Comparing Simvastatin-Ezetimibe to Simvastatin Alone in Elderly Patients


A recent analysis of the IMPROVE-IT results found that simvastatin-ezetimibe was associated with greater reductions in LDL-C and lower rates of MI, stroke and CVD than simvastatin monotherapy.

New data from a recent analysis is giving physicians a better idea of the impact of simvastatin-ezetimibe compared to simvastatin alone as a therapy for lowering lipid levels in elderly patients following acute coronary syndrome (ACS).

An analysis of the IMPROVE-IT trial found treatment with simvastatin-ezetimibe resulted in lower rates of death from cardiovascular disease (CVD), myocardial infarction (MI), stroke, and other cardiovascular conditions after a hospitalization for ACS when compared to simvastatin alone.

Investigators performed a secondary analysis of the IMPROVE-IT trial that assessed effects of the treatments through double-blind randomization with follow-up for a median of 6 years. Of the 18,144 patients enrolled in the IMPROVE-IT trial, 2798 were aged 75 or older at randomization. Investigators noted that the median age of the group at baseline was 85 years.

The primary composite endpoint of the current analysis was death from CVD, MI, stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days. Investigators also analyzed individual adverse ischemic and safety end points and lipid variables.

Upon analyses investigators found LDL-C levels achieved were 15 to 17 mg/dL lower with simvastatin-ezetimibe compared to simvastatin monotherapy. Investigators noted that, when age was considered as a continuous variable, treatment-age interactions were not significant, which they wrote was suggests there is no apparent differential effect of age on lowering lipid levels by adding ezetimibe to simvastatin.

Treatment with simvastatin-ezetimibe resulted in lower rates of the composite primary end point than simvastatin monotherapy (32.7% versus 34.7%). Additionally, treatment with simvastatin-ezetimibe resulted in an absolute reduction of the primary composite end point for patients younger than 65 years of 0.9% (29.9% vs 30.8%; HR, 0.97; 95% CI, 0.90-1.05), for patients aged 65 to 74 years of 0.8% (35.1% vs 35.9%; HR, 0.96; 95% CI, 0.87- 1.06), and for patients 75 years or older of 8.7% (38.9% vs 47.6%; HR, 0.80; 95% CI, 0.70-0.90).

Investigators noted that when patients were stratified by age and clinical risk using the TIMI Risk Score for Secondary Prevention, simvastatin-ezetimibe significantly lower the risk of CCVD death, MI, and ischemic stroke among higher-risk patients in those 75 years and older (HR, 0.75; 95% CI, 0.63-0.89; P = .001) and those younger than 75 (HR, 0.85; 95% CI, 0.74-0.98; P = .03). The absolute risk reduction by simvastatin-ezetimibe for high-risk patients was 4.2% for patients younger than 75 and 9.8% for patients 75 or older. 

Investigators added that the rate of adverse events did not increase in the simvastatin-ezetimibe group when compared to the simvastatin monotherapy group, regardless of age.

In an invited commentary, Antonio Gotto Jr, MD, of Weill Cornell Medicine, wrote that the results of the current study addressed whether the benefit seen in the IMPROVE-IT trial extends to older populations. 

“While the results reported by Bach et al are part of a post hoc analysis, they provide valuable information for both the patient and the practitioner,” Gotto Jr wrote. “They strongly support the benefit of intensive therapy to reduce LDL-C levels in elderly individuals with atherosclerotic cardiovascular disease.”

This study, titled “Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older,” is published in JAMA Cardiology.

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