Argentine multicenter evaluation of fluvastatin in the treatment of patients with hypercholesterolemia

An open-label, multicenter, uncontrolled clinical trial was conducted to assess the efficacy and tolerability of fluvastatin, the first hydroxymethylglutaryl-coenzyme A reductase synthetic inhibitor in the treatment of primary hypercholesterolemia in patients with or without coronary artery disease...

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Autor principal: Buzzi, A.P
Otros Autores: Pastore, M.A
Formato: Capítulo de libro
Lenguaje:Inglés
Publicado: Excerpta Medica Inc. 1997
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Acceso en línea:Registro en Scopus
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024 7 |2 scopus  |a 2-s2.0-0031446852 
024 7 |2 cas  |a cholesterol, 57-88-5; fluindostatin, 93957-54-1 
040 |a Scopus  |b spa  |c AR-BaUEN  |d AR-BaUEN 
030 |a CTCEA 
100 1 |a Buzzi, A.P. 
245 1 0 |a Argentine multicenter evaluation of fluvastatin in the treatment of patients with hypercholesterolemia 
260 |b Excerpta Medica Inc.  |c 1997 
270 1 0 |m Buzzi, A.P.; Faculty of Medicine, University of Buenos Aires, Vuelta de Obligado 1947-P.B., Buenos Aires 1428, Argentina 
506 |2 openaire  |e Política editorial 
504 |a Castelli, W.P., Serum lipids and risk of coronary artery disease (1990) Atherosclerosis Reviews, pp. 7-19. , Leaf A, Weber PC, eds. New York: Raven Press 
504 |a Dallongeville, J., Fruchart, J.C., Pfister, P., Bard, J.M., Fluvastatin reduces levels of plasma Apo B-containing particles and increases those Lp A-I (1994) Am J Med., 96, pp. 32-33 
504 |a Troendle, A.J., Clinical review of fluvastatin: Short-term and long-term data (1994) Clin Cardiol., 17, pp. 11-15 
504 |a Betteridge, D.J., Durrington, P.N., Fairhurst, G.J., Comparison of lipid lowering effects of low-dose fluvastatin and conventional-dose gemfibrozil in patients with primary hypercholesterolemia (1994) Am J Med., 96, pp. 45-54 
504 |a Foley, D.P., Bonnier, H., Jackson, G., Prevention of restenosis after coronary balloon angioplasty: Rationale and design of the fluvastatin angioplasty restenosis (FLARE) trial (1994) Am J Cardiol., 73, pp. 50-61 
504 |a Milani, M., Cimminiello, C., Merlo, B., Effects of fluvastatin and pravastatin on lipid profiles and thromboxane production on type IIa hypercholesterolemia (1995) Am J Cardiol., 76, pp. 51-53 
504 |a La Rosa, J.C., Combination of drugs in lipid-lowering therapy (1994) Am J Med., 96, pp. 399-400 
504 |a Jacotot, B., Benghozi, R., Pfister, P., Holmes, D., Comparison of fluvastatin versus pravastatin treatment of primary hypercholesterolemia (1995) Am J Cardiol., 76, pp. 54-56 
504 |a Jacotot, B., Banga, J.D., Pfister, P., Mehra, M., Efficacy of a low dose-range of fluvastatin in the treatment of primary hypercholesterolaemia. A dose response study in 431 patients (1994) Br J Clin Pharmacol., 38, pp. 257-263 
504 |a Insull, W., Black, D., Dujovne, C., Efficacy and safety of once-daily vs twice-daily dosing with fluvastatin, a synthetic reductase inhibitor, in primary hypercholesterolemia (1994) Arch Inter Med., 154, pp. 2449-2455 
504 |a Summary of the second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (1993) JAMA, 269, pp. 3015-3023 
504 |a Peters, T.K., Mehra, M., Muratti, E.N., Efficacy and safety of fluvastatin in hypertensive patients (1993) Am J Hypertens, 6, pp. 340-345 
504 |a Peters, T.K., Muratti, E.N., Mehra, M., Fluvastatin in primary hypercholesterolemia: Efficacy and safety in patients at high risk (1994) Am J Med., 96, pp. 79-83 
504 |a Deslypere, J.P., The role of HMG-CoA reductase inhibitors in the treatment of hyperlipidemia: A review of fluvastatin (1995) Curr Ther Res., 56, pp. 111-128 
504 |a Greten, H., Beil, F.U., Schneider, H., Treatment of primary hypercholesterolemia: Fluvastatin versus bezafibrate (1994) Am J Med., 96, pp. 55-63 
