Effects of Low and High Dose Atorvastatin on Exercise-induced Muscle Injury: Downhill Walking Protocol

Purpose: The purpose of this study is to examine the effects of a low (10 mg) and high (80mg) dose of cholesterol lowering medication, atorvastatin on the development of muscle soreness and markers of muscle proteins in the blood. In this study, you will perform a strenuous exercise that consists of 3 bouts of 15 minutes of walking on a specially designed treadmill that allows you to walk downhill. You will be asked to take atorvastatin for a total of 5 weeks. We will assess the effects of the dose of atorvastatin on muscle soreness produced from the exercise. Atorvastatin (LIPITORä ) is an FDA-approved marketed product.

The strenuous exercise that will be used is an exercise of downhill walking performed on a modified treadmill. The exercise causes muscle soreness 1 to 2 days after exercise and an increase in muscle proteins in the blood. The number of research subjects to be tested is approximately 45 for this study, which is scheduled for June 2005-June 2006. Your participation will be for approximately 8 weeks. You are eligible for this study if you are a man between 18-65 years of age who has high cholesterol (low density lipoprotein cholesterol (LDL-C)>130 mg/dL). Your blood cholesterol levels will be determined at the first study visit.

Eligibility and requirements for the study: To be eligible for this study you should be a man between 18-65 years of age who has high blood cholesterol (low density lipoprotein cholesterol (LDL-C) >100 mg/dL), and who has not previously taken a statin or has not taken a statin within the previous six weeks. Cholesterol levels will be determined at the first study visit through a blood sample. The study staff will discuss these and any other reasons why you may not be allowed in the study.

During the course of the study it is very important that you do not perform strenuous exercise outside of the laboratory or drink excessive alcohol. It is important that you maintain hydration by drinking fluids regularly. You must report any health problems to us immediately by calling the study phone number, regardless of whether or not you think they are directly related to the study.

If you choose to participate and meet the eligibility criteria for the study, you will be required to attend all 7 visits in order to complete the study. The entire study will take 8 weeks to complete.