Participants
- 145 patients
- Comparison
- SoC withdrawal attempt vs no withdrawal attempt during aficamten treatment
- SoC withdrawaln = 64
Methodological detailsprotocol-guided SoC downtitration and withdrawal
- Protocol-guided SoC downtitration and withdrawal
Primary result
As reported in the abstract
- Attempted withdrawal (of those receiving SoC)
- 64 (47%)
- Successful withdrawal (≥50% dose reduction in ≥1 medication)
- 59 (92.2%)
- Completely discontinued ≥1 medication
- 38 (64.4%)
- Achieved aficamten monotherapy
- 27 (45.8%)
- Later restarted a SoC medication (of monotherapy)
- 2
Further findings
Clinical measures after successful SoC withdrawal
- NYHA class improved by ≥1 class from baseline
- 79.2%
- KCCQ-Clinical Summary Score improved to (mean ± SD, points)
- 83.0 ± 15.8
- Resting LV outflow tract gradient improved to (mean ± SD, mm Hg)
- 14.3 ± 10.9
- Valsalva LV outflow tract gradient improved to (mean ± SD, mm Hg)
- 32.9 ± 21.4
- Hs-troponin I improved to median (Q1-Q3: 3.5-10.7 ng/L)
- 6.0 ng/L
- SoC downtitration and withdrawal did not impact these results; changes similar in patients without SoC withdrawal
- all P values for change were >0.05
Safety
Adverse events (AEs) with SoC withdrawal · 1 to 2 weeks after any SoC withdrawal
- No serious AEs attributed to SoC withdrawal
- Treatment-emergent AEs similar between groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM. J Am Coll Cardiol. Published 5 November 2024. doi:10. 1016/ j. jacc. 2024. 09. 002
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