Trial Outcomes & Findings for 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 (NCT NCT03958071)

NCT ID: NCT03958071

Last Updated: 2021-11-15

Results Overview

IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic age for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

Recruitment status

COMPLETED

Target enrollment

13264 participants

Primary outcome timeframe

Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Results posted on

2021-11-15

Participant Flow

This retrospective database study was conducted to understand differences in characteristics of Idiopathic pulmonary fibrosis (IPF) patients who were newly prescribed pirfenidone or nintedanib, and those who did not receive a prescription for an antifibrotic treatment.

The study includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data.

Participant milestones

Participant milestones
Measure
Nintedanib
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Overall Study
STARTED
347
423
12494
Overall Study
COMPLETED
347
423
12494
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nintedanib
n=347 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
n=423 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
n=12494 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Total
n=13264 Participants
Total of all reporting groups
Sex/Gender, Customized
Male
234 Participants
n=39 Participants
281 Participants
n=41 Participants
6179 Participants
n=35 Participants
6694 Participants
n=31 Participants
Sex/Gender, Customized
Female
113 Participants
n=39 Participants
142 Participants
n=41 Participants
6314 Participants
n=35 Participants
6569 Participants
n=31 Participants
Sex/Gender, Customized
Unknown
0 Participants
n=39 Participants
0 Participants
n=41 Participants
1 Participants
n=35 Participants
1 Participants
n=31 Participants
Race/Ethnicity, Customized
White
305 Participants
n=39 Participants
370 Participants
n=41 Participants
10039 Participants
n=35 Participants
10714 Participants
n=31 Participants
Race/Ethnicity, Customized
Non-white
16 Participants
n=39 Participants
15 Participants
n=41 Participants
1093 Participants
n=35 Participants
1124 Participants
n=31 Participants
Race/Ethnicity, Customized
Unknown
26 Participants
n=39 Participants
38 Participants
n=41 Participants
1362 Participants
n=35 Participants
1426 Participants
n=31 Participants
Age, Continuous
71.6 years
STANDARD_DEVIATION 6.7 • n=39 Participants
72.1 years
STANDARD_DEVIATION 6.8 • n=41 Participants
70.9 years
STANDARD_DEVIATION 8.9 • n=35 Participants
70.96 years
STANDARD_DEVIATION 8.79 • n=31 Participants

PRIMARY outcome

Timeframe: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.

IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic age for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

Outcome measures

Outcome measures
Measure
Nintedanib
n=347 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
n=423 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
n=12494 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Baseline Patient Characteristics: Age
71.6 years
Standard Deviation 6.7
72.1 years
Standard Deviation 6.8
70.9 years
Standard Deviation 8.9

PRIMARY outcome

Timeframe: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. One patient from the untreated cohort was missing gender information and is not shown in the table

IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic sex for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

Outcome measures

Outcome measures
Measure
Nintedanib
n=347 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
n=423 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
n=12493 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Baseline Patient Characteristics: Sex
Male
234 Participants
281 Participants
6179 Participants
Baseline Patient Characteristics: Sex
Female
113 Participants
142 Participants
6314 Participants

PRIMARY outcome

Timeframe: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.

The patient characteristic Body mass index (BMI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

Outcome measures

Outcome measures
Measure
Nintedanib
n=347 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
n=423 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
n=12494 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Baseline Patient Characteristics: BMI
29.5 kilogram/height in meters squared(kg/m²)
Standard Deviation 6.4
30.1 kilogram/height in meters squared(kg/m²)
Standard Deviation 5.8
28.6 kilogram/height in meters squared(kg/m²)
Standard Deviation 6.5

PRIMARY outcome

Timeframe: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.

IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized HIPPA compliant database populated with patient data from ambulatory care records. Charlson Comorbidity Index (CCI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.

Outcome measures

Outcome measures
Measure
Nintedanib
n=347 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
n=423 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
n=12494 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Baseline Patient Characteristics: Charlson Comorbidity Index (CCI)
0.71 Score on a scale
Standard Deviation 1.0
0.79 Score on a scale
Standard Deviation 1.1
1.09 Score on a scale
Standard Deviation 1.4

PRIMARY outcome

Timeframe: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.

IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with inhaled corticosteroids for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

Outcome measures

Outcome measures
Measure
Nintedanib
n=347 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
n=423 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
n=12494 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline
125 Participants
134 Participants
3311 Participants

PRIMARY outcome

Timeframe: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.

IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with Proton pump inhibitors for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

Outcome measures

Outcome measures
Measure
Nintedanib
n=347 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
n=423 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
n=12494 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline
113 Participants
133 Participants
3141 Participants

SECONDARY outcome

Timeframe: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.

Odds ratio of receiving nintedanib or pirfenidone vs. no antifibrotic treatment, adjusting for patient characteristics; to identify baseline characteristics that drive initiation of a treatment while minimizing prescription bias. Logistic regression models were developed to assess the odds. Baseline patient characteristics that were sufficiently populated, had ASD \>10% or p-value \<0.05, and were agreed upon as important variables to include, were included as covariates for a full model. Linearity of age was confirmed before including it as a continuous variable in one version of the model. Backward selection was applied to develop a reduced model, only retaining covariates with p\<0.1 after forcing age at index, gender, geographic region, BMI, CCI, and Chronic obstructive pulmonary disease (COPD) into the model. Odds presented for key patient characteristics. Odd ratio of \>1 indicates increased odds of receiving treatment.

Outcome measures

Outcome measures
Measure
Nintedanib
n=13264 Participants
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription.
Pirfenidone
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription.
Untreated
Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts.
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Age
1.022 Odds ratio
Interval 1.012 to 1.032
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Gender
0.490 Odds ratio
Interval 0.419 to 0.574
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
BMI category: Overweight
1.359 Odds ratio
Interval 1.113 to 1.66
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Comorbidities: Stroke
0.449 Odds ratio
Interval 0.226 to 0.889
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
BMI category: Obese
1.833 Odds ratio
Interval 1.483 to 2.265
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
BMI category: Very obese
1.638 Odds ratio
Interval 1.281 to 2.096
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Comorbidities: COPD
0.581 Odds ratio
Interval 0.457 to 0.739
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Comorbidities: Heart failure
0.449 Odds ratio
Interval 0.299 to 0.675
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Comorbidities: Hypertension
0.663 Odds ratio
Interval 0.527 to 0.835
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Comorbidities: Peripheral arterial diseases
0.383 Odds ratio
Interval 0.186 to 0.787
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Comorbidities: Severe diseases
0.463 Odds ratio
Interval 0.328 to 0.653
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Gastroesophageal reflux disease
1.621 Odds ratio
Interval 1.291 to 2.036

Adverse Events

Nintedanib

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Pirfenidone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Untreated

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Results disclosure agreements

  • Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER