Managing comorbidities in oncology: A multisite randomized controlled trial of continuing versus discontinuing statins in the setting of life-limiting illness.

Patient and Survivor Care
Session Type and Session Title: 
Clinical Science Symposium, Palliative Care: Interventions That Matter
Abstract Number: 



J Clin Oncol 32:5s, 2014 (suppl; abstr LBA9514)


Amy Pickar Abernethy, Jean Kutner, Patrick Jud Blatchford, Christine Ritchie, Diane Fairclough, Laura Hanson, Janet Bull, PCRC Investigators; Duke University Medical Center, Durham, NC; University of Colorado Denver, Denver, CO; University of California, San Francisco, San Francisco, CA; The University of North Carolina at Chapel Hill, Chapel Hill, NC; Four Seasons Hospice, Flat Rock, NC

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Abstract Disclosures


Background: For patients with life-threatening illness such as advanced cancer, optimal management of longstanding medications prescribed for comorbid illness is uncertain. Risks may outweigh benefits; e.g., benefits from HMG Co-A reductase inhibitors (“statins”) may take years to accrue and may not be relevant for a person with limited prognosis. Is it safe to discontinue statins for the patient with less than a year to live? Methods: This was a multicenter, unblinded pragmatic trial. At enrollment, participants were randomized (1:1) to discontinue or continue their statin medication. Eligible patients were adults with advanced life-limiting illness on a statin for ≥3 months for primary or secondary prevention, a life expectancy of greater than one month, and evidence of recent deterioration in performance status. Outcomes measured at baseline and at least monthly included survival, cardiovascular-related events, quality of life (QOL), symptoms, and polypharmacy. Rate of death within 60 days of randomization was the primary outcome. Results: 381 patients were enrolled (189 discontinue statins; 192 continue statins). Mean age was 74 years (SD 12); 22% were cognitively impaired; 49% had cancer as the primary diagnosis; and, 69% had used statins for >5 years. Rate of death within 60 days was not statistically different between groups (discontinue vs. continue, 23.8% vs. 20.3%, 90% CI -3.5% to 10.5%, p=0.36). The group discontinuing statins had longer median time-to-death (229 days [90% CI 186–332] vs. 190 days [90% CI 170-257]; p=0.60). Total QOL was significantly better among the group discontinuing statins (McGill QOL: 7.11 vs. 6.85, p=0.037) and there were fewer symptoms in this group (Edmonton Symptom Assessment Scale: 25.2 vs. 27.4, p=0.128). People in the discontinue statins group took significantly fewer medications (10.1 vs. 10.8, p = 0.034). Few participants in either group experienced cardiovascular events (13 vs. 11). Conclusions: In the setting of life-limiting illness such as advanced cancer, it is unlikely that harm will accrue when statins being used for primary or secondary prevention are discontinued; these patients may even benefit. Clinical trial information: NCT01415934.