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| ID | Type | Description | Link |
|---|---|---|---|
| PRME 14-0037 | Other Grant/Funding Number | French minister of Health |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients stopping statin | Experimental |
| |
| Patients continuing statin | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cessation of statin | Drug | The intervention evaluated is the cessation of statin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life as measured by the SF12 | 3, 12, 24 and 36 moth after inclusion |
| Clinical events occurence | Clinical events: cardiovascular events, diabetes, cognitive disorders |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine BENARD | USMR - CHU de Bordeaux | Study Chair |
| Jean-philippe JOSEPH, Pr | University of Bordeaux | Principal Investigator |
| Fabrice BONNET, Pr | University Hospital, Bordeaux | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32307005 | Derived | 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. | |
| 28322812 | Derived | 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. |
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| 3, 12, 24 and 36 moth after inclusion |