Side Effects of mipomersen injection: A Synthesis of Findings from 6 Studies

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Original Abstract of the Article

Major Research Findings

Mipomersen, an antisense oligonucleotide targeting apolipoprotein B synthesis, significantly reduces LDL-C and other atherogenic lipoproteins in familial hypercholesterolemia when added to ongoing maximally tolerated lipid-lowering therapy. 4

Mipomersen is currently being studied in patients with mild to severe hypercholesterolaemia as add-on therapy to other lipid-lowering therapy, as monotherapy in patients who are intolerant of HMG-CoA reductase inhibitors (statins) and who are at high risk for CVD. 3

Mipomersen reduces LDL-C (significantly) and Lp(a) (non-significantly) in patients on maximal lipid-lowering drug therapy and regular apheresis, but is often associated with side effects. 6

Mipomersen is a 20-mer oligonucleotide, a second-generation antisense oligonucleotide (AOS), complementary to the coding region for human-specific apo-B-100 messenger RNA (mRNA). Mipomersen inhibits apo-B-100 synthesis and is consequently a new treatment strategy to lower apo-B-containing lipoproteins like LDL-C and Lp(a) in patients at high risk for CVD not on target or intolerant to statins. 3

Mipomersen has been shown to produce significant reductions in LDL-C from baseline values compared with placebos. Clinical trials have demonstrated that mipomersen reduces LDL-C up to 44% in patients with familial hypercholesterolemia and patients with significantly elevated LDL despite taking maximum doses of statins. 5

Reasons for Side Effects

Mipomersen is an antisense oligonucleotide, a new type of drug that targets human gene expression. Side effects may occur because mipomersen acts directly on the body and affects gene expression.

Common Side Effects

Injection Site Reactions

The most common side effect of mipomersen is injection site reactions, which have been reported in up to 90-100% of studies. 3

Elevated Liver Enzymes

Mipomersen can cause elevated liver enzymes, which have been reported in 6-15% of studies. 2

Headache

Mipomersen can cause headaches, which have been reported in many studies. 3

Nasopharyngitis

Mipomersen can cause nasopharyngitis, which have been reported in many studies. 3

Myalgia

Mipomersen can cause myalgia, which have been reported in many studies. 3

Nausea

Mipomersen can cause nausea, which have been reported in many studies. 3

Fatigue

Mipomersen can cause fatigue, which have been reported in many studies. 3

Side Effects Management

Injection Site Reactions

Injection site reactions can be alleviated by using steroid creams or patches.

Elevated Liver Enzymes

Elevated liver enzymes are reduced by discontinuing mipomersen administration. However, if the elevation in liver enzymes is mild, mipomersen administration may be continued. Regular monitoring of liver function is required.

Comparison of Studies

Commonalities

All studies have shown that mipomersen significantly reduces LDL-C.

All studies have shown that mipomersen can cause side effects such as injection site reactions.

Differences

The LDL-C lowering effect of mipomersen varies across studies.

The incidence of side effects of mipomersen varies across studies.

Notes on Real-Life Applications

Mipomersen may be a promising additional lipid-lowering therapy for patients at high risk of cardiovascular disease. However, because mipomersen has a risk of side effects, it is important to discuss with a doctor whether to use mipomersen.

Current Research Limitations

The long-term safety and efficacy of mipomersen are not yet fully understood.

The effect of mipomersen on cardiovascular disease has not yet been proven.

Future Research Directions

Clinical trials are needed to evaluate the long-term safety and efficacy of mipomersen.

Clinical trials are needed to evaluate the effect of mipomersen on cardiovascular disease.

Conclusion

Mipomersen may be a promising additional lipid-lowering therapy for patients at high risk of cardiovascular disease. However, because mipomersen has a risk of side effects, it is important to discuss with a doctor whether to use mipomersen. Further research is needed to evaluate the long-term safety and efficacy of mipomersen, as well as its effect on cardiovascular disease.

Literature analysis of 6 papers
Positive Content
6
Neutral Content
0
Negative Content
0
Article Type
3
0
0
1
6
1.

[The dose-dependent effects of oral premedication with midazolam].

Author: BiroP, WeidmannG, PietzschS, AlonE, BruggerP

Midazolam effective amnesia
Midazolam effective sedation
Side effects

Oral midazolam before surgery provided dose-dependent sedation and amnesia, but no significant anxiolysis compared to placebo. 7.5mg midazolam offered the best balance of benefits and side effects. The study highlights the importance of pre-operative communication and patient care by the anesthesiologist.

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.
English AbstractA summary of a research paper/publication written in English for a wider audience.
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 : German

3.

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

4.

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

5.

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

6.

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

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