FDA Approves Lodoco, First Anti-Inflammatory Drug for Cardiovascular Disease. Here’s Why It’s a Big Deal

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The FDA’s approval of Lodoco (colchicine) medication for cardiovascular disease could be a game-changer for treatment. andreswd/Getty Images
  • The FDA recently approved the first anti-inflammatory drug for cardiovascular disease called LODOCO (colchicine).
  • The recently approved medication has been shown to reduce cardiac event risk in adults with atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for cardiovascular disease by an additional 31% compared to standard-of-care treatment.
  • LODOCO can be used alone or in combination with cholesterol-lowering medications.

The Food and Drug Administration (FDA) has approved the first-ever anti-inflammatory drug for cardiovascular disease. 

Called LODOCO (colchicine, 0.5mg), the recently approved medication has been shown to reduce cardiac event risk in adults with atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for cardiovascular disease by an additional 31% compared to standard-of-care treatment. This means colchicine can be used in the prevention and treatment of cardiovascular disease. 

The FDA-approval is supported by data from a multi-national, randomized, double-blind, placebo-controlled clinical trial including 5,522 people with chronic coronary disease taking guideline-directed medical care including high-intensity statins.

In the study’s findings, LODOCO was shown to reduce risk of:

  • myocardial infarction (MI)
  • stroke
  • coronary revascularization
  • cardiovascular death

LODOCO can be used alone or in combination with cholesterol-lowering medications.

How colchicine works 

“We have known for a number of years about the role of inflammation in the development of plaque buildup in the arteries,” says Dr. Brett Nowlan, a cardiologist with Hartford HealthCare Heart & Vascular Institute.

“Up until this new approval of colchicine, we did not have any medications in the cardiac field to specifically address this risk.”

Nowlan also explains the anti-inflammatory mechanisms at work in colchicine are different from other medications such as steroids, or NSAIDs like aspirin. 

“It is a pill intended to be taken once per day and is a long-term preventive medication. It would be added on to any other risk-reducing medications, such as aspirin or statins, and would not replace use of these,” he notes. 

“Although we have long suspected inflammation as playing a major role in the development of coronary disease, it was only in the last 10 years that major trials have come out which showed how useful an anti-inflammatory such as colchicine could be in reducing the cardiovascular risk in patients with heart disease,” says Dr. Cheng-Han Chen, PhD, interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, California.

“The drug works through multiple pathways to decrease the activity of our different types of inflammatory cells. In doing so, it has been shown to reduce such serious risks as heart attack and stroke,” says Chen. 

Why the FDA’s approval of widely-used medication is a game-changer

“Interestingly, colchicine is not a new medication,” says Chen.

“It has been used widely for different inflammatory conditions throughout the body such as gout and liver inflammation,” says Dr. Chen. Nowlan adds it’s also used for pericarditis or reducing inflammation of the fibrous sac lining around the heart.

“The reason this FDA approval is such a game changer is that we now believe it can be very useful in cardiovascular disease, specifically in patients we are already treating with our whole arsenal of efficacious heart medications such as statins,” Chen tells Healthline.

“We now have a way to treat the disease through a different angle that we never used before, which is through attacking underlying inflammation,” says Chen. 

“With colchicine, we now have a unique way of lowering cardiovascular risk, which adds to and complements other medications that we currently use,” says Nowlan. This treatment results from the study compare very well with other medications we use, he adds.

What to know about the safety of colchicine 

“As with all medications, colchicine is not right for everyone,” says Nowlan. “The most common side effect with this medication is gastrointestinal upset.”

“There are also uncommon but known effects of colchicine of lowering blood cell counts, and causing muscle weakness,” he says. 

“[Colchicine] can also interfere with levels of medications such as some antifungal and antibiotic drugs,” Nowlan adds.

Common side effects reported in clinical studies according to the FDA:

  • Diarrhea
  • Abdominal cramping
  • Muscle pain or myalgia

Serious side effects, including death, are associated with taking more than the recommended dose. Colchicine overdose can lead to the following:  

  • Abdominal pain 
  • Muscle numbness and weakness (ie., neuromuscular toxicity).
  • Vomiting
  • Lower blood cell counts (ie., low red blood cell counts, low white blood cell counts, and low platelet counts, all of which may be life-threatening and can lead to death).
  • Kidney problems
  • Skin problems including rashes and alopecia (hair loss)
  • Fatal overdoses in adults and children

The FDA says to keep colchicine out of reach of children. 

Highlighting the importance of reducing inflammation

Nowlan tells Healthline the approval of colchicine also highlights the importance of inflammation as a risk factor for heart disease and should encourage everyone to make lifestyle choices that can help lower inflammation. He says these include:

  • Stopping or avoiding smoking
  • Eating more whole and unprocessed foods 
  • Consuming less sugar
  • Engaging in regular physical activity
  • Getting adequate sleep

When it comes to eating more whole and unprocessed foods or eating to reduce inflammation, the American Heart Association suggests the Mediterranean diet, which has been shown to lower the risk of heart disease and stroke.

Takeaway

The FDA recently approved the first anti-inflammatory drug for cardiovascular disease called LODOCO (colchicine).

The recently approved medication has been shown to reduce cardiac event risk in adults with atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for cardiovascular disease by an additional 31% compared to standard-of-care treatment.

LODOCO can be used alone or in combination with cholesterol-lowering medications.

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