1. Rationale and design of a secondary prevention trial of increasing serum high-density lipoprotein cholesterol and reducing triglycerides in patients with clinically manifest atherosclerotic heart disease (the Bezafibrate Infarction Prevention Trial)
- Author
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Shimeon Braun, Leornardo Reisin, Elieser Kaplinsky, Yehezkiel Kishon, Michael Flich, Daniel Tzivoni, Libi Sherf, Solomon Behar, Lori Mandelzweig, Monty Zion, Yaacov Friedman, Natalio Kristal, Nathan Roguin, Edward Abinader, Daniel Brunner, Samuel Sclarovsky, Avraham Caspi, Eran Graft, Walter Markiewicz, Tiberio Rosenfeld, Noa Leil, Joshua Weisbort, Henrietta Reicher-Reiss, Abraham Palant, Alon Marmor, Leon Aharon, Daniel David, Babeth Rabinowitz, Jacob Agmon, Zwi Schlesinger, Uri Goldbourt, Izhar Zahavi, and Benjamin Pelled
- Subjects
Male ,medicine.medical_specialty ,Heart disease ,Myocardial Infarction ,Infarction ,Coronary Artery Disease ,Coronary artery disease ,chemistry.chemical_compound ,Clinical Protocols ,Double-Blind Method ,Risk Factors ,Internal medicine ,medicine ,Humans ,Myocardial infarction ,Triglycerides ,Aged ,Bezafibrate ,Triglyceride ,business.industry ,Cholesterol ,Cholesterol, HDL ,Middle Aged ,medicine.disease ,Death, Sudden, Cardiac ,chemistry ,Cardiology ,Feasibility Studies ,lipids (amino acids, peptides, and proteins) ,Female ,Ischemic chest pain ,Cardiology and Cardiovascular Medicine ,business ,Algorithms ,medicine.drug - Abstract
Controlled clinical trials have demonstrated the efficacy of reducing the blood levels of low-density lipoprotein cholesterol in reducing the incidence of coronary artery disease in hypercholesterolemic middle-aged men. However, a similar reversibility of the risk of coronary artery disease has not been demonstrated for high-density lipoprotein cholesterol elevation and triglyceride reduction. Therefore, the effect of administering 400 mg of bezafibrate retard daily versus placebo (double blind) to patients with myocardial infarction preceding randomization by 6 months to 5 years, or a clinically manifest anginal syndrome documented by objective evidence of dynamic myocardial ischemia, or both, is being investigated. Three thousand subjects (aged 45 to 74 years) are being enrolled from 19 cardiac departments in Israel, with total serum cholesterol between 180 and 250 mg/dl, high-density lipoprotein cholesterolor = 45 mg/dl and triglyceridesor = 300 mg/dl. In addition, low-density lipoprotein cholesterol concentrations are required to beor = 180 mg/dl (or = 160 mg/dl for patients aged50 years). Patients needing lipid-modifying therapy, exhibitingor = 1 prespecified exclusion criterion or not giving informed consent, or a combination, are not randomized. The primary end points for evaluating efficacy are the incidence of fatal and nonfatal myocardial infarction, and sudden death. The hypothesized effect of bezafibrate administration under the aforementioned protocol is to reduce an estimated cumulative end point event incidence ofor = 15% by 20 to 25% over an average follow-up period of 6.25 years, through early 1998, when the last patient recruited will have completed 5 years.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1993