SITE: Statins In The Elderly

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02547883

Collaborator

(none)

1,230

Enrollment

Location

Arms

77.5

Anticipated Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mortality	Drug: Cessation of statin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 15, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients stopping statin	Drug: Cessation of statin The intervention evaluated is the cessation of statin
No Intervention: Patients continuing statin

Arm

Intervention/Treatment

Experimental: Patients stopping statin

Drug: Cessation of statin

The intervention evaluated is the cessation of statin

No Intervention: Patients continuing statin

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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