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Rosuvastatin Improves Apolipoprotein Levels: Presented at ISA

By Eurona Earl Tilley

KYOTO, JAPAN -- October 1, 2003 -- Use of rosuvastatin was associated with beneficial effects on atherogenic and antiatherogenic apolipoprotein levels in patients with hypercholesterolaemia, according to findings presented here September 30^th at the 13^th International Symposium on Atherosclerosis.

According to presenter Evan A. Stein, MD, President, Medical Research Laboratories International, Highland Heights, Kentucky, United States, previous studies showed the levels of apolipoprotein B (apo B), apolipoprotein A-1 (apo A-1), and the ratio of apo B to apo A-1 is predictive of the development of cardiovascular disease.

In the current study, Dr. Stein and associates evaluated the effects of rosuvastatin, atorvastatin, simvastatin, and pravastatin on apo B, apo A-1, and apo B:apo A-1.

For this trial, the researchers analysed adults with hypercholesterolaemia from 182 centres in the United States, with 154 to 165 patients per group. Each participant had a low-density lipoprotein (LDL) level between 160 and 250 mg/dL, as well as a triglyceride level of less than 400 mg/dL. They underwent a 6-week dietary lead-in period prior to the study, at which time the use of all lipid-lowering drugs and supplements was suspended.

Each patient was randomly placed in 1 of 15 treatments groups: rosuvastatin 10 mg/day, 20 mg/day, 40 mg/day, or 80 mg/day; atorvastatin 10 mg/day, 20 mg/day, 40 mg/day, or 80 mg/day; simvastatin 10 mg/day, 20 mg/day, 40 mg/day, or 80 mg/day; pravastatin 10 mg/day, 20 mg/day, or 40 mg/day. Each dose was given orally for 6 weeks.

The rosuvastatin 10-40 mg/day groups had a decrease in apo B of 37% to 45% compared to 29% to 43% in the atorvastatin groups, 22% to 35% in the simvastatin groups, and 15% to 23% in the pravastatin groups. In addition, rosuvastatin was associated with a 7% to 8.8% increase in apo A-1 levels. Apo A-1 increases in the other groups -- atorvastatin, simvastatin, and pravastatin -- were 0.1% to 5.6%, 4.9% to 7.8%, and 3.5% to 6.5% respectively.

Dr. Stein explained that during the study, a Federal Drug Administration advisory committee declared the 80 mg dose of rosuvastatin to be unsafe. Consequently, this data is excluded from the results.

Comparable percentages and types of adverse effects were seen in the other treatment groups. The most common adverse effects were pain, pharyngitis, myalgia, and headache.

In closing, Dr. Stein stressed that rosuvastatin 10 to 40 mg decreased apo B levels more than equivalent doses of atorvastatin. Moreover, rosuvastatin 10 to 40 mg was superior to equivalent or greater doses of simvastatin and pravastatin in reducing apo B.

Rosuvastatin at 10 and 20 mg also resulted in the greatest mean increases in apo A-1. The lowest increases were seen in the atorvastatin 80 mg, atorvastatin 40 mg, and pravastatin 10 mg groups. Furthermore, rosuvastatin 10 to 40 mg had the most favourable reductions in the apo B:apo A-1 ratio when compared to the other statins.


[Study title: Rosuvastatin Improves Apolipoproteins A-1 and B More Than Atorvastatin, Simvastatin, and Pravastatin (STELLAR Trial Results). Abstract 2P-0585]

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