Effect of Tadalafil on cardiac function and left ventricular dimensions in Duchenne muscular dystrophy: safety and cardiac MRI substudy results from a randomized, placebo-controlled trial

Table 6 Summary of echocardiographic LVID Z-scores

	Placebo (N = 116)	Tadalafil 0.3 mg/kg (N = 102)	Tadalafil 0.6 mg/kg (N = 113)
LVIDd Z-score
n	107	96	100
Baseline mean (SD)	-0.39 (1.4)	-0.54 (1.5)	-0.19 (1.4)
Endpoint mean (SD)	-0.64 (1.4)	-0.51 (1.5)	0.01 (1.5)
LS mean change (SE)^a	-0.25 (0.1)	-0.03 (0.1)	0.27 (0.1)
LS mean difference vs. placebo^a		0.22	0.52
95% confidence interval^a		(-0.09, 0.53)	(0.21, 0.82)
p-value^a		0.158	0.001
LVIDs Z-score
n	107	95	99
Baseline mean (SD)	-0.18 (1.8)	-0.40 (1.5)	0.03 (1.5)
Endpoint mean (SD)	-0.29 (1.6)	-0.26 (1.6)	0.19 (2.0)
LS mean change (SE)^a	-0.11 (0.14)	0.06 (0.15)	0.25 (0.14)
LS mean difference vs. placebo^a		0.17	0.36
95% confidence interval^a		(-0.23, 0.56)	(-0.04, 0.75)
p-value^a		0.411	0.076

N: number of patients randomized; n: number of patients with data for the variable; LVIDd: left ventricular internal dimension at diastole; LVIDs, left ventricular internal dimension at systole; SD, standard deviation; SE, standard error; LS, least squares
^aLS mean, standard error, 2-sided 95% confidence interval and p-value for the difference of tadalafil minus placebo are from an analysis of covariance (ANCOVA) with change from baseline as dependent variable, baseline value as covariate, and treatment as fixed effects

ISSN: 1471-2261