Treatment of Hyperlipidemia Part 1

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There was a time when heart disease was considered a “man’s disease.” However, we now know that women are just as likely to be afflicted, especially after reaching the age of menopause. Coronary artery disease (CAD) is the number one killer of American women and men. Another way to interpret this startling statistic is that about every 29 seconds an American will suffer a coronary event, and about every minute someone will die from one. CAD is also the leading cause of premature, permanent disability in the United States labor force. The direct and indirect cost of coronary artery disease for the year 2000 was estimated at $118 billion.

Risk Factors for coronary artery disease

Many risk factors are involved in the development of CAD. Age, gender, smoking history, physical inactivity, obesity, hypertension, family history of premature coronary artery disease events (e.g., heart attack), diabetes, and cholesterol level are among the most important. Whereas a person cannot control his or her age, gender, or family history, he or she can control tobacco use, amount of physical activity, weight, blood pressure, blood sugar, and blood cholesterol levels. Of these, controlling cholesterol levels may be among the easiest, given the efficacy of the cholesterol-lowering drugs currently available. The second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II) affirms that an elevated low-density lipoprotein (LDL)-cholesterol level significantly increases the risk of CAD, and therefore makes its reduction a primary target for controlling hyperlipidemia. Close to 100 million American adults have borderline or high cholesterol levels. Furthermore, more than 50 million adults have an LDL-cholesterol level that is high enough to qualify them for treatment. Desirable LDL-cholesterol levels based on risk factors and primary and secondary prevention status can be found in Table 1.

Lowering Cholesterol Levels

The primary key to reducing cardiovascular morbidity and mortality in patients with clinically apparent coronary artery disease — as well as in patients without CAD — is to lower elevated LDL-cholesterol levels. Clinical trials have conclusively demonstrated this. Additionally, patients with low HDL-cholesterol also have a high CAD risk. Recent clinical trials in these patients also demonstrate that reducing LDL-C will reduce coronary artery disease events. These trials all point to the same conclusion: lowering elevated LDL-C levels to treatment goals reduces heart attacks and other CAD events.

One pharmacological approach that is highly effective in lowering LDL-cholesterol is the use of “statins” — HMG-CoA reductase inhibitors (e.g., atorvastatin/Lipitor, cerivastatin/Baycol, fluvastatin/ Lescol, lovastatin/Mevacor, pravastatin/Pravachol, and simvastatin/Zocor). The Scandinavian Simvastatin Survival Study Group (4S) was one of the first studies designed to test the hypothesis that lowering cholesterol with a statin would improve survival of patients with coronary artery disease. The results were impressive: Over 5 years, simvastatin significantly reduced LDL-cholesterol levels, and increased HDL-cholesterol levels, as compared with placebo. The 6-year probability of survival in the simvastatin group was 91.3% compared to 87.6% for those patients on placebo, but there was a 42% reduction in coronary deaths, which accounted for the improvement in survival. Subsequent randomized, placebo-controlled trials with other statins have showed that reducing LDL-cholesterol significantly decreased risk of CAD events in both primary and secondary populations.

Treatment and Compliance Issues

Despite the clear demonstration that lowering LDL-cholesterol improves cardiovascular risk, most adults who are eligible for cholesterol-lowering therapy do not receive it, including over half of those who qualify for drug therapy. The discouraging statistics continue. The compliance rate for patients with hyperlipidemia, even those with clinically apparent coronary artery disease, is dismal — only 40% to 60% remain on their lipid-lowering medication therapy after one year. As any good pharmacist knows, it does not matter how well drug studies are performed, how conclusive their results, or how superior a drug may be; if the patient does not swallow the pill it will not make a difference. Furthermore, too often studies do not address compliance issues; compliance is taken for granted. A recent study asked whether compliance rates reported in clinical trials reflect rates in primary care settings. Not surprising to healthcare providers, the answer was an emphatic “No.” Discontinuation of medications is much less in clinical trials than in routine practice.

In addition to the undertreatment of hyperlipidemia and noncompliance with antihyperlipidemic medication, there is a third area of concern — the number of patients taking lipid-lowering agents who are not reaching treatment goals. In primary care settings, successful attainment of NCEP goals ranges from only 8% to 38%.These numbers are disheartening. Even if patients could be appropriately identified for treatment and receive appropriate intervention, they will not obtain the full therapeutic benefit if they do not comply with therapy. What can be done? What healthcare professional can make an impact in these three troubling areas? Answer: the pharmacist.