Patients treated with very intensive statin therapy lowered LDL-C levels on average by about 50 percent, increased HDL-C levels by 15 percent, and showed regression of coronary atherosclerosis, according to a study that will appear in the April 5 issue of JAMA: The Journal of the American Medical Association.
The study is being released early online to coincide with its presentation at the American College of Cardiology annual conference.
Atherosclerosis (the accumulation of fatty deposits inside arterial walls) is generally viewed as a chronic, progressive disease. Prior intravascular ultrasound (IVUS) trials have demonstrated slowing or halting of atherosclerosis progression with statin therapy but have not shown convincing evidence of atherosclerosis regression, as measured using percent atheroma (fatty deposit buildup in an artery) volume (PAV), the most rigorous IVUS indicator of disease progression and regression, according to background information in the article.
Steven E. Nissen, M.D., of the Cleveland Clinic, and colleagues with the ASTEROID Trial conducted a study to determine the effects of high-intensity statin therapy on IVUS-derived measures of coronary atherosclerosis regression. Rosuvastatin is one of the most recently introduced statins and typically produces greater reductions in low-density lipoprotein cholesterol (LDL-C) and larger increases in high-density lipoprotein cholesterol (HDL-C) than previously available agents. The trial was performed at 53 community and tertiary care centers in the United States, Canada, Europe, and Australia. Coronary atheroma burden was measured at baseline and after 24 months of treatment. Between November 2002 and October 2003, 507 patients had a baseline IVUS examination and received at least 1 dose of study drug, rosuvastatin, 40 mg/d. After 24 months, 349 patients had evaluable serial IVUS examinations.
The researchers found that the average baseline LDL-C level of 130.4 mg/dL declined to 60.8 mg/dL, an average reduction of 53.2 percent. Average HDL-C level at baseline was 43.1 mg/dL, increasing to 49.0 mg/dL, an increase of 14.7 percent. For the primary efficacy parameter of change in PAV, the average decrease was -0.98 percent and 63.6 percent of patients showed regression of atherosclerosis. For the second primary efficacy parameter, change in atheroma volume in the 10-mm subsegment with the greatest disease severity, there was a median (midpoint) reduction of 9.1 percent in atheroma volume, and 78.1 percent of patients demonstrated regression of atherosclerosis. The secondary efficacy parameter, change in total atheroma volume, showed a 6.8 percent median reduction. Adverse events were infrequent and similar to other statin trials.