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(PAM-0655) Quality of Life in Patients with Statin-Associated Myopathy


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Quality of Life and Metabolic Alterations in Patients with Statin-Associated Myopathy

Principal Investigator:
Patricia Maningat MD

Investigators:
Jeanne Walker ANP-C
Barbara O'Sullivan MD, MPH
Diane Meehan MS, RD
Suzanne Magnotta MS, RD
Jan L. Breslow M.D.
Diana Bernal-Messinger

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Alt. Telephone: 1-800-782-2737
Email: RUCARES@ROCKEFELLER.EDU
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The Rockefeller University Hospital is conducting a study looking at the relationship between statin medications and muscle pain. Volunteers who participate in the study will be randomly placed in a group that will receive statin treatment or a group that will receive a placebo – a pill that looks like the statin, but is a sugar or a starch pill. Researchers will compare the volunteers’ progress while taking these pills, over a period of about 8 weeks.



Detailed Description of Protocol:
The study will focus on possible effects of statins on muscle strength and fatigability, quality of life, and metabolic measurements related to fuel utilization. We will recruit subjects who are currently taking statins, experiencing muscle side-effects that interfere with their daily living, and are not at high risk of heart attack. A total of 100 subjects will participate for 8 weeks.

The first part of the study will be referred to as the run-in period. The first 20 subjects will be randomized 50:50 to receive either placebo or statin. These subjects will complete questionnaires and have lab specimens drawn.

Based on this information the investigators will define which of the subsequent subjects will undergo metabolic testing in addition to completing the questionnaire. In total, there will be 20 completers of the run-in, 20 of the metabolic, and 60 in the questionnaire only part of the study. Profile:
100 subjects, 20 of which will undergo metabolic testing



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

Inclusion Criteria:
- 30-60 years old
- Experience of muscle pain, weakness, numbness, or cramping that interfere with daily life, but able to walk
- Taking statin medication (such as Atorvastatin or Simvastatin)
- Willingness for investigator to notify health care provider
Exclusion Criteria:
- Diabetes
- History of heart attack or heart problems

Gender:
Both

Age(s):
30-60

Children permitted to participate:
No

Potential Benefits.....
All subjects will have a thorough evaluation including a medical history, physical examination and laboratory tests. The subjects will also have an extensive evaluation of muscle strength and fatigability.

The subjects’ complaints, which may not be prioritized in routine clinical visits, will also be heard and the impact on their quality of life be evaluated. Several specialized metabolic tests will be performed and the results of these will help elucidate processes involved in the development of statin-associated myopathy.



Compensation:
Compensation is provided.