Statins In The Elderly

Study Overview
=================
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

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

Conditions
-----------------
Mortality

Intervention / Treatment
-----------------
* Drug: Cessation of statin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients stopping statin<br> | Drug: Cessation of statin<br>* The intervention evaluated is the cessation of statin<br>|
| No Intervention: Patients continuing statin<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Cost per QALY gained | Ratio between QALYs (quality-adjusted life years) gained estimated by the EQ-5D scale and cost for the French healthcare system | 36 month after inclusion | 
| Overall mortality |  | 36 month after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life as measured by the SF12 | 3, 12, 24 and 36 moth after inclusion | 
| Clinical events occurence | Clinical events: cardiovascular events, diabetes, cognitive disorders | 3, 12, 24 and 36 moth after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins, Elderly, Mortality, Quality of life, Randomized trial, Cost effectiveness study, Primary care