Effects of evolocumab injection: A Synthesis of Findings from 15 Studies

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Original Abstract of the Article

Major Research Findings

Evolocumab is a monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that helps regulate cholesterol levels in the blood. 9 , 11 , 13 , 10 , 4 , 8 Research suggests that evolocumab can significantly lower LDL cholesterol, a type of cholesterol linked to heart disease. 9 It may also help reduce the risk of heart attacks, strokes, and other cardiovascular events. 9 Furthermore, 4 showed that evolocumab improved walking ability in patients with peripheral artery disease and intermittent claudication.

Benefits and Risks

Benefit Summary

Evolocumab can significantly lower LDL cholesterol levels, 9 , 13 , 10 , 8 and may reduce the risk of heart attacks, strokes, and other cardiovascular events. 9 It also improved walking ability in patients with peripheral artery disease and intermittent claudication. 4

Risk Summary

The most common side effect of evolocumab is injection site reactions. 9 Other side effects are reported in 9 , 13 , 7 , 6 , but many of these are mild and do not usually require discontinuation of evolocumab. As stated in 5 , Evolocumab is an expensive treatment, raising concerns about cost-effectiveness.

Comparison Between Studies

Commonalities in Studies

These studies consistently show that evolocumab effectively lowers LDL cholesterol levels and may reduce the risk of cardiovascular disease. They also provide information about the safety of evolocumab.

Differences in Studies

These studies were conducted using different patient populations and study designs, which can lead to variations in results. For example, 11 found that the effectiveness of evolocumab varies depending on age and sex.

Consistency and Contradictions in Results

The findings about evolocumab's effect on lowering LDL cholesterol levels are consistent across these studies. However, more research is needed to confirm its impact on reducing the risk of cardiovascular disease.

Considerations for Real-Life Application

Evolocumab could be a beneficial treatment option for patients at high risk of cardiovascular disease. However, it's crucial to discuss the use of evolocumab with a doctor to ensure it is suitable for individual circumstances.

Limitations of Current Research

These studies have a relatively short follow-up period, so further research is necessary to assess the long-term effects of evolocumab. Additionally, these studies were conducted on specific patient populations, leaving uncertainty about whether the findings are applicable to all individuals. As stated in 5 , Evolocumab is an expensive treatment, raising concerns about cost-effectiveness.

Future Research Directions

Future research should focus on evaluating the long-term effects of evolocumab, conducting studies on diverse patient populations, and addressing cost-effectiveness concerns. Additionally, it is important to conduct research, such as 6 , on the impact of evolocumab on cognitive function.

Conclusion

Evolocumab is a promising medication for lowering LDL cholesterol and may help reduce cardiovascular disease risk. However, further research is needed to understand its long-term effects. Consultation with a doctor is essential to determine whether evolocumab is appropriate for individual patients.

Literature analysis of 15 papers
Positive Content
15
Neutral Content
0
Negative Content
0
Article Type
5
4
2
3
15
1.

Phase 1 and pharmacodynamic trial of everolimus in combination with cetuximab in patients with advanced cancer.

Author: CiunciChristine A, PeriniRodolfo F, AvadhaniAnjali N, KangHyunseon C, SunWeijing, RedlingerMaryann, HarlackerKathleen, FlahertyKeith T, GiantonioBruce J, RosenMark A, DivgiChaitanya R, SongHee Kwon, EnglanderSarah, TroxelAndrea, SchnallMitchell, O'DwyerPeter J

Disease control
Mucositis
Skin toxicity

Everolimus and cetuximab can be safely administered together at standard doses and are associated with prolonged disease control. The recommended dose for Phase 2 trials is 70 mg of oral everolimus weekly in combination with standard cetuximab. Imaging studies indicate that metabolic inhibition by everolimus alone and in combination with cetuximab predominates over changes in tumor perfusion in this patient population.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Relationship between metabolic toxicity and efficacy of everolimus in patients with neuroendocrine tumors: A pooled analysis from the randomized, phase 3 RADIANT-3 and RADIANT-4 trials.

Author: FazioNicola, CarnaghiCarlo, BuzzoniRoberto, ValleJuan W, HerbstFabian, RidolfiAntonia, StrosbergJonathan, KulkeMatthew H, PavelMarianne E, YaoJames C

Tumor treatment
Hypercholesterolemia
Hyperglycemia

Hyperglycemia and hypercholesterolemia did not have a significant impact on PFS in patients treated with everolimus.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Everolimus therapy and side‑effects: A systematic review and meta‑analysis.

Author: ArenaClaudia, BizzocaMaria Eleonora, CaponioVito Carlo Alberto, TroianoGiuseppe, ZhurakivskaKhrystyna, LeuciStefania, Lo MuzioLorenzo

Cancer treatment
Adverse events

This systematic review aimed to evaluate the type and incidence of side effects in patients treated with everolimus. The primary adverse events reported were stomatitis, leukopenia, anorexia, anemia, and fatigue, with the majority of patients experiencing grade 1 or 2 adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

4.

The addition of evolocumab to maximal tolerated statin therapy improves walking performance in patients with peripheral arterial disease and intermittent claudication (Evol-PAD study).

