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Background <p>Despite guideline recommendations for high-intensity statins in acute coronary syndrome (ACS) patients, real-world data show underutilization and suboptimal low-density lipoprotein cholesterol (LDL-C) target achievement. The statin-associated muscle symptoms (SAMS) is often a major limitation to drug compliance and hence to achieving LDL-C targets.</p> Methods <p>In this prospective, open label, randomized controlled trial, 502 ACS patients were randomized 1:1 to atorvastatin 80&#xa0;mg monotherapy (Group A) versus atorvastatin 40&#xa0;mg plus ezetimibe 10&#xa0;mg (Group AE), aiming to compare the efficacy, safety, and tolerability of both treatment arms. Lipid profiles, safety, and clinical outcomes were assessed at baseline, 6 weeks, 6 months, and 12 months. The primary endpoints were LDL-C reduction, SAMS, and major adverse cardiovascular events (MACE).</p> Results <p>The mean age of participants was 56 ± 10 years, with 83% males, 55% diabetics, and 77% hypertensives. Baseline characteristics were comparable between groups. Group AE demonstrated superior LDL-C reduction at all timepoints (<i>p</i> &lt; 0.01), with greater improvements in high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG). Group AE also showed significantly fewer events of treatment discontinuation (DC) or dose reduction (DR) (OR 0.50; 95% CI 0.31–0.81) and a 25.7% relative risk reduction (RRR) in the composite of MACE compared to Group A. SAMS and non-limiting muscle aches were significantly lower in Group AE (<i>p</i> &lt; 0.05), with no cases of rhabdomyolysis reported. Subgroup analysis confirmed consistent benefits of Group AE in both diabetic and non-diabetic patients.</p> Conclusion <p>Atorvastatin 40&#xa0;mg plus ezetimibe 10&#xa0;mg demonstrated superior LDL-C reduction, improved tolerability, and fewer MACE compared to atorvastatin 80&#xa0;mg monotherapy in ACS patients. These findings support the use of combination therapy as a viable starting alternative to atorvastatin 80&#xa0;mg monotherapy following ACS, particularly in patients likely to have statin intolerance.</p>

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Consistency over intensity: atorvastatin 40 mg plus ezetimibe 10 mg versus atorvastatin 80 mg in ACS patients: a comparative study of efficacy, tolerability, and cardiovascular outcomes

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  • 发表日期：

    2025年12月12日

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  • Ahmad Samir,
  • Kareem Mahmoud,
  • Mohamed Ashraf,
  • Hossam Elhossary,
  • Hesham Salah Eldin Taha

摘要

Background

Despite guideline recommendations for high-intensity statins in acute coronary syndrome (ACS) patients, real-world data show underutilization and suboptimal low-density lipoprotein cholesterol (LDL-C) target achievement. The statin-associated muscle symptoms (SAMS) is often a major limitation to drug compliance and hence to achieving LDL-C targets.

Methods

In this prospective, open label, randomized controlled trial, 502 ACS patients were randomized 1:1 to atorvastatin 80 mg monotherapy (Group A) versus atorvastatin 40 mg plus ezetimibe 10 mg (Group AE), aiming to compare the efficacy, safety, and tolerability of both treatment arms. Lipid profiles, safety, and clinical outcomes were assessed at baseline, 6 weeks, 6 months, and 12 months. The primary endpoints were LDL-C reduction, SAMS, and major adverse cardiovascular events (MACE).

Results

The mean age of participants was 56 ± 10 years, with 83% males, 55% diabetics, and 77% hypertensives. Baseline characteristics were comparable between groups. Group AE demonstrated superior LDL-C reduction at all timepoints (p < 0.01), with greater improvements in high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG). Group AE also showed significantly fewer events of treatment discontinuation (DC) or dose reduction (DR) (OR 0.50; 95% CI 0.31–0.81) and a 25.7% relative risk reduction (RRR) in the composite of MACE compared to Group A. SAMS and non-limiting muscle aches were significantly lower in Group AE (p < 0.05), with no cases of rhabdomyolysis reported. Subgroup analysis confirmed consistent benefits of Group AE in both diabetic and non-diabetic patients.

Conclusion

Atorvastatin 40 mg plus ezetimibe 10 mg demonstrated superior LDL-C reduction, improved tolerability, and fewer MACE compared to atorvastatin 80 mg monotherapy in ACS patients. These findings support the use of combination therapy as a viable starting alternative to atorvastatin 80 mg monotherapy following ACS, particularly in patients likely to have statin intolerance.