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Medication Discontinuation in the IMPROVE-IT Trial.

Ann Marie Navar^1,2, Matthew T Roe¹, Jennifer A White¹

¹Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.M.N., M.T.R., J.A.W., Y.L., L.K.N., M.A.B.).

Circulation. Cardiovascular Quality and Outcomes

|January 12, 2019

Summary

Premature discontinuation of cholesterol-lowering drugs reduces their effectiveness. The IMPROVE-IT trial found that adding ezetimibe to simvastatin did not increase discontinuation rates, but patient factors influenced adherence.

Keywords:

acute coronary syndrome cholesterol ezetimibe medication adherence statin

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Published on: September 17, 2011

Area of Science:

Cardiology
Pharmacology
Clinical Trials

Background:

Cholesterol-lowering medications are vital for reducing recurrent cardiovascular events.
Premature discontinuation of these medications significantly limits their therapeutic effectiveness.
Systematic reporting of discontinuation rates in lipid-lowering trials remains limited.

Purpose of the Study:

To evaluate medication discontinuation rates and predictors within the IMPROVE-IT trial.
To compare discontinuation between placebo+simvastatin and ezetimibe+simvastatin treatment arms.
To analyze the impact of patient-level and regional factors on medication adherence.

Main Methods:

Longitudinal evaluation of medication discontinuation from randomization to study end (median 71.9 months).
Kaplan-Meier (KM) analysis of discontinuation rates at 30 days, 1 year, and 7 years.
Cox proportional hazards modeling to identify predictors of discontinuation.

Main Results:

Overall, 46.7% of subjects discontinued study medication, with a 7-year KM rate of 50.9%.
Discontinuation risk was highest early but stabilized to approximately 8% per year after year 1.
Higher discontinuation was observed with placebo+simvastatin versus ezetimibe+simvastatin (52.0% vs. 49.8%) and in the United States (57.4% at 7 years).
Predictors of higher discontinuation included smoking, prior revascularization, hypertension, unstable angina, female sex, nonwhite race, and US location.

Conclusions:

While discontinuation risk decreases over time, most occurred after the first year due to prolonged follow-up.
Adding ezetimibe to statin therapy did not elevate the risk of medication discontinuation.
Trial design and analysis should account for geographic variations and patient-specific factors influencing adherence.