Quality of Life in Patients With Statin-Associated Myopathy

This study has been terminated.
(Investigator left institution and no PI has been found to continue the study)
Sponsor:
Collaborators:
Cornell University
Adelphi University
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00850460
First received: February 23, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 INQoL and 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 IMCL
  5. improved insulin sensitivity.

Condition Intervention Phase
Statin-Associated Myopathy
Drug: Statins
Drug: Lactose placebo pills
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Quality of Life and Metabolic Alterations in Patients With Statin-Associated Myopathy

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Improvement in INQoL and SF-36 scores [ Time Frame: Day 1, wk. 4, wk. 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle strength and fatigability [ Time Frame: Day 1 and wk. 8 ] [ Designated as safety issue: No ]
  • Insulin Sensitivity [ Time Frame: Day 1 and Wk. 8 ] [ Designated as safety issue: No ]
  • VO2 max [ Time Frame: Day 1 and wk. 8 ] [ Designated as safety issue: No ]
  • Respiratory Exchange Ratio [ Time Frame: Day 1 and wk. 8 ] [ Designated as safety issue: No ]
  • Intramyocellular Lipid Content (IMCL) [ Time Frame: Day 1 and wk. 8 ] [ Designated as safety issue: No ]
  • Mitochondrial Activity [ Time Frame: Day 1 and wk. 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactose Drug: Lactose placebo pills
Placebo pills will consist of lactose
Active Comparator: Statins
Statins lower LDL-C levels and reduce the relative risk for cardiovascular events by 25-30%. Subjects will be randomized to continue their statin or placebo for 8 weeks
Drug: Statins
Subjects will be randomized to continue their statin (whichever type they were on when they enrolled into the study) or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ( ALT or AST ≥ 3x upper limit of normal, creatinine ≥ 3x or 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 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 MRS prescreening criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850460

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Cornell University
Adelphi University
Investigators
Principal Investigator: Patricia D Maningat, MD Rockefeller University
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00850460     History of Changes
Other Study ID Numbers: PAM-0655
Study First Received: February 23, 2009
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014