作者: R MAS , G CASTANO , J ILLNAIT , L FERNANDEZ , J FERNANDEZ
DOI: 10.1016/S0009-9236(99)70139-6
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摘要: Introduction This study was undertaken to evaluate the efficacy, safety, and tolerability of policosanol, a new cholesterol-lowering drug, in patients with type II hypercholesterolemia additional coronary risk factors. Patients methods After 5 weeks standard step-1 lipid-lowering diet, 437 were randomized receive, under double-blind conditions, mg policosanol or placebo once day evening meal for 12 10 next weeks. Results Both groups similar at randomization. Policosanol (5 mg/day) significantly reduced (P < .001) serum low-density lipoprotein cholesterol (18.2% 25.6%, respectively) (13.0% 17.4%), it raised .01) high-density (15.5% 28.4%). Triglycerides remained unchanged after first lowered (5.2%; P completion. safe well tolerated, no drug-related disturbances observed. Two male who received died during study—one because myocardial infarction other cardiac arrest that occurred surgical intervention. There 11 serious adverse events (5.1%) (4.6%), 7 which vascular, compared reported receiving .01). Conclusions Subjects group treated did not have 24-week study. This shows is effective, safe, tolerated concomitant factors. Clinical Pharmacology & Therapeutics (1999) 65, 439–447; doi: