Clinical trial NCT02547883: Statins In The Elderly
Official title: Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mortality
Keywords: Statins
Elderly
Mortality
Quality of life
Randomized trial
Cost effectiveness study
Primary care
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 1230
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Incremental Cost per QALY gained
timeFrame: 36 month after inclusion
measure: Overall mortality
timeFrame: 36 month after inclusion
Secondary outcomes:
measure: Quality of life
timeFrame: 3, 12, 24 and 36 moth after inclusion
measure: Clinical events occurence
timeFrame: 3, 12, 24 and 36 moth after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: USMR - CHU de Bordeaux
name: Antoine BENARD
role: STUDY_CHAIR
affiliation: University of Bordeaux
name: Jean-philippe JOSEPH, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Fabrice BONNET, Pr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bonnet 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.