From the Guidelines
The ODYSSEY trial is not directly mentioned in the provided evidence, however, based on the available information, the most relevant trial related to heart failure treatment is the EMPHASIS-HF trial, which demonstrated the benefits of mineralocorticoid receptor antagonists in patients with systolic heart failure and mild symptoms. The EMPHASIS-HF trial 1 showed that treatment with eplerenone led to a 37% reduction in cardiovascular death or heart failure hospitalization, and a 24% reduction in death from any cause.
Key Findings
- The trial enrolled 2737 patients with NYHA functional class II symptoms and an EF ≤30% (≤35% if the QRS duration was ≥130 ms) 1.
- Patients had to have either experienced a cardiovascular hospitalization within the previous 6 months or have an elevated plasma natriuretic peptide concentration and be treated with an ACE inhibitor, ARB, or both, and a beta-blocker 1.
- The evidence-based doses of disease-modifying drugs used in key randomized trials in heart failure are outlined in Table 14, which includes the starting and target doses for ACE inhibitors, beta-blockers, ARBs, and MRAs 1.
Treatment Implications
- The use of mineralocorticoid receptor antagonists, such as eplerenone, is supported by the EMPHASIS-HF trial as an effective treatment for patients with systolic heart failure and mild symptoms 1.
- The trial provides evidence for the benefits of eplerenone in reducing cardiovascular death, heart failure hospitalization, and death from any cause in these patients 1.
- The results of the EMPHASIS-HF trial can be used to inform treatment decisions for patients with heart failure, particularly those with systolic dysfunction and mild symptoms 1.
From the Research
Overview of the ODYSSEY Trial
- The ODYSSEY trial is a series of studies evaluating the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in patients with hypercholesterolemia and high cardiovascular risk 2, 3, 4, 5, 6.
- The trials assess the effectiveness of alirocumab in reducing low-density lipoprotein cholesterol (LDL-C) levels and its safety profile in various patient populations.
Study Designs and Populations
- The ODYSSEY APPRISE study is a prospective, single-arm, Phase 3b open-label study that enrolled 994 patients with heterozygous familial hypercholesterolaemia (HeFH) or very-high LDL-C levels despite maximally tolerated dose of statin ± other lipid-lowering therapies (MTD ± LLTs) 2.
- The ODYSSEY COMBO I and II trials are randomized, double-blind studies that evaluate the efficacy and safety of alirocumab as add-on therapy to stable, maximally tolerated daily statin, with or without other lipid-lowering therapy (LLT), in patients with hypercholesterolemia at high cardiovascular risk 3.
- The ODYSSEY-KT study is a randomized, double-blind study that assesses the efficacy and safety of alirocumab in Korean patients with hypercholesterolemia and high cardiovascular risk 5.
Efficacy and Safety Results
- The ODYSSEY APPRISE study found that alirocumab reduced LDL-C levels by 54.8% from baseline, with 69.1% of patients achieving LDL-C levels below 1.8 mmol/L and/or a ≥50% reduction from baseline 2.
- The ODYSSEY COMBO I and II trials demonstrated that alirocumab significantly reduced LDL-C levels compared to placebo or ezetimibe, with a similar safety profile regardless of revascularization status 3, 4.
- The ODYSSEY-KT study showed that alirocumab was effective in improving LDL-C levels and related lipid profiles in Korean patients, with a similar safety profile to that observed in other studies 5.
Key Findings
- Alirocumab has been shown to be effective in reducing LDL-C levels and improving lipid profiles in patients with hypercholesterolemia and high cardiovascular risk 2, 3, 4, 5, 6.
- The safety profile of alirocumab is generally similar to that of placebo or ezetimibe, with injection site reactions being the most common adverse event 2, 3, 4, 5, 6.