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.