0
Pulmonary Vascular Disease |

Long-term Riociguat Treatment in Inoperable and Persistent/Recurrent CTEPH Patients in WHO Functional Class (FC) I/II Versus FC III/IV at Baseline: Results From the 16-Week Phase III CHEST-1 Study and CHEST-2 Open-Label Extension FREE TO VIEW

Chen Wang, MD; Andrea M D’Armini, MD; Hossein-Ardeschir Ghofrani, MD; Friedrich Grimminger, MD; Marius M Hoeper, MD; Pavel Jansa, MD; Nick H Kim, MD; Gerald Simonneau, MD; Adam Torbicki, MD; Martin Wilkins, MD; Arno Fritsch, PhD; Neil Davie, MD; Eckhard Mayer, MD
Author and Funding Information

Beijing Institute of Respiratory Medicine, Beijing Chao Yang Hospital, Dept of Respiratory Medicine, Capital Medical University, Beijing Key Laboratory of Respiratory & Pulmonary Circulation Disorders, Beijing, China


Chest. 2014;145(3_MeetingAbstracts):535B. doi:10.1378/chest.1824508
Text Size: A A A
Published online

Abstract

SESSION TITLE: DVT/PE/Pulmonary Hypertension

SESSION TYPE: Slide Presentations

PRESENTED ON: Sunday, March 23, 2014 at 12:15 PM - 01:15 PM

PURPOSE: The long-term effect of riociguat was compared in patients with CTEPH in FC I/II versus FC III/IV at CHEST-1 baseline.

METHODS: In CHEST-1, patients were randomized to riociguat individual-dose titration (up to 2.5 mg tid) or placebo. Patients could enter CHEST-2 after completing CHEST-1 without ongoing riociguat-related SAEs; placebo patients were titrated to their optimum riociguat dose (up to 2.5 mg tid) and riociguat patients continued on their optimum dose.

RESULTS: 91% of CHEST-1 patients (n=237) entered CHEST-2. Of these, 211 (89%) were ongoing in this interim analysis (cut-off March 2013; mean treatment duration 582 days); the numbers of patients in FC I/II/III/IV at CHEST-1 baseline were 3/73/154/6. At CHEST-1 completion, mean±SD 6MWD in the FC I/II subgroup increased by 56±65 m and 20±51 m in riociguat and placebo patients, respectively, versus 47±55 m and 2±68 m in the FC III/IV subgroup. After 12 weeks of CHEST-2, 6MWD in the FC I/II subgroup increased by 70±55 m and 41±61 m in ex-riociguat and ex-placebo patients, versus 51±74 m and 45±78 m in the FC III/IV subgroup. In all patients at 1 year, 6MWD increased by 51±52 m in the FC I/II subgroup (n=61) and 52±68 m in the FC III/IV subgroup (n=110). At CHEST-1 completion in the FC I/II subgroup, FC improved/stablilized/worsened in 16/76/8% and 12/84/4% of riociguat and placebo patients; proportions in the FC III/IV subgroup were 44/55/1% and 18/80/2%, respectively. In all patients at 1 year, proportions were 25/67/8% in the FC I/II subgroup (n=63) and 58/40/1% in the FC III/IV subgroup (n=114; data missing for n=1). At the cut-off, 7 (9%) patients in the FC I/II subgroup had experienced clinical worsening and 4 (5%) had died, versus 31 (19%) and 9 (6%), respectively, in the FC III/IV subgroup.

CONCLUSIONS: Riociguat increased 6MWD and improved/stabilized FC in most patients in FC I/II and FC III/IV.

CLINICAL IMPLICATIONS: Long-term riociguat appears to show benefit in persistent/recurrent and inoperable CTEPH patients in both WHO FC I/II and WHO FC III/IV.

DISCLOSURE: Andrea M D’Armini: Other Andrea D’Armini received fees for participation in review activities from Bayer: Hossein-Ardeschir Ghofrani: Grant monies (from industry related sources) Hossein-Ardeschir Ghofrani has received grant money paid to his institution by Bayer HealthCare: Friedrich Grimminger: Grant monies (from industry related sources) Friedrich Grimminger has received grant money paid to his institution by Bayer HealthCare: Marius M Hoeper: Consultant fee, speaker bureau, advisory committee, etc. Marius M. Hoeper has received consulting fees, honorarium and/or support for travel from Bayer: Pavel Jansa: Consultant fee, speaker bureau, advisory committee, etc. Pavel Jansa has received consulting fees, honorarium and/or support for travel to meetings from Bayer: Nick H Kim: Consultant fee, speaker bureau, advisory committee, etc. Nick H. Kim has received consulting fees, honorarium and/or support for travel to meetings from Bayer: Gerald Simonneau: Grant monies (from industry related sources) Gerald Simonneau has received grant money paid to his institution from Bayer: Adam Torbicki: University grant monies Adam Torbicki has received university grant monies for statute activities of the university: Martin Wilkins: Consultant fee, speaker bureau, advisory committee, etc. Martin Wilkins has received consulting fees, honorarium and/or support for travel to meetings from Bayer HealthCare: Arno Fritsch: Employee Arno Fritsch is a full-time employee of Bayer HealthCare: Neil Davie: Employee Neil Davie is a full-time employee of Bayer HealthCare: Eckhard Mayer: Consultant fee, speaker bureau, advisory committee, etc. Eckhard Mayer has received consulting fees, honorarium and/or support for travel to meetings from Bayer The following authors have nothing to disclose: Chen Wang

No Product/Research Disclosure Information


Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543