Statins In The Elderly

Not Applicable

Completed

• Conditions: Mortality
• Interventions: Drug: Cessation of statin

• Registration Number: NCT02547883
• Lead Sponsor: University Hospital, Bordeaux

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

Study Timeline

• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Study Start: 2016-06-15
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients stopping statin	Cessation of statin	-

Primary Outcome Measures

Name	Time	Method
Incremental Cost per QALY gained	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	36 month after inclusion

Secondary Outcome Measures

Name	Time	Method
Quality of life	3, 12, 24 and 36 moth after inclusion	Quality of life as measured by the SF12
Clinical events occurence	3, 12, 24 and 36 moth after inclusion	Clinical events: cardiovascular events, diabetes, cognitive disorders

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France