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Statin Discontinuation in Advanced Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01415934
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this study is to determine if there is a difference in survival rate at 60 days after enrollment between patients with advanced life-limiting illness for whom statins are discontinued vs. for patients with advanced life-limiting illness who are maintained on the medication. Secondary outcomes of this study will determine the effects of medication cessation on overall survival, important cardiovascular events, quality of life (QOL), symptoms, performance status, polypharmacy issues, satisfaction with care, and costs.

Condition or disease Intervention/treatment Phase
Palliative Medicine Cardiovascular Disease Other: discontinue statins Not Applicable

Detailed Description:

Currently, over 80% of the population is expected to die of chronic life-limiting illnesses, predominant among which are the various manifestations of cardiovascular disease, cancer, dementia, and chronic lung disease. Patients with high cholesterol and those potentially at risk for atherosclerotic heart disease and stroke are often treated preventively with HMG Co-A reductase inhibitors (a.k.a., statins). Clinical trial evidence supports the use of statins for patients with hyperlipidemia and established ischemic heart disease to reduce risk of future cardiovascular events and mortality, and to reduce risk of future cardiovascular events in patients with multiple cardiac risk factors. Beneficial outcomes are evident in these trials after 3-6 years of treatment. Hence, statins are among the most prescribed medications in the world. In the United States, over 25% of Medicare beneficiaries take a statin medication. Statin medications are frequently continued until the patient can no longer eat or swallow at the end of life, because there are no evidence-based guidelines regarding when or how to discontinue medications for co-morbidities. The risks and costs vs. benefits of statins for palliative care patients, for whom prognosis is limited, remains a genuine clinical uncertainty. Meanwhile, medications for symptoms and other concerns accumulate as illness progresses, and therefore polypharmacy and compounding medication side effects are troublesome problems in the setting of advanced life-limiting illness. While multiple studies have demonstrated the benefit of long-term preventive statin use for patients at cardiovascular risk, other studies have supported the discontinuation of medications (specifically statins) in end-stage disease. A rational approach to medication discontinuation, specifically statin discontinuation, therefore has the potential to reduce patient burden, polypharmacy, and side effects, while also preserving healthcare resources for more beneficial interventions.

This study is a multi-site randomized controlled trial of discontinuing vs. continuing statin medications in patients with advanced life-limiting illness. Eligible participants are adults with advanced life-limiting illness with an estimated prognosis of 1-6 months who are on statins for primary or secondary prevention of cardiovascular events. The primary outcome is survival rate at 60 days; secondary outcomes address cardiovascular events, polypharmacy, medication adverse effects, quality of life (QOL), and measures of the patient's health-related experience. The primary hypothesis is that discontinuing statins will not influence survival. Secondary hypotheses are that discontinuation of statins will not adversely affect cardiovascular events or overall QOL, but will improve statin-related symptoms and decrease polypharmacy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Multisite Randomized Controlled Trial of Continuing vs. Discontinuing Statins
Actual Study Start Date : June 3, 2011
Actual Primary Completion Date : July 15, 2013
Actual Study Completion Date : July 15, 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Continue Statins
Participant will continue on statins as per usual
Experimental: Discontinue statins
Participant will stop taking their statin drugs
Other: discontinue statins
patients will be randomized to either continue taking statins or discontinue.

Primary Outcome Measures :
  1. Proportion of Deaths Within 60 Days of Enrollment. [ Time Frame: Within 60 days of Subject Enrollment ]
    To determine, among patients with life-limiting illness, if there is a difference in the proportion who die within 60 days after enrollment between patients for whom statins are discontinued vs. patients who are maintained on the medication.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age >18 years old;
  • have an advanced life-limiting illness;
  • have a life expectancy of >1 month, AND patient exhibits declining functional status, defined as a reduction in Australia-modified Karnofsky Performance Status (AKPS)22 score to <80% in the previous 3 months;
  • be on a statin medication for primary or secondary prevention of cardiovascular disease for ≥3 months;
  • have adequately intact cognitive status to provide informed consent and complete the baseline assessment, as evidenced by a Short Portable Mental Status Questionnaire (SPMSQ)23 score of ≥6;
  • provide informed consent; and,
  • speak and read English at or above a grade 5 level (per patient or caregiver report).

Exclusion Criteria:

  • primary treating physician/care provider estimates their life expectancy as < 1 month;
  • under the care of a primary treating physician/primary care provider who is unwilling to have the patient enrolled;
  • not consenting;
  • having known active cardiovascular disease or sufficient risk of active cardiovascular disease to require ongoing therapy with statin drugs, in the opinion of the treating physician; OR,
  • exhibiting obvious symptoms of myositis, known liver function test (LFT) abnormalities of >2.5x the upper limit of normal (ULN), known creatine kinase (CK) abnormalities of >2.5x ULN, or other contraindications to continuing statins, in the opinion of the treating physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01415934

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United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, California
San Diego Hospice and the Institute for Palliative Medicine
San Diego, California, United States, 92103
United States, Colorado
University of Colorado, Denver
Denver, Colorado, United States, 80217
Kaiser Permanente
Denver, Colorado, United States, 80231
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Four Seasons Hospice and Palliative Care
Flat Rock, North Carolina, United States, 28731
United States, Ohio
Hospice of Western Reserve
Cleveland, Ohio, United States, 44106
United States, Virginia
Capital Caring
Falls Church, Virginia, United States, 22042
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Nursing Research (NINR)
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Principal Investigator: Amy Abernethy, MD Duke University
Principal Investigator: Jean Kutner, MD University of Colorado, Denver
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT01415934    
Other Study ID Numbers: 11-0314
UC4NR012584 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2011    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: September 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases