Pills on a Pedestal — Will Diet & Exercise Survive the Statin Craze?
By Sharon Palmer, RD
Today’s Dietitian
Vol. 8 No. 2 P. 36

Before your clients bow down before the statin gods, be sure they know that diet and exercise are critical to cardiovascular wellness and lowering cholesterol.

Following a rite of passage for 40-year-old men, John Smith* recently had a physical. Upon discovering that his total and low-density lipoprotein (LDL) cholesterol levels were elevated, his physician handed him a prescription for statins along with a few words of advice: “You’ve got three kids, a house, and your business to worry about. You’re not going to be able to exercise and eat a low-cholesterol diet, so I’m putting you on statins.” Sound familiar? Dietitians are speaking up about a trend that finds more patients on the fast track to the statin club without bothering with the messy details of diet and exercise.

“With the growing number of patients on statin medication, I do see a trend toward minimizing the importance of diet therapy while on these drugs,” says Danita Saunders, MA, RD, LD, clinical dietitian and health and wellness counselor in Cloquet, Minn. “Oftentimes, physicians don’t have the time or the staff to address diet effectively, which sends the message that diet doesn’t matter.

“While working in a small, rural, hospital-based cardiac rehabilitation program [CRP], I found that most patients had not received any diet therapy before lipid-lowering medications were prescribed. Usually the first diet therapy these patients received was initiated in a CRP after a cardiac event has already occurred.”

When it comes to public perception, statins cancel out the need for diet therapy, says Virgilio Licona, MD, a family physician with the SALUD Family Health Centers in Fort Lupton, Colo., and a member of the board of directors of the American Academy of Family Physicians. “I believe that this is a common misperception, in part propagated by the pharmaceutical industry because of glitzy ads that let consumers walk away with the message, ‘I’m on statins, that’s the most important thing.’” (Licona notes that the statin advertisements do include recommendations for diet and exercise.)

Michael Crouch, MD, associate professor of family and community medicine at Baylor College of Medicine and author of an article in American Family Physician in January 2001 on the effectiveness of statins in preventing coronary heart disease (CHD), believes patients’ assumption that statins negate the need for diet intervention is a common misbelief. Crouch says, “Fortunately, the statins do compensate to a large extent for dietary saturated fat excesses, but they definitely lower LDL cholesterol more effectively if the individual also eats in a heart-healthy manner most of the time.”

“We do not have data to report if statin use is replacing diet therapy, but in recent years diet and exercise has been offered at a suboptimal rate. Diet and exercise therapy should be part of comprehensive treatment for anyone with cardiovascular disease, whether the risk is low, moderate, or high,” says Jun Ma, MD, PhD, research associate at the Stanford Prevention Research Center. Ma was the lead author of a Stanford study that discovered that doctors are prescribing statins in only one half of their patients who would benefit most from them and that less than one half of moderate-risk patients were counseled about changes in their diet and exercise that could decrease their risk of heart disease.1

The Scoop on Statins
Statins are big business. With nearly 102 million Americans with total blood cholesterol values greater than or equal to 200 milligrams per deciliter, there are many patients who are prime candidates for dietary or cholesterol-lowering drug therapy.2 Lipitor (atorvastatin) is the biggest selling prescription medication in America, topping antidepressants, antiheartburn agents, and pills for hypertension.3 Atherosclerotic vascular disease (ASVD) is responsible for nearly 75% of all deaths from cardiovascular disease, the leading cause of death for both men and women in the United States. Elevated cholesterol, especially cholesterol in LDL particles, is an important risk factor for the development of ASVD.2

Because of their effectiveness, tolerability, and safety, statins have become the first-line agents for primary and secondary prevention of CHD in patients with elevated LDL levels.4 Statins approved for use in the United States include atorvastatin, fluvastatin, lovastatin, pravastitin, simvastatin, and rosuvastatin. These agents work by inhibiting HMG-CoA reductase, the enzyme essential for the conversion of HMG-CoA to mevalonate. Competitive inhibition of this enzyme causes upregulation of LDL receptors on the surface of the liver and increased removal of LDL cholesterol from the blood.2

Primary and secondary prevention trials have shown that the use of statins to lower elevated LDL cholesterol levels can substantially reduce coronary events and death from CHD.1 According to the American Society of Health-System Pharmacists (ASHP) therapeutic position statement, statins effectively reduce LDL cholesterol by 20% to 55%.2 Cost-benefit analysis shows that lipid-lowering therapy is relatively cost-effective compared with other interventions.4

Statins are well tolerated by most people. However, they can cause muscle aches and pains in 4% to 5% of people who use them, and 15% to 20% of people with an underactive thyroid who develop elevated cholesterol levels due to the thyroid condition are mistakenly prescribed statins. Rarely, side effects may include very high liver enzyme levels.3 Most patients require long-term therapy to maintain serum cholesterol within a desired range. However, few studies have evaluated the long-term effects of statins on non-cardiovascular mortality.2

“Physicians always have to balance the risk and benefits of treatments for patients. When you use statins, you have to be aware of the damage it can do to the liver or muscles. There are very negative side effects to the drug. You need to balance it against the disease. Heart disease is the No. 1 killer for women, so this is clearly an issue,” says Licona.

