Moderate Dose, Three-Drug Therapy With Niacin, Lovastatin, and Colestipol to Reduce Low-Density Lipoprotein Cholesterol <100 mg/dl in Patients With Hyperlipidemia and Coronary Artery Disease
Section snippets
Patient Group
Thirty-one consecutive patients were enrolled for a comparison of the polygel controlled-release and regular niacin. All had been participants in the Familial Atherosclerosis Treatment Study (FATS) trial.[3] After its completion, they elected to continue for another 30-month cycle using an open-label regimen that combined 3 approved drugs given at the following target doses: lovastatin 20 mg bid, colestipol 10 g bid, and niacin 500 mg qid. All were men ≤65 years old at high risk for future
Baseline Characteristics
Of 31 patients randomized, 2 left the study during the 12-month run-in phase due to time conflict. Twenty-nine patients completed the 32-month study (Table 1).
Lipid and Clinical Laboratory Response
These data are presented in Table 2. During the 12-month dose-finding period, all 3 drugs were adjusted to achieve target cholesterol levels and minimize side effects. At 12 months prescribed dosages averaged 2.3 ± 0.8 g/day for regular niacin, 38 ± 8 mg/day for lovastatin, and 19.5 ± 3.4 g/day for colestipol. After 12 months on this
Discussion
Overall, the 3-drug regimen proved extremely effective and well-tolerated, in part due to close follow-up and careful patient education, and in part due to a moderate dosing schedule for each of the 3 drugs. Significant differences between the 2 niacin preparations (in compliance, total and LDL cholesterol and LDL/HDL ratio reduction, flushing, and overall preference) favored the controlled-release preparation although it was somewhat less effective in raising HDL.
This experience stands in
Acknowledgements
The efforts of Robert P. Kelly in preparing this manuscript are greatly appreciated. The pharmaceutical supplies were provided by Merck Research Laboratories, Inc., West Point, Pennsylvania; Upjohn Co., Inc., and Upsher-Smith, Inc., Minneapolis, Minnesota.
This study was supported in part by grants R01 HL 19451, PO 1 HL 30086, 35816, P30 DK 17047, and R01 HL 42419 from the National Heart, Lung, and Blood Institute and National Institutes of Health, Bethesda, Maryland; in part by the University
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