STUDY
THE GALAXY™ PROGRAM'S ATHEROSCLEROSIS STUDIES
Atherosclerosis often remains asymptomatic for many years.1,9
Early detection and treatment of asymptomatic atherosclerosis can improve the prognosis of patients with cardiovascular disease.1,9
The use of vascular imaging techniques is an increasingly valuable approach to detect asymptomatic disease and assess the effects of treatment.1,9
These techniques also allow assessment of the effect of treatment on atherosclerosis.1,9
The GALAXY atherosclerosis studies are using these techniques to directly assess the effect of CRESTOR on the atherosclerotic disease process.1,9
1-Jones P et al. Am J Cardiol 2003;92:152–160; 2-McKenney J et al. Curr Med Res Opin 2003;19:689–698; 3-Jones P et al. Clin Ther 2004;26:1388–1399; 4-Deedwania P et al. Am J Cardiol 2005;95:360–366;5-Jones P et al. Atheroscler Suppl 2005; 6: 110 Abs W16-P-040; 6-Bays H et al. J Am Geriatr Soc 2004;52:S126; 7-Ballantyne C et al. Diabetalogia 2005;48:Abs 1083; 8-Asztalos BF et al. Am J Cardiol2007;99(5):681–685; 9-Stalenhoef A et al. Eur Heart J 2005;26:2664–2672.
Estudios completados de aterosclerosis GALAXY (1), (2) y (3)
GALAXY ATHEROSCLEROSIS STUDIES COMPLETED (2)
GALAXY ATHEROSCLEROSISSTUDIES COMPLETED (3)
ORION
ORIONGALAXY ATHEROSCLEROSIS STUDIES COMPLETED (1)
A 24-month, randomized, double-blind study to assess carotid artery atheroma progression by MRI and ultrasound in hypercholesterolemic subjects with asymptomatic carotid disease following treatment with CRESTOR® 5 mg or 40/80 mg.1-6
METEOR
METEORGALAXY ATHEROSCLEROSIS STUDIES COMPLETED (2)
A 24-month, randomized, double-blind, placebo-controlled study evaluating CRESTOR® 40 mg on the progression of carotid atherosclerosis by measurement of intima-media thickness (IMT) in low-risk, asymptomatic, hypercholesterolemic subjects with subclinical evidence of atherosclerosis.13-16
ASTEROID
ASTEROIDGALAXY ATHEROSCLEROSIS STUDIES COMPLETED (2)
A 24-month, open-label, non-comparative study using intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) to evaluate the effect of CRESTOR® 40 mg on coronary artery atheroma regression in patients with coronary heart disease requiring coronary angiography.7-12
COSMOS
COSMOSGALAXY ATHEROSCLEROSIS STUDIES COMPLETED (3)
An 18-month, single-arm, multicenter, open-label study using intravascular ultrasound to evaluate the effect of CRESTOR on plaque volume progression in Japanese subjects with hypercholesterolemia and coronary heart disease.17-18
Estudios EN CURSO DE ATEROSCLEROSIS GALAXY
GALAXY ATHEROSCLEROSIS STUDY ONGOING
SATURN
SATURNGALAXY ATHEROSCLEROSIS STUDIES COMPLETED (1)
A 104-week, multicenter, randomized, double-blind, parallel-group study comparing the effects of CRESTOR® 40 mg with atorvastatin 80 mg on percent atheroma volume (PAV) of a coronary artery, as measured by IVUS, in patients with coronary artery disease (CAD).19
References:
*In the ORION protocol, the original intent was that all subjects in the high-dose group received rosuvastatin 40 mg for 4 weeks and then increasing the rosuvastatin dose to 80 mg. Retrogradation to 40 mg wasallowed for subjects who could not tolerate the 80 mg dose or reached LDL-C levels <50 mg/dL. Following a protocol modification in May 2002, all subjects receiving 80 mg rosuvastatin were titrated to 40 mgrosuvastatin (80 mg exposure: n=14; range, 70-701 days) again. The 80 mg dose of rosuvastatin was only used in the clinical development program and was never licensed.1- Hatsukami TS et al. Atheroscler Suppl 2001;2:47–48 Abs P4; 2- Chu B et al. Stroke 2004;35:2444–2448; 3- Saam T et al. Late-breaking Poster EAS, Prague, 2005; 4- Shepherd J. Atherosclerosis2005;181:S1–S7; 5- Hatsukami TS et al. Eur Heart J 2005;26(Suppl): 6-26 Abs 3700; 6Underhill H et al. Am Heart J 2008;155:584.e1–584.e8.7-Nissen S et al. JAMA 2006;295:1556–1565; 8- Nissen S. Atheroscler Suppl 2003;4:27 Abs 1P-0037; 9- Chhatriwalla A et al. Future Cardiol 2006;2(6),651–654; 10-Sipahi I et al. Cleve Clin J Med 2006;73:937–944;11- Nicholls SJ et al. Circulation 2006;114 (18 Suppl S):808 Abs 3779; 12- Ballantyne C et al. Circulation 2008;117(19):2458–2466; 13- Crouse JR III et al. Cardiovasc Drugs Ther 2004;18:231–238; 14-Crouse III JRet al. Curr Med Res Opin 2007;23(3):641–648; 15- Crouse JR III et al. JAMA 2007;297: (12):1344–1353; 16- Crouse JR III et al. Atheroscler Suppl 2008;9 (1):200. 17-Takayama T et al. Circ J 2007;71(2):271–275;18- Nicholls SJ et al. Atheroscler Suppl 2008;9(1):202; 2Late breaker at the 73rd Annual Scientific Meeting of the Japanese Circulation Societ y, 20–22 March 2009, Oska, Japan. 19-Takayama T et al. Circ J2007;71(2):271–275; 2Nicholls SJ et al. Atheroscler Suppl 2008;9(1):202.
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