Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and RosuvastatinReport as inadecuate




Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin - Download this document for free, or read online. Document in PDF available to download.

Trials

, 7:35

First Online: 21 December 2006Received: 03 May 2006Accepted: 21 December 2006DOI: 10.1186-1745-6215-7-35

Cite this article as: Clearfield, M.B., Amerena, J., Bassand, JP. et al. Trials 2006 7: 35. doi:10.1186-1745-6215-7-35

Abstract

BackgroundMany patients at high risk of cardiovascular disease do not achieve recommended low-density lipoprotein cholesterol LDL-C goals. This study compared the efficacy and safety of low doses of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia.

MethodsA total of 996 patients with hypercholesterolemia LDL-C ≥ 3.4 and < 5.7 mmol-L 130 and 220 mg-dL and coronary heart disease CHD, atherosclerosis, or a CHD-risk equivalent were randomized to once-daily rosuvastatin 10 mg or atorvastatin 20 mg. The primary endpoint was the percentage change from baseline in LDL-C levels at 6 weeks. Secondary endpoints included LDL-C goal achievement National Cholesterol Education Program Adult Treatment Panel III NCEP ATP III goal < 100 mg-dL; 2003 European goal < 2.5 mmol-L for patients with atherosclerotic disease, type 2 diabetes, or at high risk of cardiovascular events, as assessed by a Systematic COronary Risk Evaluation SCORE risk ≥ 5% or 3.0 mmol-L for all other patients, changes in other lipids and lipoproteins, cost-effectiveness, and safety.

ResultsRosuvastatin 10 mg reduced LDL-C levels significantly more than atorvastatin 20 mg at week 6 44.6% vs. 42.7%, p < 0.05. Significantly more patients achieved NCEP ATP III and 2003 European LDL-C goals with rosuvastatin 10 mg compared with atorvastatin 20 mg 68.8% vs. 62.5%, p < 0.05; 68.0% vs. 63.3%, p < 0.05, respectively. High-density lipoprotein cholesterol was increased significantly with rosuvastatin 10 mg versus atorvastatin 20 mg 6.4% vs. 3.1%, p < 0.001. Lipid ratios and levels of apolipoprotein A-I also improved more with rosuvastatin 10 mg than with atorvastatin 20 mg. The use of rosuvastatin 10 mg was also cost-effective compared with atorvastatin 20 mg in both a US and a UK setting. Both treatments were well tolerated, with a similar incidence of adverse events rosuvastatin 10 mg, 27.5%; atorvastatin 20 mg, 26.1%. No cases of rhabdomyolysis, liver, or renal insufficiency were recorded.

ConclusionIn high-risk patients with hypercholesterolemia, rosuvastatin 10 mg was more efficacious than atorvastatin 20 mg at reducing LDL-C, enabling LDL-C goal achievement and improving other lipid parameters. Both treatments were well tolerated.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-7-35 contains supplementary material, which is available to authorized users.

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Author: Michael B Clearfield - John Amerena - Jean-Pierre Bassand - Hugo R Hernández García - Sam S Miller - Froukje FM Sosef

Source: https://link.springer.com/







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