Latest Lipid-related Trials

Latest Lipid-related Trials

ODYSSEY OUTCOMES trial

  1. Compared with placebo in patients with recent acute coronary syndrome (ACS), alirocumab 75 or 150 mg subcutaneous Q2W targeting LDL-C levels 25-50 mg/dL and allowing levels as low as 15 mg/dL:

           a. Reduced major adverse cardiovascular events (MACE), myocardial infarction (MI) and ischemic stroke

           b. Was associated with a lower rate of all-cause death

           c. Was safe and well-tolerated over the duration of the trial.

Lipoprotein(a) [Lp(a)] reduction in persons with CVD:

  1. APO(a)-LRx reduced Lp(a) levels in a dose-dependent manner in patients who had elevated Lp(a) levels and established CVD.
  2. There were no significant differences between any APO(a)-LRx dose and placebo with respect to platelet counts, liver and renal measures, or influenzalike symptoms.
  3. The most common adverse events were injection-site reactions. Single ascending dose study of small interfering RNA (siRNA) targeting Lp(a) production in individuals with elevated plasma Lp(a) levels:

           a. Subcutaneous injection of an siRNA (SLN360) targeting mRNA for the LPA gene lowered Lp(a) up to 98%.

           b. >70% and >80% reductions in Lp(a) persisted for 150 days after the 300 mg and 600 mg doses.

           c. The highest doses reduced LDL-C and apoB by 20% to 30%.

      d. There were no major safety issues, although low-grade, transient, dose-dependent injection site reactions occurred. These findings support the further development of this therapy.

PCSK9 Inhibitor therapy with Inclisiran

  1. Inhibition of PCSK9 inhibitor with inclisiran is a very promising and potentially the simplest and most effective approach to further reducing LDL-C, the cause of atherosclerosis.

          a. LDL-C variability within individuals is practically eliminated.

          b. Injection burden reduced substantially.

          c. Sustained effect between infrequent injections

          d. Opportunity to improve patient adherence.

2. Phase II and the ongoing Phase III studies have robust long-term efficacy with no safety issues.

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