Clinical trial NCT03663049: The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty
Official title: Trial of Statin Holiday in Patients Receiving Maintenance Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ESRD
Cardiovascular Diseases
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms in the study. Patients will be randomized to either continue medication in the statin group or discontinue.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients who are on chronic dialysis and 70 and older are frequently on multiple medications including statins. However, the benefit of statins in dialysis patient population is uncertain. Several randomized trials showed no benefit of statins on mortality in dialysis patient population. Guidelines recommend not starting statins in patients on dialysis who are not already taking them. However, there are no guidelines on what to do in patients who are already taking statins. The investigators are doing a short pilot study to discontinue statin in our dialysis patient population and evaluating the effects on discontinuation of statins on quality of life, cognition, as physical strength.

Detailed description: Dialysis patients who are 70 years and older suffer from cognitive dysfunction, physical impairment, and frailty. Polypharmacy in this subgroup of patients is prevalent and can lead to drug toxicities and increased side effects which can contribute to adverse outcomes such as worsening cognitive decline and increased frailty. One frequent component of polypharmacy in dialysis patient population is the use of statins. The use of statins, however, has not been proven to be beneficial in this patient population. While statin medications have been shown to reduce atherosclerotic cardiovascular disease in adults without dialysis dependent chronic kidney disease (CKD), the benefit of statin use in chronic dialysis patients has not been proven. A Cochrane meta-analysis published in 2013 included 25 trials of statin medications in patients receiving maintenance dialysis (total of 8289 patients) and found no benefit of statin medications for preventing atherosclerotic cardiovascular disease events or mortality. The meta-analysis did note that evidence for side effects for statins was incomplete and potential harms from statin medications remain uncertain in this population. Furthermore, statins have recently come under scrutiny by the FDA with regards to their safety due to associations with memory loss and weakness.

Previous clinical trials of statins only assessed the known adverse effects of statins such as abnormal liver function tests and acute kidney injury, adverse effects that occur rarely (\< 1%). Trials did not assess other side effects such as cognitive decline or muscle weakness that may be more common in older patients with kidney failure. The aim of this pilot study is to examine the potential side effects of statin medication use in older patients receiving dialysis by conducting a randomized pilot trial of a statin holiday (3 months of discontinuation) vs. no holiday and measuring changes in cognitive function, muscle strength, quality of life and frailty. The investigators hypothesize that measures of cognitive function, grip strength, quality of life and overall frailty will improve after 6 weeks of discontinuation of statins. After obtaining informed consent, patients will complete assessments of quality of life (SF-20), cognition, muscle strength and frailty at baseline and again at 6 and 12 weeks after statin holiday (intervention group) vs. no statin holiday (control group). All patients will resume statin medications after the 3 month trial. The overall goal is to determine whether changes in cognition, strength, frailty or quality of life can be measured using standard instruments. If changes can be detected, pilot data from this study will be used to design a larger trial.

Eligibility criteria: Inclusion Criteria:

1. Age 70 years and older,
2. Receiving maintenance dialysis for at least 6 months,
3. Must be on a statin medication,
4. Receiving dialysis at the Loyola University Medical Center dialysis unit ,
5. Can be on hemodialysis or peritoneal dialysis,

Exclusion Criteria:

1. Age less than 70 years old
2. Any recent hospital admission (within 2 weeks)
3. Recent dialysis start (within 6 months)
4. Any cancer diagnosis, with exception of innocuous skin cancers and previously treated cancers
5. Any recent (\< 1 year) solid organ transplant
6. Active on kidney transplant wait list
7. Recent acute coronary event (e.g. recent NSTEMI, stent, angioplasty, CABG) within 6 months
8. Non-English speaking
9. Diagnosis of dementia
10. Patients who are unable to provide informed consent

Primary outcomes:
measure: Change in quality of life
timeFrame: Change in quality of life over 12 weeks
Secondary outcomes:
measure: Change in handgrip strength
timeFrame: Change in handgrip strength over 12 weeks
Other outcomes:
measure: Change in cognition
timeFrame: Change in cognition over 12 weeks
measure: Change in frailty
timeFrame: Change in frailty at 12 weeks
measure: Change in mobility
timeFrame: Change in mobility at 12 weeks
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Julia Schneider
role: PRINCIPAL_INVESTIGATOR
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