Quality of Life in Patients With Statin-Associated Myopathy
Condition: Statin Adverse Reaction
Intervention: Statins; Placebo
Intervention description: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth.; Placebo pills will consist of lactose and will be given one capsule once daily
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 40 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The proposed study will focus on possible effects of statins on muscle strength and why they
      become tired more easily, quality of life, and measurements to understand why muscles are not
      able to fully utilize fats. The investigators are specifically interested in statin users and
      the impact of muscle symptoms on daily activities and quality of life.

      This study hypothesize that patients with likely statin-associated myopathy have a metabolic
      dysregulation in fuel utilization such that compared to patients continuing statins, those on
      placebo will show:

        1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36)
           scores (primary end point)

        2. alleviation of muscle symptoms,

        3. increased utilization of fatty acids as a fuel source reflected by the metabolic test
           results

        4. decreased intramyocellular lipid (IMCL)

        5. improved insulin sensitivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males and females 30-60 yrs old

          -  experiencing muscle pain, weakness, numbness or cramping that they perceive to
             interfere with activities of daily living (ADLs), but able to ambulate independently
             (in order to perform exercise tests)

          -  muscle symptoms started/ occurred within one year of starting statin treatment or
             within one year of changing statin brand or dose adjustment

          -  currently taking a statin (has been taking medications ≥ 80% of the time or at least 5
             days/week)

          -  ≤ 15% probability of having a cardiovascular (CV) event in the next 10 years
             calculated using an online CV risk calculator (while on current statin) for the
             questionnaire portion; AND with a low or a moderate American College of Sports
             Medicine (ACSM) risk stratification for a cardiovascular event during a treadmill test
             for the full metabolic study

          -  must agree to have a letter sent to inform the health care provider who prescribed the
             statin of study participation except for subjects referred by Metropolitan Hospital
             physicians

        Exclusion Criteria:

          -  concomitant treatment with other lipid-lowering agents

          -  impaired liver or kidney function ( alanine aminotransferase (ALT) or asparate
             aminotransferase (AST) ≥ 3x upper limit of normal, creatinine ≥ 3x or creatine
             phosphokinase (CPK) ≥ 5x 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 within 5 years of enrollment except basal or squamous cell carcinoma (CA) of
             the skin

          -  diabetes

          -  HIV-1 infection

          -  Uncontrolled blood pressure ≥ 160/100

          -  known coronary artery disease or peripheral vascular disease

          -  chronic illnesses such as lupus, rheumatoid arthritis, psoriasis

          -  any condition, that at the investigators' discretion would impact/ bias the study data

          -  long term oral, nasal, or inhaler steroid use > 6 months

          -  on Hormone Therapy except for thyroid replacement

          -  alcohol consumption ≥ 40 g/day (3 glasses/day wine or beers or binge drinking ≥ 4
             glasses/night)

          -  engaged in significant amounts of sport or strenuous leisure activity (> 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)

        Exclusions for the metabolic study:

          -  currently taking beta blockers

          -  body mass index > 28 kg/m2

          -  premenopausal females < 50 yrs (menopause defined as 12 consecutive months without
             menstruation (in order to avoid the confounding effect of the menstrual cycle phase on
             fuel selection)

          -  physical disability or previous injury that prevents safe exercise testing

          -  do not meet the magnetic resonance spectroscopy (MRS) prescreening criteria