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Responder analysis


Responder analysis in PAH and CTEPH


Clinical response criteria applied to data for patients with inoperable, persistent or recurrent CTEPH, and with PAH, provide further insight into the efficacy of riociguat


David Langleben MD Center for Pulmonary Vascular Disease, DIvision of Cardiology and Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Quebec Canada


Threshold values that correlate with survival among patients with pulmonary arterial hypertension (PAH) have been defined for a number of parameters. Those parameters have been identified as indicators of a clinical treatment response among people with PAH. The values include six-minute walking distance (6MWD) ≥380m, World Health Organization functional class (WHO FC) I/II, cardiac index ≥2.5l/min/m2


, mixed venous oxygen saturation (SvO2 ) ≥65%, and N-terminal


pro-brain natriuretic peptide (NT- proBNP) <1800pg/ml. Treatment goals for patients with PAH now incorporate these responder thresholds. By contrast, pulmonary vascular resistance (PVR) >500dyn•sec•cm–5


strongly correlates


with increased risk of mortality among patients with chronic thromboembolic pulmonary hypertension (CTEPH).1


CTEPH and CHEST-1 analysis D’Armini et al undertook an exploratory analysis of patients in the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase-Stimulator (CHEST-1) study to determine the proportion of patients who achieved responder thresholds that correlate with improved outcome in patients with PAH, determined at baseline and after 16 weeks of treatment with riociguat compared with those who took placebo.1,2


Response thresholds of parameters predictive of long-term response, mostly


“For all clinical and haemodynamic parameters with riocuguat treatment in CHEST-1, a consistent improvement was shown compared with placebo”


in PAH, were applied (four as part of the pre-planned analysis, and three post hoc) to the CHEST-1 population. The authors noted that for all the clinical and haemodynamic parameters with riociguat treatment, a consistent improvement was shown compared with placebo.


At baseline, 37% of patients in the riociguat-treated group (n=173) had 6MWD ≥380m compared with 43% in the group that received placebo (n=88). After 16 weeks, the proportion of patients receiving riociguat who achieved that threshold increased by 21%


compared with 1% in the placebo-treated group, and 53% of patients in the riociguat group achieved ≥40m increase in 6MWD compared with 24% of the placebo group. At baseline, 34% of the riociguat group and 29% of the placebo group were classified WHO FC I/II, a proportion that rose by 23% to 57% in the riociguat-treated group and by 9% to 38% in those receiving placebo at week 16.


An NT-proBNP level of <1800pg/ml were recorded in 73% of riociguat- treated patients and 71% of placebo-


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