{
  "abstract": "Background and Importance Pulmonary fibrosis is a progressive disease, often treated with nintedanib. However, its use is frequently associated with adverse effects, necessitating careful management to optimise treatment outcomes.Aim and Objectives The primary objective of this study was to evaluate the incidence and risk factors associated with adverse events related to nintedanib treatment in patients with pulmonary fibrosis. The secondary objective was to determine whether efficacy, measured by forced vital capacity (FVC) and carbon monoxide diffusion capacity (DLco), was maintained throughout follow-up.Material and Methods This was an observational, retrospective, single-centre study including patients with pulmonary fibrosis who initiated nintedanib treatment between July 2024 and July 2025. Demographic and clinical variables were collected: age, sex, smoking status, oxygen therapy, carob flour use, body mass index (BMI), FVC, DLco, and type of adverse reactions. T-student was applied for qualitative variables and chi-square test for qualitative ones.Results Ninety-seven patients were included (64 women). Median age was 71 years [39-88], and median BMI was 28 [19-51]. Sixty-three (65%) had a history of smoking, and 28 (29%) were on oxygen therapy.Median baseline FVC was 78% [40-109] and 74% [50-115] at the end of the study. Median DLco was 51% [27-75] at baseline and 49% [13-86] at study completionTreatment persistence was 84.54%. Sixty-six patients (16.5%) maintained the full 300 mg/day dose, while 24.7% required dose reduction. Sixteen patients (16.5%) discontinued therapy due to gastrointestinal intolerance (56.3%), weight loss (6.3%), death (6.3%), patient decision (12.5%) or other causes (18.8%).Thirty-five patients (36.1%) showed hepatic enzyme alterations. Fifty-nine (60.8%) had adverse gastrointestinal reactions: mainly diarrhoea (53.6%) and 15.46% nausea. Of these, 38.14% needed to include carob flour in their diet. Additionally, 38.1% presented other adverse events.BMI and hepatic enzyme alterations showed a significant inverse correlation (p = 0.045), lower BMI was associated with more hepatic profile alteration. No other significant associations were found between clinical or demographic variables.Conclusion and Relevance During nintedanib therapy, active monitoring and management of adverse events are essential to sustain the treatment persistence. Among the variables analysed, body mass index (BMI) was the only factor significantly associated with adverse events. FVC and DLco values showed a modest decline during follow-up.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, L’hospitalet De Llobregat, Spain"
      ],
      "name": "MD Comas-Sugrañes"
    },
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, L’hospitalet De Llobregat, Spain"
      ],
      "name": "S Gamarra Calvo"
    },
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, L’hospitalet De Llobregat, Spain"
      ],
      "name": "E Murillo Moreno"
    },
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, Hospital De Llobregat, Spain"
      ],
      "name": "M Santos"
    },
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, L’hospitalet De Llobregat, Spain"
      ],
      "name": "C Ribera Puig"
    },
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, L’hospitalet De Llobregat, Spain"
      ],
      "name": "M Canedo Castelo"
    },
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, L’hospitalet De Llobregat, Spain"
      ],
      "name": "V Vicens Zygmunt"
    },
    {
      "affiliations": [
        "Hospital Universitari De Bellvitge, Hospital Pharmacy, L’hospitalet De Llobregat, Spain"
      ],
      "name": "MB Badia Tahull"
    }
  ],
  "title": "4CPS-215 Adverse effects and their management in patients with pulmonary fibrosis treated with nintedanib",
  "uid": "61e36c08-639b-5f19-bd1d-55a7b24f7e4c"
}