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

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Original Abstract of the Article

Main Research Findings

Mipomersen, a second-generation antisense oligonucleotide that inhibits the synthesis of apolipoprotein B (ApoB), has been shown to lower LDL cholesterol levels in multiple studies. 25 , 23 , 16 , 13 , 9 , 6 , 3 Mipomersen significantly reduced LDL cholesterol levels in patients with homozygous familial hypercholesterolemia (HoFH) compared to placebo. 25 Mipomersen also showed a reduction in LDL cholesterol levels in patients with heterozygous familial hypercholesterolemia (HeFH). 17 , 23 Mipomersen has been shown to lower LDL cholesterol levels in hypercholesterolemic patients on statin therapy. 24 , 20 Furthermore, mipomersen reduced LDL cholesterol levels in patients with severe LDL hypercholesterolemia and atherosclerosis treated with lipoprotein apheresis. 7 Mipomersen has also been shown to lower levels of lipoprotein (a) [Lp(a)] in patients receiving lipid-lowering therapy. 6 , 18 Side effects reported with mipomersen include injection site reactions, flu-like symptoms, and elevated liver enzymes. 25 , 23 , 16 , 13 , 3 However, unlike other ApoB-targeting medications such as microsomal triglyceride transfer proteins, mipomersen has not been shown to cause hepatic or intestinal fat accumulation and does not affect dietary fat absorption. 20 , 8

Benefits and Risks

Benefit Summary

Mipomersen may be beneficial for patients with homozygous familial hypercholesterolemia, heterozygous familial hypercholesterolemia, hypercholesterolemia on statin therapy, or severe LDL hypercholesterolemia and atherosclerosis treated with lipoprotein apheresis by lowering their LDL cholesterol levels. It may also be beneficial for lowering lipoprotein (a) levels in patients receiving lipid-lowering therapy.

Risk Summary

Mipomersen has been associated with side effects such as injection site reactions, flu-like symptoms, and elevated liver enzymes. However, unlike other ApoB-targeting medications such as microsomal triglyceride transfer proteins, mipomersen has not been shown to cause hepatic or intestinal fat accumulation and does not affect dietary fat absorption.

Comparison Between Studies

Commonalities Between Studies

Multiple studies have shown that mipomersen is effective in lowering LDL cholesterol levels. Additionally, studies have reported side effects such as injection site reactions, flu-like symptoms, and elevated liver enzymes associated with mipomersen.

Differences Between Studies

The effectiveness and side effects of mipomersen may vary depending on the patient's condition and dosage. Additionally, the method and duration of mipomersen administration and co-administered medications may influence its effectiveness and side effects.

Consistency and Contradictions in the Results

While multiple studies have shown the effectiveness of mipomersen in lowering LDL cholesterol levels, there is some variability in the degree of effectiveness and the frequency of side effects. This variability may be attributed to factors such as the patient's condition, dosage, and co-administered medications.

Cautions for Application in Real Life

While mipomersen shows promise in lowering LDL cholesterol levels for patients with conditions such as homozygous familial hypercholesterolemia and heterozygous familial hypercholesterolemia, it is important to be aware of the potential side effects. Mipomersen should be used under the guidance of a healthcare professional.

Limitations of Current Research

More research is needed to assess the long-term effects and safety of mipomersen. Additionally, the impact of mipomersen on the incidence of cardiovascular events is still unknown.

Future Research Directions

Further research is necessary to investigate the long-term effects and safety of mipomersen, as well as its impact on the incidence of cardiovascular events. Research is also needed to determine the optimal administration method, duration, and co-administered medications for mipomersen.

Conclusion

Mipomersen is a promising medication for lowering LDL cholesterol levels, but it is important to be aware of the potential side effects. Mipomersen should be used under the guidance of a healthcare professional. Further research is needed to investigate the long-term effects and safety of mipomersen, as well as its impact on the incidence of cardiovascular events.

