An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In an open single arm pilot study, two men (aged 45 years and 46 years) were described; the 45-year-old man developed elevation in INR following concomitant administration of tranilast and warfarin, and increase in HR during treatment with tranilast, while the 46-year-old man developed impairment of renal function during treatment with tranilast for cardiomyopathy of muscular dystrophy [routes and durations of treatments to reactions onsets not stated].
Patient 1: A 45-year-old man had Becker muscular dystrophy, advanced cardiomyopathy, advanced heart failure and severe cardiac dysfunction. Additionally, he had deletion of exons 3 and 4 in the dystrophin gene. He had been under treatment with unspecified angiotensin converting enzyme inhibitors (for 20 years) and...
- Matsumura T, et al. A Pilot Study of Tranilast for Cardiomyopathy of Muscular Dystrophy. Internal Medicine 57: 311-318, No. 3, 1 Feb 2018. Available from: URL: http://doi.org/10.2169/internalmedicine.8651-16 - Japan