(Circulation. 1995;91:2528-2540.)
© 1995 American Heart Association, Inc.
Articles |
Effects of Lipid Lowering by Pravastatin on Progression and Regression of Coronary Artery Disease in Symptomatic Men With Normal to Moderately Elevated Serum Cholesterol Levels
The Regression Growth Evaluation Statin Study (REGRESS)
From the Department of Cardiology (J.W.J., A.V.G.B.) and Department of Diagnostic Radiology and Nuclear Medicine (J.H.C.R.), University Hospital, Leiden; Department of Cardiology, University Hospital, Groningen (A.J.v.B., K.I.L.); St Antonius Hospital, Nieuwegein (E.T.B.); Department of Medical Statistics, Leiden University (A.H.Z.); SCOR Laboratory for Lipid Research, Erasmus University, Rotterdam (H.J.); CORE Laboratory for Lipid Analysis, Lipid Reference Laboratory, University Hospital "Dijkzigt," Rotterdam (G.J.M.B.); and Interuniversity Cardiology Institute, Utrecht (F.M.v.R.), Netherlands.
Correspondence to Albert V.G. Bruschke, MD, Department of Cardiology, Bldg I, C5-P, University Hospital Leiden, Rijnsburgerweg 10, 2333 AA Leiden, Netherlands.
Background Intensive lowering of serum cholesterol may retard progression of coronary atherosclerosis in selected groups of patients. However, few data are available on the potential benefit of serum cholesterol reduction in the broad range of patients with coronary atherosclerosis and normal to moderately elevated serum cholesterol levels who undergo various forms of treatment. The Regression Growth Evaluation Statin Study (REGRESS) addresses this group of patients.
Methods and Results REGRESS is a double-blind, placebo-controlled multicenter study to assess the effects of 2 years of treatment with the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor pravastatin on progression and regression of coronary atherosclerosis in 885 male patients with a serum cholesterol level between 4 and 8 mmol/L (155 and 310 mg/dL) by quantitative coronary arteriography. Primary end points were (1) change in average mean segment diameter per patient and (2) change in average minimum obstruction diameter per patient. Clinical events were also analyzed. Of the 885 patients, 778 (88%) had an evaluable final angiogram. Mean segment diameter decreased 0.10 mm in the placebo group versus 0.06 mm in the pravastatin group (P=.019): The mean difference between treatment groups was 0.04 mm, with a 95% CI of 0.01 to 0.07 mm. The median minimum obstruction diameter decreased 0.09 mm in the placebo group versus 0.03 mm in the pravastatin group (P=.001): The difference of the medians between the treatment groups was 0.06 mm, with a CI of 0.02 to 0.08 mm. At the end of the follow-up period, 89% (CI, 86% to 92%) of the pravastatin patients and 81% (CI, 77% to 85%) of the placebo patients were without new cardiovascular events (P=.002).
Conclusions In symptomatic men with significant coronary atherosclerosis and normal to moderately elevated serum cholesterol, less progression of coronary atherosclerosis and fewer new cardiovascular events were observed in the group of patients treated with pravastatin than in the placebo group.
