Statins In The Elderly

Mortality Clinical Trial

— SITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547883
• Other study ID #: CHUBX 2014/41
• Secondary ID: PRME 14-0037
• Status: Completed
• Phase: N/A
• Start date: June 15, 2016
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mortality

Intervention

Drug:
• Cessation of statin
The intervention evaluated is the cessation of statin

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall mortality		36 month after inclusion
Secondary	Quality of life	Quality of life as measured by the SF12	3, 12, 24 and 36 moth after inclusion
Secondary	Clinical events occurence	Clinical events: cardiovascular events, diabetes, cognitive disorders	3, 12, 24 and 36 moth after inclusion