Effects of alirocumab injection: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Major Research Findings

Alirocumab is a new drug used to treat high cholesterol, a type of medicine called a PCSK9 inhibitor. 21 、 3 、 2 、 9 Several studies have shown that alirocumab significantly reduces LDL cholesterol, a type of bad cholesterol. 19 、 25 、 26 、 11 、 2 、 9 These studies have reported that alirocumab significantly reduces LDL cholesterol, especially in patients who are intolerant to statins, a common cholesterol-lowering drug, or those who cannot achieve their LDL cholesterol targets with statins alone. 14 、 4 、 3 、 13 Alirocumab may also reduce the risk of cardiovascular events. 8 、 3 、 11 However, some studies reported side effects such as injection site reactions. 23 、 22 、 3 、 8 These side effects are usually mild to moderate and resolve within a short period of time. 22 、 8 Further research is needed to understand the long-term safety and effectiveness of alirocumab. 4 、 8

Benefits and Risks

Benefit Summary

Alirocumab may reduce the risk of cardiovascular events by significantly reducing LDL cholesterol. 8 、 3 、 11 It may be a good treatment option for patients who are intolerant to statins or those who cannot achieve their LDL cholesterol targets with statins alone. 14 、 4 、 3 、 13

Risk Summary

The most common side effect of alirocumab is injection site reactions. 23 、 22 、 3 、 8 These side effects are usually mild to moderate and resolve within a short period of time. 22 、 8 Further research is needed to understand the long-term safety and effectiveness of alirocumab. 4 、 8

Comparison Across Studies

Similarities Across Studies

Many studies have shown that alirocumab significantly reduces LDL cholesterol. 19 、 25 、 26 、 11 、 2 、 9 Alirocumab has also been generally reported to be well tolerated. 14 、 4 、 3 、 13 However, some studies reported side effects such as injection site reactions. 23 、 22 、 3 、 8

Differences Across Studies

There is some variability across studies about the impact of alirocumab on cardiovascular events. 8 、 3 、 11 While some studies have suggested that alirocumab may reduce the risk of cardiovascular events, other studies have not found a clear effect. 8 、 3 、 11 Further research is needed to understand the long-term safety and effectiveness of alirocumab. 4 、 8

Consistency and Contradictions Across Findings

A significant reduction in LDL cholesterol and good tolerability of alirocumab has been consistently reported across many studies. 19 、 25 、 26 、 11 、 2 、 9 、 14 、 4 、 3 、 13 However, there are some inconsistencies regarding the impact of alirocumab on cardiovascular events. 8 、 3 、 11 Further research is needed to better understand the long-term safety and effectiveness of alirocumab. 4 、 8

Notes on Applying Findings in Real-Life

Alirocumab might be a good treatment option for patients who are intolerant to statins or those who cannot achieve their LDL cholesterol targets with statins alone. 14 、 4 、 3 、 13 However, it's important to be aware of the potential side effects, such as injection site reactions. 23 、 22 、 3 、 8 Carefully consider the risks and benefits of using alirocumab before making a decision. 4 、 8

Limitations of Current Research

Further research is needed to understand the long-term safety and effectiveness of alirocumab. 4 、 8 There is also some variability across studies about the impact of alirocumab on cardiovascular events. 8 、 3 、 11 Larger, longer-term studies are needed to address these questions. 4 、 8

Directions for Future Research

Large, long-term studies are needed to evaluate the long-term safety and effectiveness of alirocumab. 4 、 8 More research is also needed to clarify the impact of alirocumab on cardiovascular events. 8 、 3 、 11

Conclusion

Alirocumab is a promising new drug for patients who are intolerant to statins or those who cannot achieve their LDL cholesterol targets with statins alone. 14 、 4 、 3 、 13 However, it's important to be aware of potential side effects, such as injection site reactions, and to carefully consider the risks and benefits of using alirocumab. 4 、 8 Further research is needed to understand the long-term safety and effectiveness of alirocumab. 4 、 8

