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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: September 21, 2016
Last verified: September 2016
  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 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.

Condition Intervention Phase
Statin Adverse Reaction
Drug: Statins
Drug: Placebo
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:
  • Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8 [ Time Frame: Week 0 to Week 8 ] [ Designated as safety issue: No ]
    Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).

  • Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8 [ Time Frame: Week 0 to Week 8 ] [ Designated as safety issue: No ]
    Scores from the self-administered SF-36 (Physical component) questionnaire were measured at the start (Week 0) of the study and at the end (Week 8) among patients in the placebo- and statin-treated group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of scores.


Enrollment: 14
Study Start Date: February 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Lactose placebo pill
Drug: Placebo
Placebo pills will consist of lactose and will be given one capsule once daily
Other Name: lactose pills
Active Comparator: Statins
Statin medications
Drug: Statins
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.
Other Name: atorvastatin, simvastatin, pravastatin, rosuvastatin

Detailed Description:

The proposed study will focus on possible effects of statins on muscle strength and quality of life, and measurements to understand why muscles of statin users 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 hypothesizes 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.
  Eligibility

Ages Eligible for Study:   40 Years to 60 Years   (Adult)
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 ( 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
  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

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00850460     History of Changes
Other Study ID Numbers: PAM-0655 
Study First Received: February 23, 2009
Results First Received: February 12, 2016
Last Updated: September 21, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Simvastatin
Rosuvastatin Calcium
Atorvastatin Calcium
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 09, 2016