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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| Formato: | Capítulo de libro |
| Lenguaje: | Inglés |
| Publicado: |
Excerpta Medica Inc.
1997
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| Acceso en línea: | Registro en Scopus DOI Handle Registro en la Biblioteca Digital |
| Aporte de: | Registro referencial: Solicitar el recurso aquí |
| LEADER | 08362caa a22009497a 4500 | ||
|---|---|---|---|
| 001 | PAPER-20149 | ||
| 003 | AR-BaUEN | ||
| 005 | 20230518205133.0 | ||
| 008 | 190411s1997 xx ||||fo|||| 00| 0 eng|d | ||
| 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://doi.org/10.1016/S0011-393X(97)80068-9 |y DOI |
| 856 | 4 | 0 | |u https://hdl.handle.net/20.500.12110/paper_0011393X_v58_n12_p1013_Buzzi |y Handle |
| 856 | 4 | 0 | |u https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_0011393X_v58_n12_p1013_Buzzi |y Registro en la Biblioteca Digital |
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| 999 | |c 81102 | ||