Importance of the Heart Calcium Score

The Heart Calcium Score, also known as the Coronary Artery Calcium (CAC) Score, is an essential tool in modern heart health. It helps evaluate the presence and extent of calcified plaque in the coronary arteries, offering critical insights into a person’s risk of cardiovascular diseases.

STEP: Heart Failure in Obesity & Diabetes

Semaglutide benefits obesity-related heart failure in type 2 diabetes, improving symptoms and aiding weight loss. The STEP trial evaluated the effects of semaglutide (Ozempic or Wegovy) 2.4 mg weekly in participants with heart failure, obesity, and type 2 diabetes. Patients received either semaglutide or placebo for 52 weeks.

SELECT: Obesity & Heart Health

Semaglutide, marketed as Ozempic or Wegovy and administered at a weekly dosage of 2.4 mg, has demonstrated a noteworthy reduction in cardiovascular events by 20% among non-diabetic individuals with obesity. Most participants had a diagnosis of prediabetes and a history of either myocardial infarction (MI) or stroke at the beginning of the study.

What is Insulin Resistance?

Insulin resistance is a condition in which the body’s cells become less responsive to the effects of insulin, a hormone produced by the beta cells in the pancreas. Insulin is central for regulating blood sugar (glucose) levels, facilitating the uptake of glucose by cells for energy.

Leqvio – Revolutionary Cholesterol Medication

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the United States and worldwide. In the US alone, a person dies from cardiovascular-related causes every 33 seconds. Therefore, it is crucial to develop new therapies that aim to reduce the risk of cardiovascular disease.

Diabetes & Cardiovascular Disease

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death among patients with diabetes. Therefore, managing ASCVD risk is crucial in preventing the progression of atherosclerosis and reducing serious events like heart attacks and strokes in individuals with diabetes.

ORION: Gene Silencing, PCSK9 & LDL Cholesterol

Leqvio (Inclisiran) has received FDA approval as an additional therapy to diet and maximally tolerated statin medications for adults diagnosed with either heterozygous familial hypercholesterolemia (HeFH) or severe ASCVD who require further reduction of LDL cholesterol.

New FDA approval: fish oil (vascepa) for cardiovascular risk reduction

Vascepa is a form of omega-3 fish oil named icosapent ethyl. It was first approved by the FDA in 2012 for the treatment of severe hypertriglyceridemia, as defined by blood triglyceride levels >500 mg/dL.

The FDA has now added a second indication for Vascepa. It can be utilized in patients with established cardiovascular disease or in those who have diabetes plus two or more other risk factors (e.g., hypertension, hypercholesterolemia, smoking, kidney dysfunction) for cardiovascular disorder. Before treatment, patients must also have baseline triglyceride measures >150 mg/dL.

This significant approval comes after reviewing the results of REDUCE-IT, a landmark randomized clinical trial published in NEJM, January 2019. REDUCE-IT confirmed significant cardiovascular outcome reduction of 25% in patients receiving icosapent ethyl when added to statin therapy.

I anticipate widespread use of the fish oil, icosapent ethyl, especially in patients with diabetes, who, by its nature of insulin resistance, frequently have both the increased risk of ASCVD and high triglycerides. Clinicians should be aware of possible induction or worsening of atrial fibrillation, atrial flutter, and bleeding with Vascepa, particularly in the predisposed individuals.

GT

FDA warning: biotin interferes with heart test

The FDA has now released a new warning against biotin interference with troponin, an essential heart blood test. Biotin or vitamin B7 is a water-soluble molecule found in many over-the-counter supplements such as multivitamins, prenatal, and in those that are meant to improve or protect the health of hair, skin, and nail.

Vitamin B7 is a central catalyst in many laboratory tests, especially those measuring troponin and thyroid hormone levels. When patients take high doses of biotin, especially >30 micrograms daily, it has the potential to underestimate the blood troponin concentration. Troponin measurements are critical in identifying adults with heart disease and particularly those having an acute event such as heart attack or myocardial infarction.

High doses of biotin intake, up to 300 mg daily, have been documented in patients with multiple sclerosis. These extraordinary doses may translate up to 1,200 ng/mL blood concentrations. Biotin has a short half-life of about two hours. It may be reasonable to suspend vitamin B7 intake for two to three days before undergoing any laboratory testing that incorporates biotin-analyte technology.

Patients, physicians, and laboratory personnel should be aware of possible interference of oral biotin with blood troponin and thyroid hormone testing, particularly in decisive clinical circumstances. A grave example would be a biotin user who presents clinically with a heart attack, and yet troponin measurements appear to be normal. Non-elevated troponin can lead to missed diagnosis and life-saving intervention.

GT

Diabetes medication, Farxiga, crosses over into the cardiology world

SGLT-2 inhibitors first came into the market in 2013. FDA approved farxiga in January 2014. SGLT-2 inhibitors, as a class, have consistently shown to reduce cardiac outcomes in patients with type 2 diabetes, who also have clinical or subclinical heart failure.

The New England Journal of Medicine published the results of DAPA-HF, a major randomized clinical trial, in September 2019. Investigators evaluated the potential heart benefits of farxiga in patients without diabetes. A group of 5000 adults with heart failure stages 2–4 and an ejection fraction of <40% were randomized to receive farxiga or placebo. Participants were followed and analyzed at 18 months.

During this relatively short interval, farxiga improved the following outcomes significantly: 25% reduction in the primary endpoint (worsening of heart failure ± cardiovascular death), 30% reduction in worsening of heart failure, 18% reduction in cardiovascular death and a 17% reduction in mortality from any cause.

Surprisingly, these benefits were similar between patients with and without diabetes, indicating that the mechanism of heart failure protection of the SGLT-2 inhibitor is independent of hyperglycemia. The rates of adverse events were similar among adults receiving farxiga or a placebo.

DAPA-HF trial adds strong evidence for the use of SGLT-2 inhibitors in heart failure management, independent of diabetes status. I anticipate more extensive use of these medications by the cardiologists. It is fascinating to see how a class of drugs designed and utilized initially for diabetes is crossing over into the cardiology world.

GT

More bad news for Niacin

The New England Journal of Medicine first published the results of the HPS2-THRIVE randomized clinical trial in 2014. Niacin addition to statin therapy did not improve cardiovascular outcomes. Instead, the trial found an increased rate of adverse events.

Last month, Clinical Therapeutics published a detailed analysis of the trial’s adverse events. Authors found that niacin addition significantly increased the risk of new-onset diabetes, worsening of diabetes, severe bleeding, and serious infections by about 30%, 55%, 40%, and 20% respectively.

The above adverse outcomes were more pronounced in the first year after the start of niacin. The infection rate was an exception, which stayed elevated throughout the trial. Investigators followed and analyzed a group of 25,000 patients with high baseline risk for the vascular disease over four years.

Based on HPS2-THRIVE data, it is difficult to justify the clinical use of niacin from the cardiovascular standpoint.

GT