TY - JOUR
T1 - Recommendations for the clinical management of patients receiving macitentan for pulmonary arterial hypertension (PAH)
T2 - A Delphi consensus document
AU - Rahaghi, Franck F.
AU - Alnuaimat, Hassan M.
AU - Awdish, Rana L.A.
AU - Balasubramanian, Vijay P.
AU - Bourge, Robert C.
AU - Burger, Charles D.
AU - Butler, John
AU - Gregory Cauthen, C.
AU - Chakinala, Murali M.
AU - deBoisblanc, Bennett P.
AU - Eggert, Michael S.
AU - Engel, Peter
AU - Feldman, Jeremy
AU - Wesley McConnell, J.
AU - Park, Myung
AU - Sager, Jeffrey S.
AU - Sood, Namita
AU - Palevsky, Harold I.
N1 - Funding Information:
Editorial assistance was provided by AXON Communications and funded by an independent grant provided by Actelion Pharmaceuticals US, Inc.
Funding Information:
All authors had access to the Delphi questionnaire analysis and data and participated in the review, revision, and approval of the content of the manuscript for submission. Eight authors were SERAPHIN investigators and their institutions received funds for patient enrollment in the trial. FFR received support for the design and conduct of this study through an independent grant from Actelion Pharmaceuticals US, Inc. and is a consultant, speaker, and has received research funding from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., Lung Biotechnology, United Therapeutics Corporation, Bayer Corporation, and research funding from Bellerophon Therapeutics, Ikaria, Inc., and Eiger BioPharmaceuticals. HMA receives research funding from Actelion Pharmaceuticals US, Inc. and United Therapeutics Corporation and has served as an Advisory Board Member for Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., and United Therapeutics Corporation. RLAA receives research funding from Actelion Pharmaceuticals US, Inc., Bayer Corporation, and United Therapeutics Corporation and has served as an Advisory Board member for Bayer Corporation. VPB receives research funding from United Therapeutics Corporation and serves as an Advisory Board member for Bayer Corporation, Gilead Sciences, Inc., United Therapeutics Corporation, and Actelion Pharmaceuticals US, Inc. RCB has received research support and served as a consultant for Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., United Therapeutics Corporation, Bellerophon Therapeutics, Medtronic, and St. Jude’s and has served on Speaker Bureaus for Gilead Sciences, Inc., and St. Jude’s. CDB has received research grant support from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., and United Therapeutics Corporation for multicenter pharmacological studies. In addition, CDB has served as a consultant or Advisory Board member for Actelion Pharmaceuticals US, Inc. and Gilead Sciences, Inc. JB has served on Speaker Bureaus and Advisory Boards for Actelion Pharmaceuticals US, Inc. and Bayer Corporation. CGC has served as an Advisory Board member for Actelion Pharmaceuticals US, Inc., United Therapeutics Corporation, and Gilead Sciences, Inc. MMC has received research support from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., Medtronic, Reata Pharmaceuticals, Inc., Eiger BioPharmaceuticals, Inc, GeNO LLC, and GlaxoSmithKline plc, consulting fees from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., United Therapeutics Corporation, WebMD LLC (Medscape), SteadyMed Therapeutics, Inc., and Express Scripts Holding Company, and honoraria for speaking for Gilead Sciences, Inc. and Bayer Corporation. BPD was the principal site investigator at LSU Health Sciences Center for the SERAPHIN Trial that resulted in FDA registration of macitentan. LSU has received research support from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., and Bayer Corporation. MSE has received research support from United Therapeutics Corporation and Actelion Pharmaceuticals US, Inc., and participates in Speakers Bureaus for United Therapeutics Corporation, Gilead Sciences, Inc., and Actelion Pharmaceuticals US, Inc. PE has received research support from United Therapeutics Corporation and Actelion Pharmaceuticals US, Inc., and has served on Speakers Bureaus and Advisory Boards sponsored by Actelion Pharmaceuticals US, Inc. JF has served as a consultant and on Advisory Boards for Actelion Pharmaceuticals US, Inc., and as a consultant and on Speaker Bureaus and Advisory Boards for Gilead