According to several studies, in patients with high-risk atherosclerotic disease, such as those affected by coronary artery disease, achieving target LDL levels through high-intensity statin therapy has been shown to lead to a significant reduction in long-term cardiovascular events. Therefore, the management of dyslipidemia has become a fundamental pillar of secondary prevention.
However, reaching such a goal is difficult, as evidenced by the discrepancy between guideline recommendations (in terms of doses) and actual clinical practice, where low adherence due to adverse effects is quite frequent.
As a response to this issue, researchers hypothesized that early initiation of a combination of low-dose statins and ezetimibe could achieve equivalent LDL reduction with fewer adverse effects.
This premise gave rise to the RACING study, which demonstrated the non-inferiority of the combination of rosuvastatin 10 mg and ezetimibe 10 mg compared with rosuvastatin 20 mg monotherapy in a 3-year follow-up. In addition to showing better treatment adherence, a more pronounced reduction in LDL was observed in patients in the combination group.
The aim of this study is to assess the applicability of the findings from the RACING study in patients who underwent coronary percutaneous intervention (PCI), using data from the Korean National Health Insurance Service (NHIS) database.
The analysis included a total of 72,622 patients who underwent PCI, of whom 11,280 received the drug combination and 61,342 received statin monotherapy. The primary endpoint was a composite of cardiovascular events that included death, myocardial infarction, coronary revascularization, hospitalization for heart failure or non-fatal stroke, during a three-year follow-up.
Safety secondary endpoints included treatment discontinuation for more than 180 days and adverse effects such as new-onset diabetes mellitus, rhabdomyolysis, gallbladder disease requiring cholecystectomy, and new cancer diagnosis.
In the group of patients treated with the drug combination, 89.7% of them continued with the same statin dose, as opposed to 78.1% in the monotherapy group (P <0.001). Furthermore, the primary endpoint was significantly lower in the combination group (11.6% vs. 15.2%; hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.70-0.79; P <0.001). Subgroup analyses supported these beneficial results. Regarding safety, treatment discontinuation was less frequent in the combination group (6.5% vs. 7.6%; HR, 0.85; 95% CI, 0.78-0.94; P <0.001) and was associated with a lower incidence of new-onset diabetes (7.7% vs. 9.6%; HR, 0.80; 95% CI, 0.72-0.88; P <0.001).
Conclusions
In summary, in patients undergoing PCI, the combination of lipid-lowering medications was associated with a decrease in cardiovascular events, a lower treatment discontinuation rate, and a lower incidence of adverse effects, including new-onset diabetes. While these results support the efficacy and safety of combination therapy, it is important to note that these findings are based on a population studied in Korea, and broader validation is required to gain a comprehensive understanding of appropriate lipid-lowering treatment.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Combination Lipid-Lowering Therapy in Patients Undergoing Percutaneous Coronary Intervention.
Reference: Lee, Seung-Jun et al. “Combination Lipid-Lowering Therapy in Patients Undergoing Percutaneous Coronary Intervention.” Journal of the American College of Cardiology vol. 82,5 (2023): 401-410. doi:10.1016/j.jacc.2023.05.042.
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