ArticlesRenal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial
Introduction
The number of patients with declining renal function progressing to end-stage renal disease is rising worldwide, particularly as a result of atherosclerosis and type 2 diabetes.1 Lifestyle and dietary changes can reduce the risk of adverse renal outcomes, as can glucose-lowering and blood pressure-lowering drugs.2, 3, 4, 5, 6 Nevertheless, residual progressive renal function loss is high,7 and end-stage renal disease imposes enormous health and cost burdens on high-income countries.8
Cholesterol is thought to be an important risk factor for loss of renal function. Experimental studies have shown that cholesterol might have a role in renal disease progression, and lowering cholesterol concentrations with statins has renoprotective effects.9 However, in clinical studies, statins seem to have varying effects on renal function,10 and a recent large study with a renal hard outcome failed to show that a combination of simvastatin and ezetimibe had a renoprotective effect.11, 12 We did the Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients with Progressive Renal Disease (PLANET I) trial to assess the renal effects of two different statins on patients with diabetes and proteinuria.
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Study design and participants
We did this randomised, double-blind, parallel-group trial at 147 research centres in Argentina, Brazil, Bulgaria, Canada, Denmark, France, Hungary, Italy, Mexico, Romania, and the USA. During an 8-week lead-in period, patients with diabetes and proteinuria were given dietary advice and underwent optimisation of existing hypertension treatment and stopped taking statins (if applicable). Eligible patients were aged 18 years or older and had type 1 or type 2 diabetes with proteinuria (urine
Results
We did PLANET I from Feb 8, 2006, to March 3, 2009. We screened 1642 patients, of whom we enrolled 353. 118 patients were assigned to rosuvastatin 10 mg, 124 to rosuvastatin 40 mg, and 111 to atorvastatin 80 mg. 325 patients constituted the intention-to-treat population (figure 1); 47 patients (14·5%) had type 1 diabetes and 278 (85·5%) had type 2 diabetes. Baseline demographic, clinical, and biochemical characteristics and concomitant treatments were balanced between treatment groups (table 1;
Discussion
The PLANET I study showed that urinary protein excretion was reduced during 1 year of treatment with atorvastatin 80 mg, with no significant changes in eGFR in patients with diabetes and proteinuria. In patients given rosuvastatin 40 mg, urinary protein excretion was not significantly different from baseline, but the patients did have a significant decrease from baseline in eGFR, and doubling of serum creatinine and acute renal failure were more common in this group. Although the study was not
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Dr Vidt died in April, 2013