Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial.

Area of Science:

• Geriatric Medicine
• Cardiovascular Disease Prevention
• Health Economics

Background:

• The established risk/benefit ratio of statins for primary prevention of cardiovascular (CV) events in the elderly remains unclear.
• Evidence for statin efficacy, potential side effects, and drug interactions in individuals over 75 is limited, prompting investigation into treatment cessation.

Purpose of the Study:

• To assess the cost-effectiveness of statin cessation in patients aged 75 years and older.
• To examine the non-inferiority of statin cessation compared to continued statin use in terms of overall mortality.

Main Methods:

• The "Statins in the elderly" (SITE) study is a 3-year, open-label, randomized clinical trial involving 2430 participants aged 75+ on statins for primary CV prevention.
• Participants are randomized to either a statin-cessation strategy or to continue their usual statin treatment.
• Cost-effectiveness is evaluated via incremental cost per quality-adjusted life years (QALYs) gained, with overall mortality as the primary clinical endpoint.

Main Results:

• The study is ongoing, and main results are pending.
• Sample size calculation ensures 90% power to demonstrate non-inferiority of statin cessation, assuming a 5% non-inferiority margin for mortality.

Conclusions:

• The SITE study is among the first to investigate the safety and cost-effectiveness of statin cessation in older adults (75+).
• Findings will inform clinical guidelines regarding the discontinuation of statin therapy for primary prevention in this demographic.