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Signs and Symptoms of Chest Diseases |

Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH): 1-Year Results from the CHEST-2 Long-term Extension Study

Gérald Simonneau, MD; Andrea D’Armini, MD; Hossein Ghofrani, MD; Friedrich Grimminger, MD; Marius Hoeper, MD; Pavel Jansa, MD; Nick Kim, MD; Chen Wang, MD; Martin Wilkins, MD; Arno Fritsch, PhD; Neil Davie, PhD; Gerrit Weimann, MD; Eckhard Mayer, MD
Author and Funding Information

Univ. Paris-Sud; Inserm U999; AP-HP, Hôpital Bicêtre, Service de Pneumologie, Le Kremlin-Bicêtre, France


Chest. 2013;144(4_MeetingAbstracts):1023A. doi:10.1378/chest.1783236
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Abstract

SESSION TITLE: Late-Breaking Abstracts

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Tuesday, October 29, 2013 at 04:30 PM - 05:30 PM

PURPOSE: In the 16-week Phase III CHEST-1 study, riociguat, a novel soluble guanylate cyclase stimulator, significantly improved 6-minute walking distance (6MWD) and a range of secondary endpoints in patients with CTEPH. These improvements were maintained for a further 12 weeks in the CHEST-2 long-term extension study. Here we present 1-year data from CHEST-2.

METHODS: Patients with inoperable CTEPH or persistent/recurrent pulmonary hypertension (PH) after pulmonary endarterectomy could enter CHEST-2 after successfully completing CHEST-1 without ongoing riociguat-related serious adverse events. During the initial 8-week blinded titration period of CHEST-2, patients in the riociguat arm continued on their optimum dose (up to 2.5 mg tid) while receiving sham titration; patients in the placebo arm were titrated to their optimum dose of riociguat (up to 2.5 mg tid). The primary endpoints were safety and tolerability; secondary endpoints included change in 6MWD and WHO functional class (FC).

RESULTS: Of 261 patients enrolled in CHEST-1, 237 (91%) entered CHEST-2. In this interim analysis (cut-off March 2013), 211 (89%) patients were ongoing and 179 (76%) had received ≥1 year of treatment. Riociguat was well tolerated, with 3% of patients withdrawing due to adverse events. At the end of CHEST-1, mean±SD 6MWD had increased by 50±59 m in the riociguat arm and 8±63 m in the placebo arm of the cohort entering CHEST-2. After 1 year of CHEST-2 (overall population; n=172), 6MWD had increased by 51±62 m versus CHEST-1 baseline. At the end of CHEST-1, FC was improved/stable/worsened in 35/62/3% of riociguat patients and 16/81/2% of placebo patients; after 1 year of CHEST-2 (overall population; n=178), the proportions were 46/49/3% (data missing for two patients) versus CHEST-1 baseline. Twenty-two (9%) patients received additional PH medication during CHEST-2 (n=19 due to worsening PH).

CONCLUSIONS: Riociguat has a good long-term safety profile and is the first therapy to show sustained benefits in 6MWD and FC in patients with CTEPH.

CLINICAL IMPLICATIONS: Riociguat is a promising option for the long-term treatment of patients with inoperable CTEPH.

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

Riociguat is an investigational new drug currently in process for registration submission to health authorities, after successful finalisation of a RCT in patients with PAH


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