Saroglitazar efficacy and safety
1 evidence topic · 2 sources
Summary
In the phase 3 portion of EPICS-III, 148 participants were randomized. The sponsor reported biochemical response at week 52 in 56.7% receiving saroglitazar and 9.8% receiving placebo. Serious adverse events were reported in 6.3% and 11.1%, respectively. The EASL Congress report described a statistically significant pruritus improvement at six months that was not maintained at 12 months. These results support a biochemical treatment effect but do not establish a reduction in liver transplantation or mortality.