Kutner JS, Blatchford PJ, Taylor DH Jr, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial [published correction appears in JAMA Intern Med. 2015 May;175(5):869] [published correction appears in JAMA Intern Med. 2019 Jan 1;179(1):126-127]. JAMA Intern Med. 2015;175(5):691–700.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/25798575
Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4618294/
| Methods | Study design: Multicentre randomized controlled trial
Number of groups: 2 |
| Participants | Number of participants: 381
Active group: 189 Control group: 192 Age: 74.1 ± 11.6 Sex: 171 female (45%) Participants with dementia: 84 (22%) Inclusion criteria: ≥18 years of age ≥3 months statin exposure for primary/secondary prevention of cardiovascular disease Documented advanced, life-limiting illness Physician expects life expectancy ≤1 year Recent deterioration in functional status Exclusion criteria: Active cardiovascular disease or sufficient risk of same Symptoms of myositis Liver function test or creatinine kinase levels 2.5x upper limit normal Other contradictions to continuing statins Concomitant medicines: 11.6 ± 5.0 Country: US Setting: Community/Palliative Care Research Cooperative sites |
| Interventions | Medicine: Statins
Intervention: Participants randomized to cease statins Withdrawal schedule: Not described Comparator: Continued statin therapy |
| Outcomes | 60-day mortality
Time to cardiovascular event or invasive cardiovascular procedure Survival (time to death) Performance (Australian-modified Karnofsky Performance Status scale) Quality of life (McGill QOL Questionnaire) Symptoms (Edmonton Symptom Assessment scale) Number of non-statin medicines Statin-related adverse effects Satisfaction with care (5-point Likert scale) Cost savings |
| Dates | Dates: June 2011 to May 2013
Follow-up duration: 12 months |
| Funding sources | US National Institute of Nursing Research |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low | Block randomization was used in a 1:1 ratio stratified by study site and cardiovascular disease history using SAS v9.2 |
| Allocation concealment (selection bias) | Low | A secure web-site was used to communicate randomization allocation to study site personnel. |
| Blinding of participants and personnel (performance bias) | High | Study was unblinded for both patients and personnel |
| Blinding of outcome assessment (detection bias) | High | Outcomes assessed by a trained research assistant, blinding not described |
| Incomplete outcome data (attrition bias) | Low | All participants accounted for, withdrawals described |
| Selective reporting (reporting bias) | Low | Clinical trial registration |
| Other bias | ||
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