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Rosuvastatin Therapy Results in Significant Regression of Atherosclerosis

March 15, 2006

By: Sahar Bedrood and Asher Kimchi M.D.

Cleveland, Ohio - The inhibition of atherosclerotic progression by statin therapy is a heavily studied area of cardiovascular medicine today. While there have been many previous clinical studies showing the benefits of rosuvastatin, Dr. Steven Nissen et al from the Cleveland Clinic Foundation used intravascular ultrasound (IVUS) to monitor whether intensive statin therapy could regress coronary atherosclerosis. The study, published in the March 13, 2006 issue of The Journal of the American Medical Association, found very high-intensity rosuvastatin at 40 mg/d achieved an average LDL-C level of 60.8 mg/dL and increased the HDL-C by 14.7%, resulting in significant regression of atherosclerosis.

Prior IVUS trials have demonstrated slowing or halting of atherosclerotic progression with statin therapy. The study by Nissen et al performed a more extensive analysis by measuring the change from baseline in the percent atherosclerotic volume (PAV) and nominal atheroma volume change in the subsegment with the greatest disease severity. 

Between November 2002 and October 2003, 507 patients had a baseline IVUS examination and received at least 1 dose of study drug. After 24 months, 349 patients had evaluable serial IVUS examinations. All patients received intensive statin therapy with rosuvastatin, 40 mg/d.

The mean (SD) baseline low-density lipoprotein cholesterol (LDL-C) level of 130.4 (34.3) mg/dL declined to 60.8 (20.0) mg/dL, a mean reduction of 53.2% (P<.001). Mean (SD) high-density lipoprotein cholesterol (HDL-C) level at baseline was 43.1 (11.1) mg/dL, increasing to 49.0 (12.6) mg/dL, an increase of 14.7% (P<.001). The mean (SD) change in PAV for the entire vessel was 0.98% (3.15%), with a median of 0.79% (97.5% CI, 1.21% to 0.53%) (P<.001 vs. baseline). The mean (SD) change in atheroma volume in the most diseased 10-mm subsegment was 6.1 (10.1) mm3, with a median of 5.6 mm3 (97.5% CI, 6.8 to 4.0 mm3) (P<.001 vs. baseline). Change in total atheroma volume showed a 6.8% median reduction; with a mean (SD) reduction of 14.7 (25.7) mm3, with a median of 12.5 mm3 (95% CI, 15.1 to 10.5 mm3) (P<.001 vs. baseline). Adverse events were infrequent and similar to other statin trials.

It was concluded that very high-intensity statin therapy using rosuvastatin 40 mg/d achieved an average LDL-C of 60.8 mg/dL and increased HDL-C by 14.7%, resulting in significant regression of atherosclerosis for all IVUS measures of disease burden. The total atheroma volume showed a 6.8% median reduction from baseline. Lowering of LDL-C levels and increasing HDL-C levels can regress atherosclerosis in coronary disease patients.

This study was presented on March 12, 2006 at the American College of Cardiology conference in Atlanta, Georgia.

Co-authors: Steven E. Nissen, MD; Stephen J. Nicholls, MBBS, PhD; Ilke Sipahi, MD; Peter Libby, MD; Joel S. Raichlen, MD; Christie M. Ballantyne, MD; Jean Davignon, MD; Raymond Erbel, MD; Jean Charles Fruchart, PhD; Jean-Claude Tardif, MD; Paul Schoenhagen, MD; Tim Crowe, BS; Valerie Cain, MS; Kathy Wolski, MPH; Marlene Goormastic, MPH; E. Murat Tuzcu, MD; for the ASTEROID Investigators

 

 


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