What question did this study set out to answer?

To investigate the safety and efficacy of mipomersen, an apolipoprotein B-100 synthesis inhibitor, in patients at high risk for cardiovascular disease who cannot tolerate statins.

April 17, 2012European Heart JournalOpen Access

Mipomersen, an apolipoprotein B synthesis inhibitor, lowers low-density lipoprotein cholesterol in high-risk statin-intolerant patients: a randomized, double-blind, placebo-controlled trial

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Authors

MVMaartje E. VisserAmsterdam UMC Location University of Amsterdam GWGilbert WagenerUCB Pharma (Germany)BBBrenda F. BakerIonis Pharmaceuticals (United States)

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Implication

Randomized double-blind trial reveals mipomersen substantially reduces LDL cholesterol in statin-intolerant patients, indicating its potential despite liver-related safety risks.

Key Points

To investigate the safety and efficacy of mipomersen, an apolipoprotein B-100 synthesis inhibitor, in patients at high risk for cardiovascular disease who cannot tolerate statins.
Conducted a randomized, double-blind, placebo-controlled trial across 33 statin-intolerant subjects assigned 2:1 to weekly subcutaneous mipomersen 200 mg or placebo for 26 weeks (NCT00707746).
Measured percent change from baseline to Week 28 in LDL cholesterol (primary endpoint), apolipoprotein B, lipoprotein(a), and tracked hepatic safety through transaminase levels, magnetic resonance spectroscopy, and liver biopsies.
Mipomersen reduced low-density lipoprotein cholesterol by 47 ± 18% compared to placebo at Week 28 (P < 0.001 vs. placebo).
Mipomersen also significantly reduced apolipoprotein B by 46% and lipoprotein(a) by 27% (both P < 0.001 vs. placebo).
Discontinuation due to adverse events occurred in 19% (4/21) of mipomersen-treated and 17% (2/12) of placebo-treated subjects, with persistent transaminase elevations (≥3× ULN) observed in 33% (7/21) on mipomersen.

Cite This Study

Visser et al. (2012) studied this question.

synapsesocial.com/papers/6a6fc1ae26a7f98052dc5d08 https://doi.org/10.1093/eurheartj/ehs023

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Implication

Randomized double-blind trial reveals mipomersen substantially reduces LDL cholesterol in statin-intolerant patients, indicating its potential despite liver-related safety risks.

Mipomersen, an apolipoprotein B synthesis inhibitor, lowers low-density lipoprotein cholesterol in high-risk statin-intolerant patients: a randomized, double-blind, placebo-controlled trial

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Implication

Key Points

Cite This Study

Mipomersen, an apolipoprotein B synthesis inhibitor, lowers low-density lipoprotein cholesterol in high-risk statin-intolerant patients: a randomized, double-blind, placebo-controlled trial

Discussion

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Implication

Key Points

Cite This Study

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