TY - JOUR
T1 - An expert panel delphi consensus statement on patient selection and management for transitioning between oral and inhaled treprostinil
AU - Rahaghi, Franck F.
AU - Allen, Roblee P.
AU - Balasubramanian, Vijay P.
AU - Chakinala, Murali M.
AU - Elwing, Jean M.
AU - Feldman, Jeremy
AU - Leary, Peter J.
AU - Rischard, Franz
AU - Safdar, Zeenat
AU - Sood, Namita
AU - Oudiz, Ronald J.
N1 - Funding Information:
JME has served as a consultant for Actelion and receives research funding from Actelion, Arena, Reata, United Therapeutics, Bellerophon, Lung LLC, Eiger, Akros, Liquidia, Phase Bio, Complexa Pharmaceuticals.
Funding Information:
PJL currently receives grant funding from the American Heart Association (17SDG33670199) and NHLBI (1R61HL142539-01). He has received grant funding from the CHEST Foundation and American Heart Association within the last three years. PJL is or recently was a site investigator for studies by United Therapeutics, Bayer, and Actelion. PJL has served on an advisory board for Bayer.
Funding Information:
FR is funded by the National Heart Lung and Blood Institute NHLBI U01 grant RFA-HL-14-027. He has received grant funding and consultancy, and advisory board compensation from Gilead, and Actelion Pharmaceuticals, Bayer and United Therapeutics.
Funding Information:
ZS received support for the design and conduct of this study through an independent grant from Genentech, 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, Genentech and Boehringer Ingelheim.
Funding Information:
VPB is a consultant, speaker, and has received research funding from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., Lung Biotechnology, United Therapeutics Corporation, and Bayer Corporation.
Funding Information:
FFR 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.
Publisher Copyright:
© 2020
PY - 2021/2
Y1 - 2021/2
N2 - Treprostinil, a prostacyclin analogue used in the treatment of pulmonary arterial hypertension (PAH), is available for administration by parenteral, oral, or inhaled routes. Transitioning between routes may be beneficial for appropriate patients; however, there is little published data on transitions between oral and inhaled treprostinil. We used a modified Delphi process to develop expert consensus recommendations on transitions between these formulations. Three questionnaires were used to develop statements about relevant aspects of transition management, which the panelists rated, using a Likert scale, from −5 (strongly disagree) to +5 (strongly agree). Eleven physicians with expertise in PAH treatment modalities, participated in the panel. Of the 492 statements evaluated, consensus was reached on 215 (43.7%). Key consensus recommendations included (1) accurately defining successful transition, as stable or improved PAH with good tolerability and adherence, and (2) patients with stable, low-risk PAH showing insufficient response or tolerability to their existing treprostinil therapy (and due to restrictions in up titration of dosing), as appropriate candidates for transitions between treprostinil formulations. Panelists did not reach consensus for an overall strategy for performing these transitions, mainly because of variability in their practice parameters. Consensus was also achieved on recommendations for adverse event management, including reassurance, administration of oral treprostinil 3 times daily with food, and dosing inhaled treprostinil at intervals ≥3 hours apart. The Delphi process aided in developing expert consensus recommendations that may provide clinically useful guidance for transitioning between treprostinil formulations. However, additional data from centers with high volumes of PAH patients undergoing treprostinil transitions would be optimal for defining more complete and robust strategies to facilitate successful transition.
AB - Treprostinil, a prostacyclin analogue used in the treatment of pulmonary arterial hypertension (PAH), is available for administration by parenteral, oral, or inhaled routes. Transitioning between routes may be beneficial for appropriate patients; however, there is little published data on transitions between oral and inhaled treprostinil. We used a modified Delphi process to develop expert consensus recommendations on transitions between these formulations. Three questionnaires were used to develop statements about relevant aspects of transition management, which the panelists rated, using a Likert scale, from −5 (strongly disagree) to +5 (strongly agree). Eleven physicians with expertise in PAH treatment modalities, participated in the panel. Of the 492 statements evaluated, consensus was reached on 215 (43.7%). Key consensus recommendations included (1) accurately defining successful transition, as stable or improved PAH with good tolerability and adherence, and (2) patients with stable, low-risk PAH showing insufficient response or tolerability to their existing treprostinil therapy (and due to restrictions in up titration of dosing), as appropriate candidates for transitions between treprostinil formulations. Panelists did not reach consensus for an overall strategy for performing these transitions, mainly because of variability in their practice parameters. Consensus was also achieved on recommendations for adverse event management, including reassurance, administration of oral treprostinil 3 times daily with food, and dosing inhaled treprostinil at intervals ≥3 hours apart. The Delphi process aided in developing expert consensus recommendations that may provide clinically useful guidance for transitioning between treprostinil formulations. However, additional data from centers with high volumes of PAH patients undergoing treprostinil transitions would be optimal for defining more complete and robust strategies to facilitate successful transition.
KW - Adverse events
KW - Prostacyclin
KW - Pulmonary arterial hypertension
KW - Therapy adherence
KW - Treprostinil
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UR - http://www.scopus.com/inward/citedby.url?scp=85098890229&partnerID=8YFLogxK
U2 - 10.1016/j.pupt.2020.101979
DO - 10.1016/j.pupt.2020.101979
M3 - Letter
C2 - 33259923
AN - SCOPUS:85098890229
VL - 66
JO - Pulmonary Pharmacology and Therapeutics
JF - Pulmonary Pharmacology and Therapeutics
SN - 1094-5539
M1 - 101979
ER -