ArticleTrials2020
Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02547883 (Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Deprescribing statins for adults 65 years of age and older: Evidence-based clinical practice guideline.Canadian family physician Medecin de famille canadien · 2026Guideline
- How can non-inferiority studies with mortality end points be ethically justified?Journal of medical ethics · 2026Article
- Article
- Cardiovascular Risk Prediction in Older Adults.Current atherosclerosis reports · 2025Review
- A Comprehensive Review of the Latest Approaches to Managing Hypercholesterolemia: A Comparative Analysis of Conventional and Novel Treatments: Part I.Life (Basel, Switzerland) · 2025Review
- Managing Hypercholesterolemia in Adults Older Than 75 years Without a History of Atherosclerotic Cardiovascular Disease: An Expert Clinical Consensus From the National Lipid Association and the American Geriatrics Society.Journal of the American Geriatrics Society · 2025Article
- Article
- Cholesterol Lowering in Older Adults: Should We Wait for Further Evidence?Current atherosclerosis reports · 2024Review
- Statin treatment is not associated with an increased risk of adrenal insufficiency in real-world setting.Frontiers in endocrinology · 2023Article
- Sex-Differences in Discontinuation of Statin Treatment in Cancer Patients the Year before Death.Pharmaceuticals (Basel, Switzerland) · 2021Article
- D.I.Ri.M.O. project: deprescription, inappropriateness evaluation and therapeutic reconciliation in hospital medicine.Global & regional health technology assessmentArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundThe risk/benefit ratio of using statins for primary prevention of cardiovascular (CV) events in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 years and over, treated with statins for primary prevention of CV events.
methodsThe "Statins in the elderly" (SITE) study is an ongoing 3-year follow-up, open-label comparative multi-centre, randomized clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are included: people aged 75 years and older being treated with statins as primary prevention for CV events, who provide informed consent. After randomization, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALYs) gained at 36 months, from the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2430 individuals. DISCUSSION: There is some debate on the value of statins in people over 75 years old, especially for primary prevention of CV events, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective and a safe strategy in people of 75 years and over, formerly treated with statins.
trial registrationClinicalTrials.gov: NCT02547883. Registered on 11 September 2015.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.