Reply discusses fracture risk associated with PPAR agonists in primary biliary cholangitis, indicating need for further studies.
Key Points
The response aims to clarify the fracture risk associated with selective versus non-selective PPAR agonists in patients with primary biliary cholangitis.
Analysis of fracture rates from the phase 3 RESPONSE trial for seladelpar and BEZURSO trial data.
Comparison of fracture rates between placebo and bezafibrate groups as reported by Corpechot et al.
Discussion on the mechanisms behind PPAR agonism and fracture risk.
Fracture rates were 4.1, 3.0, and 2.7 per 100 subject-years for seladelpar across three years, similar to bezafibrate's rates (2.2 and 3.1 per 100 subject-years).
Toe and thumb fractures were mentioned, deemed non-osteoporotic and raising concerns for bezafibrate's overall fracture risk.
Emphasis on the need for further studies to understand the implications of PPAR agonist treatments on bone health.