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Pulmonary Vascular Disease |

Long-term Riociguat Treatment in PAH Patients in WHO Functional Class (FC) I/II Versus FC III/IV at Baseline: Results From the 12-Week Phase III PATENT-1 Study and PATENT-2 Open-Label Extension FREE TO VIEW

Gisela Meyer, MD; Nazzareno Galiè, MD; Friedrich Grimminger, MD; Ekkehard Grünig, MD; Marc Humbert, MD; Zhi-Cheng Jing, MD; Anne M. Keogh, PhD; David Langleben, MD; Lewis J Rubin, MD; Arno Fritsch, PhD; Neil Davie, MD; Hossein-Ardeschir Ghofrani, MD
Author and Funding Information

Centro de Hipertensão Pulmonar, Complexo Hospitalar Santa Casa de Porto Alegre, Porto Alegre, Brazil


Chest. 2014;145(3_MeetingAbstracts):513A. doi:10.1378/chest.1824389
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Abstract

SESSION TITLE: Pulmonary Hypertension Posters II

SESSION TYPE: Poster Presentations

PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM

PURPOSE: To compare the long-term effect of riociguat in PAH patients in FC I/II versus FC III/IV at PATENT-1 baseline.

METHODS: In PATENT-1, patients were randomized to riociguat individual-dose titration (up to 2.5 mg tid), riociguat capped-dose titration (up to 1.5 mg tid; exploratory arm), or placebo. Patients could enter PATENT-2 after PATENT-1 completion without ongoing riociguat-related SAEs. Individual-titration patients continued on their optimum dose; placebo and capped-dose patients were titrated to their optimum dose (up to 2.5 mg tid).

RESULTS: 89% of PATENT-1 patients (n=396) entered PATENT-2. Of these, 324 (82%) patients were ongoing in this interim analysis (cut-off March 2013; mean treatment duration 663 days); the numbers of patients in FC I/II/III/IV at PATENT-1 baseline were 12/169/212/2. At PATENT-1 completion, mean±SD 6MWD in the FC I/II subgroup increased by 37±52 m and 24±59 m in individual-titration and placebo patients, respectively, versus 37±52 m and -2±54 m in the FC III/IV subgroup. After 12 weeks of PATENT-2, 6MWD in the FC I/II subgroup increased by 55±60 m and 55±58 m in ex-individual-titration and ex-placebo patients, versus 50±62 m and 35±87 m in the FC III/IV subgroup. In all patients at 1 year, 6MWD increased by 59±62 m in the FC I/II subgroup (n=149) and 45±83 m in the FC III/IV subgroup (n=178). At PATENT-1 completion in the FC I/II subgroup, FC improved/stabilized/worsened in 5/92/3% and 5/77/18% of individual-titration and placebo patients; proportions in the FC III/IV subgroup were 34/66/1% and 27/73/0%, respectively. In all patients at 1 year, proportions were 10/80/10% in the FC I/II subgroup (n=153) and 51/45/4% in the FC III/IV subgroup (n=186). At the cut-off, 18 (10%) FC I/II patients had experienced clinical worsening and 5 (3%) had died, versus 66 (31%) and 22 (10%), respectively, in the FC III/IV subgroup.

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

CLINICAL IMPLICATIONS: Long-term riociguat appears to be beneficial in both WHO FC I/II and WHO FC III/IV PAH patients.

DISCLOSURE: Gisela Meyer: Consultant fee, speaker bureau, advisory committee, etc.: Gisela Meyer has received advisory board and speaker fees from Bayer, Lilly and GlaxoSmithKline. 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 M. 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., Other: David Langleben received fees for participation in review activities, paid to his institution by Bayer Inc. Lewis J Rubin: Consultant fee, speaker bureau, advisory committee, etc.: Lewis J. Rubin has received consulting fees, honorarium and/or support for travel to meetings from Bayer, Pfizer, Actelion, GlaxoSmithKline, United Therapeutics, Gilead, GeNo, Aires, Regeneron and Liquidia., Other: Lewis J. Rubin has received fees for participation in review activities from Bayer, Pfizer, Actelion, GlaxoSmithKline, United Therapeutics, Gilead, GeNo, Aires, Regeneron and Liquidia. 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. Hossein-Ardeschir 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 process for registration submission to health authorities, after successful finalisation of a RCT in patients with PAH.


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