PHILADELPHIA — Tafamidis was associated with improvements in a variety of metrics of quality of life in patients with transthyretin amyloid cardiomyopathy, according to a new analysis from the ATTR-ACT trial.
As Healio previously reported, in the main results of the ATTR-ACT trial, tafamidis (Vyndamax, FoldRx/Pfizer) was associated with reduced risk for all-cause mortality and CV hospitalization at 30 months compared with placebo. Tafamidis and tafamidis meglumine (Vyndaqel, FoldRx/Pfizer) were approved by the FDA in May.
“That was an excellent result,” Mazen Hanna, MD, staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine in the Sydell and Arnold Miller Family Heart & Vascular Institute and co-director of the Amyloidosis Program at Cleveland Clinic, said during a presentation at the Heart Failure Society of America Scientific Meeting. “A key secondary endpoint was that the decline in health care-related quality of life was less in the tafamidis arm than in the placebo arm, so this analysis looked a little more deeply at the Kansas City Cardiomyopathy Questionnaire overall summary score’s different domains.”
The trial’s 441 patients (median age, 75 years) were randomly assigned in a 2:1:2 ratio to receive 80 mg tafamidis, 20 mg tafamidis or placebo once daily for 30 months. The two tafamidis groups were pooled together for the analysis.
Hanna said that patients assigned tafamidis had reduced decline in the KCCQ overall summary score and each of its four components compared with patients assigned placebo (P < .001 for all).
For the quality of life score, mean change was –1.53 in the tafamidis group compared with –15.94 in the placebo group (least squares mean difference, 14.4; 95% CI, 9.07-19.74); for the total symptoms score, mean change was –6.26 in the tafamidis group compared with –18.75 in the placebo group (least squares mean difference, 12.48; 95% CI, 8.13-16.84); for the social limitations score, mean change was –8.79 in the tafamidis group compared with –24.66 in the placebo group (least squares mean difference, 15.87; 95% CI, 10.34-21.4); and for the physical limitations score, , mean change was –9.98 in the tafamidis group compared with –22.62 in the placebo group (least squares mean difference, 12.64; 95% CI, 8.54-16.75), Hanna said.
“Treatment with tafamidis reduced the decline in the four KCCQ domains, and this reduction ranged between 12 and 16 points, which is very clinically meaningful,” Hanna said during the presentation. – by Erik Swain
Hanna M, et al. Abstract 016. Presented at: Heart Failure Society of America Scientific Meeting; Sept. 13-16, 2019; Philadelphia.
Disclosure: Hanna reports no relevant financial disclosures.