Quality of Life in Patients With Statin-Associated Myopathy

NCT00850460 | Terminated Phase 4 Results

• 1 other identifier: PAM-0655
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 1.improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point)
2. 2.alleviation of muscle symptoms,
3. 3.increased utilization of fatty acids as a fuel source reflected by the metabolic test results
4. 4.decreased intramyocellular lipid (IMCL)
5. 5.improved insulin sensitivity.

Conditions

Statin Adverse Reaction

Outcome Measures

Primary Outcomes (2)

• Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From 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

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Lactose placebo pill

Drug: Placebo

Statins

ACTIVE COMPARATOR

Statin medications

Drug: Statins

Interventions

Statins DRUG

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.

Also known as: atorvastatin, simvastatin, pravastatin, rosuvastatin

Statins

Placebo DRUG

Placebo pills will consist of lactose and will be given one capsule once daily

Also known as: lactose pills

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead
• Cornell University: collaborator
• Adelphi University: collaborator

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Simvastatin; Pravastatin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Principal Investigator
• Organization: The Rockefeller University Center for Clinical and Translational

trinnamaningatmd@yahoo.com

212 327-8408

Study Officials

• Patricia D Maningat, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 7, 2016
• Results First Posted: November 7, 2016

Record last verified: 2016-09

Locations

US (1)