Author: ClavijoLeonardo C, CaroJorge, ChoiJongkyu, CaroJorge A, TunHan, RoweVincent, KumarS Ram, ShavelleDavid M, MatthewsRay V

Improved walking performance
Increased FMD
Reduced IMT

This double-blind, randomized, placebo-controlled study compared maximal walking time (MWT) and pain-free walking time (PFWT) in patients with PAD and claudication treated with monthly subcutaneous injections of evolocumab or placebo. The addition of evolocumab to maximal tolerated statin therapy improved maximal walking time in patients with PAD and claudication, increased FMD, and decreased IMT.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Cognitive function with evolocumab in pediatric heterozygous familial hypercholesterolemia.

Author: GaudetDaniel, RuzzaAndrea, BridgesIan, MaruffPaul, SchembriAdrian, HamerAndrew, MachFrançois, BergeronJean, GaudetIsabelle, PierreJulie St, KasteleinJohn J P, HovinghG Kees, WiegmanAlbert, RaalFrederick J, SantosRaul D

Cognitive safety

Evolocumab, a PCSK9 inhibitor, is used to lower cholesterol in adults and pediatric patients with familial hypercholesterolemia. While its cognitive safety has been established in adults, it is not yet described in children.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Effectiveness and safety of PCSK9 inhibitor therapy in patients with familial hypercholesterolemia within a therapeutic program in Poland: Preliminary multicenter data.

Author: ChlebusKrzysztof, CybulskaBarbara, DobrowolskiPiotr, Romanowska-KocejkoMarzena, Żarczyńska-BuchowieckaMarta, Gilis-MalinowskaNatasza, StróżykAneta, Borowiec-WolnaJustyna, PajkowskiMarcin, BobrowskaBeata, Rajtar-SalwaRenata, KwapiszewskaAleksandra, Waluś-MiarkaMałgorzata, ChmaraMagdalena, GałąskaRafał, MałeckiMaciej, ZdrojewskiTomasz, GruchałaMarcin

Reduced LDL-C levels
Fatigue
Flu-like symptoms
Injection site reactions
Musculoskeletal symptoms

This study assessed the efficacy and safety of alirocumab and evolocumab in patients with heterozygous familial hypercholesterolemia (FH) in Poland. Treatment with PCSK9 inhibitors resulted in a significant decrease in LDL-C levels after 3 months and 1 year of therapy. The most common adverse effects were flu-like symptoms, injection site reactions, fatigue, and musculoskeletal symptoms. PCSK9 inhibitors were highly effective in reducing LDL-C levels in FH patients, but further research is needed to assess their long-term safety and effectiveness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

9.

Meta-analysis of clinical outcomes of PCSK9 modulators in patients with established ASCVD.

Author: TalasazAzita H, HoAi-Chen Jane, BhattyFawzia, KoenigRachel A, DixonDave L, BakerWilliam L, Van TassellBenjamin W

ASCVD risk reduction
LDL-C reduction
PCSK9 inhibition
Injection site reaction
Myalgia
Neurocognitive disorders

This meta-analysis evaluated the lipid-lowering effects, cardiovascular outcomes, and safety of PCSK9-targeting agents. The analysis found that all agents significantly and consistently reduced LDL-C levels. While individual effects on mortality, cardiovascular death, myocardial infarction (MI), and stroke were not significant, a consistent reduction was observed in composite outcomes of cardiovascular events. Injection site reactions were more frequent in patients receiving these agents compared to placebo, but there was no significant difference in severe adverse events or other safety outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

10.

Efficacy and safety of PCSK9 inhibition in cardiovascular disease: a meta-analysis of 45 randomized controlled trials.

Author: GengQiang, LiXuan, SunQingjiao, WangZhengzhong

Reduced ASCVD
Safety concerns

This study evaluated the efficacy and safety of three PCSK9 inhibitors – alirocumab, evolocumab, and bococizumab – in patients with atherosclerotic cardiovascular disease (ASCVD).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

11.

LDL-cholesterol lowering with evolocumab, and outcomes according to age and sex in patients in the FOURIER Trial.

Author: SeverPeter, Gouni-BertholdIoanna, KeechAnthony, GiuglianoRobert, PedersenTerje R, ImKyungAh, WangHuei, KnuselBeat, SabatineMarc S, O'DonoghueMichelle L

Cardiovascular health
Injection site reaction

Evolocumab showed consistent efficacy and safety across a broad range of ages and in both men and women in 27,564 patients with atherosclerotic cardiovascular disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia.

Author: SantosRaul D, RuzzaAndrea, HovinghG Kees, WiegmanAlbert, MachFrançois, KurtzChristopher E, HamerAndrew, BridgesIan, BartuliAndrea, BergeronJean, SzamosiTamás, SantraSaikat, StefanuttiClaudia, DescampsOlivier S, Greber-PlatzerSusanne, LuirinkIlse, KasteleinJohn J P, GaudetDaniel,

Reduced LDL cholesterol

Evolocumab significantly reduced LDL cholesterol levels and other lipid variables in pediatric patients with familial hypercholesterolemia. The treatment was well-tolerated with a similar incidence of adverse events compared to placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Pharmacological Strategies beyond Statins: Ezetimibe and PCSK9 Inhibitors.

Author: ChoiJah Yeon, NaJin Oh

Lowered LDL cholesterol
Reduced ASCVD risk
High cost
Injection site reaction
Myalgia

This article discusses the use of statins for dyslipidemia, highlighting their effectiveness in reducing atherosclerotic cardiovascular disease (ASCVD) risk and the need for additional cholesterol-lowering agents like ezetimibe and PCSK9 inhibitors to further reduce residual cholesterol risk.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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