The challenge of regulating development and approval drugs with pleiotropic action in cardiovascular disease

American Journal of Cardiology

Volumn 81, Issue 8 A, 1998, Pages 5F-9F

  Temple, Robert ^a   Dujovne, Carlos A ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Kansas Foundation for Clinical Pharmacology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL;

CARDIOVASCULAR DISEASE; CHOLESTEROL BLOOD LEVEL; CONFERENCE PAPER; DISEASE MARKER; DRUG EFFICACY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; MORTALITY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; TREATMENT OUTCOME;

EID: 0345020455     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-9149(98)00249-5     Document Type: Conference Paper

References (10)

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7. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias MN, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al. Mortality and morbidity in patients receiving encainide, flecanide or placebo. N Engl J Med 1991;324:781-788.
8. The Cardiac Arrhythmia Suppression Trial II Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med 1992;327:227-233.
9. Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4,444 patients with coronary artery disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1995;344:1383-1389.
10. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med 1995;333:1301-1306.