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Rosuvastatin May Be Better Than Atorvastatin in Patients With Metabolic Syndrome: Presented at DALM

VENICE, ITALY -- October 25, 2004 -- Rosuvastatin shows significantly greater improvements in markers of the metabolic syndrome compared with either placebo or atorvastatin, researchers said here on October 24th at the XV International Symposium on Drugs Affecting Lipid Metabolism.

The benefits of rosuvastatin were seen in levels of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), apoprotein (apo) A-I and apo B, total cholesterol, and nonHDL-C, according to results of an international, 12-week, double-blind, double-dummy, randomised, 3-arm, parallel-group study.

Jan Murin, MD, national coordinator and professor of cardiology, 1st internal medicine department, University Hospital, Bratislavia, Slovakia, presented the data on behalf of the 68-centre COMparative study with rosuvastatin in subjects with METabolic Syndrome (COMET) study group.

"The study deals with the problem of patients with the metabolic syndrome, which is a group of patients somewhere between normal people and patients with diabetes, based on the NCEP ATP III [National Cholesterol Education Program Adult Treatment Panel III] definition of the metabolic syndrome," Dr. Murin said.

Of 1341 patients entered in the 4-week dietary lead-in period, 401 were randomised to 1 of 3 treatment arms in a 1:2:2 ratio for 6 weeks: 79 to placebo, 165 to 10 mg of rosuvastatin (RSV10), or 157 to atorvastatin 10 mg (ATV10).

After the initial 6 weeks of treatment, the placebo and RSV10 groups were switched to rosuvastatin 20 mg (placebo/RSV20 and RSV10/20, respectively) and the ATV10 group received atorvastatin 20 mg (ATV10/20) for a further 6 weeks.

The primary efficacy analysis was performed for the intent-to-treat (ITT) population, and the primary end point was the change from baseline in LDL-C in 6 weeks. The percentage changes from baseline of the lipoprotein parameters that were also assessed were compared between treatment groups using analysis of variance and the achievement of LDL-C goals was compared by logistic regression analysis.

Patients' baseline characteristics, as the randomised populations by as-allocated treatments, showed no significant differences between the 3 12-week groups, with mean ages of 57.8, 58.1, and 57.3 years (placebo/RSV20, RSV10/20 and ATV10/20, respectively).

At 6 weeks, RSV10 reduced LDL-C significantly more than placebo and ATV10 (42.7% vs 0.3% and 36.6%, respectively; P <.0001). At 12 weeks, the placebo/RSV20 and RSV10/20 groups showed significantly greater reductions in LDL-C than ATV10/20 (48.9% vs 42.5%, respectively; P <.001).

A significantly greater number of the rosuvastatin-treated patients achieved the recommended LDL-C goals after 12 weeks, in comparison with atorvastatin-treated patients (1998 European goal: 90% vs 83%, P <.05; NCEP ATP III goal: 91% vs 79%, P <.05).

The 12-week data, which was paralleled by 6-week data, showed further significant improvements between the combined placebo/RSV20 and RSV10/20 group and ATV10/20, in terms of increased HDL-C levels (10.4% vs 5.8%, respectively; P <.01) and apo A-I (6.5% vs 2.7%, respectively; P <.01), and decreased apo B (40.8% vs 35.9%, respectively; P <.001), non-HDL-C (46.6% vs 40.8%, respectively; P <.001), and total cholesterol (36.8% vs 32.5%, respectively; P <.001).

Changes in triglycerides and high-sensitivity C-reactive protein were not significantly different between these 2 groups (22.9% vs 25.2% and 28.6% vs 27.7%, respectively).

The overall occurrence of adverse events was similar between these 3 groups (placebo/RSV20, 34.2%; RSV10/20, 40.5%; and ATV10/20, 37%), although clinically important elevations in alanine aminotransferase did occur in 1 RSV10/20 patient, and creatine kinase was elevated in 2 patients (1 RSV10/20, and 1 ATV10/20).

Dr. Murin concluded that although the LDL-C levels were not specifically high at the start of this study, "The most important thing was that in these patients the metabolic syndrome [LDL-C levels] came down further with rosuvastatin than with atorvastatin, with the change in HDL also being very important, and with the full data showing a general improvement in the quality of the lipids spectrum [in rosuvastatin-treated patients compared to atorvastatin and placebo]."


[Presentation title: Rosuvastatin Has Greater Beneficial Effects Than Atorvastatin on LDL-C, HDL-C and Apolipoproteins A-I and B In Subjects With the Metabolic Syndrome. Poster 179]

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