Expert consensus on the management of adverse events and prescribing practices associated with the treatment of patients taking pirfenidone for idiopathic pulmonary fibrosis: a Delphi consensus study

BMC Pulmonary Medicine

Joao A. de Andrade¹  Franck F. Rahaghi²  Zeenat Safdar³  Steven D. Nathan⁴  Anne Whitney Brown⁴  Christopher S. King⁴  Kevin R. Flaherty⁵  Maria L. Padilla⁶  Imre Noth⁷  Mary Beth Scholand⁸  Adrian Shifren⁹  Robert J. Kaner^1,10 

[1] Birmingham VA Medical Center;Department of Pulmonary and Critical Care Medicine, Cleveland Clinic Florida;Houston Methodist Lung Center;Inova Fairfax Hospital;Michigan Medicine Pulmonary Clinic;The Mount Sinai Hospital;The University of Chicago Medicine;University of Utah School of Medicine;Washington University School of Medicine;Weill Cornell Medicine Pulmonary & Critical Care Medicine;

关键词: Adverse events;    Idiopathic pulmonary fibrosis;    Management;    Pirfenidone;    Expert consensus;   

DOI  :  10.1186/s12890-020-01209-4

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown