Cardiovascular and bleeding risk factors in Esbriet clinical trials: retrospective analysis 22

Study design

  • A retrospective blinded review of AE preferred terms to identify MACE-plus and bleeding events (up to 28 days post-treatment) in three randomized, placebo-controlled phase 3 trials of pirfenidone (ASCEND, CAPACITY 004, and CAPACITY 006)*
  • Patients with unstable or deteriorating cardiac disease within 6 months before enrollment were ineligible for phase 3 trials of pirfenidone
  • MACE-plus is defined as major adverse cardiac events–plus, which included non-fatal myocardial infarction, non-fatal stroke, acute coronary syndrome, and any CV death due to myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures (immediate), or other CV causes (eg, pulmonary embolism, peripheral arterial disease)

CV=cardiovascular; RAAS=renin-angiotensin-aldosterone system; BMI=Body Mass Index.
*MACE-plus events were adjudicated by an external academic cardiologist who was blinded to the treatment assignment.
CV risk factors, not including age or sex, were defined as smoking, hypertension, hypercholesterolemia, hyperlipidemia, diabetes, sleep apnea, and obesity (BMI ≥30).
The ASCEND study did not enroll current smokers.
§Obesity was based on the World Health Organization classification of BMI.

 

CV and bleeding events were evaluated in 1247 patients with IPF in a post hoc analysis of three phase 3 trials with Esbriet vs placebo 22

STUDY LIMITATIONS

  • This is a post hoc analysis; therefore, the findings may need to be interpreted with caution
  • This analysis is limited to a selected IPF clinical trial population. The occurrence of CV events might be higher in a broader group of patients with IPF
  • Concomitant use of warfarin and heparin was limited in this cohort

PERCENT OF PATIENTS WITH TREATMENT-EMERGENT MACE-PLUS EVENTS 22

PERCENT OF PATIENTS WITH TREATMENT-EMERGENT BLEEDING EVENTS 22

Adapted from Advances in Therapy. Glassberg MK, Nathan SD, Lin CY, et al. 2019;36(10):2910-2926.
||Other includes: GI hemorrhage, hemorrhagic stroke, pulmonary alveolar hemorrhage, vaginal hemorrhage, catheter-site hemorrhage, extravasation blood, urinary tract hemorrhage, hemorrhoidal hemorrhage, injection-site hemorrhage, large intestinal hemorrhage, peptic ulcer hemorrhage, postmenopausal hemorrhage, pulmonary hemorrhage.