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Comparative Study of a Microporous Cholestyramine Analogue (Filicol) and Gemfibrozil for Treatment of Severe Primary Hypercholesterolemia: Short- and Long-term Results

Comparative Study of a Microporous Cholestyramine Analogue (Filicol) and Gemfibrozil for... Abstract The hypolipidemic effect of gemfibrozil in severe hypercholesterolemia is not well established. Fifty patients with primary hypercholesterolemia (including 18 patients with familial hypercholesterolemia) and stable low-density lipoprotein cholesterol levels greater than 3.90 mmol/L (>150 mg/dL) (6.10 1.30 [SD] mmol/L; 236 ±50 mg/dL) while on a hypolipidemic diet were assigned to treatment for 12 weeks with either 9 g/d of filicol, a microporous cholestyramine analogue, or 1.2 g/d of gemfibrozil in a randomized clinical trial. Tolerance was good with both drugs. Filicol and gemfibrozil caused similar decrements of total cholesterol (14% for both), low-density lipoprotein cholesterol (20% and 18%, respectively), and apolipoprotein B (16% and 21%, respectively). Close to 40% of the patients had decreases of greater than 25% in low-density lipoprotein cholesterol levels with both drugs. Gemfibrozil, but not filicol, significantly increased plasma high-density lipoprotein cholesterol (16%) and apolipoprotein A-I (17%) levels and reduced triglyceride levels (35%). No loss of efficacy was observed with either drug in subsets of patients who had a good 12-week response rate and had extended therapy for up to 12 months. This study demonstrates that gemfibrozil may have a beneficial effect on all aspects of the plasma lipid profile in patients with severe hypercholesterolemia, a clinical situation where it can be used with potential advantages over standard doses of anion-exchange resins. (Arch Intern Med. 1991;151:301-305) References 1. Kannel WB, Castelli W, Gordon T, McNamara PM. Serum cholesterol, lipoproteins, and risk of coronary heart disease: the Framingham Study . Ann Intern Med. 1971;74:1-12.Crossref 2. Relationship of blood pressure, serum cholesterol, smoking habit, relative weight and ECG abnormalities to incidence of major coronary events: final report of the Pooling Project Research Group . J Chronic Dis. 1978;31:201-306.Crossref 3. Goldbourt V, Holtzman E, Neufeld HN. Total and high density lipoprotein cholesterol in the serum and risk of mortality: evidence of a threshold effect . BMJ. 1985;290:1239-1243.Crossref 4. Stamler J, Wentworth D, Neaton J. Is the relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? findings in 356 222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT) . JAMA. 1986;256:2823-2828.Crossref 5. Anderson KM, Castelli WP, Levy D. Cholesterol and mortality: the 30 years of follow-up from the Framingham Study . JAMA. 1987;257:2176-2180.Crossref 6. Martin MJ, Hulley SB, Brouwner WS, Kuller LH, Wentworth D. Serum cholesterol, blood pressure, and mortality: implications from a cohort of 361662 men . Lancet. 1986;2:933-936.Crossref 7. Grundy SM. Cholesterol and coronary heart disease: a new era . JAMA. 1986;256:2849-2858.Crossref 8. Turpeinen O, Karvonen MJ, Pekkarinen M, Miettinen M, Elosuo R, Paavilainen E. Dietary prevention of coronary heart disease: the Finnish Mental Hospital Study . Int J Epidemiol. 1979;8:99-118.Crossref 9. Hjermann I, Byre KV, Holme I, Leren P. Effect of diet and smoking intervention on the incidence of coronary heart disease: report from the Oslo Study Group of a randomized trial in healthy men . Lancet. 1981;2:1303-1310.Crossref 10. A cooperative trial in the primary prevention of ischemic heart disease using clofibrate: report from the Committee of Principal Investigators . Br Heart J. 1978;40:1069-1118.Crossref 11. Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial results: reduction in incidence of coronary heart disease . JAMA. 1984;251:351-364.Crossref 12. Frick MH, Elo O, Haapa K, et al. Helsinki Heart Study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia: safety of treatment, changes in risk factors, and incidence of coronary heart disease . N Engl J Med. 1987;317:1237-1245.Crossref 13. Canner PL, Berge KG, Wenger NK, et al. Fifteen-year mortality in Coronary Drug Project patients: long-term benefit with niacin . J Am Coll Cardiol. 1986;8:1245-1255.Crossref 14. Levy RI, Brensike JF, Epstein SE, et al. The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary disease: results of the NHLBI type II Coronary Intervention Study . Circulation. 1984;69:325-337.Crossref 15. Blankenhorn D, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts . JAMA. 1987;257:3233-3240.Crossref 16. The NIH Consensus Development Conference to Lower Blood Cholesterol for the Prevention of Heart Disease . JAMA. 1985;253:2080-2086.Crossref 17. National Cholesterol Education Program. Report of the Expert Panel on the Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults . Bethesda, Md: National Institutes of Health publication 88-2925; 1988. 18. European Atherosclerosis Society Study Group. The recognition and management of hyperlipidemia in adults: a policy statement of the European Atherosclerosis Society . Eur Heart J. 1988;9:571-600. 19. Sociedad Española de Arteriosclerosis. Estrategias para la prevención de la arteriosclerosis en España . Clin Invest Arteriosclerosis. 1989;1:1-19. 20. Brown WV, Goldberg IJ, Ginsberg HN. Treatment of common lipoprotein disorders . Prog Cardiovasc Dis. 1984;27:1-21.Crossref 21. Hoeg JM, Gregg RE, Brewer HB. An approach to the management of hyperlipoproteinemia . JAMA. 1986;255:512-521.Crossref 22. Illingworth DR. Lipid-lowering drugs: an overview of indications and optimum therapeutic use . Drugs. 1987;33:259-279.Crossref 23. De Simone R, Conti F, Lovati MR, Sirtori M, Cocuzza E, Sirtori CR. New microporous cholestyramine analog for treatment of hypercholesterolemia . J Pharm Sci. 1978;67:1695-1698.Crossref 24. Sirtori M, Franceschini G, Gianfranceschi G, Motanari G, Cocuzza E, Sirtori CR. Microporous cholestyramine in suspension form . Lancet. 1982;2:383.Crossref 25. Gaddi A, Rimondi S, Perini P, Sangiorgi Z, Descovich C. Familial and sporadic hypercholesterolemias: new microporous cholestyramine analog hypolipidemic effects . Curr Ther Res. 1985;38:548-554. 26. Ros E, Zambón D, Cusó E. Ingesta excesiva de grasas y colesterol en individuos hipercolesterolémicos: efectos de la intervención dietética sober los lípidos plasmáticos y colesterol lipoproteico . Med Clin (Bare) . 1989;92:41-46. 27. Rifkind BM, Segal P. Lipid Research Clinic Program reference values for hyperlipidemia and hypolipidemia . JAMA. 1983;14:1869-1872.Crossref 28. Burnstein M, Scholnick HR, Morfin R. Rapid method for the isolation of lipoproteins from human serum by precipitation with polyanions . J Lipid Res. 1970;11:583-591. 29. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low density lipoprotein cholesterol without use of the preparative ultracentrifuge . Clin Chem. 1972;18:499-506. 30. Heuck CC, Erbe I, Flint-Hansen P. Immunonephelometric determination of apolipoprotein A-I in hyperlipoproteinemic serum . Clin Chem. 1983;29:120-125. 31. Vander Heiden GL, Sasse EA, Yorde DE, Madiedo G, Barboriak JJ. Examination of a competitive enzyme-linked immunoassay (CELIA) technique and laser nephelometric immunoassay technique for the measurement of apolipoprotein B . Clin Chim Acta. 1983;135:209-218.Crossref 32. Angelin B, Einarsson K. Cholestyramine in type IIa hyperlipoproteinemia: is low-dose treatment feasible? Atherosclerosis. 1981;38:33-38.Crossref 33. Tikkanen MJ, Helve E, Jäättelä A, et al. Comparison between lovastatin and gemfibrozil in the treatment of primary hypercholesterolemia: the Finnish Multicenter Study . Am J Cardiol. 