Safety and Efficiency of Dipeptidyl Peptidase IV Inhibitors in Patients with Diabetic Kidney Disease: A Systematic Review and Meta-Analysis.

Background: To investigate the safety and efficiency of dipeptidyl peptidase-4 (DPP-4) inhibitors in patients with diabetic kidney disease.

Methods: We conducted a comprehensive literature search across multiple databases, including Embase, PubMed, CNKI, and the Cochrane Central Register of Controlled Trials, from inception to January 2024. The search focused on randomized controlled trials (RCTs) that directly compared DPP-4 inhibitors with placebos or other glucose-lowering therapies.

Drug Review and Approval Policies Based on Real-world Evidence in China and the United States: A Comparative Study.

Purpose: The use of real-world evidence (RWE) in regulatory reviews and approvals is currently experiencing significant changes amid increasingly active discussions, primarily reflected in relevant policies, regulations, and guidance documents. However, disparities persist between China and the United States regarding the acceptance and formulation of policies for incorporating real-world data/evidence (RWD/E) in regulatory evaluation and authorization. Furthermore, the current policies lack specific operational details necessary for effective implementation and widespread adoption.