Keywords
Benefit Keywords
HIV treatment
1
Reduced ASCVD
2
Atherosclerotic event reduction
LDL reduction
3
Reduced LDL-C
4
Reduces LDL-C
Safe and well-tolerated
5
LDL-C reduction
6
Lower cholesterol
7
ASCVD risk reduction
LDL-C reduction
PCSK9 inhibition
8
Reduced LDL-C levels
9
ASCVD treatment
10
Lowered LDL cholesterol
Reduced ASCVD risk
11
Reduced LDL cholesterol
Reduced cardiovascular events
12
Reduced LDL-C
Reduced cardiovascular risk
13
Hypercholesterolemia treatment
14
Hypercholesterolemia treatment
15
LDL reduction
effective treatment
16
Hypercholesterolemia treatment
17
LDL-C reduction
18
Hypercholesterolemia treatment
19
Lower LDL cholesterol
Reduce Lp(a) levels
20
Improved HDL cholesterol
Lower LDL cholesterol
21
Well tolerated
22
Reduced LDL-C levels
24
Improved lipid profile
Increased HDL-C
Reduced LDL-C
25
Efficient lipid lowering
26
Improved lipid levels
27
Lipid-lowering therapy
28
Risk Keywords
QTc prolongation
1
Safety concerns
2
Injection site reaction
3
Diabetes
Neurocognitive events
4
Dry throat
Injection site reaction
Nasal congestion
5
Injection-site reactions
Upper respiratory tract infection
6
Gingival discomfort
Gingival ischemia
Petechiae
7
Injection site reaction
Myalgia
Neurocognitive disorders
8
Fatigue
Flu-like symptoms
Injection site reactions
Musculoskeletal symptoms
9
High cost
Injection site reaction
Myalgia
11
Injection site reactions
Myalgia
Neurocognitive events
Ophthalmologic events
12
Intolerance to statin
15
injection site reaction
16
Injection site reactions
18
Concentration difficulties
Flu-like syndrome
20
Triglyceride side effect
21
Influenza-like illness
Injection-site reactions
Myalgia
22
Injection site reactions
23
Adverse events
24
Abnormal liver function
Injection site reactions
25
Injection site reactions
27
Literature analysis of 28 papers
Positive Content
28
Neutral Content
0
Negative Content
0
Article Type
5
4
1
6
27
1.

A Randomized Trial to Assess the Effect of Doravirine on the QTc Interval Using a Single Supratherapeutic Dose in Healthy Adult Volunteers.

Author: KhaliliehSauzanne G, YeeKa Lai, FanLi, LiuRachael, HeberWalter, DunzoElise, TriantafyllouIlias, HussainiAzra, IwamotoMarian

HIV treatment
QTc prolongation

Doravirine, a novel HIV-1 non-nucleoside reverse transcriptase inhibitor, had no significant effects on the heart-rate corrected QT (QTc) interval in healthy adults when administered at a supratherapeutic dose.

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.

Language : English

2.

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

3.

The Pharmacologic Role and Clinical Utility of PCSK9 Inhibitors for the Treatment of Hypercholesterolemia.

Author: WhiteC Michael

Atherosclerotic event reduction
LDL reduction
Injection site reaction

PCSK9 inhibitors, including monoclonal antibodies and RNA inhibitors, show promise for lowering LDL cholesterol levels and reducing atherosclerotic events, but their high cost remains a barrier to widespread use.

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

4.

Alirocumab for the treatment of hypercholesterolemia.

Author: TomlinsonBrian, HuMiao, ZhangYuzhen, ChanPaul, LiuZhong-Min

Reduced LDL-C
Diabetes
Neurocognitive events

Alirocumab is a human monoclonal antibody inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9) that is administered by subcutaneous injection every 2 weeks. Alirocumab produces substantial reductions in low density lipoprotein cholesterol (LDL-C) in patients with and without background statin treatment.

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.

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study.

