Secondary EndpointsIn FREEDOM-EV, Orenitram demonstrated durable improvements across multiple prognostic risk factors1,2
Patients demonstrated statistically significant improvements in 6MWD at weeks 36 and 481*
- Change in 6MWD was not statistically significant at week 241
- Baseline median 6MWD was 405 m.1
- Least squares mean, P-values, and estimated difference were from the MMRM with the change in 6MWD from baseline as dependent variable, treatment, week, treatment-by-week interaction as the fixed effects, and baseline 6MWD as covariate. MMRM is a statistical analysis that does not require imputation of missing data and considers the entirety of the data.
- Placebo-adjusted change.
Orenitram reduced NT-proBNP, an important indicator of right ventricle dysfunction1,3
- Statistically significant reductions in NT-proBNP were seen as early as week 12 (P=0.0002)1
- P-value was obtained from the analysis of covariance with change from baseline in log-transformed data in NT-proBNP as the dependent variable, treatment as fixed effect, and log-transformed baseline NT-proBNP as a covariate.
Orenitram is the only oral prostacyclin-class therapy that has demonstrated improvements in WHO FC1,4
Statistically significant improvements in functional class were seen as early as week 12 with Orenitram (P=0.0009) and were maintained through week 48 (P=0.0028)1*
- Functional class was not measured at week 60. P-values were obtained from Fisher’s exact test.1