Statins In The Elderly (SITE)
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|ClinicalTrials.gov Identifier: NCT02547883|
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : February 24, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Mortality||Drug: Cessation of statin||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial|
|Actual Study Start Date :||June 15, 2016|
|Actual Primary Completion Date :||January 31, 2023|
|Actual Study Completion Date :||January 31, 2023|
|Experimental: Patients stopping statin||
Drug: Cessation of statin
The intervention evaluated is the cessation of statin
|No Intervention: Patients continuing statin|
- Incremental Cost per QALY gained [ 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
- Overall mortality [ Time Frame: 36 month after inclusion ]
- Quality of life [ Time Frame: 3, 12, 24 and 36 moth after inclusion ]Quality of life as measured by the SF12
- Clinical events occurence [ Time Frame: 3, 12, 24 and 36 moth after inclusion ]Clinical events: cardiovascular events, diabetes, cognitive disorders
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|Ages Eligible for Study:||75 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Life prognosis below 6 months
- Patient with known homozygous or double heterozygous familial hypercholesterolemia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547883
|CHU de Bordeaux|
|Study Chair:||Antoine BENARD||USMR - CHU de Bordeaux|
|Principal Investigator:||Jean-philippe JOSEPH, Pr||Bordeaux university|
|Study Director:||Fabrice BONNET, Pr||University Hospital, Bordeaux|
|Responsible Party:||University Hospital, Bordeaux|
|Other Study ID Numbers:||
PRME 14-0037 ( Other Grant/Funding Number: French minister of Health )
|First Posted:||September 11, 2015 Key Record Dates|
|Last Update Posted:||February 24, 2023|
|Last Verified:||February 2023|
Quality of life
Cost effectiveness study