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Therapeutic Areas: Musculoskeletal
Disease Category: Muscle Pain

Trial Information

Quality of Life in Patients who are Taking Cholesterol-Lowering Medications

The Rockefeller University Hospital is conducting a study looking at the relationship between cholesterol-lowering 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 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.

Patient Inclusion Criteria:

• Males and Females 40-60 years old Experience of muscle pain, weakness, numbness, or cramping that interfere with daily life, but able to walk
• BMI < 28
• Experience of muscle pain, weakness, numbness, or cramping that interfere with daily life, but able to walk
• Taking a statin medication such as Lipitor or Zocor (Atorvastatin or Simvastatin)
• Willingness for investigator to notify health care provider
• Not at high risk for having a cardiovascular event according to the investigator

Patient Exclusion Criteria:

• concomitant treatment with other lipid-lowering agents
• impaired liver or kidney function ( ALT or AST = 3x upper limit of normal, creatinine or CPK = 3x upper limit of normal)
• untreated hypo or hyperthyroidism
• current treatment with other medications known to increase risk of myopathy (e.g. cyclosporine, azithromycin, erythromycin and other macrolide antibiotics, azole antifungals, fusidic acid, digoxin)
• documented history of muscle disorder or myopathy other than statin-associated myopathy
• anemia (Hb< 110 g/dL)
• cancer
• diabetes
• HIV-1 infection on anti-retroviral drugs
• high blood pressure necessitating =1 drug for optimal control = 130/80 - currently taking beta-blockers
• known coronary artery disease or peripheral vascular disease
• chronic illnesses such as lupus, rheumatoid arthritis, psoriasis
• long term oral, nasal, or inhaler steroid use
• physical disability or previous injury that prevents safe exercise testing
• pregnant or breastfeeding, or planning to become pregnant during the study
• females on Hormone Therapy
• alcohol consumption = 40 g/day (3 glass/day wine or beers or binge drinking = 4 glasses/night)
• engaged in significant amounts of sport or strenuous leisure activity (30-60 min four times per week)
• surgery in the past 6 months except for minor excision/incision procedures,
• 12-L electrocardiogram demonstrating old/new myocardial infarction/ ischemia or other findings that, at the cardiologist’s discretion, may put the subject at high risk
• cognitive impairment that prevents comprehension of questionnaires
• inability to read English (questionnaire language)

The Rockefeller University Hospital
1230 York Avenue
New York, NY 10065
Phone: 1-800-RUCARES
EMail: RUCARES@ROCKEFELLER.EDU

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