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REPLY
Cost-effectiveness of Combined Statin-Resin Therapy
Dennis L. Sprecher, MD, and
Leonard Jokubaitis, MD
1 October 1994 | Volume 121 Issue 7 | Pages 548-549
IN RESPONSE:
The comments of Dr. Katz regarding cost-effectiveness and its value in reports on new drugs are well advised. However, his suggestion that pharmaceutical company sponsorship of this clinical trial was the rationale for nondisclosure of cost is unfounded. Our manuscript [1] was submitted to Annals before the Food and Drug Administration approved fluvastatin for clinical use. The determination of pharmaceutical pricing is a labile phenomenon, and the specific price of fluvastatin was not available to the authors at the time of submission.
Table 1 provides a simple cost-effectiveness comparison of various therapeutic regimens, based on currently available pricing data and previously observed reductions [1-4] in low-density lipoprotein (LDL) cholesterol levels.
An analysis of cost per 1% reductin in LDL levels, given that the least expensive tablet at any dose of hemoglobin CoA reductase inhibitors other than fluvastatin is more than $1.60, suggests that fluvastatin is the most cost-effective monotherapy. For a reduction in LDL levels of approximately 30%, the combination of fluvastatin and cholestyramine was more cost-effective than higher doses of other reductase-inhibitor monotherapy.
Note that the efficacy of a 40-mg dose of fluvastatin (average wholesale price, $1.14) in general hypercholesterolemic patients has yet to be reported (24% mean LDL reduction in heterozygous familial hypercholesterolemia [5]), that the 10-mg formulation of fluvastatin used in our study is not commercially available and therefore not displayed, and that an LDL reduction of 22% was observed with fluvastatin (20 mg) in a larger randomized trial [5]. In addition, the selection of a particular monotherapy or combination regimen must be tailored to a particular patient, including his or her lipoprotein profile and preexisting conditions or therapy. A rigorous cost-effectiveness assessment would also warrant the factoring of indirect costs (for example, care associated with adverse effects of therapy).
1. Sprecher DL, Abrams J, Allen JW, Keane WF, Chrysant SG, Ginsberg H, et al. Low-dose combined therapy with fluvastatin and cholestyramine in hyperlipidemic patients. Ann Intern Med. 1994; 120:537-43.
2. Bradford RH, Shear CL, Chremos AN, Dujovne C, Downton M, Franklin FA, et al. Expanded clinical evaluation of Lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia. Arch Intern Med. 1991; 151:43-9.
3. The Lovastatin Pravastatin Study Group. A multicenter comparative trial of lovastatin and pravastatin in the treatment of hypercholesterolemia. Am J Cardiol. 1993; 71:810-5.
4. Full prescribing information for Zocor (simvastatin; Merck, Sharp & Dohme, West Point, Pennsylvania). In: Physician's Desk Reference. Montvale, New Jersey: Medical Economics Data.
5. Lescol (fluvastatin). East Hanover, New Jersey: Sandoz Pharmaceuticals. U.S. package insert; 1994.
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