The Efficacy of Intensive Dietary Therapy Alone or Combined with Lovastatin in Outpatients with Hypercholesterolemia

Donald B. Hunninghake, Evan A. Stein, Carlos A. Dujovne, William S. Harris, Elaine B. Feldman, Valery T. Miller, Jonathan A. Tobert, Peter M. Laskarzewski, Elaine Quiter, Jolene Held, Alice M. Taylor, Suzanne Hopper, Sandra B. Leonard, Brenda K. Brewer

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Background: A diet low in saturated fat and cholesterol is the standard initial treatment for hypercholesterolemia. However, little quantitative information is available about the efficacy of dietary therapy in clinical practice or about the combined effects of diet and drug therapy. Methods: One hundred eleven outpatients with moderate hypercholesterolemia were treated at five lipid clinics with the National Cholesterol Education Program Step 2 diet (which is low in fat and cholesterol) and lovastatin (20 mg once daily), both alone and together. A diet high in fat and cholesterol and a placebo identical in appearance to the lovastatin were used as the respective controls. Each of the 97 patients completing the study (58 men and 39 women) underwent four consecutive nine-week periods of treatment according to a randomized, balanced design: a high-fat diet-placebo period, a low-fat diet-placebo period, a high-fat diet-lovastatin period, and a low-fat diet-lovastatin period. Results: The level of low-density lipoprotein (LDL) cholesterol was a mean of 5 percent (95 percent confidence interval, 3 to 7 percent) lower during the low-fat diet than during the high-fat diet (P<0.001). With lovastatin therapy as compared with placebo, the reduction was 27 percent. Together, the low-fat diet and lovastatin led to a mean reduction of 32 percent in the level of LDL cholesterol. The level of high-density lipoprotein (HDL) cholesterol fell by 6 percent (95 percent confidence interval, 4 to 8 percent) during the low-fat diet (P<0.001) and rose by 4 percent during treatment with lovastatin (P<0.001). The ratio of LDL to HDL cholesterol and the level of total triglycerides were reduced by lovastatin (P<0.001), but not by the low-fat diet. Conclusions: The effects of the low-fat-low-cholesterol diet and lovastatin on lipoprotein levels were independent and additive. However, the reduction in LDL cholesterol produced by the diet was small, and its benefit was possibly offset by the accompanying reduction in the level of HDL cholesterol., In 1987, the Expert Panel of the National Cholesterol Education Program (NCEP) issued guidelines for the treatment of adults with hypercholesterolemia1. The first step in the treatment of patients with sustained elevation of levels of low-density lipoprotein (LDL) cholesterol is a diet low in saturated fat and cholesterol. The efficacy of such therapy, however, has not been clearly defined, because there have been few randomized, controlled trials of intensive dietary therapy in outpatients with hypercholesterolemia. Most previous studies1 of lipid-lowering diets have been conducted in institutional settings or under metabolic-ward conditions, in which adherence to a diet can be…

Original languageEnglish (US)
Pages (from-to)1213-1219
Number of pages7
JournalNew England Journal of Medicine
Issue number17
StatePublished - Apr 29 1993
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


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