Acoramidis lowers mortality, CV hospitalization in ATTR-CM

Treatment with acoramidis results in a decrease in the composite of all-cause mortality or first cardiovascular-related hospitalization (CVH) in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), reports a study.

A total of 632 participants were randomized, of whom 611 (97 percent) were included in efficacy analyses (acoramidis: n=409; placebo: n=202).

Acoramidis, compared with placebo, brought about a reduction in the incidence of the composite of all-cause mortality or first CVH (35.9 percent vs 50.5 percent; hazard ratio [HR], 0.64, 95 percent confidence interval [CI], 0.50‒0.83; p=0.0008) and of first CVH (26.7 percent vs 42.6 percent; HR, 0.60, 95 percent CI, 0.45‒0.80; p=0.0005).

Compared with placebo, acoramidis also reduced the annualized frequency of CVH (0.22 vs 0.45; relative risk ratio, 50 percent, 95 percent CI, 0.36‒0.70; p<0.0001).

“The efficacy of acoramidis on the composite of ACM or first CVH was consistent across subgroups,” the authors said. “Acoramidis was well tolerated, with no safety signals of potential clinical concern identified.”

This study on patients with ATTR-CM carried out efficacy analyses in the modified intention-to-treat population. The authors used Kaplan-Meier curves to plot CVH and the composite of all-cause mortality and first CVH, which were summarized via stratified Cox proportional hazards model.

In addition, a negative binomial regression model was used to assess the annualized CVH frequency. Subgroup analyses were also performed for the composite endpoints.

“Acoramidis is a selective, oral transthyretin stabilizer recently approved by the US Food and Drug Administration for the treatment of ATTR-CM,” according to the authors.