title: Protection Against Nephropathy in Diabetes with Atorvastatin (PANDA): a randomized double-blind placebo-controlled trial of high- vs. low-dose atorvastatin(1).
abstract: OBJECTIVE
  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.
authors.affiliation: Cardiovascular Medicine Research Group, School of Biomedicine, University of Manchester, Manchester, UK.
authors.forename: M K
authors.initials: MK
authors.lastname: Rutter
authors.forename: H R
authors.initials: HR
authors.lastname: Prais
authors.forename: V
authors.initials: V
authors.lastname: Charlton-Menys
authors.forename: M
authors.initials: M
authors.lastname: Gittins
authors.forename: C
authors.initials: C
authors.lastname: Roberts
authors.forename: R R
authors.initials: RR
authors.lastname: Davies
authors.forename: A
authors.initials: A
authors.lastname: Moorhouse
authors.forename: P
authors.initials: P
authors.lastname: Jinadev
authors.forename: M
authors.initials: M
authors.lastname: France
authors.forename: P G
authors.initials: PG
authors.lastname: Wiles
authors.forename: J M
authors.initials: JM
authors.lastname: Gibson
authors.forename: J
authors.initials: J
authors.lastname: Dean
authors.forename: P A
authors.initials: PA
authors.lastname: Kalra
authors.forename: J K
authors.initials: JK
authors.lastname: Cruickshank
authors.forename: P N
authors.initials: PN
authors.lastname: Durrington
mesh_terms: D000419:Albuminuria / Q000378:metabolism; D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D000069059:Atorvastatin; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D003928:Diabetic Nephropathies / Q000139:chemically induced / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005919:Glomerular Filtration Rate; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000378:metabolism; D007676:Kidney Failure, Chronic / Q000139:chemically induced / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011758:Pyrroles / Q000008:administration & dosage*; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D010919:Placebos; D011758:Pyrroles; D000069059:Atorvastatin