Delphi Consensus Recommendations on Management of Dosing, Adverse Events, and Comorbidities in the Treatment of Idiopathic Pulmonary Fibrosis with Nintedanib.

Autor:	Rahaghi F; Cleveland Clinic Florida, Weston, FL, USA., Belperio JA; University of California Los Angeles, Los Angeles, CA, USA., Fitzgerald J; University of Texas (UT) Southwestern Medical Center, Dallas, TX, USA., Gulati M; Yale University, New Haven, CT, USA., Hallowell R; Massachusetts General Hospital, Boston, MA, USA., Highland KB; Cleveland Clinic, Cleveland, OH, USA., Huie TJ; National Jewish Health, Denver, CO, USA., Kim HJ; University of Minnesota, Minneapolis, MN, USA., Kolb M; McMaster University Firestone Institute for Respiratory Health (FIRH), Hamilton, ON, Canada., Lasky JA; Tulane University School of Medicine, New Orleans, LA, USA., Southern BD; Cleveland Clinic, Cleveland, OH, USA., Swigris JJ; National Jewish Health, Denver, CO, USA., de Andrade JA; Vanderbilt University School of Medicine, Nashville, TN, USA.
Jazyk:	angličtina
Zdroj:	Clinical medicine insights. Circulatory, respiratory and pulmonary medicine [Clin Med Insights Circ Respir Pulm Med] 2021 Mar 30; Vol. 15, pp. 11795484211006050. Date of Electronic Publication: 2021 Mar 30 (Print Publication: 2021).
DOI:	10.1177/11795484211006050
Abstrakt:	Purpose: Nintedanib is an approved treatment for idiopathic pulmonary fibrosis (IPF), which slows disease progression. Management of patients with IPF receiving nintedanib can be complicated by tolerability issues, comorbidities, and concomitant medications. We developed consensus recommendations on the management of dosing, adverse events and comorbidities in patients with IPF treated with nintedanib. Methods: A modified Delphi process using 3 questionnaires was used to survey 14 pulmonologists experienced in using nintedanib. Panelists rated their agreement with statements on a Likert scale from -5 (strongly disagree) to +5 (strongly agree). Consensus was predefined as a mean score of ⩽-2.5 or ⩾+2.5 with a standard deviation not crossing zero. Results: The panelists' recommendations were largely aligned with clinical trial data, real-world evidence, and the prescribing information, and provided additional guidance regarding minimizing gastrointestinal effects, periodic monitoring for liver dysfunction, caution with respect to concomitant administration of cytochrome P450 3A4 and P-glycoprotein 1 inhibitors and inducers and anticoagulants, and management of comorbidities. The panelists unanimously agreed that adverse event management should be individualized, based on careful consideration of the risks and benefits of each possible intervention and discussion with the patient. Conclusions: These consensus recommendations provide additional guidance on the appropriate management of IPF with nintedanib, for use alongside evidence-based literature and the prescribing information. Competing Interests: Declaration of conflicting interests:The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: FFR reports personal fees from Boehringer Ingelheim (BI) and Genentech. JAB has no competing interests to disclose. JF has no competing interests to disclose. MG reports grants, non-financial support, and other support from BI; personal fees, non-financial support, and other support from the France Foundation; personal fees from Genentech; and grants, non-financial support, and other support from the Pulmonary Fibrosis Foundation. RH has no competing interests to disclose. KBH reports grants and personal fees from Actelion Pharmaceuticals, BI, and United Therapeutics; personal fees from Bayer; and grants from Genentech, Eiger Pharmaceuticals, and Reata Pharmaceuticals. TJH reports research support from BI and Promedior and writing support funded by BI. HJK has no competing interests to disclose. MK reports grants and personal fees from BI, Gilead, GlaxoSmithKline, Prometic, and Roche; and personal fees from AstraZeneca, Covance, Galapagos NV, Indalo, and Third Pole Inc. JAL reports personal fees from Biogen, BI, Galecto, Roche/Genentech, and Veracyte. BDS reports grants from Genentech and personal fees from BI. JJS has no competing interests to disclose. JAD reports personal fees from BI. (© The Author(s) 2021.)
Databáze:	MEDLINE
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