The impact of the national cholesterol education program adult treatment panel III guidelines on drug development

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Abstract

In the newest guidelines of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III, more intensive low-density lipoprotein cholesterol-lowering therapy, together with more attention to other lipid and lipoprotein parameters, are recommended for a larger group of dyslipidemic patients than was covered under ATP I and ATP II. A discussion to evaluate how future drug development might be affected by these new guidelines took place at the 14th International Symposium on Drugs Affecting Lipid Metabolism (DALM) conference, held in New York in September 2001. These discussions involved how to develop new lipid-lowering drugs in an era in which so much compelling evidence demonstrates the benefits of statins. Also covered were issues related to the development of drugs with triglyceride indications and whether the proportion of patients achieving NCEP guidelines should be included in the label of lipid-lowering drugs. Additional topics discussed included: (1) the possibility of incorporating a non-high-density lipoprotein cholesterol (HDL-C) indication for lipid-lowering drugs, (2) the possibility of obtaining indications for lipid-lowering drugs specifically in patients with diabetes, (3) the place of combination lipid-lowering drug therapy in drug development, and (4) whether drugs could be approved to increase levels of HDL-C in patients with isolated low HDL-C.

Section snippets

Question 1

Data generated by the statin trials demonstrating beneficial effects on cardiovascular endpoints, in large part, contributed to the changed guidelines. Based on these data, it is becoming increasingly unethical to treat patients without a statin. Can a new, nonstatin agent be developed for patients on background statin therapy?

Conclusions

NCEP ATP III will have an impact on the development of lipid-lowering drugs. The issue of placebo controls and background statin therapy are factors that need to be considered in all long-term lipid studies. Clearly, new studies will need to be conducted to evaluate the beneficial effects of lowering triglycerides, increasing HDL-C, and combination drug regimens. There are multiple metabolic mechanisms involved in HDL-C elevation. The mechanism of action may define whether the HDL-C elevation

References (1)

  • Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)

    JAMA

    (2001)

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