Anti-Inflammatory Drug is Big Step Forward in Fighting High-Risk Heart Disease

The precise role that inflammation plays in heart attack and stroke risks is very much the subject of evolving research, but there has been a breakthrough. This summer, the U.S. Food and Drug Administration (FDA) approved the first-ever anti-inflammatory drug for cardiovascular disease.

It is meant for individuals with well-established heart disease who are at high risk for heart attack or stroke. And it is meant to work with established medical therapies such as medications to treat the buildup of fats, cholesterol and other substances on or within artery walls.

Cardiologists with Baptist Health Miami Cardiac & Vascular Institute are optimistic about the potential of this anti-inflammatory – colchicine -- and its approved level of 0.5mg for heart disease patients who may benefit the most.

Jonathan Fialkow, M.D., Chief Population Health Officer for Baptist Health and chief of cardiology at Baptist Health Miami Cardiac & Vascular Institute.

The approval of colchicine is an “exciting next step” in helping patients at highest risks for life-threatening events such as a heart attack or stroke, explains Jonathan Fialkow, M.D., chief of cardiology at Baptist Health Miami Cardiac & Vascular Institute and Chief Population Health Officer at Baptist Health South Florida. 

“Over the decades, we've learned that coronary artery disease, which is what most commonly leads heart attacks and cardiac deaths, is the result of an inflammatory process,” said Dr. Fialkow. “It's inflammation in the artery walls and it leads to plaque development. For many years, the treatments to avoid heart attacks have been focused on various components, such as lowering your blood pressure or keeping your cholesterol under control or not having or controlling diabetes. But this is the first approval of a medication that specifically works against inflammation.”

While there’s much optimism, there’s also a careful protocol to consider before implementing colchicine into heart disease therapies, said Lisa Davis, PA, a clinical lipid specialist and APP manager of cardiovascular risk reduction programs at Baptist Health Miami Cardiac & Vascular Institute. For decades, different dosages of colchicine have been used to treat inflammation and pain, particularly in patients with gout, a type of arthritis that causes sudden, severe joint pain. In treating gout, colchicine works by reducing the inflammation caused by the crystals of uric acid that build up in joints.

“That’s important because it shows that colchicine has been well studied,” said Ms. Davis. “We look at safety and efficacy. It's been used for gout. It's also been used for pericarditis (swelling and irritation of the thin, sac-like tissue surrounding the heart). So we have a lot of data showing safety and efficacy, especially safety in long-term use for many patients.”

A so-called hs-CRP (high-sensitivity C-reactive protein) test can help determine a patient’s risk of getting coronary artery disease. C-reactive protein is the biomarker most widely used to predict residual inflammatory risk linked to heart disease.

Dr. Fialkow emphasizes that colchicine is not a remedy for heart disease, but a major step forward in helping patients who may not fully respond to established therapies including statins, a group of medicines that can help lower the level of low-density lipoprotein (LDL) cholesterol in the blood.

“There’s excitement around colchicine because it’s one more formidable weapon that we may have to better understand why some people get cardiovascular disease and some people don't,” said Dr. Fialkow. “It's not a panacea, but it's an exciting next step in our evolution. Most importantly, discuss this with your doctor because it’s not for everyone and we're still learning more about it.”

The FDA’s approval of colchicine was based on the results of a multi-national, randomized placebo-controlled clinical trial that included 5,522 people with chronic coronary disease taking guideline-directed medical treatments including high-intensity statins. Heart attack or stroke risks were reduced by an additional 31 percent, compared to standard-of-care treatment, according to the study’s results.  The study found that colchicine was found to reduce the risks of myocardial infarction (heart attack), stroke, coronary revascularization (treatments or procedures that restore blood flow to areas of the heart), and cardiovascular death.

“The majority of the patients were on statin therapy,” said Ms. Davis. “It’s important to note that colchicine is not meant to replace any of the standard-of-care treatments.  It's meant to be safely utilized in addition to these therapies.”