Author: LiHaiyan, WeiYudong, YangZhenhua, ZhangShuang, XuXiuxiu, ShuaiMengmeng, VitseOlivier, WuYiwen, Baccara-DinetMarie T, ZhangYi, LiJianyong

Reduces LDL-C
Safe and well-tolerated
Dry throat
Injection site reaction
Nasal congestion

Alirocumab 75, 150, and 300 mg was safe and well-tolerated in Chinese subjects. Pharmacokinetic/pharmacodynamic parameters, including clinically meaningful reductions in LDL-C and other lipids/lipoproteins, were consistent with data from Japanese and Western populations.

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.

Language : English

6.

ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand.

Author: HanYaling, ChenJiyan, ChopraVijay Kumar, ZhangShuyang, SuGuohai, MaChangsheng, HuangZhouqing, MaYingyan, YaoZhuhua, YuanZuyi, ZhaoQiang, KuanprasertSrun, Baccara-DinetMarie T, ManvelianGaren, LiJianyong, ChenRui

LDL-C reduction
Injection-site reactions
Upper respiratory tract infection

Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduced LDL-C in high cardiovascular risk patients from Asia compared to ezetimibe. At week 24, LDL-C levels were reduced by 56.0% in the alirocumab group and 20.3% in the ezetimibe group. Alirocumab was generally well tolerated, with the most common adverse event being upper respiratory tract infection.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Pragmatic Clinical TrialA trial conducted in a real-world clinical setting. It evaluates the effectiveness of interventions in everyday healthcare environments.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Gingival Ischemia and Petechiae in a Patient Medicated With PCSK9 Inhibitor for Hypercholesterolemia: An Adverse Drug Event?

Author: ThermosGrigoris, TosiosKonstantinos I

Lower cholesterol
Gingival discomfort
Gingival ischemia
Petechiae

This case report describes a patient who developed gingival discomfort, ischemia, and petechiae after receiving a subcutaneous injection of alirocumab, a PCSK9 inhibitor used to treat hypercholesterolemia.

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.

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

9.

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

10.

Efficacy and safety of alirocumab in patients with or without prior coronary revascularization: Pooled analysis of eight ODYSSEY phase 3 trials.

Author: KereiakesDean J, LeporNorman E, GerberRobert, Veronica LeeL, ElassalJoe, ThompsonDesmond, Michael GibsonC

ASCVD treatment

This study assessed the efficacy and safety of alirocumab, a PCSK9 inhibitor, in patients with atherosclerotic cardiovascular disease (ASCVD) with or without prior coronary revascularization. The results demonstrated that alirocumab effectively reduced LDL-cholesterol levels and was well tolerated in this patient population.

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

11.

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

12.

Efficacy and safety of alirocumab in reducing lipids and cardiovascular events.

Author: RobinsonJennifer G, FarnierMichel, KrempfMichel, BergeronJean, LucGérald, AvernaMaurizio, StroesErik S, LangsletGisle, RaalFrederick J, El ShahawyMahfouz, KorenMichael J, LeporNorman E, LorenzatoChristelle, PordyRobert, ChaudhariUmesh, KasteleinJohn J P,

Reduced LDL cholesterol
Reduced cardiovascular events
Injection site reactions
Myalgia
Neurocognitive events
Ophthalmologic events

Alirocumab significantly reduced low-density lipoprotein (LDL) cholesterol levels in patients with high cardiovascular risk who were receiving statin therapy at the maximum tolerated dose over a period of 78 weeks. There was evidence of a reduction in the rate of cardiovascular events with alirocumab.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
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

13.

Novel strategies to target proprotein convertase subtilisin kexin 9: beyond monoclonal antibodies.

Author: SeidahNabil G, PratAnnik, PirilloAngela, CatapanoAlberico Luigi, NorataGiuseppe Danilo

Reduced LDL-C
Reduced cardiovascular risk

PCSK9 is a protein that plays a key role in regulating cholesterol levels in the body. This review explores various strategies developed to modulate PCSK9 levels for the treatment of hypercholesterolemia. It discusses the benefits of PCSK9 inhibitors, including monoclonal antibodies and siRNAs, and explores other promising approaches like antibodies targeting the C-terminal domain of PCSK9, small molecules, CRISPR-Cas9 strategies, and PCSK9 vaccines.