1988;62:35J-43J.Crossref 34. Franceschini G, Sirtori M, Vaccarino V, Gianfranceschi G, Chiesa G, Sirtori CR. Plasma lipoprotein changes after treatment with pravastatin and gemfibrozil in patients with familial hypercholesterolemia . J Lab Clin Med. 1989;114:250-259. 35. Saku K, Gartside PS, Hynd BA, Kayshap ML. Mechanism of action of gemfibrozil on lipoprotein metabolism . J Clin Invest . 1985;75:1702-1712.Crossref 36. Miller NE. Associations of high-density lipoprotein subclasses and apolipoproteins with ischemic heart disease and coronary atherosclerosis . Am Heart J. 1987;113:589-597.Crossref 37. Castelli WP, Garrison RJ, Wilson PWF, Abbot RD, Kalousdian S, Kannel WB. Incidence of coronary heart disease and lipoprotein cholesterol levels: the Framingham Study . JAMA. 1986;256:2835-2838.Crossref 38. Manninen MO, Elo MO, Frick MH, et al. Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki Heart Study . JAMA. 1988;260:641-651.Crossref 39. Nikkila EA, Viikinkoski P, Vale M, Frick MH. Prevention of progression of coronary atherosclerosis by treatment of hyperlipidemia: a 7-year prospective angiographic study . BMJ. 1984;289:220-223.Crossref 40. Arntzenius AC, Kromhunt D, Barth JD, et al. Diet, lipoproteins, and the progression of coronary atherosclerosis: the Leiden Intervention Trial . N Engl J Med. 1985;312:805-810.Crossref 41. Avogaro P, Bitollo Bon G, Cazzalato G, Quinci GB. Are apolipoproteins better discriminators than lipids for atherosclerosis? Lancet. 1979;1:901-903.Crossref 42. Grundy SM. HMG-CoA reductase inhibitors for treatment of hypercholesterolemia . N Engl J Med. 1988;319:24-33.Crossref 43. Hoeg JM, Maher MB, Bailey KR, et al. Effects of combination cholestyramine-neomycin treatment on plasma lipoprotein concentrations in type II hyperlipoproteinemia . Am J Cardiol. 1985;55:1282-1286.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Comparative Study of a Microporous Cholestyramine Analogue (Filicol) and Gemfibrozil for Treatment of Severe Primary Hypercholesterolemia: Short- and Long-term Results

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Publisher
American Medical Association
Copyright
Copyright © 1991 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinte.1991.00400020059013
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Abstract

Abstract The hypolipidemic effect of gemfibrozil in severe hypercholesterolemia is not well established. Fifty patients with primary hypercholesterolemia (including 18 patients with familial hypercholesterolemia) and stable low-density lipoprotein cholesterol levels greater than 3.90 mmol/L (>150 mg/dL) (6.10 1.30 [SD] mmol/L; 236 ±50 mg/dL) while on a hypolipidemic diet were assigned to treatment for 12 weeks with either 9 g/d of filicol, a microporous cholestyramine analogue, or 1.2 g/d of gemfibrozil in a randomized clinical trial. Tolerance was good with both drugs. Filicol and gemfibrozil caused similar decrements of total cholesterol (14% for both), low-density lipoprotein cholesterol (20% and 18%, respectively), and apolipoprotein B (16% and 21%, respectively). Close to 40% of the patients had decreases of greater than 25% in low-density lipoprotein cholesterol levels with both drugs. Gemfibrozil, but not filicol, significantly increased plasma high-density lipoprotein cholesterol (16%) and apolipoprotein A-I (17%) levels and reduced triglyceride levels (35%). No loss of efficacy was observed with either drug in subsets of patients who had a good 12-week response rate and had extended therapy for up to 12 months. This study demonstrates that gemfibrozil may have a beneficial effect on all aspects of the plasma lipid profile in patients with severe hypercholesterolemia, a clinical situation where it can be used with potential advantages over standard doses of anion-exchange resins. (Arch Intern Med. 1991;151:301-305) References 1. Kannel WB, Castelli W, Gordon