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Flexible Dosing Plan for Atorvastatin Allows Patients to Achieve Target LDL: Presented at ISA

By Eurona Earl Tilley

KYOTO, JAPAN -- October 6, 2003 -- Initiating atorvastatin at higher doses than the usual 10 mg starting dose provides patients with a greater success rate in achieving low-density lipoprotein (LDL) cholesterol goals, according to a study presented on October 1^st at the 13^th International Symposium on Atherosclerosis.

Peter Jones, MD, Director of Clinical Trials, Medical Director for Weight Management, Methodist Wellness Services, Co-director, Lipid Metabolism and Atherosclerosis Clinic, Baylor College of Medicine, Houston, Texas, United States, presented the results from a study using various doses of atorvastatin.

In 2002, the United States Food and Drug Administration permitted an increase in the starting dose of atorvastatin to 40 mg once daily if a patient required a 45% or more reduction in LDL level. If necessary, patients could receive 80 mg once daily to achieve proper LDL levels.

Dr. Jones and associates designed a large-scale study to assess the LDL benefits of atorvastatin at different starting doses after an 8-week washout, placebo run-in period. The researchers randomised 919 patients from 51 outpatient centres to 1 of 4 treatment groups for 8 weeks of: atorvastatin 10 mg/day; atorvastatin 20 mg/day, atorvastatin 40 mg/day, or atorvastatin 80 mg/day.

Participants were evaluated for percent change from baseline to the study end point in LDL, total cholesterol, high-density lipoprotein (HDL), ratio of LDL to HDL, apolipoprotein B (apo B), and triglycerides. The researchers also evaluated the proportion of patients reaching the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III LDL cholesterol goals at the end of the study.

By the completion of the study, Dr. Jones and associates found that there was a 36% decrease in LDL levels with atorvastatin 10 mg, a 42% decrease in LDL with the 20 mg dose, a 49% decrease in LDL with 40 mg, and a 53% decrease with the 80 mg dose.

Levels of triglycerides, total cholesterol, ratio of LDL to HDL, and apo B were reduced in all dose groups. An increase in HDL was seen in all groups. In addition, NCEP ATP III LDL goals were reached in 59% of the 10 mg group, 74% of the 20 mg group, 87% of the 40 mg group, and 85% of the 80mg group by the completion of the study.

Dr. Jones explained that although 40 patients discontinued the study due to adverse events, all doses of atorvastatin were well tolerated, and no dose-response relationship in the overall incidence of adverse events was observed. The most common reported side effect was myalgia, and less than 1% of patients experienced elevations in liver transaminases and creatinine phosphokinase.


[Study title: Comparison of the Efficacy and Safety of Atorvastatin Initiated at Different Starting Doses. Abstract 3P-0815]

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