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Poster Presentations: Wednesday, October 26, 2011 |

Long-term Outcomes of Patients With Pulmonary Arterial Hypertension Associated With Connective Tissue Disease as Compared With Idiopathic or Heritable Pulmonary Arterial Hypertension Treated With Tadalafil FREE TO VIEW

Nazzareno Galie, MD; Robyn Barst, MD; Bruce Brundage, MD; Hossein Ghofrani, MD; Ronald Oudiz, MD; Gerald Simonneau, MD
Author and Funding Information

Institute of Cardiology, University of Bologna, Bologna, Italy



Chest. 2011;140(4_MeetingAbstracts):734A. doi:10.1378/chest.1111111
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Abstract

PURPOSE: Tadalafil was efficacious and well-tolerated in patients with pulmonary arterial hypertension (PAH) in a previous randomized, double-blind, placebo [PBO]-controlled 16-week trial (PHIRST, Pulmonary Arterial HypertensIon and ReSponse to Tadalafil). We now report results of an additional 52 weeks of treatment (PHIRST-2) in patients with PAH associated with connective tissue disease (PAH-CTD) and idiopathic/heritable PAH (I/H-PAH).

METHODS: In PHIRST-2, patients were assigned to tadalafil 20mg (T20) or 40mg (T40) QD. PHIRST patients on T20 without clinical worsening ([CW], e.g. death, lung transplantation, atrial septostomy, new chronic PAH treatment initiated, worsening functional class, or hospitalization for worsening PAH) remained on T20 (T20/T20) in PHIRST-2; all others switched to (T2.5-T20/T40) or remained on T40 (T40/T40). Four treatment groups were analyzed for the I/H-PAH and PAH-CTD subgroups, respectively: T20/T20 (n=37, n=16), T40/T40 (n=43, n=13), T2.5-T20/T40 (n=94, n=34), and PBO/T40 (n=49, n=15). Data analyses included 6-minute walk distance (6MWD), proportions of patients with CW and treatment-emergent adverse events (TEAEs).

RESULTS: During PHIRST-2, mean 6MWD was maintained in patients in the T20/T20 and T40/T40 treatment groups for the I/H-PAH and PAH-CTD subgroups. In the PBO/T40 and T2.5-T20/T40 groups, mean 6MWD numerically improved in both subgroups. The proportions of patients with CW were 19%, 14%, 26%, and 14% in I/H-PAH patients and 25%, 46%, 15%, and 33% in PAH-CTD patients in the T20/T20, T40/T40, T2.5-T20/T40, and PBO/T40 treatment groups, respectively. Overall, 48% of patients with I/H-PAH and 50% with PAH-CTD had ≥1 TEAE related to study drug, with headache most frequently reported.

CONCLUSIONS: In PHIRST-2, the increase in 6MWD in PHIRST was maintained or improved in the PAH-CTD and I/H-PAH subgroups; CW was numerically higher in PAH-CTD than I/H-PAH across all treatment groups, except T2.5-T20/T40. These data suggest patients with PAH-CTD may do worse than those with I/H-PAH. TEAEs were similar for both subgroups and consistent with those observed in PHIRST.

CLINICAL IMPLICATIONS: Patients with PAH-CTD may do worse than patients with I/H-PAH. Whether more aggressive or earlier combination therapy would provide greater efficacy, requires further study.

DISCLOSURE: Nazzareno Galie: Consultant fee, speaker bureau, advisory committee, etc.: Has been involved with Steering Committee activities for Eli Lilly and Company, Actelion, Pfizer, Bayer-Schering, and GlaxoSmithKline; Has been a paid lecturer, for Eli Lilly and Company, Actelion, Pfizer, Bayer-Schering, and GlaxoSmithKline; Has done contract research for Actelion, Pfizer, United Therapeutics, Bayer-Schering, and GlaxoSmithKline.

Robyn Barst: Consultant fee, speaker bureau, advisory committee, etc.: Has received research support and/or has acted as a consultant for Actelion, Eli Lilly and Company, GlaxoSmithKline, Gilead, Novartis, Pfizer, and United Therapeutics.

Bruce Brundage: Consultant fee, speaker bureau, advisory committee, etc.: Has Chaired or been a member of Data Monitoring Committees for clinical trials involving patients with pulmonary arterial hypertension for Actelion, Dong A, Gilead, Novartis, Pfizer, and United Therapeutics, and is a member of the End-point Adjudication Committee for Novartis and the Scientific Advisory Committee for Eli Lilly and Company regarding the PHIRST-1 clinical trial.

Hossein Ghofrani: Consultant fee, speaker bureau, advisory committee, etc.: Has received honoraria, acted as a consultant, and/or has been a Steering Committee member for Actelion, Bayer-Schering, Eli Lilly and Company, Ergonex, GlaxoSmithKline, Novartis, Pfizer, and United Therapeutics.

Ronald Oudiz: Consultant fee, speaker bureau, advisory committee, etc.: Has received research support, consulted, and/or has been a speaker for Actelion, Bayer, Gilead, LungRx, and United Therapeutics

Gerald Simonneau: Consultant fee, speaker bureau, advisory committee, etc.: Has received research support and/or acted as a consultant for Actelion, Bayer-Schering, GlaxoSmithKline, Pfizer, and United Therapeutics.

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