Dose Reduction and Discontinuation With Anti-Fibrotic Medications
Study Details
Study Description
Brief Summary
The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pirfenidone initiators Patients who initiated pirfenidone treatment |
Drug: Pirfenidone
Pirfenidone
|
| Nintedanib initiators Patients who initiated nintedanib treatment |
Drug: Nintedanib
Nintedanib
|
Outcome Measures
Primary Outcome Measures
- Incidence of dose reduction and/or temporary dose reduction [up to 12 months]
Incidence of dose reduction/interruption will be defined as average daily dose not following the prescribing information of nintedanib and pirfenidone, for at least 60 consecutive days. Correspondence to ≤ 90% dose strength for pirfenidone or ≤ 66.67% dose strength for nintedanib
Secondary Outcome Measures
- Drug discontinuation [up to 12 months]
Defined as: Presence of sixty or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Presence of at least one pirfenidone or nintedanib prescription during the identification period (0/01/2014 to 09/30/2021; the date of first prescription for pirfenidone/nintedanib is the index date)
-
Evidence of IPF: patient with at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF during the study period (10/01/2013 to 09/30/2022)
-
At least 18 years old at the index date
-
Have at least 12 months of continuous enrollment in the health plan during pre-index period, and at least 6 months of continuous enrollment in post-index period
Exclusion Criteria:
-
Any history of lung transplant during the 12-months pre-index/baseline period
-
Any claims for a skilled nursing facility, a long-term care facility or hospice care during the 12-month pre-index period
-
Evidence of non-IPF chronic fibrosis Interstitial Lung Disease (ILD) or connective tissue diseases during the 12-months pre-index period. The following conditions will be excluded: autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's syndrome, and mixed connective tissue disease (CTD), sarcoidosis, and hypersensitivity pneumonitis).
-
Missing demographic information (i.e., age or sex)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim | Ridgefield | Connecticut | United States | 06877 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1199-0526