520 3 |a An open-label, multicenter, uncontrolled clinical trial was conducted to assess the efficacy and tolerability of fluvastatin, the first hydroxymethylglutaryl-coenzyme A reductase synthetic inhibitor in the treatment of primary hypercholesterolemia in patients with or without coronary artery disease (CAD) risk factors. This trial was conducted in 2566 men and women 18 years of age or older who received the study medication for at least 12 weeks. Following a minimum of 4 weeks on a low-fat diet (National Cholesterol Education Program), eligible patients took one capsule of fluvastatin 20 mg/d orally, in the evening, during the first 6 weeks and 20 or 40 mg/d (1 or 2 20-mg capsules), in the evening, during the remainder of the trial. Overall, patients had the following risk factors: arterial hypertension, 65.4%; family history of CAD, 54.9%; obesity, 47.9%; nicotine addiction, 34.9%; diabetes, 18.1%; total cholesterol (TC) levels ≤300 mg/dL, 43.2%; CAD, 17.9%; and peripheral vascular disease, 9.4%. Patients were divided into two groups depending on the initial TC levels. The first group was composed of 1451 patients with mild-to-moderate hypercholesterolemia (TC, 200 to 299 mg/dL); the second group included 1115 patients with severe hypercholesterolemia (TC, ≤300 mg/dL). The results showed a 22.41% decrease in TC levels in the first group and a 30.94% decrease in the second group. At the end of the study, low-density lipoprotein cholesterol levels decreased by 26.15% and 32.63% in the first and second groups, respectively. High-density lipoprotein cholesterol levels increased by 8.94% in the mild-to-moderate hypercholesterolemia group and by 9.22% in the severe hypercholesterolemia group. Only 9.3% of the patients in the first group and 16.4% of the patients in the second group required an increase from 20 mg/d to 40 mg/d of fluvastatin after the first 6 weeks of treatment. Fluvastatin was well tolerated, with gastrointestinal disorders the most frequent adverse event observed (4.68%). No myopathies were reported. These study results, which are similar to those from other international trials with fluvastatin published to date, show that it is an effective and well-tolerated treatment for hypercholesterolemia.  |l eng 
536 |a Detalles de la financiación: This study was supported by a grant from Novartis Argentina (formerly Sandoz Argentina), Buenos Aires, Argentina. 
593 |a Faculty of Medicine, University of Buenos Aires, Buenos Aires, Argentina 
593 |a Novartis Argentina, Buenos Aires, Argentina 
593 |a Department of Internal Medicine, Faculty of Medicine, University of Buenos Aires, Vuelta de Obligado 1947-P.B., Buenos Aires (1428), Argentina 
690 1 0 |a EFFICACY 
690 1 0 |a FLUVASTATIN 
690 1 0 |a HYPERCHOLESTEROLEMIA 
690 1 0 |a MYOPATHIES 
690 1 0 |a CHOLESTEROL 
690 1 0 |a FLUINDOSTATIN 
690 1 0 |a HIGH DENSITY LIPOPROTEIN CHOLESTEROL 
690 1 0 |a HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR 
690 1 0 |a LOW DENSITY LIPOPROTEIN CHOLESTEROL 
690 1 0 |a ADULT 
690 1 0 |a ARTICLE 
690 1 0 |a CHOLESTEROL BLOOD LEVEL 
690 1 0 |a CLINICAL TRIAL 
690 1 0 |a CORONARY ARTERY DISEASE 
690 1 0 |a DIABETES MELLITUS 
690 1 0 |a DRUG EFFICACY 
690 1 0 |a DRUG INDUCED DISEASE 
690 1 0 |a DRUG TOLERABILITY 
690 1 0 |a FAMILY HISTORY 
690 1 0 |a FEMALE 
690 1 0 |a GASTROINTESTINAL SYMPTOM 
690 1 0 |a HUMAN 
690 1 0 |a HYPERCHOLESTEROLEMIA 
690 1 0 |a HYPERTENSION 
690 1 0 |a LIPOPROTEIN BLOOD LEVEL 
690 1 0 |a LOW FAT DIET 
690 1 0 |a MAJOR CLINICAL STUDY 
690 1 0 |a MALE 
690 1 0 |a MULTICENTER STUDY 
690 1 0 |a MYALGIA 
690 1 0 |a OBESITY 
690 1 0 |a PERIPHERAL VASCULAR DISEASE 
690 1 0 |a PRIORITY JOURNAL 
690 1 0 |a SMOKING 
651 4 |a ARGENTINA 
700 1 |a Pastore, M.A. 
773 0 |d Excerpta Medica Inc., 1997  |g v. 58  |h pp. 1013-1028  |k n. 12  |p Curr. Ther. Res. Clin. Exp.  |x 0011393X  |t Current Therapeutic Research - Clinical and Experimental 
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856 4 0 |u https://hdl.handle.net/20.500.12110/paper_0011393X_v58_n12_p1013_Buzzi  |y Handle 
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