Berne Christian, Siewert-Delle Annica
University Hospital, Uppsala, Sweden.
Cardiovasc Diabetol. 2005 Jun 3;4:7. doi: 10.1186/1475-2840-4-7.
The Use of Rosuvastatin versus Atorvastatin iN type 2 diabetes mellitUS (URANUS) study compared rosuvastatin with atorvastatin for the reduction of low-density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes.
After a 6-week dietary run-in, patients aged > or = 18 years with type 2 diabetes and LDL-C > or = 3.3 mmol/L were randomised to double-blind treatment with rosuvastatin 10 mg (n = 232) or atorvastatin 10 mg (n = 233) for 4 weeks. Doses were then titrated up to a maximum of rosuvastatin 40 mg or atorvastatin 80 mg over 12 weeks to achieve the 1998 European LDL-C goal (<3.0 mmol/L).
Rosuvastatin reduced LDL-C levels significantly more than atorvastatin during the fixed-dose and titration periods (p < 0.0001). Significantly more patients reached the 1998 LDL-C goal with rosuvastatin 10 mg compared with atorvastatin 10 mg at 4 weeks (81% vs 65%, p < 0.001). At 16 weeks, significantly more patients achieved their LDL-C goal with rosuvastatin compared with atorvastatin (94% vs 88%, p < 0.05) and more patients receiving rosuvastatin remained at their starting dose with reduced requirement for dose titration. At 4 weeks, 65% of rosuvastatin patients had reached their 2003 European LDL-C goal (< 2.5 mmol/L), compared with 33% of atorvastatin patients (p < 0.0001). Both treatments were similarly well tolerated with no unexpected safety concerns.
At the start dose and following dose titration, rosuvastatin was significantly more effective than atorvastatin at reducing LDL-C and achieving European LDL-C goals in patients with type 2 diabetes.
瑞舒伐他汀与阿托伐他汀治疗2型糖尿病(URANUS)研究比较了瑞舒伐他汀与阿托伐他汀降低2型糖尿病患者低密度脂蛋白胆固醇(LDL-C)的效果。
经过6周的饮食导入期后,年龄≥18岁、患有2型糖尿病且LDL-C≥3.3 mmol/L的患者被随机分为两组,进行为期4周的双盲治疗,一组服用10 mg瑞舒伐他汀(n = 232),另一组服用10 mg阿托伐他汀(n = 233)。然后在12周内将剂量逐步滴定至最大剂量,瑞舒伐他汀为40 mg,阿托伐他汀为80 mg,以实现1998年欧洲LDL-C目标(<3.0 mmol/L)。
在固定剂量期和滴定期,瑞舒伐他汀降低LDL-C水平的效果显著优于阿托伐他汀(p < 0.0001)。在4周时,服用10 mg瑞舒伐他汀的患者达到1998年LDL-C目标的比例显著高于服用10 mg阿托伐他汀的患者(81%对65%,p < 0.001)。在16周时,服用瑞舒伐他汀的患者达到LDL-C目标的比例显著高于阿托伐他汀(94%对88%,p < 0.05),并且更多服用瑞舒伐他汀的患者维持在起始剂量,减少了剂量滴定的需求。在4周时,65%服用瑞舒伐他汀的患者达到了2003年欧洲LDL-C目标(<2.5 mmol/L),而服用阿托伐他汀的患者这一比例为33%(p < 0.0001)。两种治疗的耐受性相似,没有出现意外的安全问题。
在起始剂量和剂量滴定后,瑞舒伐他汀在降低2型糖尿病患者LDL-C水平及实现欧洲LDL-C目标方面显著优于阿托伐他汀。