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

14.

Alirocumab: A Review in Hypercholesterolemia.

Author: GreigSarah L, DeeksEmma D

Hypercholesterolemia treatment

Alirocumab is a new medication that lowers cholesterol by inhibiting PCSK9, a protein that reduces the liver’s ability to remove LDL cholesterol from the blood. This review of multiple clinical trials found that alirocumab was effective at lowering LDL cholesterol levels in patients with high cholesterol, including those who could not 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

16.

Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia.

Author: DefescheJoep C, StefanuttiClaudia, LangsletGisle, HopkinsPaul N, SeizWerner, Baccara-DinetMarie T, HamonSara C, BanerjeePoulabi, KasteleinJohn J P

LDL reduction
effective treatment
injection site reaction

Alirocumab effectively reduces LDL cholesterol levels in patients with familial hypercholesterolemia, regardless of the specific gene mutation involved in the low-density lipoprotein receptor (LDLR) pathway. This study of 1191 patients found that individuals with a wide spectrum of LDLR, APOB, PCSK9, and other gene mutations experienced similar LDL cholesterol reductions with alirocumab treatment.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

Safety and efficacy of alirocumab 150 mg every 2 weeks, a fully human proprotein convertase subtilisin/kexin type 9 monoclonal antibody: A Phase II pooled analysis.

Author: KorenMichael J, RothEli M, McKenneyJames M, GipeDaniel, HanotinCorinne, FerrandAnne-Catherine, WuRichard, DufourRobert

Hypercholesterolemia treatment

This study pooled data from three Phase II studies to assess the safety and efficacy of alirocumab, a monoclonal antibody, at a dose of 150 mg every 2 weeks (Q2W) for treating hypercholesterolemia. This dose, the highest Q2W dose studied, is currently under development for Phase III trials.

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, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Impact of Age on the Efficacy and Safety of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia.

Author: GinsbergHenry N, TuomilehtoJaakko, HovinghG Kees, CariouBertrand, SantosRaul D, BrownAlan S, SanganalmathSantosh K, KorenAndrew, ThompsonDesmond, RaalFrederick J

LDL-C reduction
Injection site reactions

Alirocumab, a PCSK9 inhibitor, effectively reduced LDL-C levels and was well-tolerated in patients with heterozygous familial hypercholesterolemia (HeFH) across all age groups studied.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

19.

Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial.

Author: SteinEvan A, GipeDan, BergeronJean, GaudetDaniel, WeissRobert, DufourRobert, WuRichard, PordyRobert

Hypercholesterolemia treatment

This study evaluated the efficacy and safety of various doses and dosing intervals of REGN727, a monoclonal antibody to PCSK9, in patients with heterozygous familial hypercholesterolemia.

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

20.

Statin intolerance in heterozygous familial hypercolesterolemia with cardiovascular disease: After PCSK-9 antibodies what else?

Author: SbranaFrancesco, Dal PinoBeatrice, BigazziFederico, RipoliAndrea, PassinoClaudio, GabuttiAlessandra, PasanisiEmilio M, PetersenChristina, ValleggiAlessandro, TodiereGiancarlo, BarisonAndrea, GiannoniAlberto, PanchettiLuca, BecheriniFrancesco, PianelliMascia, LucianiRoberta, SampietroTiziana

Lower LDL cholesterol
Reduce Lp(a) levels
Concentration difficulties
Flu-like syndrome

This study explored the efficacy of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in patients with heterozygous familial hypercholesterolemia and cardiovascular disease who were intolerant to statins. The results suggest that PCSK9 inhibitors offer a promising approach for lowering LDL cholesterol in these patients, although further research is needed.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

21.

Effects of Alirocumab on Triglyceride Metabolism: A Fat-Tolerance Test and Nuclear Magnetic Resonance Spectroscopy Study.

