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Conclusion: Multimorbidity, in itself, does not seem to be a determinant factor for appropriate statin prescription. The latter appears to be determined by a patient’s type of multimorbidity, especially the presence or not of diabetes. Differentiating between diabetic and non-diabetic multimorbidity may be a pragmatic way for GPs to improve...

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Long-term persistence with evolocumab treatment and sustained reductions in LDL-cholesterol levels over 30 months: Final results from the European observational HEYMANS study

Variability in low-density lipoprotein-cholesterol (LDL-C) level control at a population level is associated with poor cardiovascular outcomes. Limited data exist on LDL-C level variability or long-term persistence with the monoclonal ..... see more

Source : https://www.atherosclerosis-journal.com/article/S0021-9150(23)00003-5/fulltext



Conclusions: Evolocumab therapy was associated with sustained LDL-C level reductions up to 30 months, and persistence with evolocumab remained high, both at 12 and 30 months. Expanding the use of monoclonal antibodies such as evolocumab could provide improvements in LDL-C level control at a population level in European clinical practice.

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An Updated Meta-Analysis for Safety Evaluation of Alirocumab and Evolocumab as PCSK9 Inhibitors

Background. Alirocumab and evolocumab, as protein convertase subtilisin kexin type 9 (PCSK9) inhibitors, have been reported to reduce cardiovascular risk. This meta-analysis is aimed at updating the safety data of ..... see more

Source : https://www.hindawi.com/journals/cdtp/2023/7362551/



Conclusions: We suggest that alirocumab and evolocumab are generally safe and well tolerated and that their addition to background lipid-lowering therapy is not associated with an increased risk of adverse events or toxicity.

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Efficacy, safety, adherence and persistence of PCSK9 inhibitors in clinical practice: A single country, multicenter, observational study (AT-TARGET-IT) - PubMed

The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/36696749/



Conclusions: PCSK9i are safe and effective in clinical practice, leading to very high adherence and persistence to therapy, and achievement of recommended LDL-C target in most patients, especially when used as combination therapy.

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Novel protein-truncating variant in the APOB gene may protect from coronary artery disease and adverse cardiovascular events

Genetic testing is still underused for the diagnosis of dyslipidemia. * Among subjects with very low LDL levels, a novel APOB truncating variant was found. * ApoB-51 seems protective against ..... see more

Source : https://www.sciencedirect.com/science/article/pii/S2667089522000189?via=ihub



Conclusions: Our data support the use of targeted NGS in well-characterized clinical settings, as well as they indicate that.a partial block of ApoB production may be well tolerated and improve cardiovascular outcomes.

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Metabolomic Approach to Screening Homozygotes in Chinese Patients with Severe Familial Hypercholesterolemia - PubMed

The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/36675412/



Conclusion: Collectively, this study demonstrated that metabolomic profiling serves as a useful and economical approach to preselecting homozygotes in FH patients with severe hypercholesterolemia and may help clinicians to conduct selective genetic confirmation testing and familial cascade screening.

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Impact of list price changes on out-of-pocket costs and adherence in four high-rebate specialty drugs

Background Insurers manage the cost of specialty medicines via rebates, however it is unclear if the savings are passed on to patients, and whether reducing rebates may lead to changes ..... see more

Source : https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0280570



Conclusions: Reducing list prices to approximate net prices (as a proxy for reducing rebates) resulted in lower patient OOP costs, particularly for those with coinsurance. Our findings suggest that future reduction of rebates may assist in patient affordability, although additional transparency is needed.

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Multizonal observational study conducted by clinical practitioners on evolocumab use in subjects with hyperlipidemia in Saudi Arabia and Kuwait: Results from the ZERBINI study

Objectives Dyslipidemia is a prevalent condition with significant morbidity and mortality across the world, including in the Arabian Gulf. The present study aimed to describe the characteristics of patients receiving ..... see more

Source : https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0278821



Conclusion: Evolocumab is an effective lipid-lowering treatment in local populations. LDL-C goal achievement is increased when evolocumab is added to background lipid-lowering therapy with high tolerability and persistence. Long-term follow-up and large-scale data are needed to further support these observations.

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SIRT3 mediates the effects of PCSK9 inhibitors on inflammation, autophagy, and oxidative stress in endothelial cells

Theranostics 2023; 13(2):531-542. doi:10.7150/thno.80289 This issue Cite Research Paper Nunzia D'Onofrio 1*, Francesco Prattichizzo 2*, Raffaele Marfella 3,4, Celestino Sardu 3, Elisa Martino 1, Lucia Scisciola 3, Lorenza Marfella 3, ..... see more

Source : https://www.thno.org/v13p0531.htm



Conclusions: Overall, these data suggest that PCSK9i bear intrinsic anti-inflammatory, anti-autophagic, and antioxidant properties in endothelial cells, and that these pleiotropic effects might be mediated, at least in part, by SIRT3. These results provide an additional mechanism supporting the emerging knowledge relative to the benefit of...

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  • January 18, 2023
    Key Points • Source: Theranostics • Conclusions: “Overall, these data suggest that PCSK9i bear intrinsic anti-inflammatory, anti-autophagic, and antioxidant properties in endothelial cells, and that these pleiotropic effects might be mediated, at least in Show More
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Safety and Effectiveness of Alirocumab, a Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor, in Patients With Familial or Non-Familial H ...

