Are there cholesterol treatments beyond statins?

October 24, 2005

The statin drugs have so thoroughly dominated the market for treating high cholesterol levels and dyslipidemia that many in the healthcare community may need to be reminded that other medications still have their place. Patients who cannot regulate their lipid levels by means of lifestyle changes or for whom statins are not sufficiently effective can be treated with drugs such as fibrates, niacin, and with combination therapies.

The statin drugs have so thoroughly dominated the market for treating high cholesterol levels and dyslipidemia that many in the healthcare community may need to be reminded that other medications still have their place. Patients who cannot regulate their lipid levels by means of lifestyle changes or for whom statins are not sufficiently effective can be treated with drugs such as fibrates, niacin, and with combination therapies.

Dyslipidemia is more than just high cholesterol levels, according to speakers at a recent workshop held in New York City and sponsored by Abbott.

The danger of high low-density cholesterol (LDL) levels as a risk factor for cardiovascular disease is well established, said Frank Sacks, M.D., professor of medicine, Harvard School of Public Health. But high LDL levels may not be the primary risk factor for many patients, he said, speaking at the workshop. Low levels of high-density lipids (HDL) are also a serious risk factor in heart disease, he emphasized. Older dyslipidemia drugs such as the fibrate drugs are useful because they raise low HDL levels-unlike the statins, which primarily lower high LDL levels. The goal for treatment is to reduce all risk factors for cardiovascular disease, not just LDL levels, Sacks said.

Low HDL levels without high LDL levels account for 20% to 30% of patients with coronary heart disease, Jones noted. Treating concurrent low HDL and high triglycerides levels can lower risk for heart attack, she added. Therapy that combines a statin and one of the fibrate drugs can be an effective treatment.

Another patient population with special needs includes people with diabetes and poor lipid profiles, said Scott Grundy, M.D., professor of internal medicine at the University of Texas, Southwestern Medical Center. The incidence of diabetes is increasing at a rapid rate, he noted. Metabolic syndrome, which increases the risk of both diabetes and cardiovascular disease, is also becoming more common.

Clinical trials have shown that combining statins with fibrates can reduce the incidence of coronary artery events in both diabetic and nondiabetic patients, Grundy observed. Fibrates also appear to provide benefits in patients with insulin resistance.

For the most part, the public still does not know enough about different blood lipid levels and their meaning, according to Nancy L. Shapiro, Pharm.D., clinical assistant professor, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy. "I think there is more that needs to be done to bring the importance of improving HDL levels to the general public."

Many of the options for dealing with low HDL levels include lifestyle improvements, such as exercise, weight loss, and smoking cessation, Shapiro said. "People don't always want to hear that. They'd rather hear that they can just take a pill and it will all get better, without any work on their part."

Statins remain the first-line treatment for high LDL levels. LDL is still the primary risk to address, and this class of drugs has benefits that go beyond just reducing LDL levels. "Once you get past that, though, providers and patients alike forget to look any further," Shapiro said. Combination therapy of a statin drug and a fibrate is a good alternative, but people tend to shy away from choosing this option for various reasons-among them the cost and the necessary monitoring, she noted. With proper monitoring, she added, combination therapy is a good alternative that can both lower recalcitrant LDL levels and raise HDL levels.

"Part of the difficulty with lipid management is that it is a chronic problem and the patient doesn't feel poorly, so it's often not in the forefront of the patient's or the provider's attention," Shapiro pointed out. "When they do look for it and try to manage it, they start a statin but then never go back to recheck labs and titrate the doses upward on it, let alone get to the point of using combination therapy."