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).