Key result
Evolocumab use is linked to a ~1.2-mmol/L mean LDL-C reduction at 6 months.
Why the study?
Evolocumab's long-term safety and effectiveness in the Saudi population with primary hypercholesterolemia or mixed dyslipidemia had not been studied.
Does evolocumab effectively lower LDL cholesterol and demonstrate a safe profile in real-world patients with primary hypercholesterolemia or mixed dyslipidemia?
Cohort (n=469)
Yes
Does evolocumab effectively lower LDL cholesterol and demonstrate a safe profile in real-world patients with primary hypercholesterolemia or mixed dyslipidemia?
Real-world data demonstrates that evolocumab effectively reduces LDL cholesterol with an acceptable safety profile in patients for whom statins are insufficient.
Answers are grounded in this paper and cite their sources.
Supports real-world LDL reduction with evolocumab; extends RCT data but leaves practice change open pending prospective confirmation.
Introduction: Evolocumab's short-term efficacy and safety were proven in phase-3 clinical trial, but its long-term safety and effectiveness in the Saudi population are yet to be studied. The aim of this study was to assess the long-term safety and effectiveness of evolocumab in Saudi patients with primary hypercholesterolemia or mixed dyslipidemia. Method: A retrospective cohort study evaluated adult patients who had newly been prescribed evolocumab for hypercholesterolemia or mixed dyslipidemia. Safety events included myocardial infarction, unstable angina, stroke, transient ischemic attack, heart failure, rhabdomyolysis, renal dysfunction, and myalgia. Effectiveness outcomes included changes in lipid profiles from baseline, assessed at 6-, 12-, 18-, and 24-month. Results: The study sample were 469 who newly prescribed evolocumab, from which 69.1 % being male, were included. The most prevalent comorbidities were coronary artery disease, diabetes, and hypertension. Statin was the most commonly used therapy. The most common adverse events at 6-month follow-up, based on the incidence rate per 1000 person-years, were coronary revascularization (63.20), myalgia (44.96), myocardial infarction (31.53), unstable angina (31.49), heart failure (26.94), rhabdomyolysis without renal dysfunction (8.93), transient ischemic attack (4.46), and rhabdomyolysis with renal dysfunction (4.46). Stroke incidence increased with follow-up length, from 8.87 per 1000 person-years at 6 months to 12.84 per 1000 person-years at 24 months. Evolocumab use significantly reduced LDL and total cholesterol levels at 6, 12, 18, and 24 months follow-up, while having no significant effect on HDL or triglycerides levels. Conclusion: Evolocumab appeared to be safe and effective therapeutic option for patients with primary hypercholesterolemia or mixed dyslipidemia to potentially reduce LDL levels to therapeutic levels when statins are insufficient.
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Almutairi et al. (2024) conducted a cohort in Primary hypercholesterolemia and mixed dyslipidemia (n=469). Evolocumab vs. Baseline (unexposed/pre-treatment values) was evaluated on Mean difference in LDL cholesterol at 6 months follow-up (MD -1.17, 95% CI -1.66, -0.68, p=<0.001). Evolocumab use was associated with a significant mean reduction in LDL cholesterol of 1.17 mmol/L at 6 months compared to baseline in real-world patients.
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