Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I)
| Autor: | Donald G. Vidt, Giuseppe Remuzzi, Hans-Henrik Parving, Deborah Anzalone, Dick de Zeeuw, John T. Monyak, Michael D. Cressman, Bruce A. Molitoris, Hiddo J.L. Heerspink, James R. Sowers, Valerie A. Cain |
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| Přispěvatelé: | Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET) |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
CHRONIC KIDNEY-DISEASE
Endocrinology Diabetes and Metabolism Atorvastatin Angiotensin-Converting Enzyme Inhibitors Type 2 diabetes Kidney PLACEBO-CONTROLLED TRIAL Gastroenterology GLOMERULAR-FILTRATION-RATE chemistry.chemical_compound Endocrinology Diabetic Nephropathies Rosuvastatin Calcium education.field_of_study Sulfonamides Lipids Europe Proteinuria Creatinine SAFETY HEART medicine.drug Adult medicine.medical_specialty NEPHROPATHY Population Diabetes Complications Angiotensin Receptor Antagonists Irbesartan Double-Blind Method Internal medicine Internal Medicine medicine Humans Rosuvastatin Pyrroles education METAANALYSIS Analysis of Variance IRBESARTAN Dose-Response Relationship Drug business.industry nutritional and metabolic diseases South America medicine.disease Fluorobenzenes Pyrimidines chemistry LOWERING LDL CHOLESTEROL ATHEROSCLEROSIS Heptanoic Acids North America business Kidney disease |
| Zdroj: | Lancet Diabetes & Endocrinology, 3(3), 181-190. ELSEVIER SCIENCE INC |
| ISSN: | 2213-8587 |
| Popis: | Summary 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 [U PCR ] 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 U PCR 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. U PCR 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 U PCR 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. |
| Databáze: | OpenAIRE |
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