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Rosuvastatin Shows Better Results in Lipid Parameters Among Diabetic Patients: Presented at DALM

By Chris Berrie

VENICE, ITALY -- October 25, 2004 -- In comparison with atorvastatin, rosuvastatin appears to result in significantly greater improvements in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (HDL-C), apoprotein (apo) A-I and apo B, and total cholesterol in patients with type 2 diabetes mellitus.

The findings, from a Swedish multicentre, 16-week, double-blind, randomised, parallel-group study, were presented here on October 24th at the XV International Symposium on Drugs Affecting Lipid Metabolism.

Dr. Annica Siewert-Delle, MD, PhD, medical director, cardiovascular area, AstraZeneca Sverige AB, Södertälje, Sweden, presented the data on behalf of the Use of Rosuvastatin versus Atorvastatin in type 2 diabetes mellitus subjects (URANUS) study.

"We wanted a study that would mimic the clinical practice in the care of diabetic patients, where they have a lipid profile with a high LDL-C, the bad cholesterol, and a low HDL-C, which is the good cholesterol, and they also have a high risk of cardiovascular disease," Dr. Siewert-Delle said.

The study was designed with a 6-week dietary run-in period followed by randomisation in a double-blind fashion to 4 weeks of either risuvastatin (RSV) 10 mg or atorvastatin (ATV) 10 mg. Subjects who did not achieve the 1998 European LDL-C goal (< 3 mmol/L; < 115 mg/dL) at this stage were then titrated to 4 weeks of RSV 20 mg or ATV 20 mg, respectively. For those still not reaching the LDL-C goal at 8 weeks, there was a further single-dose titration to 40 mg/day of RSV or 2 further dose titrations to 40 mg and 80 mg at 8 and 12 weeks for ATV.

Of the 665 patients enrolled, a total of 232 RSV patients and 233 ATV patients were analysed for efficacy in the intent-to-treat population. The patient baseline demographic characteristics were comparable across the 2 main treatment groups (RSV/ATV).

After 4 weeks, there was a significantly greater reduction in LDL-C in the RSV group than in the ATV group (47.6% vs 38.5%, P <.001), which was paralleled at 16 weeks (52.3% vs 45.5%, respectively; P <.001). Similarly, more RSV patients, as compared to ATV patients, achieved the 1998 European LDL-C goal at 4 weeks (81% vs 65%, respectively; P <.001) and 16 weeks (94% vs 88%, respectively; P <.05).

The 16-week data for RSV showed further significant improvements over ATV, seen as increased apo A-I (2.6% vs -0.2%, respectively; P <.01), and decreased apo B (42.5% vs 40.1%, respectively; P <.001), non-HDL-C (45.0% vs 39.6%, respectively; P <.001), and total cholesterol (35.4% vs 31.3%, respectively; P <.001). The slight increase in HDL-C and the reduction in triglyceride were not significantly different between these two groups (5.3% vs 4.0% increase, and 21.2% vs 21.1% decrease, respectively).

Both drugs were well tolerated, with similar incidents of adverse events (RSV, 51%; ATV, 53%). Although the serious adverse events in response to rosuvastatin were 0.8% and 3.4%, respectively, none of these were considered to be drug related. There were also no clinically important abnormalities in alanine aminotransferase or aspartate aminotransferase levels, and no significant differences between the groups for changes in urinary albumin secretion from baseline to end of treatment (RSV, 0.5 mcg/mL increase, ATV, no change).

"Most of the patients, around 8 out of 10, reach the goals on 10 mg, and you get more patients with type 2 diabetes to a better lipid profile if you start with rosuvastatin," Dr. Siewert-Delle stressed.


[Presentation title: Effects of Rosuvastatin and Atorvastatin on LDL-C and Apolipoproteins A-I and B in Patients With Type 2 Diabetes: Results of the URANUS Study. Poster 180]

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