Since the National Cholesterol Education Program (NCEP) significantly expanded its earlier recommendations for statins in the 2004 update to Adult Treatment Panel III (ATP III) guidelines (see sidebar on page 38), payors have seen an upsurge of spending and utilization in the statin class, with an increase in prescriptions for higher-dose statins.5 But even with the popularity of statins, experts are concerned that those at high risk for cardiovascular disease aren’t getting treated adequately. Though there was a twofold increase in the proportion of patients with hyperlipidemia treated with lipid-lowering agents between 1992 and 2002 (statins accounting for most of the increase), only approximately one half of patients with hyperlipidemia receive treatment.6 At the same time, experts fear that too many people are being treated aggressively with drugs who could be helped through lifestyle changes.

Crouch reports that he has been studying patient attitudes and decision making for statin therapy for the past five years. “Most patients are overly concerned about the potential for serious statin side effects, which are quite rare—less than one in 10,000 patients,” he says. Crouch also adds that many patients are fixated on the “unnaturalness” of statins and that they may be reluctant to begin using a chronic preventive prescription medicine.

After the NCEP’s ATP III 2004 update, which urged millions of Americans to consider taking statins based on a review of five clinical trials of statin treatment, the Center for Science in the Public Interest (CSPI), along with more than 35 physicians, epidemiologists, and scientists, raised questions about whether the guidelines were supported by scientific evidence and urged the National Institutes of Health (NIH) to seek an independent panel to re-review the studies. In a letter to the NIH, the National Heart, Lung, and Blood Institute (NHLBI), and the NCEP, the physicians and scientists unleashed concerns regarding conclusions from the studies on statin therapy, especially the fact that eight of the nine authors of the recommendations had financial ties to statin manufacturers.7 The NHLBI responded to the CSPI letter, saying that the ATP III recommendations were based on sound science and that the NHLBI had used a careful development process, including multiple levels of review, to ensure integrity and objectivity of the guidelines.8

How Effective Is Diet Therapy Compared With Statins?
The ASHP reports that, although diet and exercise therapy should be a fundamental part of all cholesterol-lowering treatment regimens, they are often ineffective at significantly reducing blood cholesterol and drug therapy is frequently needed to reach goals. But studies point out that diet can be just as successful in lowering cholesterol. A meta-analysis of dietary trials found that dietary lowering of serum cholesterol produces as much CHD risk reduction as do drugs.9 Researchers from the Clinical Nutrition and Risk Factor Modification Center in Toronto found in a recent study that there were no significant differences in efficacy between a statin and dietary portfolio treatment in lowering cholesterol.10 Researchers from the same center published another study that found that a combination of cholesterol-lowering foods reduced C-reactive protein (a biomarker of inflammation linked to increased cardiovascular disease) to a similar extent as the starting dose of a first-generation statin.11

“As a family physician, I start with diet and exercise. It’s important to give the patient sufficient time to see if it works. In my mind, that’s three to six months. In 2000, there was $13 billion spent on statins. There is tremendous motivation to keep the idea of being on statins as the most important thing. But some recent literature indicates that a strict diet can gain about the same improvements as statins,” adds Licona.

Crouch recommends diet therapy to lower cholesterol for one to two months before resorting to statins. “I approach this differently than most physicians, including the experts that formulate NCEP guidelines,” he says. “The misconception is that more prolonged maintenance of a given degree of dietary modification will lower LDL cholesterol more the longer that extent of modification is maintained. The reality is that LDL cholesterol responds quite quickly to a given extent of dietary change, and within a few weeks the maximum lowering possible for that amount of dietary change is reached.

“I think it is important for patients to reduce their saturated and trans fat intake as much as they are willing and able to do for four to six weeks, then have a repeat lipid profile done to give them feedback on their responsiveness to dietary change,” says Crouch.

“Some individuals with horrible baseline diets who drastically improve their eating habits can lower their LDL cholesterol 30% or more, but the average lowering effect is closer to 15% and many people don’t change much at all because of the liver adjusting and continuing to make too much cholesterol and allowing it to accumulate in the blood,” adds Crouch.

