Statins In The Elderly
SITE
Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial
2 other identifiers
interventional
1,230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedFebruary 24, 2023
February 1, 2023
6.6 years
September 10, 2015
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Quality of life
3, 12, 24 and 36 moth after inclusion
Clinical events occurence
3, 12, 24 and 36 moth after inclusion
Study Arms (2)
Patients stopping statin
EXPERIMENTALPatients continuing statin
NO INTERVENTIONInterventions
The intervention evaluated is the cessation of statin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Life prognosis below 6 months
- Patient with known homozygous or double heterozygous familial hypercholesterolemia
- Dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Bordeaux
Bordeaux, France
Related Publications (2)
Bonnet F, Benard A, Poulizac P, Afonso M, Maillard A, Salvo F, Berdai D, Salles N, Rousselot N, Marchi S, Hayes N, Joseph JP. Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial. Trials. 2020 Apr 19;21(1):342. doi: 10.1186/s13063-020-04259-5.
PMID: 32307005DERIVEDBonnet F, Poulizac P, Joseph JP. Safety and efficacy of statins. Lancet. 2017 Mar 18;389(10074):1097-1098. doi: 10.1016/S0140-6736(17)30712-2. No abstract available.
PMID: 28322812DERIVED
Study Officials
- STUDY CHAIR
Antoine BENARD
USMR - CHU de Bordeaux
- PRINCIPAL INVESTIGATOR
Jean-philippe JOSEPH, Pr
University of Bordeaux
- STUDY DIRECTOR
Fabrice BONNET, Pr
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 11, 2015
Study Start
June 15, 2016
Primary Completion
January 31, 2023
Study Completion
January 31, 2023
Last Updated
February 24, 2023
Record last verified: 2023-02