Safety and Benefit of Discontinuing Statin Therapy in the Setting of Advanced, Life-Limiting Illness: A Randomized Clinical Trial

Hoa Tang, Mercer University College of Pharmacy 2015

According to the 2013 American College of Cardiology/ American Heart Association (ACC/AHA) Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease (ASCVD) in adults, the use of statin therapy is recommended for ASCVD reduction for both primary and secondary prevention in adults.1  In elderly patients, the number of chronic conditions increases and requires many medications for treatment, prevention, and symptom control. Per the American Geriatrics Society, discontinuation of treatments in older patients is a challenging and time-consuming process due to lack of good evidence. Moreover, they suggest that clinicians may fear liability regarding underuse of therapies and may continue medications, even when the benefit of continuing therapy is unclear. 2

A recently published study evaluated the safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness.3

Title: Safety and Benefit of Discontinuing Statin Therapy in the Setting of Advanced, Life-Limiting Illness: A Randomized Clinical Trial
Design Multicenter, parallel-group, unblinded, randomized, pragmatic clinical; 381 patients
Objective To evaluate the safety, clinical and cost impact of discontinuing statin medications for patients in the palliative care setting
Study Groups Discontinued statin group (n=189) versus continued statin group (n=192)
Methods Participants were randomized to either discontinue or continue statin therapy at the time of enrollment. Eligible patients received a statin for three months or longer and had a documented diagnosis of advanced, life-limiting illness.
Duration From June 2011 through May 2013; participants remained in the study until death, 1 year after enrollment or study enclosure.
Primary Outcome Measure The proportion of deaths within 60 days of trial enrollment

The safety outcomes were survival, time to first cardiovascular-related event and important patient-centered outcomes in the setting of advanced life-limiting illness including quality of life (QOL), performance status and statin-related adverse effects.

Baseline Characteristics Mean age was 74.1. The participants were cognitively impaired (22%) and had cancer (48.8%). Baseline mean of nonstatin medications were similar in the groups (p=0.84)

Discontinued Statin group- white (81%), cognitively impaired 27%, malignant tumor (44.4%), greater than 5 years of statin use (68.3%), medicare insurance (74.1%)

Continued Statin group- white (84.4%), cognitively impaired 17.2%, malignant tumor (53.1%), greater than 5 years of statin use (69.8%), medicare insurance (72.9%)

Results The proportion of participants who died within 60 days was 45 [23.8%] in discontinued statin group and 39 [20.3%] in continued statin group (90% confidence interval [Cl], -3.5% to 10.5%; p=0.36).

Median time to death was 229 days for discontinuation group and 190 days for continuation group (p=0.60). Time to the first cardiovascular-related event (p=0.64)

Total McGill QOL- mean area under the curve (7.11 in the discontinued statin group versus 6.85 in the continued statin group; p=0.04)

Adverse Events Common Adverse Events: not reported
Serious Adverse Events: not reported
Percentage that discontinued due to Adverse Events: not reported
Study Author Conclusions This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL

associated with statin continuation in this setting are warranted.

Because of lack of formal guidelines for discontinuation of statin therapy in patients with life-limiting illness, the discontinuation of statin therapy is mostly based on patient-provider decisions. The results from this study suggest that the discontinuation of statin therapy in the setting of advanced, life-limiting illness does not affect the survival, time of first cardiovascular-related events, and the proportion of death within 60 days. However, discontinuation of statin therapy is potentially associated with benefits including improved QOL.3 Therefore, the discontinuation of statin therapy may be an appropriate option for life-limiting illness patients who express QOL and pill burden concerns.

References:

  1. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2889-934. Accessed April 1, 2015.
  2. Guiding principles for the care of older adults with multimorbidity: an approach for clinicians: American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity. J Am Geriatr Soc. 2012;60(10):E1-E25. Accessed April 2, 2015.
  3. Kutner JS, Blatchford PJ, Taylor DH, et al. Safety and Benefit of Discontinuing Statin Therapy in the Setting of Advanced, Life-Limiting Illness: A Randomized Clinical Trial. JAMA Intern Med. 2015. Accessed March 30, 2015.
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