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, and Brenda K. Brewer
Background A diet low in saturated fat and cholesterol is thestandard initial treatment for hypercholesterolemia. However,little quantitative information is available about the efficacyof dietary therapy in clinical practice or about the combinedeffects of diet and drug therapy.
Methods One hundred eleven outpatients with moderate hypercholesterolemiawere treated at five lipid clinics with the National CholesterolEducation 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 inappearance to the lovastatin were used as the respective controls.Each of the 97 patients completing the study (58 men and 39women) underwent four consecutive nine-week periods of treatmentaccording to a randomized, balanced design: a high-fat diet-placeboperiod, a low-fat diet-placebo period, a high-fat diet-lovastatinperiod, and a low-fat diet-lovastatin period.
Results The level of low-density lipoprotein (LDL) cholesterolwas a mean of 5 percent (95 percent confidence interval, 3 to7 percent) lower during the low-fat diet than during the high-fatdiet (P<0.001). With lovastatin therapy as compared withplacebo, the reduction was 27 percent. Together, the low-fatdiet and lovastatin led to a mean reduction of 32 percent inthe 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 roseby 4 percent during treatment with lovastatin (P<0.001).The ratio of LDL to HDL cholesterol and the level of total triglycerideswere reduced by lovastatin (P<0.001), but not by the low-fatdiet.
Conclusions The effects of the low-fat-low-cholesterol dietand lovastatin on lipoprotein levels were independent and additive.However, the reduction in LDL cholesterol produced by the dietwas small, and its benefit was possibly offset by the accompanyingreduction in the level of HDL cholesterol.
Source Information
From the Heart Disease Prevention Clinic, Minneapolis (D.B.H., E.Q.); the Christ Hospital Cardiovascular Research Center, Cincinnati (E.A.S., S.H.); the University of Kansas Medical Center, Kansas City (C.A.D., W.S.H.); the Medical College of Georgia, Augusta (E.B.F., S.B.L.); George Washington University, Washington, D.(V.T.M., B.K.B.); Merck Research Laboratories, Rahway, N.J. (J.A.T., A.M.T.); Medical Research Laboratories, Cincinnati (P.M.L.); and Professional Nutrition Systems, Kansas City, Kans. (J.H.). The following persons also participated in the study: Heart Disease Prevention Clinic, Minneapolis -- J. Peters and K. Gardner; Christ Hospital Cardiovascular Research Center, Cincinnati -- D.M. Black, G.E. Lamkin, and S. Ames; University of Kansas Medical Center, Kansas City -- P. Krehbiel and S. Horniman; Medical College of Georgia, Augusta -- T.T. Kuske and J.M. Greene; George Washington University, Washington, D. -- D.B. Stoy and G. Gasparis; and Medical Research Laboratories, Cincinnati -- P.M. Steiner.
Address reprint requests to Dr. Hunninghake at the Heart Disease Prevention Clinic, 151 Variety Club Heart & Research Center, 401 E. River Rd., Minneapolis, MN 55455.
Treatment of and Screening for Hyperlipidemia
Ornish D., Brown S. E., Kottke B. A., Shea S., Barth J. D., Bryan G. K., Hokanson J. E., Austin M. A., Ginsberg H. N., Tall A. R., Deckelbaum R. J., Hunninghake D. B., Criqui M. H., Heiss G., Sox H. C.
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N Engl J Med 1993;
329:1124-1128, Oct 7, 1993.
Correspondence
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(V.T.M., B.K.B.); Merck Research Laboratories, Rahway, N.J. (J.A.T., A.M.T.); Medical Research Laboratories, Cincinnati (P.M.L.); and Professional Nutrition Systems, Kansas City, Kans. (J.H.). The following persons also participated in the study: Heart Disease Prevention Clinic, Minneapolis -- J. Peters and K. Gardner; Christ Hospital Cardiovascular Research Center, Cincinnati -- D.M. Black, G.E. Lamkin, and S. Ames; University of Kansas Medical Center, Kansas City -- P. Krehbiel and S. Horniman; Medical College of Georgia, Augusta -- T.T. Kuske and J.M. Greene; George Washington University, Washington, D.
