CHEST Guidelines-The-Impact-of-Nintedanib-Dosing-on-Clinical-Outcom

The-Impact-of-Nintedanib-Dosing-on-Clinical-Outcom

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This study examines the effects of nintedanib, an antifibrotic agent used in treating idiopathic pulmonary fibrosis (IPF), comparing dosages of 150 mg twice daily and 100 mg twice daily. Antifibrotic agents like nintedanib have shown positive results, such as slowing forced vital capacity (FVC) decline in clinical trials. However, challenges like significant gastrointestinal side effects, including diarrhea, contribute to limited prescription rates among eligible patients.<br /><br />The study utilized a large data set from the OptumLabs Data Warehouse and Medicare Fee-for-Service database, focusing on U.S. patients 65 years and older. The analysis excluded patients who switched doses and matched participants based on several variables, including comorbidities, steroid use, and hospitalization frequency. A Cox proportional hazards model was used to compare outcomes.<br /><br />Outcomes showed no significant difference in mortality or hospitalization rates between the two dosing groups. The mortality hazard ratio was 0.74 (CI, 0.54 to 1.01; P = .058), and the hospitalization hazard ratio was 0.89 (CI, 0.78-1.02; P = .100). Subgroup analysis of patients who adjusted doses revealed no significant outcome differences.<br /><br />The study's limitations include potential diagnostic miscoding, inability to document actual dose adherence, and lack of pulmonary function decline data. Despite propensity matching and regression adjustments, unobserved factors might confound the results. Though the study did not provide definitive proof of reduced dosage equivalency, it aligns with post hoc analyses of INPULSIS data and other observational studies, suggesting consistent FVC decline rates regardless of dose adjustments.<br /><br />The study highlights a need for further research to explore the clinical impact of nintedanib dosing, recommending prospective registry data or randomized trials to fully understand the efficacy of reduced dosing strategies. In conclusion, real-world data indicate similar risks of mortality and hospitalization between reduced and traditional nintedanib dosing regimens in IPF treatment.

Keywords

nintedanib

idiopathic pulmonary fibrosis

antifibrotic agent

forced vital capacity

gastrointestinal side effects

Cox proportional hazards model

mortality hazard ratio

hospitalization rates

dose adherence

real-world data