A new statin: A new standard (original) (raw)
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American Journal of Cardiology, 2003
A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n ؍ 390) and 10 mg (n ؍ 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n ؍ 393) (41.9% and 46.7% vs 36.4%, both p <0.001). Treatment with rosuvastatin 5 mg (n ؍ 240) and 10 mg (n ؍ 226) also resulted in significantly greater reductions in LDL cholesterol compared with both simvastatin 20 mg (n ؍ 249) and pravastatin 20 mg (n ؍ 252) (40.6% and 48.1% vs 27.1% and 35.7%, all p <0.001). Significant differences favoring rosuvastatin 10 mg were also observed for total cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, apolipoprotein (apo) B, and apo A-I versus atorvastatin 10 mg, and for total cholesterol, HDL cholesterol, triglycerides, non-HDL cholesterol, and apo B versus simvastatin 20 mg and pravastatin 20 mg. Analyses of all the rosuvastatin 10 mg data (n ؍ 615) from the 5 trials in subgroups defined by age >65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that rosuvastatin had consistent efficacy across patient subgroups. ᮊ2003 by Excerpta Medica, Inc.
Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia
American Journal of Cardiology, 2001
Rosuvastatin is a new, synthetic, orally active statin, with marked low-density lipoprotein (LDL) cholesterol-lowering activity. We conducted 2 dose-ranging studies. In the first study, after a 6-week dietary run-in, 142 moderately hypercholesterolemic patients were randomized equally to receive double-blind placebo or rosuvastatin 1, 2.5, 5, 10, 20, or 40 mg or open-label atorvastatin 10 or 80 mg once daily for 6 weeks; in the second study, conducted to extend the rosuvastatin dose range, 64 patients were randomized to double-blind, once-daily placebo or rosuvastatin 40 or 80 mg (1:1:2 ratio) for 6 weeks. Data from both studies were combined for analysis of lipid effects. No statistical comparison of atorvastatin arms with placebo or rosuvastatin was performed. Rosuvastatin was associated with highly significant dose-dependent reductions in LDL cholesterol compared with placebo (p <0.001); decreases ranged from 34% (1 mg) to 65% (80 mg). Linear regression analysis indi-cated an additional 4.5% LDL cholesterol reduction for each doubling of the rosuvastatin dose. Across the dose range, approximately 90% of LDL cholesterol reduction occurred within the first 2 weeks of treatment. Significant, dose-dependent reductions in total cholesterol and apolipoprotein B with rosuvastatin were also observed (p <0.001). High-density lipoprotein cholesterol increases and triglyceride reductions were consistently observed and statistically significant at some dose levels. All lipid ratios were significantly reduced at all rosuvastatin dose levels (p <0.001). Adverse events were similar across placebo and active treatments. No significant increases in alanine aminotransferase or creatine kinase were seen in any patient. Over 6 weeks, rosuvastatin produced large, rapid, dose-dependent LDL cholesterol reductions and was well tolerated in hypercholesterolemic patients. ᮊ2001
Rosuvastatin: An Effective Lipid Lowering Drug against Hypercholesterolemia
The Internet Journal of Cardiovascular Research, 2006
Hypercholesterolemia (HC) is primarily implicated in the progression of coronary heart disease (CHD) and its treatment is essential. Statin such as rosuvastatin, the lipid-lowering agent, is well known for its ability to normalize patient's serum cholesterol level. The study was designed, to compare the lipid-modifying efficacy of rosuvastatin across HC. The efficacy of rosuvastatin (10mg) was found in 162 patients who met the inclusion criteria [fasting Total cholesterol (TC) concentration ≥ 200mg/dl, low density lipoprotein-Cholesterol (LDL-C) ≥ 130mg/dl and triglyceride (TG) ≤ 300 mg/dl]. Selected patients were subdivided into two groups (group 1-TC ≤ 240 mg/dl and group 2-TC > 240 mg/dl). The efficacy was determined by measuring changes from baseline in lipid parameters including LDL-C, TC, TG, high density lipoprotein-Cholesterol (HDL-C) and non-high density lipoprotein-Cholesterol (NHDL-C). TC, LDL-C, and NHDL-C significantly (p<0.001) reduced over their baselines. Mean changes at 8 weeks were-24 to-28.3% for TC,-19.5 to-20.1% for TG,-33.3 to-38.7% for LDL-C,-31.3 to-35.6% for NHDL-C, 6.5 to 6.9% for HDL-C,-28.9 to-33.2% for TC/HDL-C,-37.6 to-42.9% for LDL-C/HDL-C and-35.8 to-40% for NHDL-C/HDL-C. Rosuvastatin produces good reduction in TC and beneficial changes in other lipid fractions in hypercholesterolemic patients and is well tolerated.
American Heart Journal, 2004
Background This double-blind, multicenter, randomized trial compared rosuvastatin and atorvastatin for reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and a high risk of coronary heart disease. Methods After a 6-week dietary lead-in period, patients with LDL-C levels Ն160 and Ͻ250 mg/dL and triglyceride levels Յ400 mg/dL were randomly assigned to 24 weeks' treatment in 1 of 3 groups, each with forced dose titrations at 12 and 18 weeks. Starting and titrated doses for each group were rosuvastatin 5, 20, and 80 mg (n ϭ 127); rosuvastatin 10, 40, and 80 mg (n ϭ 128); and atorvastatin 10, 40, and 80 mg (n ϭ 128). Results At 24 weeks, LDL-C was reduced significantly more with 80 mg rosuvastatin (combined rosuvastatin group) than with atorvastatin 80 mg (60% vs 52% [P Ͻ .001]). At 12 weeks, rosuvastatin 5 and 10 mg reduced LDL-C significantly more than atorvastatin 10 mg (40% [P Ͻ .01], 47% [P Ͻ .001] vs 35%). At 18 weeks, LDL-C reductions were also significantly greater in both rosuvastatin groups than in the atorvastatin group (52% [P Ͻ .01], 59% [P Ͻ .001] vs 47%). Consequently, more patients receiving rosuvastatin achieved LDL-C goals. Total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, apolipoproteins B and A-I, and all lipid ratios were more favorably modified by rosuvastatin at 24 weeks (P Ͻ .01). Effects of the 2 agents on triglycerides were similar.