Riociguat for the treatment of chronic thromboembolic pulmonary hypertension
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Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. / Ghofrani, Hossein-Ardeschir; D'Armini, Andrea M; Grimminger, Friedrich; Hoeper, Marius M; Jansa, Pavel; Kim, Nick H; Mayer, Eckhard; Simonneau, Gerald; Wilkins, Martin R; Fritsch, Arno; Neuser, Dieter; Weimann, Gerrit; Wang, Chen; CHEST-1 Study Group.
In: NEW ENGL J MED, Vol. 369, No. 4, 25.07.2013, p. 319-29.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Riociguat for the treatment of chronic thromboembolic pulmonary hypertension
AU - Ghofrani, Hossein-Ardeschir
AU - D'Armini, Andrea M
AU - Grimminger, Friedrich
AU - Hoeper, Marius M
AU - Jansa, Pavel
AU - Kim, Nick H
AU - Mayer, Eckhard
AU - Simonneau, Gerald
AU - Wilkins, Martin R
AU - Fritsch, Arno
AU - Neuser, Dieter
AU - Weimann, Gerrit
AU - Wang, Chen
AU - CHEST-1 Study Group
AU - Klose, Hans
PY - 2013/7/25
Y1 - 2013/7/25
N2 - BACKGROUND: Riociguat, a member of a new class of compounds (soluble guanylate cyclase stimulators), has been shown in previous clinical studies to be beneficial in the treatment of chronic thromboembolic pulmonary hypertension.METHODS: In this phase 3, multicenter, randomized, double-blind, placebo-controlled study, we randomly assigned 261 patients with inoperable chronic thromboembolic pulmonary hypertension or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy to receive placebo or riociguat. The primary end point was the change from baseline to the end of week 16 in the distance walked in 6 minutes. Secondary end points included changes from baseline in pulmonary vascular resistance, N-terminal pro-brain natriuretic peptide (NT-proBNP) level, World Health Organization (WHO) functional class, time to clinical worsening, Borg dyspnea score, quality-of-life variables, and safety.RESULTS: By week 16, the 6-minute walk distance had increased by a mean of 39 m in the riociguat group, as compared with a mean decrease of 6 m in the placebo group (least-squares mean difference, 46 m; 95% confidence interval [CI], 25 to 67; P<0.001). Pulmonary vascular resistance decreased by 226 dyn·sec·cm(-5) in the riociguat group and increased by 23 dyn·sec·cm(-5) in the placebo group (least-squares mean difference, -246 dyn·sec·cm(-5); 95% CI, -303 to -190; P<0.001). Riociguat was also associated with significant improvements in the NT-proBNP level (P<0.001) and WHO functional class (P=0.003). The most common serious adverse events were right ventricular failure (in 3% of patients in each group) and syncope (in 2% of the riociguat group and in 3% of the placebo group).CONCLUSIONS: Riociguat significantly improved exercise capacity and pulmonary vascular resistance in patients with chronic thromboembolic pulmonary hypertension. (Funded by Bayer HealthCare; CHEST-1 and CHEST-2 ClinicalTrials.gov numbers, NCT00855465 and NCT00910429, respectively.)
AB - BACKGROUND: Riociguat, a member of a new class of compounds (soluble guanylate cyclase stimulators), has been shown in previous clinical studies to be beneficial in the treatment of chronic thromboembolic pulmonary hypertension.METHODS: In this phase 3, multicenter, randomized, double-blind, placebo-controlled study, we randomly assigned 261 patients with inoperable chronic thromboembolic pulmonary hypertension or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy to receive placebo or riociguat. The primary end point was the change from baseline to the end of week 16 in the distance walked in 6 minutes. Secondary end points included changes from baseline in pulmonary vascular resistance, N-terminal pro-brain natriuretic peptide (NT-proBNP) level, World Health Organization (WHO) functional class, time to clinical worsening, Borg dyspnea score, quality-of-life variables, and safety.RESULTS: By week 16, the 6-minute walk distance had increased by a mean of 39 m in the riociguat group, as compared with a mean decrease of 6 m in the placebo group (least-squares mean difference, 46 m; 95% confidence interval [CI], 25 to 67; P<0.001). Pulmonary vascular resistance decreased by 226 dyn·sec·cm(-5) in the riociguat group and increased by 23 dyn·sec·cm(-5) in the placebo group (least-squares mean difference, -246 dyn·sec·cm(-5); 95% CI, -303 to -190; P<0.001). Riociguat was also associated with significant improvements in the NT-proBNP level (P<0.001) and WHO functional class (P=0.003). The most common serious adverse events were right ventricular failure (in 3% of patients in each group) and syncope (in 2% of the riociguat group and in 3% of the placebo group).CONCLUSIONS: Riociguat significantly improved exercise capacity and pulmonary vascular resistance in patients with chronic thromboembolic pulmonary hypertension. (Funded by Bayer HealthCare; CHEST-1 and CHEST-2 ClinicalTrials.gov numbers, NCT00855465 and NCT00910429, respectively.)
KW - Aged
KW - Chronic Disease
KW - Double-Blind Method
KW - Exercise Tolerance
KW - Female
KW - Humans
KW - Hypertension, Pulmonary
KW - Least-Squares Analysis
KW - Male
KW - Middle Aged
KW - Pulmonary Embolism
KW - Pyrazoles
KW - Pyrimidines
KW - Vascular Resistance
KW - Walking
U2 - 10.1056/NEJMoa1209657
DO - 10.1056/NEJMoa1209657
M3 - SCORING: Journal article
C2 - 23883377
VL - 369
SP - 319
EP - 329
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 4
ER -