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OpenTrials
Completed

NCT Number: NCT02547883

Statins In The Elderly

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.

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Key information

Conditions

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cessation of statin

Drug

The intervention evaluated is the cessation of statin

Primary outcomes

  1. Incremental Cost per QALY gained

    Time frame: 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

  2. Overall mortality

    Time frame: 36 month after inclusion

Secondary outcomes

  1. Quality of life

    Time frame: 3, 12, 24 and 36 moth after inclusion

    Quality of life as measured by the SF12

  2. Clinical events occurence

    Time frame: 3, 12, 24 and 36 moth after inclusion

    Clinical events: cardiovascular events, diabetes, cognitive disorders

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: SITE

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2015
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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