Key Words: lipids • coronary disease • pravastatin • atherosclerosis • clinical trials
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M. Matsuzaki, K. Hiramori, T. Imaizumi, A. Kitabatake, H. Hishida, M. Nomura, T. Fujii, I. Sakuma, K. Fukami, T. Honda, et al. Intravascular ultrasound evaluation of coronary plaque regression by low density lipoprotein-apheresis in familial hypercholesterolemia: The Low Density Lipoprotein-Apheresis Coronary Morphology and Reserve Trial (LACMART) J. Am. Coll. Cardiol., July 17, 2002; 40(2): 220 - 227. [Abstract] [Full Text] [PDF]
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J. W. Jukema, Y. F. C. Smets, J. W. van der Pijl, A. H. Zwinderman, H. W. Vliegen, J. Ringers, J. H. C. Reiber, H. H. P. J. Lemkes, E. E. van der Wall, and J. W. de Fijter Impact of Simultaneous Pancreas and Kidney Transplantation on Progression of Coronary Atherosclerosis in Patients With End-Stage Renal Failure due to Type 1 Diabetes Diabetes Care, May 1, 2002; 25(5): 906 - 911. [Abstract] [Full Text] [PDF]
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S.M. Cobbe How best to combat the enemies? Lipid lowering Eur. Heart J. Suppl., February 1, 2002; 4(suppl_A): A48 - A52. [Abstract] [PDF]
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Y. Arai, N. Hirose, K. Yamamura, M. Kimura, A. Murayama, I. Fujii, and M. Tsushima Long-Term Effect of Lipid-Lowering Therapy on Atherosclerosis of Abdominal Aorta in Patients with Hypercholesterolemia: Noninvasive Evaluation by a New Image Analysis Program Angiology, January 1, 2002; 53(1): 57 - 68. [Abstract] [PDF]
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W. R. P. Agema, J. W. Jukema, S. N. Pimstone, and J. J. P. Kastelein Genetic aspects of restenosis after percutaneous coronary interventions;towards more tailored therapy Eur. Heart J., November 2, 2001; 22(22): 2058 - 2074. [PDF]
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H J G H Mulder, M J Schalij, B Kauer, R F Visser, P R M van Dijkman, J W Jukema, A H Zwinderman, and A V G Bruschke Pravastatin and endothelium dependent vasomotion after coronary angioplasty: the PREFACE trial Heart, November 1, 2001; 86(5): 533 - 539. [Abstract] [Full Text] [PDF]
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L. A. Prosser, A. A. Stinnett, L. Goldman, and M. C. Weinstein Cost-Effectiveness Analyses Ann Intern Med, September 4, 2001; 135(5): 382 - 383. [Full Text] [PDF]
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P. Amarenco Hypercholesterolemia, lipid-lowering agents, and the risk for brain infarction Neurology, September 1, 2001; 57(90002): S35 - 44. [Abstract] [Full Text]
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M. Schartl, W. Bocksch, D. H. Koschyk, W. Voelker, K. R. Karsch, J. Kreuzer, D. Hausmann, S. Beckmann, and M. Gross Use of Intravascular Ultrasound to Compare Effects of Different Strategies of Lipid-Lowering Therapy on Plaque Volume and Composition in Patients With Coronary Artery Disease Circulation, July 24, 2001; 104(4): 387 - 392. [Abstract] [Full Text] [PDF]
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B.A. van Hout and M.L. Simoons Cost-effectiveness of HMG coenzyme reductase inhibitors. Whom to treat? Eur. Heart J., May 1, 2001; 22(9): 751 - 761. [Abstract] [PDF]
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P P van Geel, Y M Pinto, A H Zwinderman, R H Henning, A J van Boven, J W Jukema, A V G Bruschke, J J P Kastelein, W H van Gilst, and G F BAXTER Increased risk for ischaemic events is related to combined RAS polymorphism Heart, April 1, 2001; 85(4): 458 - 462. [Abstract] [Full Text]
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S. M. Clee, A. H. Zwinderman, J. C. Engert, K. Y. Zwarts, H. O. F. Molhuizen, K. Roomp, J. W. Jukema, M. van Wijland, M. van Dam, T. J. Hudson, et al. Common Genetic Variation in ABCA1 Is Associated With Altered Lipoprotein Levels and a Modified Risk for Coronary Artery Disease Circulation, March 6, 2001; 103(9): 1198 - 1205. [Abstract] [Full Text] [PDF]
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M. Crisby, G. Nordin-Fredriksson, P. K. Shah, J. Yano, J. Zhu, and J. Nilsson Pravastatin Treatment Increases Collagen Content and Decreases Lipid Content, Inflammation, Metalloproteinases, and Cell Death in Human Carotid Plaques : Implications for Plaque Stabilization Circulation, February 20, 2001; 103(7): 926 - 933. [Abstract] [Full Text] [PDF]
