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Efficacy and Safety of Olezarsen in Patients With Hypertriglyceridemia: A Meta-Analysis of Randomized Controlled
Kainat Feroz1, Amna Parvez2, Noor Ul Huda Ramzan3
1Department of Medicine, King Edward Medical University, Lahore, Pakistan, kemu.edu.pk.
Aims:
Novel drugs that target apoC-III in lipoprotein metabolism to reduce plasma triglycerides are currently under development. Olezarsen, a drug similar to its predecessor, volanesorsen, is in Phase 3 trials. A meta-analysis of RCTs was done to study its effect on hypertriglyceridemia.
Material And Methods:
Screening was done on PubMed, Embase, Scopus, and the Cochrane Library from inception to August 2024. We used Review Manager (Version 5.4) for statistical analysis. Subgroups of olezarsen at doses of 10, 50, and 80 mg were made. Continuous outcomes were reported as mean differences with 95% CIs. Adverse events were reported using risk ratios and 95% CIs. The risk of bias was analyzed using the Cochrane risk of bias tool.
Results:
Four RCTs with 374 participants, 278 in intervention and 96 placebo controls, were included. At all doses of olezarsen, a significant reduction in fasting triglyceride levels (MD: 45.69; 95% CI: 35.84, 55.54; p < 0.00001) was seen. This was most pronounced at 80 mg dose (MD: 51.98 95% CI: 43.06, 60.90; p < 0.00001). A reduction in apoC-III (MD: 58.77; 95% CI: 35.94, 81.61; p < 0.00001) and an increase in HDL (MD: 0.21; 95% CI: 0.04, 0.37; p = 0.01) were also observed. No significant effect was observed on LDL levels (MD: -0.13; 95% CI: -0.40, 0.14; p = 0.34). Overall, no significant adverse effects were seen compared to placebo (RR: 1.42; 95% CI: 0.66, 3.05; p = 0.37).
Conclusion:
Olezarsen showed remarkable efficacy in lowering triglycerides, with a dose-dependent effect, while significantly increasing HDL levels and reducing apoC-III. Its safety profile is commendable. Although it performed well compared to volanesorsen, inconsistencies in LDL reduction and heterogeneity in some groups warrant further large-scale RCTs to better assess its safety and efficacy. Clinical decisions should be tailored to individual patient profiles, as hypertriglyceridemia management may vary on a case-to-case basis.
Insights
Olezarsen effectively lowers triglyceride levels and apoC-III, while increasing HDL, with a favorable safety profile. Further trials are needed to confirm its long-term efficacy and safety in hypertriglyceridemia management.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Metabolic Disorders
Background:
- Novel therapeutics targeting apolipoprotein C-III (apoC-III) are emerging for managing hypertriglyceridemia.
- Olezarsen, a drug in development, aims to reduce plasma triglycerides by modulating lipoprotein metabolism.
- This meta-analysis evaluates the efficacy and safety of olezarsen based on available randomized controlled trials (RCTs).
Purpose of the Study:
- To conduct a meta-analysis of RCTs to assess the effect of olezarsen on hypertriglyceridemia.
- To evaluate the dose-dependent efficacy of olezarsen in reducing triglyceride levels.
- To examine the impact of olezarsen on apoC-III, HDL, and LDL levels, as well as its safety profile.
Main Methods:
- A systematic literature search was performed across PubMed, Embase, Scopus, and the Cochrane Library up to August 2024.
- Four RCTs involving 374 participants (278 intervention, 96 placebo) were included in the meta-analysis.
- Statistical analysis included mean differences for continuous outcomes and risk ratios for adverse events, using Review Manager (Version 5.4).
Main Results:
- Olezarsen demonstrated a significant reduction in fasting triglyceride levels across all evaluated doses (10, 50, 80 mg), with the most pronounced effect at 80 mg.
- Significant reductions in apoC-III and increases in HDL levels were observed with olezarsen treatment.
- No significant changes were noted in LDL levels, and no significant adverse effects were reported compared to placebo.
Conclusions:
- Olezarsen exhibits significant efficacy in lowering triglycerides and apoC-III, and increasing HDL, with a favorable safety profile.
- The drug's performance suggests potential benefits in managing hypertriglyceridemia, though further large-scale RCTs are warranted.
- Individualized patient management is crucial, considering potential variations in hypertriglyceridemia treatment response.
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