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In the SURPASS-CVOT trial, tirzepatide met its primary endpoint of non-inferiority to dulaglutide for MACE-3, though it lacks an FDA-approved MACE-reduction indication in the U.S.[2] Post hoc cardiorenal analyses examined outcomes beyond the primary MACE endpoint in patients with concurrent cardiovascular and renal risk [3]

In explaining its decision, the agency flagged concerns about complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization, the potential for aggregation and a lack of human safety data

that is, if 14 patients were treated for 4 years with metformin 850 mg t.d.s., one would develop vitamin B12 deficiency