Summary

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• Inclisiran (Leqvio) is used alongside a diet and statin therapy at the highest tolerated dose for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who need further reduction of low-density lipoprotein cholesterol.
• A total of 14 systematic reviews/meta-analyses provided insights into Leqvio's efficacy and safety profile compared to drugs like evolocumab and alirocumab.
• The medication demonstrates significant effectiveness in lowering LDL-C levels in various patient groups, particularly those with heterozygous familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease. One study showed a 50.7% reduction when administered twice yearly in addition to maximally tolerated statin therapy.
• Compared to PCSK9 inhibitors such as evolocumab and alirocumab, inclisiran offers comparable reductions in LDL-C levels; however, its twice-yearly dosing regimen may improve compliance due to the less frequent administration required than monoclonal antibodies.
• In terms of safety, inclisiran was generally well-tolerated, with adverse events similar to those reported in placebo groups. Injection-site reactions were more common but were predominantly mild and did not lead to discontinuation, while serious adverse events did not significantly differ from the placebo group nor increased risk compared to other PCSK9 inhibitors.
• In specific groups such as patients at high risk of or existing ASCVD along with the HeFH population, it showed notable effectiveness by significantly reducing lipid parameters, emphasizing its potential for managing patients needing substantial LDL-C lowering beyond what can be achieved with statins alone.
• Network meta-analyses indicate that inclisiran provides similar reductions in LDL-C when added to maximum tolerated statins like evolocumab and alirocumab, but its dosing regimen could offer advantages regarding adherence and patient preference.
• Some studies suggested potential cardiovascular benefits with inclisiran associated with a reduction in major adverse cardiovascular events, aligning with the recognized benefits of lowering LDL-C levels on cardiovascular risk. However, more comprehensive and longer-term trials are necessary to conclusively determine the impact of inclisiran on events such as myocardial infarction, stroke, and cardiovascular mortality compared to other PCSK9 inhibitors and statins.