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Statin Discontinuation in Advanced Illness

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ClinicalTrials.gov Identifier: NCT01415934
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Colorado, Denver

May 10, 2011
August 12, 2011
April 20, 2018
May 2011
May 2013   (Final data collection date for primary outcome measure)
Survival Time [ Time Frame: 60 days minimum ]
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.
Survival Time [ Time Frame: 1 year ]
Objective is to determine if there is a difference in survival time 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.
Complete list of historical versions of study NCT01415934 on ClinicalTrials.gov Archive Site
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Statin Discontinuation in Advanced Illness
Multisite Randomized Controlled Trial of Continuing vs. Discontinuing Statins
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.

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 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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Palliative Medicine
  • Cardiovascular Disease
Other: discontinue statins
patients will be randomized to either continue taking statins or discontinue.
  • No Intervention: Continue Statins
    Participant will continue on statins as per usual
  • Experimental: Discontinue statins
    Participant will stop taking their statin drugs
    Intervention: Other: discontinue statins
Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289. Erratum in: JAMA Intern Med. 2015 May;175(5):869.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
1200
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01415934
11-0314
UC4NR012584 ( U.S. NIH Grant/Contract )
Yes
Not Provided
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University of Colorado, Denver
University of Colorado, Denver
National Institute of Nursing Research (NINR)
Principal Investigator: Amy Abernethy, MD Duke University
Principal Investigator: Jean Kutner, MD University of Colorado, Denver
University of Colorado, Denver
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP