Statins found to work better in studies than in practice

Drugs are very effective in research settings, but experts say a lack of compliance with regimens is the leading barrier to lowering cholesterol populationwide.

By Victoria Stagg Elliott, amednews staff. Dec. 10, 2001.

An increasing body of evidence is showing that statins should be prescribed to an ever growing number of people.

A study presented at last month's annual Scientific Sessions of the American Heart Assn. found that statins could benefit those who were at high risk of heart disease, including those with diabetes, but had normal cholesterol.

Who's taking statins, and to what effect?
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Meanwhile, in May, the National Heart, Lung and Blood Institute's National Cholesterol Education Program issued guidelines substantially expanding the number of people who should be prescribed statins from 13 million to 36 million.

"If patients take them, you should see up to a 30% reduction in cholesterol levels," said Helene Glassberg, MD, director of the preventive cardiology and lipids center at Temple University Hospital in Philadelphia.

But that's a big if. Physicians say that 90% of their patients prescribed statins should benefit from the drug. They also estimate, however, that they can get only as many as 70% of their patients to stick to a statin regimen after a cardiac event. That number plummets to 30% for patients who have high cholesterol but have not had heart trouble.

"The guidelines are way ahead of what people are really doing," said Dennis Sprecher, MD, section head of preventive cardiology and rehabilitation at the Cleveland Clinic. He researches patient compliance issues.

Doctors estimate that less than 70% of cardiac patients would follow a statin regimen.

According to a study by Dr. Sprecher also presented at the heart association conference, only one-third of patients in a clinical setting achieved their cholesterol goals three months after being prescribed a statin. Nearly half achieved some reduction but did not meet their goals, and 18% experienced no reduction or an increase in their cholesterol levels.

Researchers are currently exploring the reasons. Doctors say it is easier to get patients to take statins rather than change their diet or increase exercise. But researchers also speculate a certain number of patients may be using their statin regimen as an excuse not to exercise or improve their diet.

"People think taking statins opens the floodgates to eat whatever they want," said Dr. Glassberg. "Half my patients do that."

Those behind the study, however, blame this lack of effect primarily on a lack of patient compliance.

"We don't absolutely know," Dr. Sprecher said. "But we're struggling to figure out what else it could be."

Many reasons why

Noncompliance may result because patients are not able to afford medications. Patients may be hesitant because of the withdrawal of Baycol (cerivastatin) this summer after reports of adverse muscle reactions. In addition, refills may be a hassle. And patients may resist the idea of daily medication.

"People do not want to take a pill every day as a part of their daily routine," said Dr. Sprecher. "We have to figure out some way to make it easier.

Experts say patient compliance is one of the major barriers to achieving public health goals to lower cholesterol and, thus, cardiovascular events populationwide.

"You can take a horse to water, but you can't make them drink," said Dr. Sprecher. "With any chronic condition, no matter what you ask patients to do on a routine basis, it's not clear that the human race is really good at that."

Numerous attempts have been made to address this issue. Some hospitals have behavioral self-management courses and computerized tracking systems. High school students have been hired to call patients to remind them to take their medication. Spouses have been recruited to prod patients into compliance.

"Traditional models of medical care delivery are not very good at delivering preventive care," said Jennifer G. Robinson, MD, MPH, director of the Iowa Heart Center's Lipid Research Center in Des Moines. "But you also have to convince the patient of the importance of their cholesterol-lowering medicine. I actually don't mind the Lipitor commercials during the Super Bowl. The more places that people hear about the benefits of these drugs, the better."

Experts concede, though, that reminder systems or extensive education programs may not be feasible for most medical practices.

"Education and close follow-up keeps our patients pretty compliant," said Dr. Glassberg. "But that would be really tough for primary care doctors who have a lot of issues to cover in a 15- to 20-minute slot. They don't have the luxury of reviewing at length the risks and benefits, and then sitting down and making follow-up phone calls every day."

On the technology side, large pharmaceutical companies are also researching ways to lower cholesterol through statin patches or twice yearly injections that may improve compliance. Researchers are also looking at noninvasive tests that could even be done in the home.

"It would allow people to get feedback very quickly," said Dr. Sprecher. "But the problem with most at-home tests is that they still involve a prick, and most people don't like that. Pricks hurt."

As doctors struggle with compliance issues when treating a patient's cholesterol, experts concede that if everyone took their medicine it would have serious economic consequences.

"We'd go broke," said Dr. Sprecher. "Noncompliance is keeping us solvent. If we really get a handle on this compliance stuff, we're in serious trouble."

But some speculate the true solution to America's high cholesterol may be solved by putting statins or some other means of lowering cholesterol in the water much like fluoride.

"It would be hard to do right now," said Dr. Sprecher. "How comfortable are we in putting a medication like that -- not a vitamin -- in standard foods?"

ADDITIONAL INFORMATION:

Who's taking statins, and to what effect?

Study objective: To determine the effectiveness of statins when prescribed in clinical practice.
Method: Researchers reviewed the records of 375 patients prescribed statins in a preventive cardiology practice. Patients received at least one follow-up within 12 months of the initial visit.
Results: 34% of patients lowered their cholesterol consistent with information provided in the package insert; 18% experienced no reduction in cholesterol levels; 48% lowered their cholesterol but did not achieve expected reductions.
Conclusion: In a clinical setting, dose-response projections of statin drugs overestimate cholesterol lowering. This may be due to variation in patient adherence.

Source: American Heart Assn. Scientific Sessions 2001.