The Effect of Pirfenidone on the Prescription of Antibiotics and Antitussive Drugs in Patients With Idiopathic Pulmonary Fibrosis

Abstract

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and devastating fibrotic lung disease. 1 Patients with IPF often experience various symptoms as pulmonary function deteriorates, which are associated with an increase in the prescription of concomitant drugs. Most IPF patients are middle-aged to older adults with various comorbidities, leading to further increase in the use of concomitant drugs. 2 This polypharmacy results in complications related to the drug-drug interactions and increases in medical spending. 3 There is an urgent need to find ways to avoid polypharmacy in the management of IPF.Pirfenidone is an antifibrotic drug approved in multiple countries for the treatment of IPF. [4][5][6] In multinational phase III clinical trials, pirfenidone reduced disease progression as reflected by pulmonary function, exercise tolerance, and progression-free survival in patients with IPF. 4,5 Studies further demonstrated that pirfenidone reduces respiratory-related hospitalizations and objective cough. 7,8 Considering these findings, we posited that pirfenidone may reduce the prescription of antibiotics and antitussive drugs and contribute to the avoidance of polypharmacy. The aim of this study was to assess the potential effects of pirfenidone in delaying the prescription of concomitant drugs in patients with IPF. MethodsThis is a post hoc exploratory analysis of a phase III multicenter, randomized, double-blind, placebo-controlled trial, conducted with Japanese IPF patients to determine the efficacy and safety of pirfenidone over 52 weeks. 6 In this phase III clinical trial, 325 patients were screened at 73 centers in Japan, and 275 patients were randomized to one of the three groups: high-dose pirfenidone (1,800 mg/day), low-dose pirfenidone (1,200 mg/day), and placebo. Two hundred sixty-seven patients were deemed eligible for the full analysis set (high-dose pirfenidone, n ¼ 108; low-dose pirfenidone, n ¼ 55; placebo, n ¼ 104). Eight patients were excluded for lack of post-baseline data. The full analysis set population was used in this post hoc exploratory analysis. The clinical trial protocol was approved by the institutional review board at each center, and written informed consent was obtained from all participants. The diagnostic criteria of IPF in the trial was previously described. 6 This clinical trial was registered with the Japan Pharmaceutical Information Center on September 13, 2005 (JapicCTI-050121).

Bibliometric analysis of the pirfenidone and nintedanib in interstitial lung diseases

“…Authors with top citations were mainly from the United States, counting half of the top 10 co-cited authors. The five authors (Raghu G, King TE, Noble PW, Azuma A, Nathan SD) contributed to this research field by conducting high-quality randomized controlled trials of pirfenidone in IPF, and their work facilitated the development and application of pirfenidone in the respiratory system, basically as the milestones of this field [ 7 , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] ]. As for the co-occurrence keywords map of pirfenidone, we noticed that the clinical-related and molecular pathway-related keywords occupied more than half area of the picture.…”

Health Related Quality of Life in Interstitial Lung Disease: Can We Use the Same Concepts Around the World?

“…As disease-specific HRQOL PROMs generally reflect changes in these parameters, these have characteristically been chosen for use in those clinical trials (77,98,100). As patient-centered research in ILD expands, future interventions may target the more disease-specific symptoms (e.g., cough, dyspnea, fatigue) (158)(159)(160). For these clinical trials, domain-specific PROMs focusing on each symptom may likely be chosen as the primary endpoint and therefore these instruments will need to be adapted for use cross-culturally.…”