T, McNamara PM. Serum cholesterol, lipoproteins, and risk of coronary heart disease: the Framingham Study . Ann Intern Med. 1971;74:1-12.Crossref 2. Relationship of blood pressure, serum cholesterol, smoking habit, relative weight and ECG abnormalities to incidence of major coronary events: final report of the Pooling Project Research Group . J Chronic Dis. 1978;31:201-306.Crossref 3. Goldbourt V, Holtzman E, Neufeld HN. Total and high density lipoprotein cholesterol in the serum and risk of mortality: evidence of a threshold effect . BMJ. 1985;290:1239-1243.Crossref 4. Stamler J, Wentworth D, Neaton J. Is the relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? findings in 356 222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT) . JAMA. 1986;256:2823-2828.Crossref 5. Anderson KM, Castelli WP, Levy D. Cholesterol and mortality: the 30 years of follow-up from the Framingham Study . JAMA. 1987;257:2176-2180.Crossref 6. Martin MJ, Hulley SB, Brouwner WS, Kuller LH, Wentworth D. Serum cholesterol, blood pressure, and mortality: implications from a cohort of 361662 men . Lancet. 1986;2:933-936.Crossref 7. Grundy SM. Cholesterol and coronary heart disease: a new era . JAMA. 1986;256:2849-2858.Crossref 8. Turpeinen O, Karvonen MJ, Pekkarinen M, Miettinen M, Elosuo R, Paavilainen E. Dietary prevention of coronary heart disease: the Finnish Mental Hospital Study . Int J Epidemiol. 1979;8:99-118.Crossref 9. Hjermann I, Byre KV, Holme I, Leren P. Effect of diet and smoking intervention on the incidence of coronary heart disease: report from the Oslo Study Group of a randomized trial in healthy men . Lancet. 1981;2:1303-1310.Crossref 10. A cooperative trial in the primary prevention of ischemic heart disease using clofibrate: report from the Committee of Principal Investigators . Br Heart J. 1978;40:1069-1118.Crossref 11. Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial results: reduction in incidence of coronary heart disease . JAMA. 1984;251:351-364.Crossref 12. Frick MH, Elo O, Haapa K, et al. Helsinki Heart Study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia: safety of treatment, changes in risk factors, and incidence of coronary heart disease . N Engl J Med. 1987;317:1237-1245.Crossref 13. Canner PL, Berge KG, Wenger NK, et al. Fifteen-year mortality in Coronary Drug Project patients: long-term benefit with niacin . J Am Coll Cardiol. 1986;8:1245-1255.Crossref 14. Levy RI, Brensike JF, Epstein SE, et al. The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary disease: results of the NHLBI type II Coronary Intervention Study . Circulation. 1984;69:325-337.Crossref 15. Blankenhorn D, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts . JAMA. 1987;257:3233-3240.Crossref 16. The NIH Consensus Development Conference to Lower Blood Cholesterol for the Prevention of Heart Disease . JAMA. 1985;253:2080-2086.Crossref 17. National Cholesterol Education Program. Report of the Expert Panel on the Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults . Bethesda, Md: National Institutes of Health publication 88-2925; 1988. 18. European Atherosclerosis Society Study Group. The recognition and management of hyperlipidemia in adults: a policy statement of the European Atherosclerosis Society . Eur Heart J. 1988;9:571-600. 19. Sociedad Española de Arteriosclerosis. Estrategias para la prevención de la arteriosclerosis en España . Clin Invest Arteriosclerosis. 1989;1:1-19. 20. Brown WV, Goldberg IJ, Ginsberg HN. Treatment of common lipoprotein disorders . Prog Cardiovasc Dis. 1984;27:1-21.Crossref 21. Hoeg JM, Gregg RE, Brewer HB. An approach to the management of hyperlipoproteinemia . JAMA. 1986;255:512-521.Crossref 22. Illingworth DR. Lipid-lowering drugs: an overview of indications and optimum therapeutic use . Drugs. 