Monday, March 13, 2006

Breakthrough for high-risk individuals

Aggressive statin therapy with Crestor (rosuvastatin) can dramatically lower LDL levels, raise HDLs by an unprecedented amount, and even partially reverse coronary artery plaques volume, showed results of the ASTEROID trial that were revealed today.

Patients with coronary artery disease who took 40 mg of Crestor over two years had a mean reduction in LDL from 130 mg/dL to 60 mg/dL, a 53% drop, and a mean increase in HDL from 43 mg/dL to 49 mg/dL, an [astounding] 14.7% rise.

ASTEROID (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden) was a prospective, open-label trial with blinded endpoints.
The trial was designed to answer the question of whether 24 months of intensive therapy with Crestor could result in regression of coronary atherosclerosis, as measured by intravascular ultrasound.

The authors found that in the 349 patients who were available for follow-up at 24 months, mean LDL declined from 130.4 mg/dL to 60.8, a mean reduction of 53.2%. Mean HDL went from 43.1 mg/dL at baseline to 49.0 mg/dL, an increase of 14.7%.

Depending on the efficacy parameter, coronary artery disease was seen to regress in 64% to 78% of patients, and was seen in both men and women, in older and younger patients. Total atheroma volume reduction: 6.8%.

"Coronary atherosclerosis has traditionally been considered a chronic disease for which therapy could slow, but not prevent, progression," the study authors said. "We now know that maximally intensive lipid lowering can partially reverse the atherosclerotic disease process."

"While there will still be skeptics out there, and may be skeptics in this room still, I think the data does show regression, reversal, and I think it's a very exciting finding scientifically," said Roger S. Blumenthal, M.D., of Johns Hopkins at a briefing.

Dr. Blumenthal and his Hopkins colleague, Navin K. Kapur, M.D., wrote an editorial accompanying the ASTEROID study results in JAMA. Limitations? "While the results of this study are exciting, they are tempered by the lack of a control group receiving a somewhat less intensive LDL-C lowering regimen, the absence of paired intravascular ultrasound measurements in less diseased coronary segments to demonstrate reproducibility of atheroma volume measurements, and exclusion of patients with coronary stenoses measuring greater than 50% throughout a target segment."

While intravascular ultrasound-documented atherosclerotic regression is an intriguing finding, clinicians must remember that this may not be the best measure of the treatment's effect on hard cardiovascular end points.

"Nevertheless, the pioneering work has revolutionized the current approach to understanding the anatomy and pathophysiology of coronary atherosclerosis as well as its responsiveness to medical therapy. The results of several ongoing trials will help determine what agent or combination of pharmacologic agents is most efficacious in the long-term management of at-risk patients."

Though Crestor is one of the strongest statin drugs on the market for cholesterol, concern over side effects has played a roll in its lower than expected market share. However researchers said that patients in this study did not suffer any significant side effects.

"We were taking away many years of accumulation of cholesterol plaque in the coronary arteries and we've never been able to achieve that before with a statin therapy,” said Dr. Steven Nissen of Cleveland Clinic.

A real breakthrough.

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