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Clinical Trial
. 2013 Jul 25;369(4):319-29.
doi: 10.1056 / NEJMoa1209657。

Riociguat for the treatment of chronic thromboembolic pulmonary hypertension

Hossein-Ardeschir Ghofrani1, Andrea M D'Armini, Friedrich Grimminger, Marius M Hoeper, Pavel Jansa, Nick H Kim, Eckhard Mayer, Gerald Simonneau, Martin R Wilkins, Arno Fritsch, Dieter Neuser, Gerrit Weimann, Chen Wang; CHEST-1 Study Group
Collaborators, Affiliations
Free article
Clinical Trial

Riociguat for the treatment of chronic thromboembolic pulmonary hypertension

Hossein-Ardeschir Ghofraniet al. N Engl J Med. .
Free article

Abstract

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,NCT00855465andNCT00910429, respectively.)

Comment in

  • Riociguat for pulmonary hypertension--a glass half full.
    Archer SL. Archer SL. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. N Engl J Med. 2013. PMID:23883383 No abstract available.
  • Hypertension: Riociguat therapy for pulmonary hypertension.
    Lim GB. Lim GB. Nat Rev Cardiol. 2013 Oct;10(10):549. doi: 10.1038/nrcardio.2013.122. Epub 2013 Aug 13. Nat Rev Cardiol. 2013. PMID:23939482 No abstract available.
  • Riociguat for pulmonary hypertension.
    Ghofrani HA, Simonneau G, Rubin LJ; Authors of CHEST-1 and PATENT-1. Ghofrani HA, et al. N Engl J Med. 2013 Dec 5;369(23):2268. doi: 10.1056/NEJMc1312903. N Engl J Med. 2013. PMID:24304056 No abstract available.
  • Riociguat for pulmonary hypertension.
    Auger WR, Jamieson SW; Pulmonary Thromboendarterectomy Program at University of California, San Diego. Auger WR, et al. N Engl J Med. 2013 Dec 5;369(23):2266. doi: 10.1056/NEJMc1312903. N Engl J Med. 2013. PMID:24304057 No abstract available.
  • Riociguat for pulmonary hypertension.
    Egom EE. Egom EE. N Engl J Med. 2013 Dec 5;369(23):2266-7. doi: 10.1056/NEJMc1312903. N Engl J Med. 2013. PMID:24304058 No abstract available.
  • Riociguat for pulmonary hypertension.
    Oh J, Youn JC, Kang SM. Oh J, et al. N Engl J Med. 2013 Dec 5;369(23):2267. doi: 10.1056/NEJMc1312903. N Engl J Med. 2013. PMID:24304059 No abstract available.
  • Riociguat for pulmonary hypertension.
    Post MC. Post MC. N Engl J Med. 2013 Dec 5;369(23):2267. doi: 10.1056/NEJMc1312903. N Engl J Med. 2013. PMID:24304060 No abstract available.

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