TY - JOUR
T1 - Expert consensus on the management of adverse events and prescribing practices associated with the treatment of patients taking pirfenidone for idiopathic pulmonary fibrosis
T2 - A Delphi consensus study
AU - Rahaghi, Franck F.
AU - Safdar, Zeenat
AU - Brown, Anne Whitney
AU - De Andrade, Joao A.
AU - Flaherty, Kevin R.
AU - Kaner, Robert J.
AU - King, Christopher S.
AU - Padilla, Maria L.
AU - Noth, Imre
AU - Scholand, Mary Beth
AU - Shifren, Adrian
AU - Nathan, Steven D.
N1 - Publisher Copyright:
© 2020 The Author(s).
PY - 2020/7/14
Y1 - 2020/7/14
N2 - Background: In patients with idiopathic pulmonary fibrosis (IPF) treated with pirfenidone (Esbriet®, Genentech USA, Inc. South San Francisco, CA.), effectively managing treatment-related adverse events (AEs) may improve adherence. Due to a lack of clinical evidence and expertise, managing these AEs can be challenging for patients and physicians alike. In the absence of evidence, consensus recommendations from physicians experienced in using pirfenidone to treat IPF are beneficial. Methods: Using a modified Delphi process, expert recommendations were developed by a panel of physicians experienced with using pirfenidone for IPF. Over three iterations, panelists developed and refined a series of statements on the use of pirfenidone in IPF. Their agreement on each statement was ranked using a Likert scale. Results: A panel of 12 physicians participated and developed a total of 286 statements on dosing and administration, special populations, drug-drug interactions, laboratory analysis, warnings and precautions, and AE management. Expert recommendations were achieved with regard to slower initial titrations and slower titrations for AEs, dosing with meal(s) or substantial meals, and adding other prescribed pharmacological agents for AEs. Conclusion: Until there is further clinical evidence, the resulting consensus recommendations are intended to provide direction on the practical management of IPF with pirfenidone, by encompassing a broad experience from the real world to complement data gleaned from clinical trials.
AB - Background: In patients with idiopathic pulmonary fibrosis (IPF) treated with pirfenidone (Esbriet®, Genentech USA, Inc. South San Francisco, CA.), effectively managing treatment-related adverse events (AEs) may improve adherence. Due to a lack of clinical evidence and expertise, managing these AEs can be challenging for patients and physicians alike. In the absence of evidence, consensus recommendations from physicians experienced in using pirfenidone to treat IPF are beneficial. Methods: Using a modified Delphi process, expert recommendations were developed by a panel of physicians experienced with using pirfenidone for IPF. Over three iterations, panelists developed and refined a series of statements on the use of pirfenidone in IPF. Their agreement on each statement was ranked using a Likert scale. Results: A panel of 12 physicians participated and developed a total of 286 statements on dosing and administration, special populations, drug-drug interactions, laboratory analysis, warnings and precautions, and AE management. Expert recommendations were achieved with regard to slower initial titrations and slower titrations for AEs, dosing with meal(s) or substantial meals, and adding other prescribed pharmacological agents for AEs. Conclusion: Until there is further clinical evidence, the resulting consensus recommendations are intended to provide direction on the practical management of IPF with pirfenidone, by encompassing a broad experience from the real world to complement data gleaned from clinical trials.
KW - Adverse events
KW - Expert consensus
KW - Idiopathic pulmonary fibrosis
KW - Management
KW - Pirfenidone
UR - http://www.scopus.com/inward/record.url?scp=85088047155&partnerID=8YFLogxK
U2 - 10.1186/s12890-020-01209-4
DO - 10.1186/s12890-020-01209-4
M3 - Article
C2 - 32664913
AN - SCOPUS:85088047155
SN - 1471-2466
VL - 20
JO - BMC Pulmonary Medicine
JF - BMC Pulmonary Medicine
IS - 1
M1 - 191
ER -