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U. Rauch, J. I. Osende, V. Fuster, J. J. Badimon, Z. Fayad, and J. H. Chesebro Thrombus Formation on Atherosclerotic Plaques: Pathogenesis and Clinical Consequences Ann Intern Med, February 6, 2001; 134(3): 224 - 238. [Abstract] [Full Text] [PDF]
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B. D. Horne, J. B. Muhlestein, J. F. Carlquist, T. L. Bair, T. E. Madsen, N. I. Hart, and J. L. Anderson Statin therapy, lipid levels, C-reactive protein and the survival of patients with angiographically severe coronary artery disease J. Am. Coll. Cardiol., November 15, 2000; 36(6): 1774 - 1780. [Abstract] [Full Text] [PDF]
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J. J. P. Kastelein, J. W. Jukema, A. H. Zwinderman, S. Clee, A. J. van Boven, H. Jansen, T. J. Rabelink, R. J. G. Peters, K. I. Lie, G. Liu, et al. Lipoprotein Lipase Activity Is Associated With Severity of Angina Pectoris Circulation, October 3, 2000; 102(14): 1629 - 1633. [Abstract] [Full Text] [PDF]
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K. K. Koh Effects of statins on vascular wall: vasomotor function, inflammation, and plaque stability Cardiovasc Res, September 1, 2000; 47(4): 648 - 657. [Abstract] [Full Text] [PDF]
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R. A. O'Rourke, B. H. Brundage, V. F. Froelicher, P. Greenland, S. M. Grundy, R. Hachamovitch, G. M. Pohost, L. J. Shaw, W. S. Weintraub, W. L. Winters Jr, et al. American College of Cardiology/American Heart Association Expert Consensus Document on Electron-Beam Computed Tomography for the Diagnosis and Prognosis of Coronary Artery Disease : Committee Members Circulation, July 4, 2000; 102(1): 126 - 140. [Full Text] [PDF]
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R. A. O'Rourke, B. H. Brundage, V. F. Froelicher, P. Greenland, S. M. Grundy, R. Hachamovitch, G. M. Pohost, L. J. Shaw, W. S. Weintraub, W. L. Winters Jr, et al. American College of Cardiology/American Heart Association expert consensus document on electron-beam computed tomography for the diagnosis and prognosis of coronary artery disease J. Am. Coll. Cardiol., July 1, 2000; 36(1): 326 - 340. [Full Text] [PDF]
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L. A. Prosser, A. A. Stinnett, P. A. Goldman, L. W. Williams, M. G.M. Hunink, L. Goldman, and M. C. Weinstein Cost-Effectiveness of Cholesterol-Lowering Therapies according to Selected Patient Characteristics Ann Intern Med, May 16, 2000; 132(10): 769 - 779. [Abstract] [Full Text] [PDF]
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M. J. Zema Gemfibrozil, nicotinic acid and combination therapy in patients with isolated hypoalphalipoproteinemia: a randomized, open-label, crossover study J. Am. Coll. Cardiol., March 1, 2000; 35(3): 640 - 646. [Abstract] [Full Text] [PDF]
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C. J. Vaughan, A. M. Gotto Jr., and C. T. Basson The evolving role of statins in the management of atherosclerosis J. Am. Coll. Cardiol., January 1, 2000; 35(1): 1 - 10. [Abstract] [Full Text] [PDF]
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C. Indolfi, A. Cioppa, E. Stabile, E. Di Lorenzo, G. Esposito, A. Pisani, A. Leccia, L. Cavuto, A. M. Stingone, A. Chieffo, et al. Effects of hydroxymethylglutaryl coenzyme A reductase inhibitor simvastatin on smooth muscle cell proliferation in vitro and neointimal formation in vivo after vascular injury J. Am. Coll. Cardiol., January 1, 2000; 35(1): 214 - 221. [Abstract] [Full Text] [PDF]
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J. C. LaRosa, J. He, and S. Vupputuri Effect of Statins on Risk of Coronary Disease: A Meta-analysis of Randomized Controlled Trials JAMA, December 22, 1999; 282(24): 2340 - 2346. [Abstract] [Full Text] [PDF]
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E.-S. Tan, J. van der Meer, P. Jan de Kam, P. H. J. M. Dunselman, B. J. M. Mulder, C. A. P. L. Ascoop, M. Pfisterer, K. I. Lie, and for CABADAS Research Group of the Interuniversity Worse clinical outcome but similar graft patency in women versus men one year after coronary artery bypass graft surgery owing to an excess of exposed risk factors in women J. Am. Coll. Cardiol., November 15, 1999; 34(6): 1760 - 1768. [Abstract] [Full Text] [PDF]
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