Quality of Life in Patients With Statin-Associated Myopathy

September 21, 2016 updated by: Rockefeller University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Rockefeller University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Lactose placebo pill
Drug: Placebo
Placebo pills will consist of lactose and will be given one capsule once daily
Other Names:
  • 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 Names:
  • atorvastatin, simvastatin, pravastatin, rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8
Time Frame: Week 0 to Week 8
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).
Week 0 to Week 8
Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8
Time Frame: Week 0 to Week 8
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.
Week 0 to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Collaborators

Cornell University
Adelphi University

Investigators

  • Principal Investigator: Patricia D Maningat, MD, Rockefeller University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAM-0655

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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