Protection Against Nephropathy in Diabetes with Atorvastatin (PANDA): a randomized double-blind placebo-controlled trial of high- vs. low-dose atorvastatin

Authors: Rutter, M. K.; Prais, H. R.; Charlton-Menys, V.; Gittins, M.¹; Roberts, C.¹; Davies, R. R.; Moorhouse, A.; Jinadev, P.; France, M.; Wiles, P. G.; Gibson, J. M.; Dean, J.²; Kalra, P. A.; Cruickshank, J. K.; Durrington, P. N.

Source: Diabetic Medicine, Volume 28, Number 1, January 2011 , pp. 100-108(9)

Publisher: Wiley-Blackwell

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Abstract:

Diabet. Med. 28, 100-108 (2011) Abstract Aims

To compare the renal effects of low- vs. high-dose atorvastatin in patients with Type 2 diabetes mellitus and optimally managed early renal disease. Methods

We compared the 2-year progression of nephropathy in a double-blind randomized controlled trial of atorvastatin 80 mg/day (n = 60) vs. 10 mg/day (n = 59) in patients with Type 2 diabetes with microalbuminuria or proteinuria [mean (sd): age 64 years (10 years); HbA_1c 7.7% (1.3%), 61 mmol/mol (10 mmol/mol); blood pressure 131/73 mmHg; renin-angiotensin system blocker use > 80%; dual blockade > 67%] recruited from diabetes clinics in Greater Manchester. Results

Over (mean) 2.1 years of follow-up, the Modification of Diet in Renal Disease estimated glomerular filtration rate declined by 3 ml min⁻¹ 1.73 m⁻² in the combined group. The mean (95% CI) between-group difference during follow-up was not significant [2.2 ml min⁻¹ 1.73 m⁻² (−1.1 to 5.4 ml min⁻¹ 1.73 m⁻²), P = 0.20] after adjusting for baseline differences in renal function; positive difference favours 80 mg dose. Similarly, there was no significant difference in creatinine clearance by Cockcroft and Gault [2.5 ml/min (−2.4 to 7.3 ml/min), P = 0.32]; serum creatinine/24-h urine collections [4.0 ml/min (−4.8 to 12.7 ml/min), P = 0.38]; cystatin C (P = 0.69); or 24-h urine protein or albumin excretion (P = 0.92; P = 0.93). We recorded no significant between-group differences in deaths or adverse events. Conclusions

In patients with Type 2 diabetes with early renal disease, we found no statistical difference in renal function between those taking high- or low-dose atorvastatin over 2 years. We cannot exclude a beneficial effect of < 1.6 ml min⁻¹ 1.73 m⁻² year⁻¹ on Modification of Diet in Renal Disease estimated glomerular filtration rate, or if blood pressure management or if renin-angiotensin system blocker use had not been optimized.

Keywords: 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor; microalbuminuria; nephropathy; randomized control trial; Type 2 diabetes

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1464-5491.2010.03139.x

Affiliations: 1: Statistics, University of Manchester, Manchester 2: Bolton Primary Care Trust, Bolton, UK

Publication date: 2011-01-01

Protection Against Nephropathy in Diabetes with Atorvastatin (PANDA): a randomized double-blind placebo-controlled trial of high- vs. low-dose atorvastatin

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