Objectives. To compare the efficacy of the newest cholesterol-lowering drug, rosuvastatin (RSV) with atorvastatin (ATV) in subjects with type 2 diabetes.
Design. A 24-week, open-label, randomized, parallel-group, phase IIIb, multicentre study.
Setting. Diabetes outpatient clinics of 26 hospitals in the Netherlands.
Subjects. A total of 263 patients with type 2 diabetes treated with oral agents or insulin, age (mean ± SD) 60 ± 10 years, body mass index (BMI) 31.4 ± 6.1 kg m−2, 46% males.
Intervention. After a 6-week dietary lead-in period, patients were randomized to RSV (n = 131) or ATV (n = 132) treatment in a dose escalation scheme (RSV: 10, 20 and 40 mg or ATV: 20, 40 and 80 mg for 6 weeks each sequentially).
Main outcome measures. Primary outcome was the change in apolipoprotein B (apoB) and apoB/apolipoprotein A1 (apoA1) ratio, which has been suggested a better predictor for cardiovascular events than total (TC) or low-density lipoprotein cholesterol (LDL-C). Secondary outcomes were the changes in other lipid parameters.
Results. Baseline LDL-C in the RSV and ATV groups was 4.23 ± 0.98 mmol L−1 and 4.43 ±0.99 mmol L−1, whilst apoB/apoA1 was 0.86 ±0.22 and 0.92 ± 0.35, respectively. A greater reduction in apoB/apoA1 was seen with RSV (−34.9%, −39.2% and −40.5%) than with ATV (−32.4%, −34.7% and −35.8%, P < 0.05 at weeks 12 and 18). Significantly greater reductions in LDL-C were also seen with RSV (−45.9%, −50.6% and −53.6%) than with ATV (−41.3%, −45.6% and −47.8%, all P < 0.05). The American Diabetes Association (ADA) LDL-C goal of <2.6 mmol L−1 was reached by 82%, 84% and 92% of patients with RSV and 74%, 79% and 81% with ATV. Triglyceride reductions ranged from 16 to 24% and were not different between treatments. Both treatments were well-tolerated: nine patients in the RSV and 11 in the ATV group withdrew from treatment because of adverse events after randomization.
Conclusion. In subjects with type 2 diabetes, greater improvements of apoB/apoA1 and across the lipid profile were observed with RSV compared with ATV.