Long-Term Efficacy and Safety of Inclisiran in Patients with High Cardiovascular Risk and Elevated Low-Density Lipoprotein Cholesterol (ORION-3): Results from the 4-Year Open-Label Extension of the ORION-1 Trial

Ray, Kausik K.; Troquay, Roel P T; Visseren, Frank L J; Leiter, Lawrence A.; Wright, Scott; Vikarunnessa, Sheikh; Talloczy, Zsolt; Zhang, Xiao; Maheux, Pierre; Lesogor, Anastasia; Landmesser, Ulf

doi:10.2139/ssrn.4252675

Cited by 5 publications

(3 citation statements)

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“…Laboratory parameters or liver safety were unaffected. Findings from ORION-3, in addition to the safety information provided in earlier phase 3 studies, showed consistent tolerability and safety with inclisiran for up to 4 years [25].…”

Section: Safetymentioning

confidence: 53%

Inclisiran: present and future perspectives of a new effective LDL cholesterol-lowering agent

Giordano

Polimeni

Esposito

et al. 2023

Current Opinion in Lipidology

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Purpose of review To highlight critical aspects of inclisiran, from preclinical studies to current recommendations in clinical practice and future perspectives. Recent findings Inclisiran use has been recently approved by regulatory agencies. The evidence of its efficacy and safety makes it a promising therapeutical tool for treating dyslipidemias. Summary The link between LDL-cholesterol and atherosclerotic cardiovascular disease (ASCVD) is well established. Inclisiran, a small interfering RNA, has proven its safety and efficacy in reducing LDL-cholesterol, and FDA and EMA have recently approved its use. This review illustrates the development, structure, and mechanism of action of inclisiran and provides information regarding its efficacy, safety, and current recommendation in clinical practice. Moreover, it provides key information on the most recent/ongoing trials that will help us to implement the use of inclisiran in clinical practice.

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Section: Safetymentioning

confidence: 53%

Inclisiran: present and future perspectives of a new effective LDL cholesterol-lowering agent

Giordano

Polimeni

Esposito

et al. 2023

Current Opinion in Lipidology

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“…The magnitude of LDL-C lowering achieved with inclisiran is similar to that reported with anti-PCSK9 mAbs, but with a less frequent, twice-yearly dosing regimen (after initial and 3-month doses) compared with self-injection of anti-PCSK9 mAb every 2 or 4 weeks [ 10 , 11 , 14 , 16 , 17 , 19 ]. Moreover, data from the Phase 3 trials and ORION-3 study show that treatment with inclisiran provides a consistent LDL-C−lowering effect sustained for 6 months per dose [ 16 , 20 ]. In this subset of patients with CeVD who had a mean (SD) baseline LDL-C of 108.4 (34.3) mg/dL, 59.1%, 70.0%, and 79.1% of patients achieved LDL-C thresholds of <50 mg/dl, <70 mg/dL, and <100 mg/dL, respectively, with the addition of inclisiran to maximally tolerated statin therapy.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of inclisiran in patients with cerebrovascular disease: ORION-9, ORION-10, and ORION-11

Köenig

Ray

Landmesser

et al. 2023

American Journal of Preventive Cardiology

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“…Such a drug delivery system could also affect the adjustment of health care systems so that the drug is administered in the same way as vaccines for seasonal diseases, which would also translate into economic considerations for therapy [35]. Noteworthy is the ORION-5 study where patients with homozygous familial hypercholesterolemia and elevated LDL-C levels were studied, in this study involving 56 patients, no statistical differences were observed between the drug and placebo [36]. In 2020 meta-analysis involving 3,660 patients showed that incisiran lowered LDL cholesterol by 51% (95% confidence interval, 48 to 53%; p < 0.001) compared with placebo, over to There were no differences in adverse events, abnormalities in liver function tests or creatine kinase levels between treatment strategies, making it a good alternative to statin therapy [37].…”

Section: Inclisiranmentioning

confidence: 99%

New drugs for the treatment of hyperlipidemia in statin-intolerant patients - review

Płonka,

Pelc,

Sitarek

et al. 2024

J Educ Health Sport

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Introduction Cardiovascular diseases are the most numerous group of diseases prevalent in the world. They are a challenge for many health systems, in terms of keeping life comfortable and also economics. The cause of selected disease entities is too much cholesterol in the blood. The most popular treatment for hypercholesterolemia is based on statins. Many patients are affected by intolerance to these drugs, so an important issue is the discovery and improvement of alternatives to statins. Purpose of work The purpose of this review is to collect literature data on the latest treatments for hypercholesterolemia with drugs other than statins and ezetimibe. Materials and methods Materials are from a review of recent literature available in PubMed. To search for articles, we used keywords such as: bempedoic acid, non-statin therapy, cardiovascular risk, inclisiran, alirocumab, cardiovascular disease, dyslipidemia, evolocumab. Summary Treatment of hypercholesterolemia with statins remains the most popular management strategy. Intolerance to treatment with these drugs creates serious clinical problems for patients. Recently, we could see the emergence of new drugs as alternatives to statins. As the results show, the new drugs can effectively replace statins in the hypolipemic treatment especially of patients who cannot be treated with them.

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Long-Term Efficacy and Safety of Inclisiran in Patients with High Cardiovascular Risk and Elevated Low-Density Lipoprotein Cholesterol (ORION-3): Results from the 4-Year Open-Label Extension of the ORION-1 Trial

Cited by 5 publications

References 0 publications

Inclisiran: present and future perspectives of a new effective LDL cholesterol-lowering agent

Inclisiran: present and future perspectives of a new effective LDL cholesterol-lowering agent

Efficacy and safety of inclisiran in patients with cerebrovascular disease: ORION-9, ORION-10, and ORION-11

New drugs for the treatment of hyperlipidemia in statin-intolerant patients - review

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