The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty

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 (9).

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. We 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.

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