Keywords
Benefit Keywords
Hair growth
Reduced side effects
1
FH treatment
2
LDL reduction
3
Lipid profile improvement
4
FH treatment
5
Lower Lp(a) levels
6
LDL-cholesterol reduction
Lp(a) reduction
7
Lower LDL
Reduced steatosis risk
8
Reduced LDL-C
Reduced apoB
Reduced apolipoprotein A1
Reduced lipoprotein(a)
Reduced non-high-density lipoprotein cholesterol
Reduced total cholesterol
Reduced triglycerides
Reduced very low-density lipoprotein cholesterol
9
Reduced ApoB
Reduced LDL-C
Reduced LP(a)
Reduced non-HDL-C
10
Reduced LDL cholesterol
Reduced apolipoprotein B
Reduced non-HDL cholesterol
11
cholesterol reduction
12
Reduced LDL cholesterol
Reduced apolipoprotein B
Reduced lipoprotein(a)
13
Mipomersen for HoFH
14
Reduced LDL-cholesterol
Reduced apoB
Reduced lipoprotein(a)
15
Atherogenic lipoprotein reduction
LDL-C reduction
16
Hypercholesterolemia treatment
17
Lowering LDL-C and Lp(a)
18
LDL cholesterol reduction
Lipoprotein(a) reduction
Triglyceride reduction
19
Hyperlipidemia treatment
LDL-C reduction
20
Hyperlipidemia treatment
21
LDL-c lowering
22
Reduced LDL cholesterol
23
Reduced LDL cholesterol
Reduced apo B
24
LDL cholesterol reduction
25
Lipid-lowering therapy
26
Good safety and tolerability
27
Improved ASO tolerability
Reduced flu-like reactions
28
Risk Keywords
Local intolerance
1
Adverse events
2
Increased ALT
Injection site reaction
3
Flu-like symptoms
Hepatic enzyme elevation
Hepatic steatosis
Injection site reaction
Treatment discontinuation
4
Flu-like symptoms
Hepatotoxicity
Injection site reactions
5
Mipomersen side effects
7
Flu-like symptoms
Hepatic steatosis
Injection-site reaction
9
Elevated transaminases
Flu-like symptoms
Injection site reactions
10
Injection site reactions
Transient CRP elevation
11
flu-like symptoms
injection site reactions
12
Flu-like symptoms
Injection site reactions
Liver enzyme elevations
13
Mipomersen safety concerns
14
Hepatic steatosis
Injection site reactions
15
Side effects
18
Elevated transaminases
Flu-like symptoms
Injection site reaction
19
Elevated liver transaminases
Flu-like symptoms
Injection site reactions
20
Liver transaminase elevation
23
Hepatic transaminase increases
Injection site reactions
24
Coronary artery disease
Familial hypercholesterolaemia
25
Hepatosteatosis
Increased transaminases
27
Literature analysis of 28 papers
Positive Content
27
Neutral Content
1
Negative Content
0
Article Type
12
3
1
10
28
1.

A randomized, single-blind trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in the treatment of androgenetic alopecia in women.

Author: Blume-PeytaviUlrike, HillmannKathrin, DietzEkkehart, CanfieldDouglas, Garcia BartelsNatalie

Hair growth
Reduced side effects
Local intolerance

This randomized, controlled trial compared the efficacy, safety, and acceptability of once-daily 5% minoxidil topical foam (MTF) with twice-daily 2% minoxidil topical solution (MTS) in women with androgenetic alopecia. Once-daily 5% MTF was found to be noninferior and as effective as twice-daily 2% MTS, with several aesthetic and practical advantages.

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.

Mipomersen in Familial Hypercholesterolemia: An Update on Health-Related Quality of Life and Patient-Reported Outcomes.

Author: Chambergo-MichilotDiego, AlurAnish, KulkarniSaneel, AgarwalaAnandita

FH treatment
Adverse events

This review examines mipomersen, an antisense oligonucleotide inhibitor of apolipoprotein B-100 (apoB-100) mRNA used to treat homozygous familial hypercholesterolemia (FH). The review discusses the mechanism of action, current evidence, limitations of use, adverse events, and impact on health-related quality of life.

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.

Efficacy and Safety of Mipomersen: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Author: FogacciFederica, FerriNicola, TothPeter P, RuscicaMassimiliano, CorsiniAlberto, CiceroArrigo F G

Lipid profile improvement
Flu-like symptoms
Hepatic enzyme elevation
Hepatic steatosis
Injection site reaction
Treatment discontinuation

Mipomersen effectively reduced low-density lipoprotein cholesterol, total cholesterol, non-HDL-C, lipoprotein(a), apolipoprotein B, triglycerides, and very-low-density lipoprotein cholesterol, without affecting HDL-C levels. However, mipomersen therapy is associated with increased risk of discontinuation, injection-site reactions, hepatic steatosis, hepatic enzyme elevation, and flu-like symptoms.

