Pharmacology 4350A/B Lecture Notes - Lecture 10: Torcetrapib, Pioglitazone, Atorvastatin
Document Summary
Rosiglitazone increase vascular events + pioglitazone may decrease. Rosuvastatin no effect on heart failure + atorvastatin helps heart failure. Only young healthy volunteers while most drug toxicity occur to senior/renal/hepatic failure. Rct endpoints are efficacy endpoints, usually not safety efficacy. Example: spironolactone shown in 1 rct to help with heart failure + no hyperkalemia. No cv endpoints but meta-analysis show increase risk for cv events (rosiglitazone pulled) Allow similar endpoints equally relevant to be grouped. Better understanding on overall therapy on a particular disease. Some endpoints may be related and in a composite preserves intent-to-treat. Example: pioglitazone (treating diabetes 2), changed primary endpoints to all -cause mortality. Clinical trials are designed for a primary hypothesis with primary endpoints. Sample size + variables + power + subgroups are all geared towards primary endpoint. Are there endpoints that occur in different frequency. Fda does not require clinically relevant endpoints (death) to approve drugs based on surrogate endpoints.