1987;33:259-279.Crossref 23. De Simone R, Conti F, Lovati MR, Sirtori M, Cocuzza E, Sirtori CR. New microporous cholestyramine analog for treatment of hypercholesterolemia . J Pharm Sci. 1978;67:1695-1698.Crossref 24. Sirtori M, Franceschini G, Gianfranceschi G, Motanari G, Cocuzza E, Sirtori CR. Microporous cholestyramine in suspension form . Lancet. 1982;2:383.Crossref 25. Gaddi A, Rimondi S, Perini P, Sangiorgi Z, Descovich C. Familial and sporadic hypercholesterolemias: new microporous cholestyramine analog hypolipidemic effects . Curr Ther Res. 1985;38:548-554. 26. Ros E, Zambón D, Cusó E. Ingesta excesiva de grasas y colesterol en individuos hipercolesterolémicos: efectos de la intervención dietética sober los lípidos plasmáticos y colesterol lipoproteico . Med Clin (Bare) . 1989;92:41-46. 27. Rifkind BM, Segal P. Lipid Research Clinic Program reference values for hyperlipidemia and hypolipidemia . JAMA. 1983;14:1869-1872.Crossref 28. Burnstein M, Scholnick HR, Morfin R. Rapid method for the isolation of lipoproteins from human serum by precipitation with polyanions . J Lipid Res. 1970;11:583-591. 29. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low density lipoprotein cholesterol without use of the preparative ultracentrifuge . Clin Chem. 1972;18:499-506. 30. Heuck CC, Erbe I, Flint-Hansen P. Immunonephelometric determination of apolipoprotein A-I in hyperlipoproteinemic serum . Clin Chem. 1983;29:120-125. 31. Vander Heiden GL, Sasse EA, Yorde DE, Madiedo G, Barboriak JJ. Examination of a competitive enzyme-linked immunoassay (CELIA) technique and laser nephelometric immunoassay technique for the measurement of apolipoprotein B . Clin Chim Acta. 1983;135:209-218.Crossref 32. Angelin B, Einarsson K. Cholestyramine in type IIa hyperlipoproteinemia: is low-dose treatment feasible? Atherosclerosis. 1981;38:33-38.Crossref 33. Tikkanen MJ, Helve E, Jäättelä A, et al. Comparison between lovastatin and gemfibrozil in the treatment of primary hypercholesterolemia: the Finnish Multicenter Study . Am J Cardiol. 1988;62:35J-43J.Crossref 34. Franceschini G, Sirtori M, Vaccarino V, Gianfranceschi G, Chiesa G, Sirtori CR. Plasma lipoprotein changes after treatment with pravastatin and gemfibrozil in patients with familial hypercholesterolemia . J Lab Clin Med. 1989;114:250-259. 35. Saku K, Gartside PS, Hynd BA, Kayshap ML. Mechanism of action of gemfibrozil on lipoprotein metabolism . J Clin Invest . 1985;75:1702-1712.Crossref 36. Miller NE. Associations of high-density lipoprotein subclasses and apolipoproteins with ischemic heart disease and coronary atherosclerosis . Am Heart J. 1987;113:589-597.Crossref 37. Castelli WP, Garrison RJ, Wilson PWF, Abbot RD, Kalousdian S, Kannel WB. Incidence of coronary heart disease and lipoprotein cholesterol levels: the Framingham Study . JAMA. 1986;256:2835-2838.Crossref 38. Manninen MO, Elo MO, Frick MH, et al. Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki Heart Study . JAMA. 1988;260:641-651.Crossref 39. Nikkila EA, Viikinkoski P, Vale M, Frick MH. Prevention of progression of coronary atherosclerosis by treatment of hyperlipidemia: a 7-year prospective angiographic study . BMJ. 1984;289:220-223.Crossref 40. Arntzenius AC, Kromhunt D, Barth JD, et al. Diet, lipoproteins, and the progression of coronary atherosclerosis: the Leiden Intervention Trial . N Engl J Med. 1985;312:805-810.Crossref 41. Avogaro P, Bitollo Bon G, Cazzalato G, Quinci GB. Are apolipoproteins better discriminators than lipids for atherosclerosis? Lancet. 1979;1:901-903.Crossref 42. Grundy SM. HMG-CoA reductase inhibitors for treatment of hypercholesterolemia . N Engl J Med. 1988;319:24-33.Crossref 43. Hoeg JM, Maher MB, Bailey KR, et al. Effects of combination cholestyramine-neomycin treatment on plasma lipoprotein concentrations in type II hyperlipoproteinemia . Am J Cardiol. 1985;55:1282-1286.Crossref

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Feb 1, 1991

References