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Statins In The Elderly

Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02547883
Acronym
SITE
Enrollment
1230
Registered
2015-09-11
Start date
2016-06-15
Completion date
2023-01-31
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mortality

Keywords

Statins, Elderly, Mortality, Quality of life, Randomized trial, Cost effectiveness study, Primary care

Brief summary

In patients ≥ 75 years, there is no evidence that statins in primary prevention are associated with a decreased mortality and recent US recommendations consider statins in people only between 40 and 75 years. Moreover, statins are associated with numerous side effects impacting quality of life of those people and represent a high cost for the French healthcare system. The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin cessation in people ≥ 75 years treated in primary prevention.

Detailed description

Statins in primary prevention are associated with a 1.2% decreased absolute risk of cardiovascular events in large randomized studies. Anyway, in patients ≥ 75 years, the impact of statins on mortality have not been demonstrated and large observational studies have shown an increased risk of mortality in people with low cholesterol. Moreover, statins are associated with numerous side effects, particularly in the elderly including myalgia and myositis, diabetes, cognitive disorders, fatigue and loss of energy and of physical activities, treatment interactions. At last, the cost of statins for the French national health insurance is 800 million euros per year (including around 200 million euros for people ≥ 75 years). The benefit/risk ratio of statins is not established in primary prevention in people ≥ 75 years, leading to numerous and discordant expert advices since no specific randomized trial have been conducted in this population. Thus, in patients ≥ 75 years treated with statins in primary prevention, the studied strategy will be to stop statin therapy. The comparison strategy will be represented by the group of patient who will continue their statin at the same dose. Patients will be followed up every three months, according to general recommendations, during 36 months. Clinical events will be prospectively registered

Interventions

DRUGCessation of statin

The intervention evaluated is the cessation of statin

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* People aged ≥ 75 years * Treated with any statin from at least one year, in primary prevention * Having replied to a standardized questionnaire allowing to screen any history of cardiovascular event * Consent form signed

Exclusion criteria

* Life prognosis below 6 months * Patient with known homozygous or double heterozygous familial hypercholesterolemia * Dementia

Design outcomes

Primary

MeasureTime frameDescription
Incremental Cost per QALY gained36 month after inclusionRatio between QALYs (quality-adjusted life years) gained estimated by the EQ-5D scale and cost for the French healthcare system
Overall mortality36 month after inclusion

Secondary

MeasureTime frameDescription
Quality of life3, 12, 24 and 36 moth after inclusionQuality of life as measured by the SF12
Clinical events occurence3, 12, 24 and 36 moth after inclusionClinical events: cardiovascular events, diabetes, cognitive disorders

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026