Natural Foods Merchandiser

Statins and Supplements

In battling heart disease, America's deadliest health condition, cholesterol, is public enemy No.1.

Cardiovascular disease, including heart attacks and strokes, causes more than 40 percent of all deaths in America. High blood pressure, diabetes, smoking, obesity and a sedentary lifestyle are all contributing factors, but lifestyles are notoriously obstinate. By combating cholesterol (a fatlike substance that can clog blood vessels), both supplements and pharmaceuticals seemingly offer simpler solutions.

Pharmaceutical big guns targeting cholesterol are HMG-CoA reductase inhibitors, or statins: atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol) and simvastatin (Zocor), which reportedly reduce cholesterol by 20 to 60 percent. Other medications include bile acid sequestrants, fibric acids and nicotinic acid (high-strength, prescription-only niacin, FDA-approved for decades).

Supplement options include three prescribed in other countries—pantetheine, red yeast rice and guggul—plus vitamins B3 (niacin), B6, B9 (folic acid), B12, C and E; Co-Q10; soy; chromium picolinate and tocotrienols. Garlic is believed to inhibit HMG-CoA reductase, which reduces cholesterol production in addition to lowering LDL and increasing HDL. Claims have also been made for chitosan, beta-glucans, citrus pectin and beta-sitosterol.

In May 2001, new government guidelines disregarded cholesterol claims for various supplements (while maintaining dietary soy recommendations) and urged wider deployment of the statin arsenal.

That August, Bayer withdrew its cholesterol-lowering cerivastatin (Baycol) after reports of 31 fatalities and serious muscle problems (myositis); other statins were also linked to deaths. The FDA cited the need for ongoing liver tests and monitoring when rejecting manufacturers' requests to sell statins over the counter. (The FDA is attempting to ban Chinese red yeast rice supplements on similar grounds.)

Natural products proponents promote various supplements to augment, statins, offset their side effects, or even replace them. Some advocates argue statins pose unnecessary risks. There is even debate about whether inflammation should be the target rather than cholesterol.

Contradictory studies have supported certain supplements or found no cardiovascular benefit. More critically, researchers at the University of Washington, Seattle, reported in August 2001 that some antioxidants counteract effectiveness of statins and beneficial supplements.

Support for statins, but not supplements, was reported Nov. 13, 2001, in the Heart Protection Study, Oxford University's eight-year, randomized, double-blind clinical trial of statins and vitamins E, C and beta-carotene. (At press time, it had not been peer-reviewed for publication). Calling statins "the new aspirin" (as additions, not replacements, to the daily dose of aspirin taken by some to prevent heart attacks), researchers said major cardiovascular risks and events were reduced by one-third, and expressed "disappointment" that tested supplements weren't beneficial.

"This study shows that [E, C and beta-carotene] do not produce any reductions in the risk of heart attacks, stroke or other vascular outcomes, or ... cancers or other major outcomes, in high-risk individuals with pre-existing vascular disease or diabetes," said lead investigator Rory Collins, M.D., Oxford professor of medicine and epidemiology. "The results did, at least, resolve prior concerns about possible hazards, such as ... increases in cancers with beta-carotene, or strokes due to bleeding with vitamin E."

Four groups of 5,000 subjects received either statin and supplements, statin and placebo, supplements and placebo, or two placebos. Study-specific supplements of 600 mg E, 250 mg C and 20 mg beta-carotene were formulated by Roche Vitamins Ltd., which along with the British Heart Foundation, U.K. Medical Research Council, and Merck & Co., sponsored the study. Merck provided the 40 mg of Zocor simvastatin used in the trial. (Oxford says sponsors weren't involved in the study's design, execution or analysis.)

Supplements were selected to test hypotheses that combining the three antioxidants was more efficacious than a single antioxidant and to determine any statin interactions. Results show neither cardiovascular harm nor benefit from supplement use, either with statins or alone, in high-risk patients.

Preventive effects were not addressed because all participants were high-risk with diabetes or diagnosed heart disease, including strokes, heart attacks, peripheral vascular disease, angina or bypasses and many "were already taking treatments such as aspirin, [prescription] ACE inhibitors and beta-blockers."

Prior studies showing supplement benefits might reflect other lifestyle factors, says Collins, but current ongoing large clinical trials will clarify supplements' effects in low-risk populations, and whether folic acid lowers homocysteine levels. (High homocysteine levels are associated with increased coronary artery disease risk.)

The Heart Of The Matter
HDL helps clean up excess blood fats, while high LDL cholesterol is associated with higher heart disease risk. LDL builds up inside arteries, narrowing them and slowing or blocking blood flow. Shutting down blood supply causes tissue death and can trigger heart attacks and strokes.

Statins inhibit enzyme HMG-CoA reductase, which controls the body's cholesterol production and increases the liver's removal of LDL cholesterol from blood. Researchers from several studies (4s, CARE and LIPID) reported statins lower cholesterol by 20 percent to 60 percent, reduce triglycerides, modestly increase HDL levels, and significantly decrease heart attacks and cardiovascular mortality. Side effects include muscle pain, weakness, gas, constipation, abdominal pain and liver problems.

