CHU de Bordeaux
Bordeaux, France
NCT Number: NCT02547883
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.
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Notify Me75 year and older
All sexes
Interventional
Not applicable
Bordeaux, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention evaluated is the cessation of statin
Time frame: 36 month after inclusion
Ratio between QALYs (quality-adjusted life years) gained estimated by the EQ-5D scale and cost for the French healthcare system
Time frame: 36 month after inclusion
Time frame: 3, 12, 24 and 36 moth after inclusion
Quality of life as measured by the SF12
Time frame: 3, 12, 24 and 36 moth after inclusion
Clinical events: cardiovascular events, diabetes, cognitive disorders
University Hospital, Bordeaux
Other
Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial
Acronym: SITE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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