Key Secondary Endpoints: 6-Minute Walk Test and KCCQ-OS1

Study Endpoints   >   Secondary   >   6MWT & KCCQ-OS
6MWT Change From Baseline at Month 30
L S mean (SE) change from baseline
Month
Pooled
tafamidis
n=264
Placebo
n=177
-180
-150
-120
-90
-60
-30
0
0
6
12
18
24
30

p<0.0001

76 meter
difference

The 6MWT evaluates patients’ functional capacity by measuring their distance walked in 6 minutes.
Tafamidis 264 233 216 193 163 155
Placebo 177 147 136 111 85 70
KCCQ-OS Score Change From Baseline at Month 30
L S mean (SE) change from baseline
Month
Pooled
tafamidis
n=264
Placebo
n=177
-30
-20
-10
0
0
6
12
18
24
30

p<0.0001

14 point
difference

The KCCQ-OS score assesses patient health status using the following domains: total symptoms (symptom frequency, symptom burden), physical limitation, quality of life, and social limitation.
Tafamidis 264 241 221 201 181 170
Placebo 177 159 145 123 96 84

A significant treatment effect favoring tafamidis was first observed at Month 6 and remained consistent through Month 30 on both 6MWT distance and KCCQ-OS score.

6MWT: 6-minute walk test; KCCQ-OS: Kansas City Cardiomyopathy Questionnaire-Overall Summary; LS: Least Squares; SE: standard error.