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Enhanced low-density lipoprotein cholesterol reduction and cost-effectiveness by low-dose colestipol plus lovastatin combination therapy |
Schrott H G, Stein E A, Dujovne C A, Davidson M H, Goris G B, Oliphant T H, Phillips J C, Shawaryn G G |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Use of low-dose combination of drug regimens of colestipol and lovastatin in reducing low-density lipoprotein (LDL) cholesterol levels.
Economic study type Cost-effectiveness study.
Study population Patients with moderate hypercholesterolemia.
Setting Not explicitly stated. The economic study was conducted in the USA.
Dates to which data relate Dates for the effectiveness data were not stated. 1994 prices were used.
Source of effectiveness data Link between effectiveness and cost data Costing was undertaken retrospectively on the same patient sample as that used in the effectiveness study.
Study sample 96 patients with moderate hypercholesterolemia were randomly assigned to 4 different double-blind treatment regimens. Randomization to the 12-week drug treatment occurred after 6 weeks of low fat and low cholesterol diet, leaving 94 patients: 24 to the placebo group, 23 to the colestipol 5 g and lovastatin 20 mg/day group (C5+L20), 23 to the colestipol 10 g and lovastatin 20 mg/day group (C10+L20) and 24 to the lovastatin 40 mg/day group (L40). 3 patients did not complete the full 18 week study. The sample size was not determined by a power calculation.
Study design The study was a randomized double-blind, parallel-design, placebo-controlled design.
Analysis of effectiveness The analysis of the clinical study was based on intention to treat. The primary health outcomes used in the analysis were: total cholesterol, LDL cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, apolipoprotein A-I, apolipoprotein B, lipoprotein A-I, and lipoprotein levels.
Effectiveness results The C10+L20 group achieved the greatest reduction in total cholesterol (-32%) and LDL cholesterol (-48%) levels from baseline. This combination also achieved significantly greater reductions in LDL cholesterol levels than the C5+L20 and L40 groups (p<0.01). Whereas mean total apolipoprotein A-I levels increased with all treatments (p<0.05), lipoprotein particles A-I were significantly increased in the C10+L20 group (p<0.01) only.
Clinical conclusions The combination of low-dose lovastatin (20 mg/day) with low-dose colestipol (5 or 10 g/day) produces LDL cholesterol reductions equal to or greater than higher doses of lovastatin (40 mg/day). Side effects reported by more than 2 subjects in any group during treatment were: headache, chest pain, common cold, constipation, abdominal discomfort, nausea and joint pain. Complaints of constipation more frequent in the colestipol groups.
Measure of benefits used in the economic analysis The benefit measure was the percentage LDL cholesterol reduction.
Direct costs Direct health service costs were considered namely drug costs. Quantities and costs were not reported separately.1994 prices were used.
Estimated benefits used in the economic analysis The C10+L20 group achieved the greatest reduction in total cholesterol (-32%) and LDL cholesterol (-48%) levels from baseline. This combination also exhibited significantly greater reductions in LDl cholesterol levels than C5+L20 and L40 groups.
Cost results The annual cost was $803 for C5+L20, $1018 for C10+L20 and $1047 for L40.
Synthesis of costs and benefits The annual cost ($)/percent LDL cholesterol lowering during treatment was: $21.13 for C5+L20, $21.21 for C10+L20 and $27.56 for L40.
Authors' conclusions Low-dose combination therapy, especially with C10+L20, offered significant advantages over larger dose lovastatin treatment in terms of both LDL cholesterol reduction and cost efficiency.
CRD Commentary This was a good study both in terms of design and economic analysis. The choice of comparators was sensible and explicitly stated. Clinical evidence was based on a randomised, double blind trial with statistically significant results. Costing, however, included only drug costs. A more elaborate cost analysis including statistical tests could have been useful.
Source of funding Supported by a grant from Upjohn Laboratories, The Upjohn Company, Kalamazoo, Michigan.
Bibliographic details Schrott H G, Stein E A, Dujovne C A, Davidson M H, Goris G B, Oliphant T H, Phillips J C, Shawaryn G G. Enhanced low-density lipoprotein cholesterol reduction and cost-effectiveness by low-dose colestipol plus lovastatin combination therapy. American Journal of Cardiology 1995; 75(1): 34-39 Indexing Status Subject indexing assigned by NLM MeSH Apolipoproteins /blood; Cholesterol, LDL /blood; Colestipol /administration & Cost-Benefit Analysis; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hypercholesterolemia /blood /drug therapy /economics; Lipids /blood; Lipoproteins /blood; Lovastatin /administration & Male; Middle Aged; dosage /therapeutic use; dosage /therapeutic use AccessionNumber 21995000115 Date bibliographic record published 31/03/1998 Date abstract record published 31/03/1998 |
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