Author: MetznerThomas, LeitnerDeborah R, MellitzerKarin, BeckAndrea, SourijHarald, StojakovicTatjana, ReishoferGernot, MärzWinfried, LandmesserUlf, ScharnaglHubert, ToplakHermann, SilbernagelGünther

Improved HDL cholesterol
Lower LDL cholesterol
Triglyceride side effect

This study found that alirocumab treatment did not have a significant effect on fasting triglycerides, post-prandial triglycerides, or lipoprotein-lipase regulating proteins. However, alirocumab did significantly reduce LDL cholesterol and increase HDL cholesterol.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

22.

Adverse Events Associated With PCSK9 Inhibitors: A Real-World Experience.

Author: GürgözeMuhammed T, Muller-HansmaAnnemarie H G, SchreuderMichelle M, Galema-BoersAnnette M H, BoersmaEric, Roeters van LennepJeanine E

Well tolerated
Influenza-like illness
Injection-site reactions
Myalgia

Proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors are well-tolerated in real-world settings, with a safety profile comparable to randomized clinical trials. Common adverse events include injection-site reactions and influenza-like illness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

23.

Transient injection site reaction to alirocumab during immune system activation: a case series.

Author: BärSarah, RäberIrene, KoskinasKonstantinos C, SchlapbachChristoph, RäberLorenz

Injection site reactions

This case report describes two patients who developed transient injection site reactions to alirocumab, a PCSK9 inhibitor, after prolonged good tolerability. The reactions were possibly triggered by activation of the immune system due to upper respiratory tract infection and COVID-19 vaccination. Both patients tolerated alirocumab again after the resolution of the pro-inflammatory state.

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.

Language : English

24.

Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial.

Author: FarnierMichel, JonesPeter, SeveranceRandall, AvernaMaurizio, Steinhagen-ThiessenElisabeth, ColhounHelen M, DuYunling, HanotinCorinne, DonahueStephen

Reduced LDL-C levels
Adverse events

Adding alirocumab to rosuvastatin significantly reduced low-density lipoprotein cholesterol (LDL-C) levels compared to adding ezetimibe or doubling the rosuvastatin dose. About 80% of patients maintained the 75mg Q2W alirocumab dose, and 84.9% (baseline rosuvastatin 10 mg) and 66.7% (baseline rosuvastatin 20 mg) achieved their LDL-C targets.

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

25.

Safety and efficacy of anti-PCSK9 antibodies: a meta-analysis of 25 randomized, controlled trials.

Author: ZhangXin-Lin, ZhuQing-Qing, ZhuLi, ChenJian-Zhou, ChenQin-Hua, LiGuan-Nan, XieJun, KangLi-Na, XuBiao

Improved lipid profile
Increased HDL-C
Reduced LDL-C
Abnormal liver function
Injection site reactions

Evolocumab and alirocumab were safe and well-tolerated, significantly reducing LDL-C by over 50%, increasing HDL-C, and resulting in favorable changes in other lipids.

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

27.

Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials.

Author: LeiterL A, TinahonesF J, KaralisD G, Bujas-BobanovicM, LetierceA, MandelJ, SamuelR, JonesP H

Improved lipid levels
Injection site reactions

Alirocumab was safe for patients with and without diabetes mellitus. Local injection site reactions were more frequent with alirocumab, but fewer people with diabetes experienced these reactions. No increase in HbA1c was observed in people with diabetes receiving alirocumab.

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

28.

Safety and tolerability of injectable lipid-lowering drugs: an update of clinical data.

Author: StrilchukLarysa, FogacciFederica, CiceroArrigo Fg

Lipid-lowering therapy

This study discusses the use of lipid-lowering therapy, including statins and new injectable drugs, to manage cardiovascular (CV) risk. Statins are first-line treatment for hyperlipidemia but are not always effective in achieving LDL-C goals, and some patients are statin intolerant. New injectable lipid-lowering drugs are being developed to address these issues.

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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