Literature DB >> 31464227

Use of nintedanib in patients with idiopathic pulmonary fibrosis: Initial Indian experience.

Jai B Mullerpattan1, Sana H Porwal1, Trina A Sarkar1, Haresh D Wagh1, Zarir F Udwadia1.   

Abstract

Entities:  

Year:  2019        PMID: 31464227      PMCID: PMC6710965          DOI: 10.4103/lungindia.lungindia_195_19

Source DB:  PubMed          Journal:  Lung India        ISSN: 0970-2113


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Nintedanib is a tyrosine kinase inhibitor which has shown to reduce the progression of idiopathic pulmonary fibrosis (IPF).[12] This is a single-center, retrospective observational study of IPF patients at a tertiary care center who were prescribed nintedanib. All patients were diagnosed to have IPF based on the prevalent ATS/ERS guidelines.[3] Clinical details including demographics, symptoms, duration of IPF, and use of pirfenidone and nintedanib were recorded. Side effects of nintedanib as well as tolerability of nintedanib compared to pirfenidone were also noted. Change in forced vital capacity (FVC) and symptoms after 6 months of use of nintedanib were analyzed. We prescribed nintedanib in 25 patients with IPF. Of these, twenty patients started the drug and five patients did not start primarily due to high costs. Of the twenty patients, there were 15 males and five females. The age of the patients ranged from 45 to 80 years (mean 60 years). While 16 patients had used pirfenidone before starting nintedanib, four patients were directly started on nintedanib. The mean duration of IPF before starting nintedanib was 3.05 years. The mean duration of pirfenidone use before starting nintedanib was 2.9 years (5 months to 7 years). Reasons for switching from pirfenidone to nintedanib were disease progression despite pirfenidone (eight patients), gastric side effects (seven patients), and both worsening and side effects (one patient). The mean FVC at the time of starting nintedanib was 1.43 L (mean predicted 50.4%). Follow-up pulmonary function tests (PFTs) after 6 months of nintedanib were available in only 12 patients out of twenty patients. The FVC of patients in whom PFTs were available was stable with decrease of FVC by a mean of 0.04 L at 6 months of starting nintedanib. At the time of analysis, of the 20 patients who received nintedanib, 16 were alive and 4 had died. One patient underwent lung transplant, whereas another was awaiting a lung transplant. Nintedanib was continued in 12 patients and stopped in 8 patients. Reasons for stopping nintedanib were death in four patients, lung transplant in one patient, worsening of disease despite nintedanib in two patient, and high cost in one patient. Of the patients who continued taking nintedanib, four felt symptomatically better, seven were static, and one worsened. Of 16 patients who had taken pirfenidone before starting nintedanib, 12 said that they tolerated nintedanib better than pirfenidone. Four patients had to reduce the dose to 100 mg twice a day in view of diarrhea. At this reduced dose, all four patients could tolerate the drug and no patient needed to stop treatment due to diarrhea. None of the patients had any liver function test derangement. Limitations of our study are first it was a retrospective study. Second, a follow-up PFT was available in only 12/20 patients. Third, significant numbers (6/25) of patients prescribed nintedanib could not commence or continue it due to high costs. Nintedanib was well tolerated in Indian patients with IPF. Outcomes were mixed probably due to the advanced stage of disease at the time it was introduced. Cost remains a concern for long-term administration. Starting nintedanib early in the course of IPF might provide greater benefits.[4] Further studies are needed before combination therapy of nintedanib with pirfenidone can be offered to patients.

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Conflicts of interest

There are no conflicts of interest.
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1.  Real world efficacy and safety of nintedanib in idiopathic pulmonary fibrosis: A single center, observational study from India.

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