DI-082 Adverse events of pirfenidone and cause of suspension in clinical practice

BackgroundIn 2011, pirfenidone was the first drug to be approved for the treatment of idiopathic pulmonary fibrosis (IPF) in Europe after reduced decline in per cent predicted forced vital capacity (FVC) in two phase III trials.PurposeTo describe the adverse events observed and recorded for patients receiving treatment with pirfenidone in the pharmaceutical consultation with the pharmacist.To describe the duration of treatment with pirfenidone and the cause of its suspension, if it occurred. To compare the results obtained with those published in the clinical trials.Material and methodsA prospective, descriptive and observational study to assess the safety and duration of treatment with pirfenidone. Patients receiving treatment with pirfenidone were eligible for the study. The main variable was adverse events notified by the patient during the pharmaceutical interview at the outpatient pharmacy unit. These events are registered by the pharmacist in the electronic health record. Qualitative variables are expressed as absolute number and percentage. Quantitative variables are expressed as median ± SD.Results16 patients were included from 31 March 2014 to 31 March 2015; 4 women (25%) and 12 men (75%). Mean age of patients was 72.8 years (SD±6.82). 38 adverse events were recorded in 12 patients (75%) compared with 4 patients that did not report any. The most common adverse events were gastrointestinal disorders with 18 events (anorexia (n = 9; 75%), dyspepsia (n = 6; 50%), nausea and vomiting (n = 2; 16.7%) and diarrhoea (n = 1; 8.3%)). Other adverse events were liver enzyme elevation (ALT/AST (n = 4; 10%)), fatigue (n = 3; 8%), insomnia (n = 3; 8%), rhinorrhoea (n = 1; 2.6%), dysgeusia (n = 1; 2.6%), hypotension (n = 1; 2.6%), dizziness (n = 1; 2.6%), brittle nails (n = 1; 2.6%), photosensitivity (n = 1; 2.6%) and pruritis (n = 1; 2.6%).5 patients (31.5%) discontinued pirfenidone due to adverse events; 3 women and 2 men. The reasons were due to gastrointestinal disorders in 3 patients (60%), AST elevation in 1 patient (20%) and asthenia in 1 patient (20%). No cases discontinued due to skin related adverse events. Other adverse events were generally mild to moderate. Mean duration of treatment was 103.4 days (SD±70.8) in people who needed to stop taking the drug.ConclusionAdverse reactions found in our study were similar to those in clinical trials. We observed that women have less tolerance to pirfenidone and need lower doses for maintenance treatment. There