The NCEP ATP III cholesterol guidelines recommend consideration of cholesterol-lowering drug treatment in addition to therapeutic lifestyle changes (TLC), with the priority of attaining the goal for LDL cholesterol. After a trial of dietary therapy to reduce LDL cholesterol (roughly three months), additional therapeutic treatments are recommended, such as initial drug therapy or lifestyle changes. The guidelines note that intensive LDL lowering with TLC can obviate the need for drug therapy, augment LDL-lowering drug therapy, and may allow for lower doses of drugs. But unsuccessful trials of dietary therapy without drugs should not be continued indefinitely. For severe hypercholesterolemia, drug therapy may be appropriate simultaneously with TLC.9

Lowering Cholesterol in the Doctor’s Office
The family physician’s role is to detect lipid problems in patients and steer them down the road of long-term compliance with cholesterol treatment. But in a world where many physicians are still not screening routinely for cholesterol, most patients with high LDL levels remain unidentified and untreated.4 When patients’ elevated LDL cholesterol levels are discovered, does the prescription pad override lifestyle counseling?

Some physicians resort to statins because they fear poor compliance in particular patients. Indeed, most patients are unwilling or unable to change their eating habits enough to achieve LDL goals.4 Licona says, “I do think that is an important factor that has to be weighed when one has the patient in front of you. It’s expedient to get the pad out and write a prescription.”

James Stevens, MS, RD, sports dietitian and research assistant at Colorado State University, reports that often patients have been advised to follow a heart-healthy diet, but compliance is relatively poor. “Oftentimes, they have not seen a dietitian but rather have been just given a handout from the doctor’s office.”

According to an article written in the Cleveland Clinical Journal of Medicine, Gregg Fonarow, MD, suggests that the NCEP guidelines recommending delaying statins after a clinical event until lipids are checked at the six-week follow-up and dietary interventions have been attempted wastes valuable time.12

“As a whole, people like a silver bullet for everything. As a family physician, one of the things critical to dealing with chronic illness, without a doubt when looking at lipid disorders, is that the real issue is lifestyle,” says Licona. “One fourth of children now are medically obese. This trend is scary. It goes on into adulthood. People exercise too little, eat too much, cook less, and eat more fatty foods. It’s all a combination for an unhealthy lifestyle. We have to attack the root cause.”

Crouch reports, “I think many physicians follow dietary therapy trial recommendations, but, more importantly, many patients are somewhat to very reluctant to take statins and keep avoiding the issue by saying, ‘I want to give improving my diet another try or a longer time period before considering statin therapy seriously.’ I don’t think most physicians give patients nearly enough information or direct them to appropriate information sources to maximize the changes for successfully lowering LDL cholesterol.”

“The majority of patients I see with elevated lipids are either taking a statin drug or have been threatened by their physician with one if they don’t achieve the desired results with my program. Unfortunately, they are not provided any instruction by their physician other than to lose weight, exercise, and eat a low-fat, low-cholesterol diet,” says Debora Robinett, MA, RD, CD, owner and president of Health Enhancement Corporation in Tacoma, Wash., which specializes in nutrition and wellness education. “Physicians are not trained to provide the correct dietary instruction to patients and are often treating the symptom of elevated cholesterol without tracing the real cause of the abnormality.”

Dietitians in the Thick of Lowering Cholesterol
Many private practice dietitians report that the patients coming into their offices are highly motivated and willing to follow dietary changes to lower cholesterol. Maye Musk, MS, RD, a consultant dietitian in New York, finds that her patients come to her in hopes of avoiding medication through diet. Musk reports that patients aren’t referred to dietitians enough, adding, “The physicians don’t know where to find us.”

Susan Rodder, MS, RD, LD, works at The Finley Ewing Cardiovascular and Fitness Center of the Presbyterian Hospital of Dallas. Rodder finds that everyone in her CRP is encouraged to improve their diet—even those on statins. “Each patient is motivated to attend classes and to take advantage of the individual dietary consult. Those patients who are having difficulty modifying their diet are encouraged even more to come and see me.”

To help his patients lower their cholesterol, Stevens says, “I use a whole food approach with increased fruits, vegetables, and whole grains; more vegetarian meals; increased consumption of fish, nuts, and soyfoods; and limiting high saturated fatty acids in meats and food products with trans fatty acids.”

Rodder believes dietitians can further the message of diet therapy by correlating excessive weight, obesity, and sedentary lifestyle with the development of heart disease. She is especially concerned with childhood obesity. “As the rate of overweight and obese children reaches epidemic proportion, the effect on heart disease will become profound.” Rodder recently attended a class in which a pediatrician discussed the difficulties of prescribing statins for children.

Robinett tailors her nutrition advice to a program of healthy whole food with a focus on high dietary fiber; sufficient essential fatty acids from nuts, seeds, and flax; higher amounts of omega-3 oils from cold-water ocean fish; olive oil in cooking; and lean protein foods. She comments, “None of my recommendations require liver enzyme function follow-up studies or cause musculoskeletal pain as the statin drugs do.”

