Side Effects of evolocumab injection: A Synthesis of Findings from 13 Studies

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Original Abstract of the Article

Main Research Findings

Evolocumab is a monoclonal antibody that inhibits PCSK9, a protein that degrades LDL receptors, leading to a reduction in LDL cholesterol levels. 3 、 1 、 4 、 10 、 11 、 7 、 5 It has been shown to be effective in lowering LDL cholesterol levels in patients who cannot tolerate statins or who do not reach their LDL cholesterol goals with statins. 2 、 13 、 12 Evolocumab is also effective in patients with familial hypercholesterolemia. 5

Reasons for Side Effects

Evolocumab is a monoclonal antibody that targets PCSK9, a protein that regulates LDL receptor levels. This can lead to a reduction in LDL receptor levels, which may cause some side effects.

Common Side Effects

Injection Site Reactions

The most common side effect of evolocumab is injection site reactions, such as pain, redness, swelling, and itching. 2 、 4 、 10 、 13 、 12

Flu-like Symptoms

Some patients may experience flu-like symptoms, such as fever, headache, and muscle aches. 2 、 4 、 13

Neurocognitive Impairment

While not definitively proven, some studies have suggested a potential for neurocognitive impairment with evolocumab use. 12 More research is needed to investigate this association.

Increased Blood Sugar

Some studies have indicated a possible association between evolocumab and increased blood sugar levels, but the causal relationship is not confirmed. 12

Side Effect Management

Injection Site Reactions

Injection site reactions can be managed by applying cold compresses before injection or warm compresses after injection. 2 Keeping the injection site clean is also important.

Flu-like Symptoms

If you experience flu-like symptoms, consult your doctor. They may prescribe antipyretics or analgesics if needed.

Neurocognitive Impairment

If you experience any concerning neurocognitive changes, it's essential to consult your doctor for evaluation and management.

Increased Blood Sugar

If you have concerns about increased blood sugar levels, consult your doctor. They can monitor your blood sugar levels and prescribe medications if necessary.

Comparison between Studies

Commonalities between Studies

The majority of studies have demonstrated that evolocumab effectively lowers LDL cholesterol levels. Most studies have also found evolocumab to be generally safe and well-tolerated.

Differences between Studies

The administration method and dosage of evolocumab can vary between studies. The patient populations studied can also differ, such as those with familial hypercholesterolemia.

Considerations for Real-World Application

Evolocumab is a valuable treatment option for patients who do not respond to statins or who cannot tolerate statins. However, it's crucial to be aware of the potential for side effects. Consult your doctor to discuss the risks and benefits of evolocumab before deciding whether it is right for you.

Limitations of Current Research

Long-term safety and efficacy data for evolocumab are still being gathered. It is also important to note that evolocumab is a relatively expensive medication.

Future Research Directions

Further research is needed to comprehensively assess the long-term safety and effectiveness of evolocumab. Research aimed at reducing the cost of evolocumab is also crucial.

Conclusion

Evolocumab is an effective treatment option for lowering LDL cholesterol levels in patients who do not respond to statins or who cannot tolerate statins. While generally safe and well-tolerated, it is essential to be aware of the potential for side effects. Discuss the risks and benefits of evolocumab with your doctor to make an informed decision about whether it's right for you.

Literature analysis of 13 papers
Positive Content
13
Neutral Content
0
Negative Content
0
Article Type
2
0
0
6
13
1.

Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy.

Author: ChoLeslie, RoccoMichael, ColquhounDavid, SullivanDavid, RosensonRobert S, DentRicardo, XueAllen, ScottRob, WassermanScott M, StroesErik

LDL-C lowering
Muscle-related side effects

Evolocumab, a monoclonal antibody that binds PCSK9, is being studied as a treatment for statin-intolerant patients with hypercholesterolemia. This article describes the design of a phase 3 clinical trial (GAUSS-2) evaluating the efficacy and safety of evolocumab in this population.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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

2.

PCSK9 inhibitors.

Author: GencerBaris, LambertGilles, MachFrançois

LDL-C reduction
Injection site reactions

This paper discusses the promising therapeutic potential of PCSK9 inhibition for lowering LDL-C levels and reducing cardiovascular disease (CVD) risk. The clinical development of human monoclonal antibodies against PCSK9 has progressed, with promising results reported from phase 2 clinical studies. Large phase III studies are underway to evaluate the effect of PCSK9 inhibition on CVD events in patients with acute coronary syndrome.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial.

