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

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 3, 2012, Pages 514-520

  Marcinak, J F ^a   Viswanathan, P ^a   Arora, V ^a,b   Roebel, L E ^a   Strack, T R ^a   Leifke, E ^a  

^a TAKEDA PHARMACEUTICALS   (United States)

^b ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; AMLODIPINE; ANTIDIABETIC AGENT; ATORVASTATIN; BENAZEPRIL; BROMOCRIPTINE; CANAGLIFLOZIN; CAPTOPRIL; CLOPIDOGREL; DAPAGLIFLOZIN; EMPAGLIFLOZIN; ENALAPRIL; FLUINDOSTATIN; GLUCAGON LIKE PEPTIDE 1; HYDROCHLOROTHIAZIDE; IRBESARTAN; LINAGLIPTIN; LIRAGLUTIDE; LIXISENATIDE; PIOGLITAZONE; PRASUGREL; PRAVASTATIN; QUINAPRIL; RAMIPRIL; ROSUVASTATIN; SAXAGLIPTIN; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; TELMISARTAN; TRANDOLAPRIL; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ARTICLE; CLINICAL ASSESSMENT; FOLLOW UP; HEALTH PROGRAM; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HOSPITALIZATION; HUMAN; MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RISK ASSESSMENT; STROKE; UNSTABLE ANGINA PECTORIS;

BIOLOGICAL MARKERS; CARDIOVASCULAR DISEASES; CLINICAL TRIALS, PHASE III AS TOPIC; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FOLLOW-UP STUDIES; HOSPITALIZATION; HUMANS; HYPOGLYCEMIC AGENTS; OUTCOME ASSESSMENT (HEALTH CARE); PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS;

EID: 84857231774     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.257     Document Type: Article

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