Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial

瑞舒伐他汀 医学 阿托伐他汀 蛋白尿 2型糖尿病 内科学 泌尿科 临床终点 糖尿病 人口 瑞舒伐他汀钙 内分泌学 临床试验 环境卫生
作者
Dick de Zeeuw,Deborah Anzalone,Valerie A. Cain,Michael D. Cressman,Hiddo J.L. Heerspink,Bruce A. Molitoris,John T. Monyak,Hans‐Henrik Parving,Giuseppe Remuzzi,James R. Sowers,Donald G. Vidt
出处
期刊:The Lancet Diabetes & Endocrinology [Elsevier BV]
卷期号:3 (3): 181-190 被引量:135
标识
DOI:10.1016/s2213-8587(14)70246-3
摘要

Background The role of lipid-lowering treatments in renoprotection for patients with diabetes is debated. We studied the renal effects of two statins in patients with diabetes who had proteinuria. Methods PLANET I was a randomised, double-blind, parallel-group trial done in 147 research centres in Argentina, Brazil, Bulgaria, Canada, Denmark, France, Hungary, Italy, Mexico, Romania, and the USA. We enrolled patients with type 1 or type 2 diabetes aged 18 years or older with proteinuria (urine protein:creatinine ratio [UPCR] 500–5000 mg/g) and taking stable angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or both. We randomly assigned participants to atorvastatin 80 mg, rosuvastatin 10 mg, or rosuvastatin 40 mg for 52 weeks. The primary endpoint was change from baseline to week 52 of mean UPCR in each treatment group. The study is registered with ClinicalTrials.gov, number NCT00296374. Findings We enrolled 353 patients: 118 were assigned to rosuvastatin 10 mg, 124 to rosuvastatin 40 mg, and 111 to atorvastatin 80 mg; of these, 325 were included in the intention-to-treat population. UPCR baseline:week 52 ratio was 0·87 (95% CI 0·77–0·99; p=0·033) with atorvastatin 80 mg, 1·02 (0·88–1·18; p=0·83) with rosuvastatin 10 mg, and 0·96 (0·83–1·11; p=0·53) with rosuvastatin 40 mg. In a post-hoc analysis to compare statins, we combined data from PLANET I with those from PLANET II (a similar randomised parallel study of 237 patients with proteinuria but without diabetes; registered with ClinicalTrials.gov, NCT00296400). In this analysis, atorvastatin 80 mg lowered UPCR significantly more than did rosuvastatin 10 mg (−15·6%, 95% CI −28·3 to −0·5; p=0·043) and rosuvastatin 40 mg (−18·2%, −30·2 to −4·2; p=0·013). Adverse events occurred in 69 (60%) of 116 patients in the rosuvastatin 10 mg group versus 79 (64%) of 123 patients in the rosuvastatin 40 mg group versus 63 (57%) of 110 patients in the atorvastatin 80 mg group; renal events occurred in nine (7·8%) versus 12 (9·8%) versus five (4·5%). Interpretation Despite high-dose rosuvastatin lowering plasma lipid concentrations to a greater extent than did high-dose atorvastatin, atorvastatin seems to have more renoprotective effects for the studied chronic kidney disease population. Funding AstraZeneca.
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