Author: SullivanDavid, OlssonAnders G, ScottRob, KimJae B, XueAllen, GebskiVal, WassermanScott M, SteinEvan A

LDL cholesterol reduction
High LDL cholesterol
Statin intolerance

Statins are medications that lower cholesterol levels but some patients cannot tolerate them or require higher doses to reach treatment goals. PCSK9 is a protein that increases LDL cholesterol levels. This study evaluated the effects of AMG145, a human monoclonal antibody to PCSK9, in phase 1 studies. AMG145 was well tolerated and reduced LDL cholesterol levels.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
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

4.

Profile of evolocumab and its potential in the treatment of hyperlipidemia.

Author: CiceroArrigo F G, CollettiAlessandro, BorghiClaudio

LDL cholesterol reduction
Side effects

Evolocumab is a monoclonal antibody that reduces LDL cholesterol levels by 54% to 80% and has a low rate of mild side effects. It is a potential treatment for high-risk patients with familial hypercholesterolemia who cannot tolerate statins.

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

5.

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

6.

Efficacy and safety profile of evolocumab (AMG145), an injectable inhibitor of the proprotein convertase subtilisin/kexin type 9: the available clinical evidence.

Author: CiceroArrigo F G, TartagniElisa, ErtekSibel

LDL-C reduction
Intolerance

Statins are effective for reducing low-density lipoprotein cholesterol (LDL-C), but some patients do not achieve their LDL-C goals or experience intolerance. This highlights the need for additional effective LDL-C reducing agents.

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

7.

Treatment of hyperlipidemia with proprotein convertase subtilisin/kexin type 9 inhibitor in a patient with nephrotic syndrome: a case report.

Author: ChoiHong Sang, KimChang Seong, MaSeong Kwon, KimSoo Wan, BaeEun Hui

Hyperlipidemia control
PCSK9 inhibitor alternative
Statin intolerance

This case report describes a patient with nephrotic syndrome and toxic epidermal necrolysis (TEN) caused by statin use. The patient's hyperlipidemia was successfully controlled with a PCSK9 inhibitor, evolocumab, after statin intolerance. This case highlights the potential of PCSK9 inhibitors as an alternative treatment option for hyperlipidemia in patients with statin intolerance or serious side effects.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

[PCSK9 inhibition--A new era in cholesterol treatment].

Author: OlssonAnders

Lower LDL cholesterol
Treatment for familial hypercholesterolaemia
Subphysiological LDL cholesterol levels

The discovery of PCSK9, a protein that regulates cholesterol levels, has opened up new possibilities for treating high cholesterol. Three monoclonal antibodies are currently being studied in clinical trials and have shown to significantly reduce LDL cholesterol levels with few side effects.

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 : Swedish

10.

Retargeting the management of hypercholesterolemia - focus on evolocumab.

Author: CollettiAlessandro, DerosaGiuseppe, CiceroArrigo Fg

Lowers LDL-C
Safe and well tolerated

This abstract discusses the use of evolocumab, a PCSK9 inhibitor, for lowering LDL-C in patients with hypercholesterolemia. Evolocumab has demonstrated effectiveness in monotherapy and in combination with statins, achieving significant reductions in LDL-C. The drug has a good safety profile and is well tolerated. Ongoing clinical trials are assessing long-term effects.

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

11.

Impact of evolocumab treatment on low-density lipoprotein cholesterol levels in heterozygous familial hypercholesterolemic patients withdrawing from regular apheresis.

Author: KawashiriMasa-Aki, NoharaAtsushi, HigashikataToshinori, TadaHayato, NakanishiChiaki, OkadaHirofumi, KonnoTetsuo, SakataKenji, HayashiKenshi, InazuAkihiro, MabuchiHiroshi, YamagishiMasakazu

Apheresis withdrawal
LDL-C reduction

This study investigated the impact of evolocumab, a PCSK9 inhibitor, on the need for regular LDL apheresis in patients with heterozygous familial hypercholesterolemia. The results indicated that evolocumab could significantly reduce LDL cholesterol levels, potentially leading to a reduction or elimination of apheresis treatment.

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

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