Background: This study evaluated the safety and effectiveness of alirocumab in Japanese patients with familial hypercholesterolemia (FH) or non-FH in a real-world clinical setting. Methods and Results: This post-marketing surveillance study had ..... see more

Source : https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-22-0445/_article



Conclusions: Alirocumab was well tolerated and showed effectiveness in Japanese patients with hypercholesterolemia in a real-world clinical setting.

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Association between Familial Hypercholesterolemia and Serum Levels of Cholesterol Synthesis and Absorption Markers: The CACHE Study FH Analysis

Aim: Serum levels of cholesterol absorption and synthesis markers are known to be associated with cardiovascular risk. Familial hypercholesterolemia (FH) is a well-known inherited disorder presenting elevated low-density lipoprotein cholesterol ..... see more

Source : https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_63899/_article



Conclusion: FH group had significantly elevated serum Campe and Sito concentrations and insignificantly elevated Latho concentrations; thus, intestinal cholesterol absorption relative to hepatic cholesterol synthesis was suggested to be elevated in patients with FH. Serum Latho, Campe, and Sito concentrations showed nonlinear associations...

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Atherosclerosis With Immune Checkpoint Inhibitor Therapy: Evidence, Diagnosis, and Management: JACC: CardioOncology State-of-the-Art Review

As the clinical applications of immune checkpoint inhibitors (ICIs) expand, our knowledge of the potential adverse effects of these drugs continues to... see more

Source : https://www.sciencedirect.com/science/article/pii/S2666087322004690?via=ihub



Relevance: Immune checkpoint inhibitor (ICI) therapy is associated with an increased risk of atherosclerotic CV events likely mediated by accelerated atherosclerosis.

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CYP2C19 metabolizer phenotypes may affect the efficacy of statins on lowering small dense low-density lipoprotein cholesterol of patients with coronary artery disease

BackgroundDyslipidemia is a major cause of arteriosclerotic cardiovascular disease (ASCVD), and low-density lipoprotein cholesterol (LDL-C) is the profile to be reduced to prevent disease progression. Small dense low-density lipoprotein cholesterol ..... see more

Source : https://www.frontiersin.org/articles/10.3389/fcvm.2022.1016126/full



Conclusion: sdLDL-C and LDLC-4 outperformed other blood lipids such as LDL-C for CAD risk screening. CYP2C19 metabolizer phenotypes had the potential to predict the efficacy of statins in lowering sdLDL-C.

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Restoring mortality data in the FOURIER cardiovascular outcomes trial of evolocumab in patients with cardiovascular disease: a reanalysis based on regulatory data

Objective The FOURIER trial showed a benefit of the PCSK9 inhibitor evolocumab over placebo with respect to cardiovascular outcomes in patients with cardiovascular disease. However, we observed some inconsistencies between ..... see more

Source : https://bmjopen.bmj.com/content/12/12/e060172



Conclusion: sdLDL-C and LDLC-4 outperformed other blood lipids such as LDL-C for CAD risk screening. CYP2C19 metabolizer phenotypes had the potential to predict the efficacy of statins in lowering sdLDL-C.

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Coronary artery calcium testing in young adults : Current Opinion in Cardiology

erosclerotic cardiovascular disease (ASCVD) risk factors, have CAC. While the definition of premature CAC has yet to be formally defined in guidelines, it has become increasingly clear that any prevalent ..... see more

Source : https://journals.lww.com/co-cardiology/Abstract/2023/01000/Coronary_artery_calcium_testing_in_young_adults.6.aspx



Summary: The identification of premature CAC is important because it suggests that calcific plaque can be detected with modern imaging earlier in the natural history than previously thought. Taken together, these findings underline a utility of selective use of CAC scoring on non-contrast computed tomography among at-risk young adults to...

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Statin therapy for primary prevention in men: What is the role for coronary artery calcium?

Statin therapy is widely prescribed for patients with established ASCVD (secondary prevention). Meta-analysis of randomized clinical trials (RCTs) show conclusively that statins substantially reduce recurrent major ASCVD events (myocardial infarction ..... see more

Source : https://www.lipidjournal.com/article/S1933-2874(22)00299-9/fulltext



Highlights: Statins reduce atherosclerotic cardiovascular disease in men and women. Men develop coronary atherosclerosis more rapidly than women. Most men 55 to 75 years are statin eligible by Pooled Cohort Equations. But statin eligibility may be better guided by coronary artery calcium (CAC).

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Repatha® (evolocumab) injection 140 mg/mL

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Help your patients lower their LDL-C with Repatha®

Hear Dr. Turnbo, primary care physician, & Dr. Shah, invasive cardiologist, talk about treating ASCVD patients with Repatha®.

Learn more at RepathaHCP.com.

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IMPORTANT SAFETY INFORMATION

• Contraindication: Repatha® (evolocumab) is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

• Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

• Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

• Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.

• Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

INDICATIONS

Repatha ® is indicated:

In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization

As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)‑lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL‑C

Please see full Prescribing Information

USA-145-84270 10/22