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Histogram of Change from Baseline to Month 30 in KCCQ‑OS Score5
Percent of Patients
-80 to -71
-70 to -61
-60 to -51
-50 to -41
-40 to -31
-30 to -21
-20 to -11
-10 to -1
0 to 9
10 to 19
20 to 29
30 to 39
40 to 49
50 to 59
KCCQ-Overall Summary Score Change From Baseline to Month 30
Placebo (N=84)
Pooled Tafamidis (N=170)
References:
- Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.
- Damy T, Garcia-Pavia P, Hanna M, et al. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart Fail. 2021;23(2):277-285.
- Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. (Supplement).
- Maurer MS, Elliott P, Merlini G, et al. Design and Rationale of the Phase 3 ATTR-ACT Clinical Trial (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial). Circ Heart Fail. 2017;10(6):e003815.
- VYNDAQEL® / VYNDAMAX® Prescribing Information. New York, NY: Pfizer Inc. June 2021.
- Data on file. Pfizer Inc, New York, NY.
- Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. (Supplemental Figure S1).
- Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. (Supplement Table S5).
- Lockwood PA, Le VH, O'Gorman MT, Patterson TA, et al. The Bioequivalence of Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine 4 x 20-mg Capsules in Healthy Volunteers. Clin Pharmacol Drug Dev. 2020;9(7):849-854.
- Elliott P, Drachman BM, Gottlieb SS, et al. Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy. Circ Heart Fail. 2022;15(1):e008193.
6MWT: 6-minute walk test; ATTRv: variant transthyretin amyloidosis; ATTRwt: wild-type ATTR-CM;
KCCQ-OS: Kansas City Cardiomyopathy Questionnaire Overall Summary; LS: least squares; SE: standard error.
Reference:
- Rapezzi C, Elliott P, Damy T, et al. Efficacy of tafamidis in patients with hereditary and wild-type transthyretin amyloid cardiomyopathy: further analysis from ATTR-ACT. JACC Heart Fail. 2021;9(2):115-123.
CV: cardiovascular; F-S: Finkelstein-Schoenfeld; NYHA: New York Heart Association; TTR: Transthyretin.
References:
- Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.
- Maurer MS, Elliott P, Merlini G, et al. Design and rationale of the phase 3 ATTR-ACT Clinical Trial (Tafamidis in Transthyretin Cardiomyopathy
Clinical Trial). Circ Heart Fail. 2017;10(6):e003815.
HF: heart failure; KCCQ: Kansas City Cardiomyopathy Questionnaire; KCCQ-OS: Kansas City Cardiomyopathy Questionnaire Overall Summary;
QoL: quality of life.
Reference:
- Medical device development tool qualification decision summary for Kansas City Cardiomyopathy Questionnaire (KCCQ) FDA. Available at
https://www.fda.gov/media/108301/download Accessed August 2021.