Acoramidis provides clinical and functional benefits in transthyretin amyloid cardiomyopathy, significantly reducing all-cause and cardiovascular mortality.
Acoramidis demonstrated clinical and functional benefits over placebo in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in the ATTRibute-CM trial. The agent was well tolerated and survival rates in patients on acoramidis approached age-matched survival rates of those without ATTR-CM.
The ATTRIbute-CM study randomly assigned 631 participants with ATRR-CM 2:1 to 800 mg twice-daily acoramidis or placebo. Tafamidis use was allowed after 12 months, and the primary endpoint was a hierarchical analysis of all-cause mortality, cumulative frequency of cardiovascular hospitalizations, change from baseline NT-proBNP, and change from baseline in 6-minute walk distance (6MWD). Julian Gillmore, MD, presented the findings at ESC Congress 2023.
At 30 months, the win ratio was 1.77 (95% CI, 1.42–2.22; P<0.0001) in favor of the acoramidis group, meeting the primary endpoint. In addition, participants on acoramidis saw a relative risk reduction (RRR) in all-cause mortality of 25%. For cardiovascular mortality, the RRR was even higher, at 30%. Furthermore, the relative risk for cardiovascular hospitalization in the acoramidis arm was 0.50 compared with the placebo arm (95% CI, 0.36-0.70; P<0.0001). There were significant differences in the other individual components of the primary endpoint as well, namely change in NT-proBNP (ratio of adjusted geometric mean fold-change, 0.529; 95% CI, 0.463–0.604; P<0.0001) and change in 6MWD (least squares mean difference of 39.64 minutes at in favor of acoramidis; 95% CI, 21.07–58.22; P<0.0001).
The rates of treatment-emergent adverse events (TEAE) were comparable for the acoramidis group (98.1%) and the placebo group (97.6%). Finally, serious TEAEs were more frequent in the placebo arm (54.6% vs 64.9%).
Dr. Gillmore concluded that the ATTRibute-CM trial showed that acoramidis was safe and efficacious in patients with ATTR-CM, delivering survival and functional benefits for this population.
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