Shift from surrogate end point to outcome trials: implications for cardiovascular safety assessment in development programs for antidiabetic drugs

• Published in: Clinical pharmacology and therapeutics Vol. 91; no. 3; p. 514
• Main Authors: Marcinak, J F, Viswanathan, P, Arora, V, Roebel, L E, Strack, T R, Leifke, E
• Format: Journal Article
• Language: English
• Published: United States 01.03.2012
• Subjects: Biomarkers - analysis; Cardiovascular Diseases - chemically induced; Clinical Trials, Phase III as Topic - methods; Diabetes Mellitus, Type 2 - drug therapy; Double-Blind Method; Endpoint Determination - methods; Follow-Up Studies; Hospitalization; Humans; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Outcome Assessment (Health Care); Prospective Studies; Randomized Controlled Trials as Topic - methods; Risk Factors

We assessed the effect of extending the range of cardiovascular (CV) end points to include hospitalization for unstable angina and hospitalization for coronary revascularization (Extended Major Adverse Cardiac Event criteria (MACE)) in addition to the standard ones, namely, CV-related death, nonfata...