The Future for Diet Therapy
“As physicians, we’re trained to prescribe drugs. We’re in a transition in our practice. One of the things I think is important is stated in the AAFP Future of Family Medicine. Population-based practice requires a team approach. We need to be able to identify that team. The AAFP is committed to a lifestyle approach,” says Licona, who reports that his community health center provides access to an RD and a CDE.

Crouch says, “I think most physicians underutilize dietitians for this and other problems. I don’t think most physicians give patients nearly enough information or direct them to appropriate information sources to maximize the chances for successfully lowering LDL cholesterol.” Crouch considers himself one of the lucky ones, as he counseled patients on dietary changes to lower cholesterol for research during his first two years of medical school. “I like nutrition and am fairly atypical in that regard for a physician, I think.”

Saunders reports that another contributing factor relates to insurance reimbursement. “At this time, Medicare does not reimburse for diet therapy for dyslipidemia or hypertension, which makes it difficult for institutions to justify dietitian hours toward education in the treatment and prevention of these conditions.” Saunders looks forward to the day when dietitians obtain insurance reimbursement for diet therapy to provide a more preventive approach toward patient care. She suggests, “Dietitians can remain up to date or become involved with current legislative efforts toward insurance reimbursement through eatright.org under the Advocacy and Profession section.”

Robinett even goes as far as saying that dietitians need to become political activists. “Dietitians need to provide physicians with the tools to educate their patients about the role of cholesterol to overall health and how to manage all of the cardiovascular risk, not just the total cholesterol reading. Doctors need to see their patients achieve and maintain results. Otherwise, they don’t feel as if they are providing good medical treatment.”

Stevens says, “Dietitians can talk to MDs about the recent research with the journal articles in hand. Food can be a potent weapon in the battle against cardiovascular disease, and we as dietitians need to be as good, if not better, salespeople than the drug reps who march in with their free samples and catered lunches.”

— Sharon Palmer, RD, is a freelance food and nutrition writer in southern California.

*Name has been changed for anonymity at the request of the individual.

References
1. Statins Underprescribed to Patients at Higher Risk of Heart Disease, Stanford Study Says. Stanford School of Medicine. May 30, 2005. Available at: http://mednews.stanford.edu/releases/2005/may/statins.html

2. ASHP Therapeutic Position Statement on the Use of Statins in the Prevention of Atherosclerotic Cardiovascular Disease in Adults. Am J Health Syst Pharm. 2003;60(6):593-598.

3. Was the Statin Prescription Right in the First Place? Tufts Health and Nutrition Letter. August 2003. Available at: http://healthletter.tufts.edu/issues/2003-08/statin.html

4. Crouch MA. Effective use of statins to prevent coronary heart disease. Am Fam Physician. 2001;63(2):309-320.

5. Payers See Increased Use of Statins After ‘04 Guidelines, Shift to Higher-Dose Agents. Drug Benefit News. May 13, 2005. Available at: http://www.aishealth.com/DrugCosts/DBN_Payers_Statins.html

6. Turnbull F. Managing Cardiovascular Risk Factors: The Gap Between Evidence and Practice. PLoS Med. 2(5):e131. Available at: http://medicine.plosjournals.org/perlserv/?request=get-document&

doi=10.1371/journal.pmed.0020131

7. Cholesterol Recommendations Questioned. CSPI. September 23, 2004. Available at: http://www.cspinet.org/integrity/press/200409231.html

8. NHLBI Responds to Center for Science in the Public Interest Letter on Cholesterol Guidelines. October 22, 2004. Available at: http://www.nhlbi.nih.gov/guidelines/cholesterol/response2.htm

9. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Executive Summary. September 2002. Available at: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp_iii.htm

10. Jenkins DJ, Kendall CW, Marchie A, et al. Effects of a dietary portfolio of cholesterol-lowering foods vs. lovastatin on serum lipids and C-reactive protein. JAMA. 2003;290(4):502-510.

11. Jenkins DJ, Kendall CW, Marchie A, et al. Direct comparison of dietary portfolio vs. statin on C-reactive protein. Eur J Clin Nutr. 2005;59(7):851-860.

12. Fonarow G. Aggressive treatment of atherosclerosis: The time is now. Cleve Clin J Med. 2003;70(5):431-434.

National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Guidelines
In July 2004, the NCEP published a paper titled “Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines,” which updated some information from the ATP III cholesterol guidelines released in 2001. ATP III has been endorsed by the National Heart, Lung, and Blood Institute, American Heart Association, and American College of Cardiology. The update takes into consideration five clinical trials of statins since the release of ATP III and offers more intensive cholesterol-lowering treatments for people at high risk and moderately high risk for heart attack. Therapeutic lifestyle changes—low saturated fat and low cholesterol diet, physical activity, and weight control—are emphasized in ATP III update. Guidelines are available at www.nhlbi.nih.gov/guidelines/cholesterol/upd-info_prof.htm.

— SP