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Signs and Symptoms of Chest Diseases |

Riociguat for the Treatment of Pulmonary Arterial Hypertension (PAH): 1-Year Results from the PATENT-2 Long-term Extension Study

Lewis Rubin, MD; Nazzareno Galiè, MD; Friedrich Grimminger, MD; Ekkehard Grünig, MD; Marc Humbert, MD; Zhi-Cheng Jing, MD; Anne Keogh, PhD; David Langleben, MD; Arno Fritsch, PhD; Flavia Menezes, MD; Dieter Neuser, MD; Hossein Ghofrani, MD
Author and Funding Information

University of California, San Diego School of Medicine, La Jolla, CA


Chest. 2013;144(4_MeetingAbstracts):1024A. doi:10.1378/chest.1783307
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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 12-week PATENT-1 study, riociguat, a novel soluble guanylate cyclase stimulator, significantly improved 6-minute walking distance (6MWD) and several secondary endpoints in PAH patients. These improvements were maintained for a further 12 weeks in the PATENT-2 long-term extension study. Here we present 1-year data from PATENT-2.

METHODS: Patients could enter PATENT-2 after successful completion of PATENT-1 without experiencing ongoing riociguat-related serious adverse events. During the initial 8-week blinded period of PATENT-2, riociguat individual-titration arm patients continued on their optimum dose (up to 2.5 mg tid) while receiving sham titration; placebo and capped-dose (up to 1.5 mg tid) arm patients were titrated to their optimum dose (up to 2.5 mg tid). The primary endpoints were safety and tolerability; secondary endpoints included 6MWD and WHO functional class (FC).

RESULTS: Of 443 patients in PATENT-1, 396 (89%) entered PATENT-2. In this interim analysis (cut-off March 2013), 324 (82%) patients were ongoing, and 334 (84%) had received ≥1 year of treatment. Overall, 8% of patients withdrew due to adverse events. Long-term riociguat was well tolerated, with no new safety signals. At the end of PATENT-1, 6MWD increased by 37±52 m (mean±SD) in the individual-titration arm, 46±51 m in the capped-dose arm, and 12±58 m in the placebo arm of the cohort entering PATENT-2. After 1 year of PATENT-2 (overall cohort; n=327), 6MWD increased by 51±74 m versus PATENT-1 baseline. At the end of PATENT-1, FC was improved/stable/worsened in 21/78/2%, 25/69/5%, and 16/74/9% (data missing for n=1) of individual-titration, capped-dose, and placebo-arm patients, respectively. After 1 year (overall cohort; n=339), the proportions were 33/61/6%. Sixty-one (15%) patients included in the safety and efficacy analyses received additional PAH medication during PATENT-2 (n=60 due to worsening pulmonary hypertension).

CONCLUSIONS: Long-term riociguat is well tolerated in PAH patients and shows sustained benefits in 6MWD and FC when used as a monotherapy or in combination with concomitant PAH therapies.

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

DISCLOSURE: Lewis Rubin: Consultant fee, speaker bureau, advisory committee, etc.: Lewis J. Rubin received consulting fees, honorariums and/or support for travel from the following companies; Bayer, Pfizer, Actelion, GlaxoSmithKline, United Therapeutics, Gilead, GeNo, Aires, Regeneron and Liquidia, Other: Lewis J. Rubin received fees for participation in review activities from the following companies; Bayer, Pfizer, Actelion, GlaxoSmithKline, United Therapeutics, Gilead, GeNo, Aires, Regeneron and Liquidia Nazzareno Galiè: Grant monies (from industry related sources): Nazzareno Galiè received grant money paid to his institution by Bayer, Consultant fee, speaker bureau, advisory committee, etc.: Nazzareno Galiè received consulting fees, honorariums and/or support for travel to meetings from Bayer 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 Ekkehard Grünig: Consultant fee, speaker bureau, advisory committee, etc.: Ekkehard Grünig received support for travel to meetings from Bayer Pharma Marc Humbert: Consultant fee, speaker bureau, advisory committee, etc.: Marc Humbert has received consultancy fees and payment for lectures including service on speakers bureaus from Bayer Zhi-Cheng Jing: Consultant fee, speaker bureau, advisory committee, etc.: Zhi-Cheng Jing has received consultancy fees and payment for lectures including service on speakers bureaus from Bayer Anne Keogh: Grant monies (from industry related sources): Anne M. Keogh has received grant money paid to her institution from Bayer, Consultant fee, speaker bureau, advisory committee, etc.: Anne M. Keogh has received consultancy fees from Bayer David Langleben: Grant monies (from industry related sources): David Langleben received grant money paid to his institution from Bayer Inc, Consultant fee, speaker bureau, advisory committee, etc.: David Langleben received consulting fees/honorarium, paid to his institution by Bayer Inc, Consultant fee, speaker bureau, advisory committee, etc.: David Langleben received support for travel to meetings from Bayer Inc, Other: David Langleben received fees for participation in review activities, paid to his institution by Bayer Inc Arno Fritsch: Shareholder: Arno Fritsch has received stock/stock options from Bayer HealthCare, Employee: Arno Fritsch is a full-time employee of Bayer HealthCare Flavia Menezes: Employee: Flavia Menezes is a full-time employee of Bayer HealthCare Dieter Neuser: Employee: Dieter Neuser is a full-time employee of Bayer Pharma AG 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

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


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