The new federal statin recommendations came from the National Cholesterol Education Program, coordinated by the National Heart Lung and Blood Institute of the National Institutes of Health. Its Adult Treatment Panel III executive summary was published May 16, 2001, in the Journal of the American Medical Association.

Key changes since the 1993 guidelines include more aggressive treatment to lower cholesterol and triglycerides; better identification of high-risk individuals; adding LDL and triglycerides to HDL and total cholesterol for preliminary screening; refining low HDL (below 40 mg/dL) as a major risk factor (up from below 35 mg/dL); lifestyle changes (including decreasing saturated fat and cholesterol, and increasing plant stanols, sterols and soluble fiber); and targeting "metabolic syndrome" risk factors (including low HDL, excess abdominal fat, and elevated blood pressure and triglycerides). The new guidelines advise against using hormone replacement therapy as an alternative to cholesterol-lowering drugs.

NIH expects the guidelines will increase the number of Americans treated dietarily for high cholesterol from 52 million to 65 million, and triple those prescribed statins from about 13 million to 36 million.

Supplement Status
Widespread statin use is recent, and research on interactions and long-term nutritional depletion is limited.

"People taking statins may be Co-Q10 deficient and should supplement to help counter the depletion in the body," says Katie Ferren, marketing director of Los Angeles-based OptiPure brand, Chemco Industries, a raw materials supplier specializing in therapeutic herbal extracts and specialty phytonutrient products. "Vitamin C, vitamin E and Co-Q10 appear to be highly effective in promoting optimal cardiovascular health by preventing oxidation of LDL cholesterol. A recent study found that if you are taking a statin drug and niacin to support healthy cholesterol levels, the antioxidant vitamins E and C, selenium and beta-carotene may suppress the boost in HDL good cholesterol. The study recommended not to take high doses of antioxidants."

Statins limit both cholesterol and the Co-Q10 essential to heart, muscle and liver function, resulting in fatigue and liver side effects, explains Syndrome X (John Wiley & Sons, 2001) co-author Jack Challem. "The issue is not just lowering LDL cholesterol, which is essential transport for fat-soluble vitamins, but preventing its oxidation," he says.

Another cardiovascular culprit is a homocysteine, which metabolizes protein. High levels may be counteracted with folic acid (B9), betaine and vitamins B6 and B12.

Some U.S. cholesterol-control supplements are prescribed elsewhere. The Ayurvedic remedy guggul, an antioxidant plant resin, has been sold in India since 1986 as an LDL-lowering drug that may also increase HDL and reduce atherosclerotic plaque. Red yeast rice, a fungus used in Traditional Chinese Medicine, contains a statin-comparable compound. Major trials are underway; prior studies suggested the Cholestin product lowers LDL by 21 percent to 32 percent, and increases HDL 14 percent.

Pantetheine, a metabolite of pantothenic acid (vitamin B5), is prescribed in Japan, Italy and Spain. "We definitely would not recommend replacing statins with Pantesin [a trade name for pantethine], although it can complement them, helping lower LDL more than statins alone, and lowering triglycerides. Its focus is raising HDL about 10 percent to 15 percent," explains Tim Jacobson, president and CEO of ingredient supplier Daiichi Fine Chemicals Inc., Vernon Hills, Ill. "For those with low to moderate cholesterol, or below minimum HDL levels, Pantesin-based supplements should prevent progression and help maintain a healthy lipid balance."

To combat cholesterol and control cardiovascular disease, board certified family practitioner Cathleen London, M.D., of Boston, uses statins and supplements. She recommends B vitamins as a team to decrease homocysteine plus vitamins C, D, A and E for protective effects ("but more is not better; too much can stress livers and promote cholesterol"), Co-Q10 "as an antioxidant, cardioprotective that stabilizes calcium channels," and Pantesin to raise low HDLs and get more benefit from statins. "Fermented red rice is a statin, but more dangerous, because it's not standardized," she cautions.

The cholesterol battle, and questions, continue.

Fort Collins, Colo., writer Wendy Lee Bonifazi, RN, CLS, APR, has earned 15 national media awards for coverage of health, aging and business.

Natural Foods Merchandiser volume XXIII/number 1/p. 32, 34-35

Heart-To-Heart Talk

  • Nearly 61 million Americans suffered from cardiovascular disease in 1998, the last year for which the Americam Heart Association reported disease statistics.

  • The AHA estimates that total direct and indirect costs of cardiovascular disease and stroke will be $298 billion in 2001—with nearly 40 percent of these costs due to lost productivity.

  • At $26.6 billion in 2000, spending on heart health products represents one of the largest health care products markets, according to compiled data by Nutrition Business Journal.

  • In 2000, cardiovascular drugs contributed $25.3 billion to U.S. drug industry sales.

  • Heart health supplements amounted to $745 million in 2000 sales.

  • The fifth largest condition-specific supplement category, heart health offers perhaps the greatest potential for the supplement industry as several products gain prominence, including omega-3 fatty acids, plant stanol compounds and L-carnitine. Other significant contributors include Co-Q10, vitamin E, garlic, hawthorn, potassium and psyllium, only portions of whose sales are ascribed to heart health.

  • Supplements used to support heart health grew 10 percent in 2000, indicative of investment and product development in the heart-health category by supplement manufacturers.

Natural Foods Merchandiser volume XXIII/number 1/p. 34

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