A new era for heart healthA new era for heart health

Look into the typical physician’s toolbox for preventing cardiovascular disease, and you’ll find two dominant tools: statin drugs and a blood test to determine if you need them. Twenty-eight years after pharmaceutical giant Merck rolled out the first cholesterol-lowering prescription drug, Lovastatin, (brand name Mevacor), statins have become the largest-selling class of drugs in the world, with one in four adults over age 40 taking them, and annual sales nearing $14 billion in 2014, according to market research firm IMS Health.

But with their popularity has come mounting complaints about reported side effects, including chronic muscle pain and increased diabetes risk, and concern that their potential to reduce heart attacks has been overblown (at best, studies show a 25-30 percent risk reduction). Patients and some practitioners are calling for alternatives, or add-ons, to pick up where statins leave off. And the supplement industry is rising to the challenge with new formulations and new tests to match the right patient with the right nutrients.

 “In terms of reducing total cholesterol, statins do a great job. However, total cholesterol is not the only marker for cardiovascular health,” says pharmacologist Bodi Zhang, PhD, general manager of strategy for Thorne Research. “To fundamentally improve cardiovascular health we need to start targeting multiple targets.”

Thorne intends to do just that with its new four-product TruCardia line, a practitioner line developed with the Nashville-Tennessee-based Hypertension Institute. Meanwhile Pure Encapsulations has rolled out a new, personalized, 13-product PureHeart line, developed in partnership with diagnostics developer Cleveland HeartLab. Orthomolecular Products and Metagenics also have robust and growing cardio-metabolic lines. And in 2014 Carlson Labs waded into the category with its new Heart Fit line. According to NBJ estimates, sales of heart health supplements hovered around $2.6 billion in 2015, up 3.7 percent.

The new white space

The launches come at a time when fish oil, the only nutritional supplement to be embraced by the notoriously conservative specialty of cardiology, is being strongly reconsidered in the wake of several studies questioning its efficacy. One 2014 study published in JAMA Internal Medicine looked at 24 studies over seven years and found only two showed fish oil to offer benefit. Another Italian trial, published in the New England Journal of Medicine in 2013, looked at 12,513 patients assigned to take Omega 3 supplements or placebo and found the supplements to have “null” impact on risk of death or hospital admission from heart disease. Sales of Omega 3 supplements are expected to fall for the third year in a row in 2015, according to NBJ, down 1.4 percent from 2014. Sales of Glaxo Smith Kline’s prescription fish oil, Lovaza, fell by nearly half in 2014, according to IMS Health.

“There are still settings where use is strongly recommended–particularly in people who cannot or will not eat fish. But these studies have definitely dampened enthusiasm,” says Stephen Devries, MD, executive director of the Chicago-based Gaples Institute for Integrative Cardiology.

Personalized medicine meets cardiology

The standard lipid panel, which tests for cholesterol and triglycerides in the blood, is the most widely used screening tool in cardiovascular medicine, notes Kelly Heim, Ph.D., a nutritional pharmacologist with Pure Encapsulations. While important, it has a tendency to miss signs of trouble within the vascular wall itself, he says. “Approximately half of all individuals faced with a cardiovascular event had normal values on their lipid panel.” On the other hand, a person with high cholesterol may in reality have a fairly low risk of heart disease.

Over the past four years, Cleveland HeartLab Inc. has rolled out a series of proprietary diagnostics which look for white blood cell activity, inflammatory markers, and signs of oxidative stress within the artery wall, as well as signs of past high blood pressure within the urine, and levels of vitamin D, Coenzyme Q10, and Omega 3 and 6 Via a collaboration between Pure Encapsulations and the Cleveland HeartLab, practitioners can direct patients to supplements developed specifically to address issues discovered via the tests. “It is an extension of personalized medicine,” says Heim.

Thorne’s TruCardia line – more than 15 years in the making—also takes a multi-pronged approach. This year, the company is slowly rolling out its inaugural product, LipoCardia, which uses unique ingredients like red yeast rice, green tea extract, aged garlic, and lycopene to normalize lipid levels, and anti-inflammatories and antioxidants like resveratrol and curcumin to promote vessel health. In coming years, Thorne intends to launch CardioPressin, to support normal blood pressure levels; ArterioCare, to promote blood flow; and MitoBio, to promote genesis of mitochondria (the energy centers within cells).

