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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