Fish Oil, Red Yeast Rice Studied for Lowering Blood Cholesterol

A great deal of scientific evidence shows that cholesterol-reducing medications known as statins can help prevent coronary artery disease. Although the safety of these medications has been well documented, as many as 40 percent of patients who receive a prescription for statins take the drug for less than one year. Doctors believe that several factors -- including cost, adverse
effects, poor understanding of statin benefits and patients' reluctance to take prescription medications long term -- may explain why some patients stop taking these medicines.

In the July issue of Mayo Clinic Proceedings, a group of researchers from Pennsylvania examine whether an alternative approach to treating high blood cholesterol may provide an effective
treatment option for patients who are unable or unwilling to take statins.

Study design

Researchers followed 74 patients with high blood cholesterol who met standard criteria for using statin therapy. Patients were randomly assigned to either the alternative treatment group or the statin group and followed for three months.

The alternative treatment group participants received daily fish oil and red yeast rice supplements, and they were enrolled in a 12-week multidisciplinary lifestyle program that involved weekly 3.5-hour educational meetings led by a cardiologist, dietitian, exercise
physiologist and several alternative or relaxation practitioners. Red yeast rice is the product of yeast grown on rice. A dietary staple in some Asian countries, it contains several compounds known to inhibit cholesterol production.

The statin group participants received 40 milligrams (mg) of Zocor (simvastatin) daily, as well as printed materials about diet and exercise recommendations. At the end of the three-month period, participants from both groups underwent blood cholesterol testing to determine the percentage change in LDL cholesterol.

Results

The researchers noted that there was a reduction in LDL cholesterol levels in both groups. The alternative treatment group experienced a 42.4 percent reduction, and the statin group experienced a 39.6 percent reduction. Members of the alternative therapy group also had a substantial reduction in triglycerides, another form of fat found in the blood, and
lost more weight.

"Our study was designed to test a comprehensive and holistic approach to lipid lowering," notes the study's lead author, David Becker, M.D., a Chestnut Hill Hospital and University of Pennsylvania Health System cardiologist. "These results are intriguing and show a potential benefit of an alternative, or naturopathic, approach to a common medical condition."

Dr. Becker acknowledges that a larger, multicenter trial with longer follow-up is necessary to determine long-term compliance with the alternative regimen, because previous studies involving diet and exercise have found a high rate of patients unable or unwilling to follow lifestyle recommendations.

"The excellent adherence in the alternative group was undoubtedly related to the intensive follow-up, education and support provided for this group," says Dr. Becker.

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Science Shows Soyfoods May Help Win 'Battle of the Belt'

Scientists have found soyfoods may be a valuable weapon in the weight loss battle. Protein-rich soyfoods, when replacing other sources of protein, may help individuals lose weight and fat -- while lowering LDL (bad) cholesterol. An evidence-based review by David Allison and Mark Cope at the University of Alabama at Birmingham, and John Erdman at the University of Illinois at Champagne-Urbana, finds soyfoods are equal to other protein sources, such as dairy or meat, in helping to battle weight by promoting fat loss.

This comprehensive review, published in the November issue of Obesity Reviews, examines current research on animals, human populations, and clinical trials related to soy protein and weight control. Researchers sought to determine the strength of the evidence on four proposed mechanisms by which soy may aid weight control: 1) soy increases weight loss when consumed at an equal calorie level as other foods, 2) soy aids weight and fat loss by decreasing caloric intake, 3) certain soyfoods benefit glucose control and heart health during weight loss, and 4) certain soyfoods will minimize the loss of bone mass during weight loss.

The review, including results from eight human studies, finds that individuals lost equivalent amounts of weight and, in some cases, equal inches of fat around the waist, using soy protein, dairy milk meal replacements, beef or pork at equal calorie levels. This illustrates the value of soy protein in a varied diet for weight control. Findings also support the possibility that soy protein decreases short-term appetite and calorie intake. Extensive follow-up trials are needed to prove the satiety, or feeling of fullness, factor of soy protein.

Researchers also examined whether soy isoflavones reduce diabetes by stopping fat tissue build up and enhancing fat breakdown. Limited animal trials and human studies suggest soy-based diets and isoflavones may lower blood glucose and insulin levels. If proven effective, a soy-based meal replacement could provide additional benefits to diabetics during weight reduction. Researchers confirmed soy-based diets, compared to other low calorie diets, reduce LDL (bad) cholesterol and triglycerides and raise HDL (good) cholesterol. Findings indicate soy may reduce bone loss in women, but additional clinical trials on soy and bone loss are needed.

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Drug Study Looks at Cost-Saving Step That Could be Used by Millions

Slicing certain pills in half could slice a hefty amount off of America’s prescription drug costs. While only some types of pills can be split safely, the practice could be used by millions of Americans – including many of those who take popular cholesterol-lowering drugs.

Now, a new University of Michigan study adds more evidence that splitting a high-dose pill and swallowing half of it, rather than taking a whole low-dose pill each time, doesn’t change those medicines’ impact on cholesterol levels. It is also the first prospective randomized controlled trial of pill-splitting, and the first to look at the impact of out-of-pocket costs on patients’ willingness to take the time to split pills.

The study is published in the June issue of the American Journal of Managed Care by a team from the UM Health System and the UM College of Pharmacy.

“This study was done in part to see what the impact would be of having some of the cost savings go back to the patient,” says first author Hae Mi Choe, PharmD, CDE, clinical assistant professor in the college and a UMHS clinical pharmacist.

While the study did not find that out-of-pocket costs had an impact on the participants’ tendency to split and take their pills in the six-month study, most participants said that reduced co-pays would be needed to entice them to continue splitting pills.

The findings have already had an impact on one large employer’s prescription drug plan: UM used them to justify a pill-splitting program that launched in early 2006. In its first full year, the program saved the University $195,000, and saved more than 500 employees and retirees a total of more than $25,000 in drug co-pay costs.

Pill-splitting relies on the fact that many medicines are manufactured in tablet formulations that contain different doses of the active ingredient. Some of the higher-dose tablets can be cut in half with a blade to produce two lower-dose tablets – for example, 80 milligram tablets can be cut to produce two 40-mg tablets.

Because drug manufacturers and wholesalers don’t usually charge twice the price for twice the dose, the cost of half of a high-dose pill is far lower than the cost of buying a whole pill containing the same dose of medicine. So, pill-splitting can save money for the insurance plan or pharmacy-benefit manager that buys the pills for a group of insured patients -- and for the employer or government agency that pays for the plan.

But few prescription plans currently structure their benefits to encourage pill-splitting, by charging lower co-pays to patients who buy high-dose pills they intend to split.

Patients have been splitting pills on their own for years. Some do it without their doctors’ knowledge, to try to save money. But others do it with help from physicians who write prescriptions for a higher dose and instruct patients on how to make one month’s supply last two months. However, this can result in potentially dangerous confusion, and skew the patient’s and doctor’s records.

In recent years, pharmacists have worked to determine which tablets can be safely split, and which — such as drugs that exit the body quickly, or that have time-release coatings — cannot.

Cholesterol-lowering drugs called statins are among the most widely-used classes of medicines, with tens of millions of Americans taking the drugs. They’re also good candidates for splitting because they linger in the body for a relatively long time, and because small day-to-day dose fluctuations that can happen when pills are split don’t make a major difference in cholesterol levels.

The UM study involved patients who were taking atorvastatin, pravastatin, or simvastatin, which are sold commercially as Lipitor, Pravachol, and Zocor or genetic simvastatin, respectively. The patients were all being treated by physicians at a single UMHS health center. They were also better educated and more likely to be white and female than the general U.S. adult population.


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