Statin Discontinuation in Advanced Illness

Not Applicable

Completed

• Conditions: Palliative Medicine; Cardiovascular Disease
• Interventions: Other: discontinue statins

• Registration Number: NCT01415934
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2011-05-10
• Study Start: 2011-06-03
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2013-07-15
• Study Completion: 2013-07-15
• Results First Submitted: 2018-07-12
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-22
• Last Update Submitted: 2018-08-22
• Results First Posted: 2018-09-21
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinue statins	discontinue statins	Participant will stop taking their statin drugs

Primary Outcome Measures

Name	Time	Method
Proportion of Deaths Within 60 Days of Enrollment.	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.

Trial Locations

Locations (15)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Beth Israel Medical Center; 🇺🇸 New York, New York, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Four Seasons Hospice and Palliative Care; 🇺🇸 Flat Rock, North Carolina, United States

Hospice of Western Reserve; 🇺🇸 Cleveland, Ohio, United States

Capital Caring; 🇺🇸 Falls Church, Virginia, United States

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

San Diego Hospice and the Institute for Palliative Medicine; 🇺🇸 San Diego, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States

University of Colorado, Denver; 🇺🇸 Denver, Colorado, United States

Kaiser Permanente; 🇺🇸 Denver, Colorado, United States