title: Effect of atorvastatin on inflammation and outcome in patients with type 2 diabetes mellitus on hemodialysis.
abstract: Statins have multiple effects, including anti-inflammatory actions, lowering C-reactive protein levels, and reducing coronary events. We performed a post hoc analysis of the randomized placebo-controlled 4D Study that had evaluated the efficacy and safety of atorvastatin in 1255 patients with type 2 diabetes mellitus who were on maintenance hemodialysis. Here we determined the relationship between atorvastatin treatment, C-reactive protein, and the outcome of patients who had pre-specified and adjudicated endpoints of all-cause mortality, composite vascular endpoint, myocardial infarction, sudden death, and stroke. Atorvastatin had no significant effect on the risk of composite vascular endpoint or death relative to placebo in any quartile of baseline C-reactive protein. These baseline levels were not significantly different between the treated and placebo group and remained stable at 6 months on atorvastatin but significantly increased in those patients on placebo. All of the patients with baseline C-reactive protein in the fourth quartile had a significantly increased risk of deaths and in composite vascular endpoint compared to patients in the first quartile. The mean value of two consecutive C-reactive protein measurements was associated with significant increases in the risk of sudden death, stroke, all-cause mortality and composite vascular endpoint. Our results show that C-reactive protein was highly predictive of outcome, but atorvastatin treatment was not associated with reduced relative risks in the composite vascular endpoint or mortality in patients on hemodialysis with or without inflammation.
authors.affiliation: Division of Nephrology, University Clinic, Würzburg, Germany. krane_v@medizin.uni-wuerzburg.de
authors.forename: Vera
authors.initials: V
authors.lastname: Krane
authors.forename: Karl
authors.initials: K
authors.lastname: Winkler
authors.forename: Christiane
authors.initials: C
authors.lastname: Drechsler
authors.forename: Jürgen
authors.initials: J
authors.lastname: Lilienthal
authors.forename: Winfried
authors.initials: W
authors.lastname: März
authors.forename: Christoph
authors.initials: C
authors.lastname: Wanner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000069059:Atorvastatin; D002097:C-Reactive Protein / Q000032:analysis; D002423:Cause of Death; D003924:Diabetes Mellitus, Type 2 / Q000473:pathology / Q000628:therapy*; D006538:Heptanoic Acids / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D007249:Inflammation / Q000188:drug therapy*; D008875:Middle Aged; D010919:Placebos; D011237:Predictive Value of Tests; D011758:Pyrroles / Q000494:pharmacology* / Q000627:therapeutic use; D006435:Renal Dialysis; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006538:Heptanoic Acids; D010919:Placebos; D011758:Pyrroles; D002097:C-Reactive Protein; D000069059:Atorvastatin