Log in to MyACC
Combined Statin-Ezetimibe for Elderly Adults With Atherosclerosis
Quick Takes
- Combination therapy with moderate-dose statin plus ezetimibe was associated with similar ASCVD rates compared to monotherapy with high-intensity statin therapy among both older adults (≥75 years) and younger adults (<75 years).
- Rates of intolerance-related drug discontinuation or dose reduction were lower in the combination arm (moderate-dose statin plus ezetimibe) compared to the monotherapy arm (with high-intensity statin) for both age groups.
- Combination therapy was more effective in lowering LDL-C levels, especially for those aged <75 years.
Study Questions:
What is the impact of moderate-intensity statin plus ezetimibe compared to high-intensity statin monotherapy in elderly patients with atherosclerotic cardiovascular disease (ASCVD)?
Methods:
Data from the RACING trial were used for the present analysis. The RACING trial was a prospective, multicenter, open-label, noninferiority trial, randomizing 3,780 patients with a history of ASCVD, from 26 centers in South Korea. Participants were randomized to either combination therapy with rosuvastatin 10 mg daily plus ezetimibe, or monotherapy with rosuvastatin 20 mg daily. The primary composite endpoint of cardiovascular (CV) death, major CV events, or nonfatal stroke was collected at 3 years. For this analysis, the primary endpoint was compared for elderly participants (≥75 years) compared to younger participants (<75 years). The secondary outcome was intolerance-related drug discontinuation or dose reduction and low-density lipoprotein cholesterol (LDL-C) level.
Results:
A total of 3,780 enrolled participants were included in the present study, of which 574 (15.2%) were aged ≥75 years at time of randomization. Participants aged <75 years were more likely to be female and have a lower body mass index compared to the younger group.
Primary endpoint rates did not differ between the combo group (moderate-intensity statin plus ezetimibe) or the monotherapy group (high-intensity statin monotherapy group). For patients aged ≥75 years, the primary outcome rates were 10.6% for the combination group and 12.3% for the monotherapy group (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.54–1.42; p = 0.581). For participants aged <75 years, the primary outcome rates were 8.8% for the combination group and 9.4% for the monotherapy group (HR, 0.94; 95% CI, 0.74–1.18; p = 0.570). There was no interaction by age or treatment strategy. Moderate-intensity statin with ezetimibe combination therapy was associated with lower rates of intolerance-related drug discontinuation or dose reduction among patients aged ≥75 years (2.3% vs. 7.2%; p = 0.010) and those aged <75 years (5.2% vs. 8.4%; p < 0.001) (p for interaction = 0.159).
Median LDL-C levels were 58 mg/dL in the combination therapy group and 62 mg/dL in the monotherapy group for those aged ≥75 years. For those aged <75 years, median LDL-C levels were lower in the combination group compared to the monotherapy group for all 3 years.
Conclusions:
A combination of moderate-intensity statin plus ezetimibe was associated with similar CV benefits to that of monotherapy with high-intensity statin therapy. Intolerance-related drug discontinuation or dose reduction among the elderly participants with ASCVD was lower in the combination therapy compared to the monotherapy group.
Perspective:
The findings from this study suggest benefits to moderate-dose statin; in this trial, 10 mg of rosuvastatin in combination with ezetimibe was equally effective in reducing ASCVD events among older and younger South Korean adults with a history of ASCVD. This combination was more effective in lowering LDL levels and with less intolerance-related drug discontinuation. Given there are alternative therapies such as PCSK9 inhibitors, examining the cost-effectiveness of this combination is warranted. Replicating this trial in other populations and without an open-label study design is also warranted.
Clinical Topics: Dyslipidemia, Geriatric Cardiology, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Statins
Keywords: Aged, Atherosclerosis, Cholesterol, LDL, Ezetimibe, Geriatrics, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Ketamine, Lipoproteins, Primary Prevention, Rosuvastatin Calcium, Stroke
< Back to Listings
