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Systematic Review

The Effect of Mipomersen in the Management of Patients with Familial Hypercholesterolemia: A Systematic Review and Meta-Analysis of Clinical Trials

1
Department of Health Research Methods, Evidence & Impact (HEI), McMaster University, Hamilton, ON L8S 4K1, Canada
2
Research Institute, St. Josef’s Healthcare, Hamilton, ON L8N 4A6, Canada
3
Faculty of Kinesiology and Health Sciences, York University, Toronto, ON M3J 1P3, Canada
4
Department of Medicine, McMaster University, Hamilton, ON L8S 4K1, Canada
*
Author to whom correspondence should be addressed.
Academic Editor: Isao Shiraishi
J. Cardiovasc. Dev. Dis. 2021, 8(7), 82; https://0-doi-org.brum.beds.ac.uk/10.3390/jcdd8070082
Received: 14 June 2021 / Revised: 9 July 2021 / Accepted: 15 July 2021 / Published: 20 July 2021
Background: Familial hypercholesterolemia (FH) lead to significant adverse effects in coronary arteries. Mipomersen is a second-generation antisense oligonucleotide that inhibits the synthesis of apolipoprotein B-100, an essential component of low density lipoprotein (LDL), and thus decreases the production of LDL. We aimed to determine the effect of mipomersen in patients with FH. Methods: We searched Ovid Medline, Ovid EMBASE, WHO ICTRP search portal, ISI database, the reference lists of relevant articles, and also Google Scholar to retrieve articles. All randomized controlled trials (RCTs) comparing patients with FH receiving mipomersen as an add-on and a parallel group receiving a placebo or no intervention were selected. Results: Five studies with more than 500 patients were included. All had low risk of bias. Pooling data showed that mipomersen probably reduces LDL compared with placebo [mean difference: −24.79, 95% CI (−30.15, −19.43)] but with a moderate level of certainty. There was a high level of evidence for injection site reactions [RR = 2.56, CI (1.47–4.44)] and a low level for increased serum alanine transaminase (ALT) > 3 times upper limit of normal (ULN) [RR = 5.19, CI (1.01–26.69)]. Conclusion: A moderate level of evidence in decreasing serum LDL indicates that we are uncertain if this drug provides benefit in any outcome important to patients. Although a low level of evidence for an increase in serum ALT leaves uncertainty about this adverse effect, injection site reactions in 10% or more of patients can be an important concern. View Full-Text
Keywords: familial hypercholesterolemia; mipomersen; systematic review; meta-analysis; low-density lipoproteins familial hypercholesterolemia; mipomersen; systematic review; meta-analysis; low-density lipoproteins
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MDPI and ACS Style

Astaneh, B.; Makhdami, N.; Astaneh, V.; Guyatt, G. The Effect of Mipomersen in the Management of Patients with Familial Hypercholesterolemia: A Systematic Review and Meta-Analysis of Clinical Trials. J. Cardiovasc. Dev. Dis. 2021, 8, 82. https://0-doi-org.brum.beds.ac.uk/10.3390/jcdd8070082

AMA Style

Astaneh B, Makhdami N, Astaneh V, Guyatt G. The Effect of Mipomersen in the Management of Patients with Familial Hypercholesterolemia: A Systematic Review and Meta-Analysis of Clinical Trials. Journal of Cardiovascular Development and Disease. 2021; 8(7):82. https://0-doi-org.brum.beds.ac.uk/10.3390/jcdd8070082

Chicago/Turabian Style

Astaneh, Behrooz, Nima Makhdami, Vala Astaneh, and Gordon Guyatt. 2021. "The Effect of Mipomersen in the Management of Patients with Familial Hypercholesterolemia: A Systematic Review and Meta-Analysis of Clinical Trials" Journal of Cardiovascular Development and Disease 8, no. 7: 82. https://0-doi-org.brum.beds.ac.uk/10.3390/jcdd8070082

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