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

Dick de Zeeuw, Deborah A. Anzalone, Valerie A. Cain, Michael D. Cressman, Hiddo J Lambers Heerspink, Bruce Molitoris, John T. Monyak, Hans Henrik Parving, Giuseppe Remuzzi, James R. Sowers, Donald G. Vidt

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)181-190
Number of pages10
JournalThe Lancet Diabetes and Endocrinology
Volume3
Issue number3
DOIs
StatePublished - Mar 1 2015

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Randomized Controlled Trials
Kidney
Creatinine
Proteinuria
Urine
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Proteins
Atorvastatin Calcium
Rosuvastatin Calcium
Lipids
Bulgaria
Romania
Hungary
Angiotensin Receptor Antagonists
Argentina
Denmark
Mexico
Chronic Renal Insufficiency
Angiotensin-Converting Enzyme Inhibitors
Type 2 Diabetes Mellitus

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine
  • Endocrinology

Cite this

Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I) : A randomised clinical trial. / de Zeeuw, Dick; Anzalone, Deborah A.; Cain, Valerie A.; Cressman, Michael D.; Heerspink, Hiddo J Lambers; Molitoris, Bruce; Monyak, John T.; Parving, Hans Henrik; Remuzzi, Giuseppe; Sowers, James R.; Vidt, Donald G.

In: The Lancet Diabetes and Endocrinology, Vol. 3, No. 3, 01.03.2015, p. 181-190.

Research output: Contribution to journalArticle

de Zeeuw, D, Anzalone, DA, Cain, VA, Cressman, MD, Heerspink, HJL, Molitoris, B, Monyak, JT, Parving, HH, Remuzzi, G, Sowers, JR & Vidt, DG 2015, 'Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): A randomised clinical trial', The Lancet Diabetes and Endocrinology, vol. 3, no. 3, pp. 181-190. https://doi.org/10.1016/S2213-8587(14)70246-3
de Zeeuw, Dick ; Anzalone, Deborah A. ; Cain, Valerie A. ; Cressman, Michael D. ; Heerspink, Hiddo J Lambers ; Molitoris, Bruce ; Monyak, John T. ; Parving, Hans Henrik ; Remuzzi, Giuseppe ; Sowers, James R. ; Vidt, Donald G. / Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I) : A randomised clinical trial. In: The Lancet Diabetes and Endocrinology. 2015 ; Vol. 3, No. 3. pp. 181-190.
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T1 - Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I)

T2 - A randomised clinical trial

AU - de Zeeuw, Dick

AU - Anzalone, Deborah A.

AU - Cain, Valerie A.

AU - Cressman, Michael D.

AU - Heerspink, Hiddo J Lambers

AU - Molitoris, Bruce

AU - Monyak, John T.

AU - Parving, Hans Henrik

AU - Remuzzi, Giuseppe

AU - Sowers, James R.

AU - Vidt, Donald G.

PY - 2015/3/1

Y1 - 2015/3/1

N2 - 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.

AB - 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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