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The impact of LEQVIO® for patients in the real world
Explore three case studies showing real-world patients who have been prescribed LEQVIO®, highlighting the clinical results of initiating treatment and an overall review of their management.
Martin’s medical profile:
- Previous ischaemic stroke
- On maximally tolerated statin
Janet’s medical profile:
- History of peripheral arterial disease
- Statin intolerant
Ethel’s medical profile:
- Previous MI
- Ezetimibe patient, statin intolerant
The above case studies are unpublished, real-world case studies from Meredith Donaldson, and have been provided at the request of Novartis. Meredith Donaldson works as a Physician Associate in Family Medicine for Marsh Medical Practice, and has received honoraria from Novartis. These case studies are not reflective of all patient responses to therapy, which may vary.
LEQVIO® showed LDL-C reductions of above 50% on average relative to placebo, seen 90 days after initiation, on top of a maximally tolerated dose of statin2,3,19
The Phase III ORION-10 (N=1,561) and ORION-11 (N=1,617) clinical trials were designed to assess the efficacy and safety profile of LEQVIO® in adult patients with ASCVD, and ASCVD or risk equivalents,* respectively, who had elevated LDL-C levels despite receiving a maximally tolerated statin, with or without additional lipid-lowering therapy.19
The co-primary endpoints were the placebo-corrected percentage change in LDL cholesterol level from baseline to Day 510 and the time-adjusted percentage change in LDL cholesterol level from baseline after Day 90 and up to Day 540.19
Primary endpoints19
Baseline mean (±SD) LDL-C across ORION-10 and ORION-11:
ORION-10: 2.70±1.02 mmol/L with LEQVIO®; 2.71±0.96 mmol/L with placebo
ORION-11: 2.77±1.08 mmol/L with LEQVIO®; 2.68±0.94 mmol/L with placebo
On top of a maximally tolerated statin, LEQVIO®:
- Month 17: delivered placebo-corrected LDL-C reductions of 52%, as compared with baseline (–51% with LEQVIO® vs +1% with placebo, 95% CI: –55.7 to –48.8; p<0.001) in ORION-10, and of 50%, as compared with baseline (–46% with LEQVIO® vs +4% with placebo, 95% CI: –53.1 to –46.6; p<0.001) in ORION-11
- Between Months 3 and 18: delivered time-adjusted LDL-C reductions of 54% (–51% with LEQVIO® vs +3% with placebo, 95% CI: –56.2 to –51.3; p<0.001) and of 49% (–46% with LEQVIO® vs +3% with placebo, 95% CI: –51.6 to –46.8; p<0.001) from baseline relative to placebo in ORION-10 and ORION-11, respectively
LEQVIO® was generally well tolerated, with a safety profile similar to placebo apart from injection-site reactions, which were more common in the LEQVIO® group; these were graded as mild or moderate, with none being severe or persistent2,3,19
- ORION-10 (LEQVIO® n=781, placebo n=778): 2.6% vs 0.9%, respectively
- ORION-11 (LEQVIO® n=811, placebo n=804): 4.7% vs 0.5%, respectively
When statins alone are not enough, confidently make LEQVIO® your first-choice treatment for patients who have had a cardiovascular event2,3,19
See how to identify and start eligible LEQVIO patients in primary and secondary care
The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.
The effect of LEQVIO® on cardiovascular morbidity or mortality has not been established.2,3
*ASCVD risk equivalents included type 2 diabetes, HeFH, or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.19
†Not a real name. No personal data has been used in this document.
Individual patient characteristics and response to treatment may vary.
ASCVD, atherosclerotic cardiovascular disease; BD, twice daily; CI, confidence interval; GTN, glyceryl trinitrate; HeFH, heterozygous familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; OD, once daily.
References:
- Steen DL, et al. J Am Heart Assoc 2022;11(9):e022198.
- LEQVIO® Great Britain. Summary of Product Characteristics.
- LEQVIO® Northern Ireland. Summary of Product Characteristics.
- Atorvastatin Summary of Product Characteristics.
- Clopidogrel Summary of Product Characteristics.
- Candesartan Summary of Product Characteristics.
- Lansoprazole Summary of Product Characteristics.
- Ramipril Summary of Product Characteristics.
- Rosuvastatin Summary of Product Characteristics.
- Simvastatin Summary of Product Characteristics.
- Alirocumab Summary of Product Characteristics.
- Ezetimibe Summary of Product Characteristics.
- Bempedoic Acid Summary of Product Characteristics.
- Apixaban Summary of Product Characteristics.
- Bisoprolol Summary of Product Characteristics.
- Felodipine Summary of Product Characteristics.
- Fluvastatin Summary of Product Characteristics.
- Pravastatin Summary of Product Characteristics.
- Ray KK, et al. N Engl J Med 2020;382(16):1507–1519 and supplementary appendix.
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