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(PAM-0672) Metabolic Features of Patient with Myopathy Associated with Statin Treatment

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Metabolic Features of Patient with Myopathy Associated with Statin Treatment

Principal Investigator:
Patricia Maningat MD

Jeanne Walker ANP-C
Diane Meehan MS, RD
Jan L. Breslow M.D.

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RU-CARES
Alt. Telephone: 1-800-782-2737
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
Statins are a class of drugs given to lower cholesterol. Although statins are considered to be generally safe, some studies show that about 10% of people on statins develop muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a life-threatening muscle breakdown condition known as rhabdomyolysis. In some, these symptoms may greatly affect their daily activities. One consideration why symptoms develop in only some patients is that they may have an underlying problem in the way their muscles use fats to produce energy. In these patients, the muscles are not able to fully utilize fats and so they become tired more easily. Fat within the muscle can also affect how your body uses a hormone called insulin, which affects your blood sugar levels.

Detailed Description of Protocol:
Study participation includes:
- 2 outpatient visits and 1 inpatient visit (3 days)
- Questionnaires
- Muscle strength and metabolic tests
- Blood tests

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- You are between 30-60 years of age AND have not had a heart attack or have not been told (you) have a heart condition by your physician
-If female, post-menopause (>12 months from last menstrual period)
-You are currently experiencing muscle pain, weakness, cramping or fatigue that may be due to statin treatment; OR
-You have experienced muscle pain, weakness, cramping or fatigue that may have been due to statin treatment
-You do not have diabetes



Children permitted to participate:

Potential Benefits.....
During this study, you will have a full physical exam, an EKG, and multiple laboratory tests, at no cost to you. If any abnormalities are uncovered during testing, you will be made aware and a copy of the EKG or lab results will be made available to you. From the results of the metabolic tests, you and others who have developed muscle symptoms may benefit from the findings resulting from this study.

Compensation is provided.