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Table 2 Comparison of data between baseline and 6 months after or at the cessation of the treatment

From: Tranilast for advanced heart failure in patients with muscular dystrophy: a single-arm, open-label, multicenter study

 

Baseline

After treatment

Change (95% CI)

p

(GM ± GSD)

(GM ± GSD)

Percentage change

BNP (pg/mL)

    

FAS

192.9 ± 1.72

188.8 ± 1.92

− 2.1% (− 21.5 to 22.0)

0.071

PPS

191.7 ± 1.71

191.3 ± 1.88

− 0.2% (− 15.7 to 18.1)

0.036

hANP (pg/mL)

189.7 ± 1.74,

199.1 ± 2.19

5.0% (− 13.6 to 27.6)

0.605

cTnT (mg/dL)

0.026 ± 1.76

0.030 ± 1.88

14.6% (1.1 to 29.9)

0.035

CK (IU/dL)

269 ± 2.12

278 ± 2.41

3.5% (− 23.0 to 39.2)

0.808

 

(mean ± SD)

(mean ± SD)

Change

 

FS (%)

9.02 ± 3.83%

9.24 ± 4.06%

0.22 (− 0.2 to 0.8)

0.401

Pinch (kg)

1.00 ± 1.74

0.78 ± 1.28

− 0.29 (− 0.83 to 0.25)

0.269

MDQoL-60

    

Mental stability

52.6 ± 16.1

55.8 ± 22.6

2.5 (− 5.7 to 10.7)

0.523

ADL

49.5 ± 29.8

53.6 ± 30.3

− 0.8 (− 11.0 to 9.3)

0.862

Environment

71.6 ± 17.1

71.5 ± 14.1

− 0.9 (− 7.3 to 5.4)

0.763

Hope

61.8 ± 22.7

55.5 ± 18.9

− 6.2 (− 19.7 to 7.3)

0.343

Activity

42.4 ± 30.4

51.3 ± 28.1

7.0 (− 11.9 to 25.9)

0.441

Sense of well-being

63.2 ± 31.6

58.9 ± 25.3

− 8.3 (− 26.6 to 9.9)

0.344

Human relation

63.2 ± 21.4

58.3 ± 23.4

− 5.7 (− 16.9 to 5.5)

0.297

Family

72.6 ± 21.1

73.0 ± 20.6

1.0 (− 6.4 to 8.4)

0.777

Sex

64.2 ± 28.4

72.2 ± 20.3

9.4 (− 0.1 to 19.0)

0.052

Respiration and bulbar function

58.5 ± 18.8

61.7 ± 31.0

0.0 (− 13.7 to 13.7)

1.000

Defecation

64.7 ± 24.7

65.0 ± 35.4

0.8 (− 16.2 to 17.9)

0.918

SF-12

    

Physical function

9.0 ± 14.1

5.6 ± 5.6

− 4.7 (− 14.5 to 5.0)

0.315

Role physical

26.1 ± 18.9

29.8 ± 18.8

0.9 (− 11.0 to 12.7)

0.880

Bodily pain

49.4 ± 11.7

48.4 ± 12.1

− 3.7 (− 10.2 to 2.7)

0.238

General health

51.6 ± 5.3

54.7 ± 7.7

3.1 (− 2.2 to 8.4)

0.234

Vitality

42.2 ± 11.1

45.1 ± 8.7

2.4 (− 3.7 to 8.6)

0.413

Social function

46.5 ± 12.1

43.6 ± 16.1

− 5.3 (− 13.9 to 3.3)

0.204

Role emotional

49.5 ± 9.3

38.9 ± 14.8

− 9.7 (− 17.5 to − 1.9)

0.018

Mental health

51.4 ± 6.9

47.8 ± 11.5

− 3.6 (− 9.6 to 2.4)

0.219

  1. GM, geometric mean; GS, geometric standard deviation; CI, confidence interval, BNP, brain natriuretic peptide; FAS, full analysis set; PPS, per protocol set; hANP, human atrial; cTnT, cardiac troponin T; CK, creatinine kinase; FS, fractional shortening; MDQoL-60, Muscular Dystrophy Quality of life-60; ADL, activities of daily living
  2. *Percentage change = (geometric mean ratio − 1) × 100