One recent, yet-to-be-published randomized controlled trial conducted at the Hypertension Institute, looked at 40 patients assigned to LipoCardia or placebo for four months. Those taking LipoCardia not only saw reductions in total cholesterol, LDL “bad” cholesterol, and triglycerides, they also saw the number of LDL particles shrink, and the size of those particles grow.

“Research is showing that particle size matters,” says Thorne pharmacologist Zhang. “If you can reduce the number of LDL particles and increase the LDL size you may be able to reduce the rate of cardiovascular incidents. We have several ingredients that do that.”

Old standbys and new arrivals

Cardiologist Dr. Dennis Goodman, director of integrative medicine at NYU Langone Medical Center, says if he were to recommend just one dietary supplement for heart health it would be magnesium.

“There are many studies that say the people with the lowest levels of magnesium have the highest levels of heart disease,” says Goodman, who spells out its benefits in the new book, Magnificent Magnesium.

Magnesium is required to convert ADP (Adenosine diphosphate) to ATP Adenosine triphosphate (ATP) inside cells, releasing energy needed to contract and relax muscles, like the heart muscle. “If you don’t convert ADP to ATP your body is like a car with the wrong octane gas n it,” says Goodman. Magnesium also has anti-inflammatory properties and has been shown in some studies to lower blood pressure. One 2013 review of 16 studies, in the American Journal of Clinical Nutrition, found that higher levels of circulating magnesium were associated with a 30 percent lower risk of cardiovascular disease.  Goodman gives every patient an RBC (red blood cell) magnesium test and recommends supplements to those who show signs of depletion.

He also sees Vitamin K2, a relative newcomer supplement, as a key tool in the heart health toolbox. “Vitamin K2 keeps calcium in the bones where it belongs and doesn’t allow it to go into the blood vessels where it can cause problems.” Nattopharma is funding research and promoting the ingredient as “the next Vitamin D” in terms of its potential blockbuster health benefits.

Goodman notes he still frequently prescribes statins, but supplements can counteract some of their side-effects. For instance, some research suggests that statin drugs may actually boost calcium accumulation, or calcification, in the arteries, promoting atherosclerosis. They may also decrease levels of Vitamin K2. “All my patients on statins get Vitamin K2,” he says.

Because statins can deplete coenzyme Q10, supplementation could also be in order.

For patients who need to do something to get their cholesterol levels down, but aren’t interested in, or can’t take a statin due to side effects, he recommends red yeast rice, noting that the first-ever statin, lovastatin, was derived from it.

Ultimately, many envision probiotics also playing a greater role in heart health.

One unique strain of Lactobacillus reuteri (NCIMB 30242), now present in a Pure Encapsulations heart health supplement, has been shown to bind to cholesterol and help usher it out of the body. “Its mechanism of action is entirely different than any nutritional supplement currently used for heart health,” says Heim.

Drugs, food, supplements, or all of the above?

Devries and his colleagues at the Gaples Institute for Integrative Cardiology, are working hard to educate physicians about the critical role nutrition can play in preventing heart disease. Unfortunately, he notes, most have had almost no formal training. One recent survey of four-year medical schools found fewer than 20 hours devoted to nutrition education. Once doctors move on to training for specialties, including cardiology, it gets worse.

“I trained in top internal medicine and top cardiology programs, and I did not have one minute of nutrition education,” says Devries, whose institute was formed with the express purpose of providing such training. “Even today, during the typical doctor visit, there is a brief mention about needing to eat well and be active and then the conversation shifts to medication.”

In his trainings, Devries, first and foremost, stresses the importance of eating healthful, real food. But he sees an important role for supplements going forward, as patients seek affordable offerings beyond the standard fare. (Of note: Two new, injectable drugs for managing cholesterol were unveiled this year under the brand names Praluent and Repatha. Their pricetag: $14,000 per year).

Devries’ advice to supplement companies: Get your science right, don’t overpromise, and be ultra-specific about who your products can benefit.

“Supplements, like prescription medication are more likely to be helpful in very particular situations at particular dosages. The problem that hinders widespread acceptance of them is when companies say everyone should be in supplement A, B, or C,” he says.  Also, ditch the term “alternative.” “Unfortunately, today there are two distinct lines of treatment: conventional on one side and non- prescription on the other. We believe the best of both worlds is best.”