N/A
Completed N=13,264
A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking
Source: ClinicalTrials.gov NCT03958071 ↗Enrolled (actual)
13,264
Serious AEs
—
Results posted
Dec 2020
Primary outcomePrimary: Baseline Patient Characteristics: Age — 71.6; 72.1; 70.9 years — p=0.2810
Summary
To understand differences in characteristics of Idiopathic Pulmonary Fibrosis (IPF) patients who are prescribed nintedanib compared to those who are prescribed pirfenidone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Patient Characteristics: Age |
71.6; 72.1; 70.9 | 0.2810 |
| PRIMARY Baseline Patient Characteristics: Sex |
234; 281; 6179; 113; 142; 6314 | 0.7681 |
| PRIMARY Baseline Patient Characteristics: BMI |
29.5; 30.1; 28.6 | 0.1659 |
| PRIMARY Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) |
0.71; 0.79; 1.09 | 0.3260 |
| PRIMARY Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline |
125; 134; 3311 | 0.2042 |
| PRIMARY Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline |
113; 133; 3141 | 0.7395 |
| SECONDARY Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment |
1.022; 0.490; 1.359; 1.833; 1.638; 0.581 | — |
Eligibility Criteria
Inclusion Criteria
- With ≥ 1 diagnosis for IPF (the International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 516.3, 516.31, 515, or ICD-10-CM codes J84.112) in the EMR between October 1, 2013 to April 30, 2018
- With ≥ 1 prescription for nintedanib between October 1, 2014 and April 30, 2018 (the selection window)
- The date of the first prescription will be defined as the index date
- With ≥ 1 record in the EMR database during the 12 months prior to the index date (the pre-index period)
- With ≥ 1 diagnosis of IPF during the 12 months prior to the index date
- Age ≥ 40 on the index date
- IQVIA will explore also requiring ≥ 1 chest CT scan before first IPF diagnosis during the pre-index period
Exclusion Criteria
- With ≥ 1 diagnosis of other known causes of interstitial lung disease (ILD) on the date of or after the first IPF diagnosis during the pre-index period
- Other known causes of ILD include conditions such as systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Sjögren disease, and hypersensitivity pneumonitis (ICD-9-CM codes 135, 237.7, 272.7, 277.3, 277.8, 446.21, 446.4, 495, 500-505, 506.4, 508.1, 508.8, 516.0, 516.1, 516.32-516.37, 516.2, 516.8, 516.9, 517.0, 517.2, 517.8, 518.3, 555, 710.0, 710.0-710.4, 714.0, 714.81, 720, and 759.5, or ICD-10-CM equivalent codes)
- With ≥ 1 prescription for nintedanib prior to the index date
- With ≥ 1 prescription for pirfenidone prior to or on the index date
Data sourced from ClinicalTrials.gov (NCT03958071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.