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

5.

Mipomersen and its use in familial hypercholesterolemia.

Author: ParhamJohnathon Seth, GoldbergAnne Carol

FH treatment
Flu-like symptoms
Hepatotoxicity
Injection site reactions

This review discusses the pharmacokinetics of mipomersen, an anti-sense oligonucleotide used for the treatment of homozygous Familial Hypercholesterolemia (FH).

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

6.

Effects of mipomersen, an apolipoprotein B100 antisense, on lipoprotein (a) metabolism in healthy subjects.

Author: NandakumarRenu, MatveyenkoAnastasiya, ThomasTiffany, PavlyhaMarianna, NgaiColleen, HolleranStephen, RamakrishnanRajasekhar, GinsbergHenry N, KarmallyWahida, MarcovinaSantica M, Reyes-SofferGissette

Lower Lp(a) levels

This study investigated the mechanisms of lipoprotein (a) [Lp(a)] lowering by mipomersen, an antisense oligonucleotide that inhibits apoB synthesis. Mipomersen reduced plasma Lp(a) levels by 21% in 14 healthy volunteers. The study found that mipomersen treatment mainly decreases Lp(a) plasma levels by increasing the fractional catabolic rate (FCR) of Lp(a).

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

7.

Effect of mipomersen on LDL-cholesterol in patients with severe LDL-hypercholesterolaemia and atherosclerosis treated by lipoprotein apheresis (The MICA-Study).

Author: WaldmannElisa, VogtAnja, CrispinAlexander, AltenhoferJulia, RiksIna, ParhoferKlaus G

LDL-cholesterol reduction
Lp(a) reduction
Mipomersen side effects

This phase II trial found that mipomersen reduced LDL-cholesterol significantly in patients on maximal lipid-lowering drug therapy and regular apheresis, but is often associated with side effects.

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.
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

8.

Complex effects of inhibiting hepatic apolipoprotein B100 synthesis in humans.

Author: Reyes-SofferGissette, MoonByoung, Hernandez-OnoAntonio, Dionizovik-DimanovskiMarija, Dionizovick-DimanovskiMarija, JimenezJhonsua, ObunikeJoseph, ThomasTiffany, NgaiColleen, FontanezNelson, DonovanDaniel S, KarmallyWahida, HolleranStephen, RamakrishnanRajasekhar, MittlemanRobert S, GinsbergHenry N

Lower LDL
Reduced steatosis risk

Mipomersen, an antisense oligonucleotide, effectively lowers LDL cholesterol by inhibiting apolipoprotein B synthesis. The study found that mipomersen reduced apoB in all lipoproteins without affecting VLDL secretion, potentially minimizing steatosis risk.

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, 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

10.

Mipomersen is a promising therapy in the management of hypercholesterolemia: a meta-analysis of randomized controlled trials.

Author: LiNa, LiQing, TianXia-Qiu, QianHai-Yan, YangYue-Jin

Reduced ApoB
Reduced LDL-C
Reduced LP(a)
Reduced non-HDL-C
Elevated transaminases
Flu-like symptoms
Injection site reactions

Mipomersen therapy is effective in reducing ApoB-containing lipoproteins in patients with severe hypercholesterolemia. However, it is associated with increased injection-site reactions, flu-like symptoms, and elevated transaminases. Further research is needed to minimize these side effects.

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

Language : English

11.

Changes in mipomersen dosing regimen provide similar exposure with improved tolerability in randomized placebo-controlled study of healthy volunteers.

Author: FlaimJoann D, GrundyJohn S, BakerBrenda F, McGowanMary P, KasteleinJohn J P

Reduced LDL cholesterol
Reduced apolipoprotein B
Reduced non-HDL cholesterol
Injection site reactions
Transient CRP elevation

Mipomersen (200mg once weekly), an apolipoprotein B synthesis inhibitor, has a similar drug exposure and overall safety profile at lower doses (30mg once daily, 70mg 3 times weekly).

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

12.

Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension.

Author: SantosRaul D, DuellP Barton, EastCara, GuytonJohn R, MoriartyPatrick M, ChinWai, MittlemanRobert S

cholesterol reduction
flu-like symptoms
injection site reactions

Mipomersen provided sustained reductions in all atherosclerotic lipoproteins measured for up to 104 weeks, with a safety profile consistent with prior controlled trials.

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.
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.

Mipomersen, an apolipoprotein B synthesis inhibitor, reduces atherogenic lipoproteins in patients with severe hypercholesterolemia at high cardiovascular risk: a randomized, double-blind, placebo-controlled trial.

Author: ThomasGregory S, CromwellWilliam C, AliShariq, ChinWai, FlaimJoAnn D, DavidsonMichael

Reduced LDL cholesterol
Reduced apolipoprotein B
Reduced lipoprotein(a)
Flu-like symptoms
Injection site reactions
Liver enzyme elevations

Mipomersen significantly reduced LDL cholesterol, apolipoprotein B, and lipoprotein(a) in patients with hypercholesterolemia not controlled by existing therapies. The most common adverse events were injection site reactions (78% with mipomersen, 31% with placebo) and flu-like symptoms (34% with mipomersen, 21% with placebo).

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.

Is mipomersen ready for clinical implementation? A transatlantic dilemma.

Author: SjoukeBarbara, BalakDeepak M W, BeuersUlrich, RatziuVlad, StroesErik S G

Mipomersen for HoFH
Mipomersen safety concerns

This review discusses the efficacy and safety considerations for the discrepancy in the US Food and Drug Administration and European Medicines Agency approval of mipomersen for patients with homozygous familial hypercholesterolemia (HoFH).

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

15.

Mipomersen and other therapies for the treatment of severe familial hypercholesterolemia.

Author: BellDamon A, HooperAmanda J, WattsGerald F, BurnettJohn R

Reduced LDL-cholesterol
Reduced apoB
Reduced lipoprotein(a)
Hepatic steatosis
Injection site reactions

This review summarizes the pathophysiology, current treatment options, and novel therapeutic strategies for familial hypercholesterolemia, focusing on mipomersen, an antisense apoB synthesis inhibitor.

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

16.

Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy.

Author: McGowanMary P, TardifJean-Claude, CeskaRichard, BurgessLesley J, SoranHandrean, Gouni-BertholdIoanna, WagenerGilbert, Chasan-TaberScott

Atherogenic lipoprotein reduction
LDL-C reduction

Mipomersen is an antisense oligonucleotide that targets apolipoprotein B synthesis. This drug significantly reduces LDL-C and other atherogenic lipoproteins in patients with familial hypercholesterolemia when added to ongoing lipid-lowering therapy. This study evaluated the safety and efficacy of mipomersen in patients with severe hypercholesterolemia.

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

17.

Apolipoprotein B synthesis inhibition with mipomersen in heterozygous familial hypercholesterolemia: results of a randomized, double-blind, placebo-controlled trial to assess efficacy and safety as add-on therapy in patients with coronary artery disease.

Author: SteinEvan A, DufourRobert, GagneClaude, GaudetDaniel, EastCara, DonovanJoanne M, ChinWai, TribbleDiane L, McGowanMary

Hypercholesterolemia treatment

Heterozygous familial hypercholesterolemia (HeFH) is a common genetic disorder leading to premature coronary artery disease. Mipomersen, an apolipoprotein B synthesis inhibitor, was evaluated to further lower LDL-C in HeFH patients with coronary artery disease.

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.
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

18.

Therapeutic potential of mipomersen in the management of familial hypercholesterolaemia.

Author: GelsingerCarmen, Steinhagen-ThiessenElisabeth, KassnerUrsula

Lowering LDL-C and Lp(a)
Side effects

Mipomersen, an antisense oligonucleotide, effectively lowers LDL-C and Lp(a) levels in patients at high risk for CVD. While showing promise, further research is needed on long-term safety and cardiovascular outcomes.

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

Language : English

20.

Mipomersen: a safe and effective antisense therapy adjunct to statins in patients with hypercholesterolemia.

