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U.S. FDA approves low dose Colchicine for ASCVD risk reduction


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Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of morbidity and mortality worldwide, affecting over 500 million individuals globally and resulting in approximately 19 million deaths annually. It is caused by the build-up of plaque that leads to hardening of the arteries. It can limit blood flow through the arteries which can result in severe conditions such as coronary heart disease, stroke, angina, or peripheral artery disease. The control of traditional cardiovascular risk factors such as diabetes, higher blood pressure, and smoking, has significantly reduced the risk of events. However, atherosclerosis is a multifactorial disease with a significant inflammatory component. Despite advancements, specific patient groups, like those with gout and rheumatoid arthritis, still face abnormally high CV risk due to systemic inflammation (1-3).


Inflammation plays a critical role in the development of ASCVD


Inflammation is a major risk factor in ASCVD that contributes to the development and gradual progression of plaque build-up in the arteries. High-sensitivity C-reactive protein (hs-CRP), an inflammatory biomarker, is found to be a strong predictor of future cardiovascular events compared to cholesterol levels in patients receiving statins. Current treatment strategies typically focus on the use of statins or aspirin to reduce the risk of CVD. While statins remain a cornerstone in cholesterol reduction and cardiovascular risk management, there is a need for inflammation-lowering therapies to reduce the risk of ASVD in all groups(4,5).


Clinical role of colchicine in the management of ASCVD


Colchicine has been widely used as a prophylactic treatment for anti-inflammatory conditions such as gout, pericarditis, and liver inflammation. Colchicine mediates its anti-inflammatory activity mainly by inhibiting the microtubule assembly. It suppresses proinflammatory cytokine release and blocks NLRP3 inflammasome activation and NF-κB signaling at the molecular level(6,7). 


Recently, the Food and Drug Administration (FDA) approved colchicine (Lodoco) for the management of cardiovascular disease. Clinical studies have demonstrated that Colchicine (0.5mg) significantly reduces the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death(8).


Colchicine reduces the risk of ASCVD events in CVD patients by 31.2% when used in addition to standard-of-care treatments. The safety and efficacy of colchicine were evaluated in a randomized, double-blind, controlled trial involving 5,522 patients who were assigned to receive either a placebo or 0.5 mg of colchicine once daily. The trial had a median follow-up period of 28.6 months during which a significant reduction in cardiovascular events with colchicine was observed. The primary endpoint – comprising a composite of cardiovascular death, ischemic stroke, ischemia-driven coronary revascularization and spontaneous (nonprocedural) myocardial infarction occurred in 6.8% of the colchicine group compared to 9.6% of the placebo group. There was an absolute risk reduction of 2.8% with Colchicine(9).


Summary


Inflammation is a significant risk factor for the development and progression of ASCVD. Current treatment options focus on lowering cholesterol by targeting LDL-C levels. Inflammation-lowering therapies have shown promise in reducing the risk of cardiovascular events by addressing the inflammatory pathways that impact major cardiac events. Colchicine, at a dose of 0.5 mg daily, is a breakthrough addition to current treatments that can reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death.

Indications


Colchicine (Lodoco) is indicated to lower the risk of myocardial infarction (MI), coronary revascularization, stroke, and cardiovascular death in adult patients with established atherosclerotic disease or several risk factors for cardiovascular disease(10).

Dosage and Administration


The recommended dosage of Colchicine (Lodoco) is 0.5 mg, once a day orally. It can be used as a continuous oral therapy. It can be safely used alone or in combination with standard-of-care lipid-lowering medications and other therapies. However, patients with renal failure, severe hepatic impairments, or pre-existing blood dyscrasias should not take Colchicine(10).

About the Author


Dr Uttara Shankar is a PhD degree holder in Biology and Chemistry. She is passionate about science and the communication aspect of it, and therefore, keen on pursuing a career in medical communications that combines both her interests.


References


  1. What is Atherosclerosis? Available at: https://www.heart.org/en/health-topics/cholesterol/about-cholesterol/atherosclerosis Accessed on 10 June 2023.

  2. Vasan RS, Enserro DM, Xanthakis V, et al. Temporal Trends in the Remaining Lifetime Risk of Cardiovascular      Disease Among Middle-Aged Adults Across 6 Decades: The Framingham Study. Circulation.  2022 Apr 26;145(17):1324-1338.

  3. Solomon DH, Liu CC, Kuo IH, et al. Effects of colchicine on risk of cardiovascular events and mortality among patients with gout: a cohort study using electronic medical records linked with Medicare claims. Ann Rheum Dis. 2016 Sep;75(9):1674-9.

  4. Libby P. Inflammation in atherosclerosis—no longer a theory. Clinical chemistry. 2021 Jan;67(1):131-42.

  5. Ridker PM, Bhatt DL, Pradhan AD, et al. Inflammation and cholesterol as predictors of cardiovascular events      among patients receiving statin therapy: a collaborative analysis of three randomised trials. The Lancet. 2023 Apr 15;401(10384):1293-301.

  6. Leung YY, Yao Hui LL, Kraus VB. Colchicine--Update on mechanisms of action and therapeutic uses. Seminars in Arthritis and Rheumatism. 2015;45(3):341-350

  7. Zhang FS, He QZ, Qin CH, et al. Therapeutic potential of colchicine in cardiovascular medicine: a pharmacological review. Acta Pharmacologica Sinica. 2022 Sep;43(9):2173-90.

  8. Lodoco: Low-dose colchicine for cardiovascular event prevention. The Medical Letter Drugs Therapy.      2023;65(1686):156-157.

  9. Nidorf SM, Fiolet AT, Mosterd A et al. Colchicine in patients with chronic coronary disease. New England journal of medicine. 2020 Nov 5;383(19):1838-47.

  10. LODOCO Prescribing information. Available at: https://lodoco.com/wp-content/uploads/2023/06/LODOCO_Prescribing-Information_6.16.23.pdf Accessed on 10 June 2024.

Disclaimer


The matter published on this platform has been developed by independent medical writers from various healthcare backgrounds including members of MedWriters Alumni Network. Although great care has been taken in compiling and checking the information, the authors, Rxnews team and its partners or agents, and sponsors shall not be responsible or in any way liable for any errors, omissions, or inaccuracies in this blog article whether arising from negligence or otherwise, however or for any consequences arising therefrom. The inclusion and exclusion of any product do not mention that the publisher advocates or rejects its use generally or in any particular field or field. For any complaints or feedback please write to content@rxnews.in

 

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