冠心病新药Lodoco冲出江湖！显著降低心血管风险！

China is one of the countries with the heaviest burden of cardiovascular disease in the world, and deaths caused by cardiovascular disease account for more than 40% of the total deaths of the Chinese population. Lodoco is a new drug for coronary heart disease that has just been launched. How effective is it? Let’s take a look!

coronary heart disease

Coronary atherosclerotic heart disease, referred to as coronary heart disease (CHD), is a form of ischemic heart disease. Coronary arteries (coronary arteries) are the arteries that supply blood to the heart. When atherosclerosis occurs in the coronary arteries, causing lumen stenosis or occlusion, resulting in myocardial ischemia, hypoxia or necrosis, causing chest pain, chest tightness and other discomforts, this heart disease is called coronary heart disease.

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Typical symptoms of heart disease caused by coronary artery lumen stenosis or occlusion are chest pain, chest tightness, and aggravation after activity. It is more common in people over 40 years old and more common in men than women. Treatment includes lifestyle changes, drugs, and surgery. According to different onset characteristics and treatment principles, coronary heart disease is mainly divided into two categories. One is chronic coronary artery disease (CAD), also known as chronic myocardial ischemic syndrome (CIS), which includes stable angina, ischemic cardiomyopathy, and occult coronary heart disease. The other is acute coronary syndrome (ACS), which includes unstable heartache (UA), non-ST elevated myocardial death (NSTEMI), and ST-segment elevation myocardial infarction (STEMI). Some scholars also include sudden death from coronary heart disease.

Lodoco

Agepha Pharma announced that the US FDA has approved the marketing of Lodoco as an atheroprotective anti-inflammatory cardiovascular disease therapy to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization and cardiovascular death in adult patients.

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Studies have shown that Lodoco inhibits the assembly of microtubules and has multiple anti-inflammatory mechanisms, and that the drug can be used safely alone or in combination with standard-of-care lipid-lowering drugs and other therapies to effectively reduce the risk of heart attack and stroke.

Lodoco – How effective is it?

On November 5, 2020, "N Engl J Med" published a multinational, randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy of Lodoco in patients with coronary heart disease. The primary efficacy endpoint was the cumulative incidence of the primary composite endpoint of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization.

The trial included a total of 5522 patients with chronic coronary heart disease, who were randomly divided into a colchicine group and a placebo group at a ratio of 1:1. The colchicine group received 0.5 mg of colchicine once a day; the placebo group only received a placebo, and all patients received high-dose statins.

The trial results showed that colchicine, when used as add-on therapy (0.5 mg once daily) to high-dose statins and other heart disease prevention drugs, significantly reduced the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% compared with placebo.

图A：心血管死亡、心肌梗死、缺血性脑卒中或缺血驱动的冠状动脉血运重建这一主要复合终点的累积发生率

To sum up, the risk of ischemic cardiovascular events caused by colchicine at a daily dose of 0.5 mg is significantly lower than that of placebo, and the effect is very impressive!

Global drug development for coronary heart disease

Currently, there are 228 drugs for coronary heart disease, in addition to Lodoco, which is already on the market. There are 112 drugs currently in the non-development stage, 4 drugs in the drug discovery stage, 5 drugs in the preclinical stage, 1 drug in the unknown clinical stage, 1 drug in the early clinical phase 1 stage, and 1 drug in the clinical phase 1 stage. There are 12 kinds of drugs, 1 kind in clinical phase 1/2, 16 kinds in clinical phase 2, 2 kinds in clinical phase 2/3, 8 kinds in clinical phase 3 currently, and 2 kinds have been applied for marketing. I believe they will meet us in the near future. In addition, there are 79 kinds of drugs that have appeared in front of you. Today I will briefly introduce them to you:

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Vilicigua

In May 2022, Vericiguat (Verquvo), a new anti-heart failure drug developed by Bayer, was approved by the National Medical Products Administration (NMPA) for marketing. It is used to treat patients with chronic heart failure with reduced ejection fraction (ejection fraction <45%) to reduce the risk of hospitalization for heart failure or the need for intravenous diuretic treatment.

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Vericiguat is a soluble guanylate cyclase (sGC) agonist. It can directly stimulate guanylate cyclase in a nitric oxide-independent manner when nitric oxide is insufficient, increase intracellular cyclic guanosine monophosphate (cGMP) levels, improve myocardial and vascular function, delay left ventricular remodeling, prevent or even reverse left ventricular hypertrophy, thereby improving myocardial and vascular function.

"For the first time, patients with residual inflammatory risk as measured by hs-CRP have a proven, FDA-approved treatment option that reduces cardiovascular disease risk by targeting inflammatory pathways," said Professor Michael Blaha, MD, director of clinical research at the Johns Hopkins Ciccarone Center for Cardiovascular Disease Prevention.

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References

[1]Cardiovasc Res. 2021 Nov 22;117(13):2525-2536. doi: 10.1093/cvr/cvab303. doi:10.1016/j.annonc.2022.08.001.

[2]Early Breast Cancer Trialists' Collaborative GroupPolychemotherapy for early breast cancer: an overview of the randomized trials. Lancet. 1998; 352: 930-942

[3]Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, López-Sendón J, Ostadal P, Koenig W, Angoulvant D, Grégoire JC, Lavoie MA, Dubé MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16. PMID: 31733140.