Author: RicottaDaniel N, FrishmanWilliam

Hyperlipidemia treatment
LDL-C reduction
Elevated liver transaminases
Flu-like symptoms
Injection site reactions

Mipomersen is an antisense oligonucleotide inhibitor of apolipoprotein (apo) B-100, currently in phase 3 of development for the treatment of hyperlipidemia in high-risk patients. This study discusses the mechanism of action, efficacy, and safety of mipomersen for the treatment of hyperlipidemia.

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

21.

Efficacy of apolipoprotein B synthesis inhibition in subjects with mild-to-moderate hyperlipidaemia.

Author: AkdimFatima, TribbleDiane L, FlaimJoAnn D, YuRosie, SuJohn, GearyRichard S, BakerBrenda F, FuhrRainard, WedelMark K, KasteleinJohn J P

Hyperlipidemia treatment

This randomized, double-blind, placebo-controlled, dose-escalation study evaluated the efficacy and safety of mipomersen monotherapy in subjects with mild-to-moderate hyperlipidaemia. Mipomersen is an apolipoprotein (apo) B synthesis inhibitor.

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

22.

Apolipoprotein B synthesis inhibition: results from clinical trials.

Author: VisserMaartje E, KasteleinJohn J P, StroesErik S G

LDL-c lowering

This review summarizes recent preclinical and clinical studies on mipomersen, a second-generation antisense oligonucleotide that inhibits apolipoprotein B-100 synthesis. The review focuses on the safety and efficacy of mipomersen in lowering LDL-c levels.

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

23.

Effect of mipomersen, an apolipoprotein B synthesis inhibitor, on low-density lipoprotein cholesterol in patients with familial hypercholesterolemia.

Author: AkdimFatima, VisserMaartje E, TribbleDiane L, BakerBrenda F, StroesErik S G, YuRosie, FlaimJoann D, SuJohn, SteinEvan A, KasteleinJohn J P

Reduced LDL cholesterol
Liver transaminase elevation

This study examined the efficacy and safety of mipomersen, an antisense inhibitor of apolipoprotein B, in patients with heterozygous familial hypercholesterolemia. Mipomersen significantly reduced LDL cholesterol and other atherogenic lipoproteins. The most common side effect was injection site reactions.

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.
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

24.

Efficacy and safety of mipomersen, an antisense inhibitor of apolipoprotein B, in hypercholesterolemic subjects receiving stable statin therapy.

Author: AkdimFatima, StroesErik S G, SijbrandsEric J G, TribbleDiane L, TripMieke D, JukemaJ Wouter, FlaimJoann D, SuJohn, YuRosie, BakerBrenda F, WedelMark K, KasteleinJohn J P

Reduced LDL cholesterol
Reduced apo B
Hepatic transaminase increases
Injection site reactions

This randomized, placebo-controlled, dose-escalation Phase 2 study evaluated the effects of mipomersen in 74 hypercholesterolemic subjects taking stable statin therapy. Mipomersen was found to significantly reduce apo B and LDL cholesterol levels, with efficacy increasing upon treatment for 13 weeks. Injection site reactions and hepatic transaminase increases were the most common adverse events. Further research is needed to address the mechanisms and clinical relevance of transaminase changes after mipomersen administration.

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.
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.

Language : English

25.

Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial.

Author: RaalFrederick J, SantosRaul D, BlomDirk J, MaraisA David, CharngMin-Ji, CromwellWilliam C, LachmannRobin H, GaudetDaniel, TanJu L, Chasan-TaberScott, TribbleDiane L, FlaimJoann D, CrookeStanley T

LDL cholesterol reduction
Coronary artery disease
Familial hypercholesterolaemia

Mipomersen is an antisense inhibitor of apolipoprotein B synthesis that is used to lower LDL cholesterol levels in patients with homozygous familial hypercholesterolaemia. This study investigated the effectiveness and safety of mipomersen as an adjunctive treatment for this condition.

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

26.

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

27.

Safety and tolerability of injectable lipid-lowering drugs: a review of available clinical data.

Author: CiceroArrigo F G, TartagniElisa, ErtekSibel

Good safety and tolerability
Hepatosteatosis
Increased transaminases

PCSK9 inhibitors (evolocumab and alirocumab) demonstrated good safety and tolerability in a large number of subjects with different clinical conditions, including statin-intolerance. Further data on long-term mipomersen safety are required.

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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