50% reduction in LDL cholesterol! This new drug, Phase II. Clinically, is dazzling

Although treatment can be performed with the largest dose of statins, such as izetimi bei and a pre-protein-converting enzyme PCSK9 inhibitor, the expected therapeutic goals are still difficult to achieve in some patients with hemoglobinated familial hypercholesterolemia.
addition, although LDL blood harvesting can further reduce LDL cholesterol levels, the use of this invasive method is limited by many conditions, which can cause greater inconvenience to patients.
, a multi-center, double-blind, placebo-controlled Phase II clinical study was conducted at the Icahn School of Medicine at Mount Sinai in New York to assess the safety and effectiveness of evinacumab, an all-human monoclonal antibody.
findings were published November 15 in the New England Journal of Medicine and as "the latest science" at the American Heart Association Scientific Conference 2020.
DOI:10.1056/NEJMoa2031049 The study recruited 272 patients and was randomly divided into the following groups: evinacumab injections: 4 50 mg, once a week (40 people); 300 mg, once a week (43 people); 300 mg, 2 times a week (39 people); placebo (41 people).
intravenous evinacumab: 15 mg per kg, 1 time per 4 weeks (39 persons);
at week 16, the minimum 2rd average difference between LDL cholesterol levels was -56.0, -52.9 and -38.5 percentage points (all groupSP was less than 0.001) between the baseline of LDL cholesterol levels between the 300 mg weekly and 300 mg subsulfic injections per 2 weeks, respectively.
difference between the 15 mg per kilogram and 5 mg intravenous evinacumab and placebo groups was -50.5 percentage points (P .lt;0.001) and -24.2 percentage points, respectively.
At week 16, calculated LDL cholesterol levels were the least-2-average change relative to the baseline, and the risk of serious adverse events during treatment was between 3% and 16% over the entire trial period.
Most patients have good tolerance to evinacumab, one patient who received an epithetic injection had difficulty breathing, and the other had mild allergic reactions, both of which stopped medication and improved symptoms with other treatments.
two deaths were reported in the trial, but were related to underlying health conditions.
of LDL cholesterol levels calculated at week 16 in patients with resophedic hypercholesterolemia compared to the baseline The final results showed that evinacumab reduced LDL cholesterol by 50 percent in patients with resophedic hypercholesterolemia.
Robert Rosenson, M.D., explains: "Evinacumab is a complete human monoclonal antibody that inhibits angiogen-like protein 3 (ANGPLT3) and lowers LDL cholesterol by not relying on LDL subjects.
genetic studies have shown that people who are known to lack ANNGPTL3 or have low levels have low levels of LDL cholesterol for life and rarely suffer from atherosclerotic cardiovascular disease.
" Drugs that treat refractic hypercholesterolemia independently of LDL-like pathways currently do not meet clinical needs, and if approved by the FDA, evinacumab may fill the clinical void in patients by reducing severely elevated LDL cholesterol.
" it is understood that Evinacumab is under regulatory review in the United States and the European Union as an aid to other fat-lowering treatments in patients with pure hexa-family hypercholesterolemia (another form of familial hypercholesterolemia).
resources: s1. Evinacumab in Patients with Refractory Hyperstemia