Quality of Life in Patients With Statin-Associated Myopathy

Statin-Associated Myopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00850460
• Other study ID #: PAM-0655
• Status: Terminated
• Phase: Phase 4
• First received: February 23, 2009
• Last updated: March 17, 2015
• Start date: February 2009
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Muscular Diseases
• Statin-Associated Myopathy

Intervention

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.
• Lactose placebo pills
Placebo pills will consist of lactose

Locations

Country	Name	City	State
United States	Rockefeller University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Rockefeller University	Adelphi University, Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in INQoL and SF-36 scores		Day 1, wk. 4, wk. 8	No
Secondary	Muscle strength and fatigability		Day 1 and wk. 8	No
Secondary	Insulin Sensitivity		Day 1 and Wk. 8	No
Secondary	VO2 max		Day 1 and wk. 8	No
Secondary	Respiratory Exchange Ratio		Day 1 and wk. 8	No
Secondary	Intramyocellular Lipid Content (IMCL)		Day 1 and wk. 8	No
Secondary	Mitochondrial Activity		Day 1 and wk. 8	No