Sciences, Inc., United Therapeutics Corporation, and Bayer Corporation. JWM has received research support from Actelion Pharmaceuticals US, Inc., and has served as a consultant and Speaker Bureau member for Actelion Pharmaceuticals, Inc. and Bayer Corporation, and as a consultant for Reata Pharmaceuticals, Inc. and United Therapeutics Corporation. MP has served as a consultant and Advisory Board member for Actelion Pharmaceuticals US, Inc., Bayer Corporation, Gilead Sciences, Inc., and United Therapeutics Corporation. JSS has received research support from Actelion Pharmaceuticals US, Inc.and has served as a consultant and on Advisory Boards and Speaker Bureaus for Actelion Pharmaceuticals US, Inc. NS has received honoraria from Bayer Corporation, Gilead Sciences, Inc., and United Therapeutics Corporation for consulting and has received research support from Actelion Pharmaceuticals US, Inc, Bayer Corporation, Gilead Sciences, Inc., Bellerophon BioPharmaceuticals, Arena Pharmaceuticals, Inc., and United Therapeutics Corporation. HIP has served on scientific advisory boards for Actelion Pharmaceuticals US, Inc, Bayer Corporation, GlaxoSmithKline plc, Janssen Pharmaceuticals, Inc., and United Therapeutics Corporation, and currently serves on a Data and Safety Monitoring Board for Eiger BioPharmaceuticals, Inc.
Publisher Copyright:
© The Author(s) 2017.
PY - 2017/9
Y1 - 2017/9
N2 - In patients treated with macitentan (Opsumit_, Actelion Pharmaceuticals Ltd., Basel, Switzerland) for pulmonary arterial hypertension (PAH), prevention and/or effective management of treatment-related adverse events may improve adherence. However, management of these adverse events can be challenging and the base of evidence and clinical experience for macitentan is limited. In the absence of evidence, consensus recommendations from physicians experienced in using macitentan to treat PAH may benefit patients and physicians who are using macitentan. Consensus recommendations were developed by a panel of physicians experienced with macitentan and PAH using a modified Delphi process. Over three iterations, panelists developed and refined a series of statements on the use of macitentan in PAH and rated their agreement with each statement on a Likert scale. The panel of 18 physicians participated and developed a total of 118 statements on special populations, add-on therapy, drug-drug interactions, warnings and precautions, hospitalization and functional class, and adverse event management. The resulting consensus recommendations are intended to provide practical guidance on real-world issues in using macitentan to treat patients with PAH.
AB - In patients treated with macitentan (Opsumit_, Actelion Pharmaceuticals Ltd., Basel, Switzerland) for pulmonary arterial hypertension (PAH), prevention and/or effective management of treatment-related adverse events may improve adherence. However, management of these adverse events can be challenging and the base of evidence and clinical experience for macitentan is limited. In the absence of evidence, consensus recommendations from physicians experienced in using macitentan to treat PAH may benefit patients and physicians who are using macitentan. Consensus recommendations were developed by a panel of physicians experienced with macitentan and PAH using a modified Delphi process. Over three iterations, panelists developed and refined a series of statements on the use of macitentan in PAH and rated their agreement with each statement on a Likert scale. The panel of 18 physicians participated and developed a total of 118 statements on special populations, add-on therapy, drug-drug interactions, warnings and precautions, hospitalization and functional class, and adverse event management. The resulting consensus recommendations are intended to provide practical guidance on real-world issues in using macitentan to treat patients with PAH.
KW - Adverse events
KW - Endothelin receptor antagonist
KW - Therapy adherence
UR - http://www.scopus.com/inward/record.url?scp=85032348172&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85032348172&partnerID=8YFLogxK
U2 - 10.1177/2045893217721695
DO - 10.1177/2045893217721695
M3 - Article
AN - SCOPUS:85032348172
VL - 7
SP - 702
EP - 711
JO - Pulmonary Circulation
JF - Pulmonary Circulation
SN - 2045-8932
IS - 3
ER -