The Effect of Mipomersen in the Management of Patients with Familial Hypercholesterolemia: A Systematic Review and Meta-Analysis of Clinical Trials
| Autor: | Nima Makhdami, Gordon H. Guyatt, Behrooz Astaneh, Vala Astaneh |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Apolipoprotein B Mipomersen mipomersen Familial hypercholesterolemia 030204 cardiovascular system & hematology Placebo law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial systematic review law Internal medicine medicine low-density lipoproteins Diseases of the circulatory (Cardiovascular) system Pharmacology (medical) 030212 general & internal medicine General Pharmacology Toxicology and Pharmaceutics Adverse effect biology familial hypercholesterolemia business.industry medicine.disease Clinical trial meta-analysis Meta-analysis RC666-701 biology.protein business |
| Zdroj: | Journal of Cardiovascular Development and Disease, Vol 8, Iss 82, p 82 (2021) Journal of Cardiovascular Development and Disease |
| ISSN: | 2308-3425 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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