title: Residual beta cell function in newly diagnosed type 1 diabetes after treatment with atorvastatin: the Randomized DIATOR Trial.
abstract: BACKGROUND
  Recent evidence suggests that the lipid-lowering agent atorvastatin is also a potent immunomodulator. The aim of this study was to investigate the possible effect of atorvastatin on the decline of residual beta cell function in recent-onset type 1 diabetes.
  
  
  RESULTS
  The randomised placebo-controlled Diabetes and Atorvastatin (DIATOR) Trial included 89 patients with newly diagnosed type 1 diabetes and islet autoantibodies (mean age 30 years, 40% females), in 12 centres in Germany. Patients received placebo or 80 mg/d atorvastatin for 18 months. As primary outcome stimulated serum C-peptide levels were determined 90 min after a standardized liquid mixed meal. An intent-to-treat analysis was performed. Fasting and stimulated C-peptide levels were not significantly different between groups at 18 months. However, median fasting serum C-peptide levels dropped from baseline to 12 and 18 months in the placebo group (from 0. 34 to 0.23 and 0.20 nmol/l, p<0.001) versus a nonsignificant decline in the atorvastatin group (from 0.34 to 0.27 and 0.30 nmol/l, ns). Median stimulated C-peptide concentrations declined between baseline and 12 months (placebo from 0.89 to 0.71 nmol/l, atorvastatin from 0.88 to 0.73 nmol/l, p<0.01 each) followed by a major loss by month 18 in the placebo group (to 0.48 nmol/l, p = 0.047) but not in the atorvastatin group (to 0.71 nmol/l, ns). Median levels of total cholesterol and C-reactive protein decreased in the atorvastatin group only (p<0.001 and p = 0.04). Metabolic control was similar between groups.
  
  
  CONCLUSIONS
  Atorvastatin treatment did not significantly preserve beta cell function although there may have been a slower decline of beta-cell function which merits further study.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00974740.
authors.affiliation: Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany. stephan.martin@uni-duesseldorf.de
authors.forename: Stephan
authors.initials: S
authors.lastname: Martin
authors.forename: Christian
authors.initials: C
authors.lastname: Herder
authors.forename: Nanette C
authors.initials: NC
authors.lastname: Schloot
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Koenig
authors.forename: Tim
authors.initials: T
authors.lastname: Heise
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
authors.forename: Hubert
authors.initials: H
authors.lastname: Kolb
mesh_terms: D000328:Adult; D000069059:Atorvastatin; D002096:C-Peptide / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006538:Heptanoic Acids / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D050417:Insulin-Secreting Cells / Q000187:drug effects / Q000473:pathology*; D008055:Lipids / Q000097:blood; D008297:Male; D011758:Pyrroles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000069059:Atorvastatin; D002096:C-Peptide; D006442:Glycated Hemoglobin; D006538:Heptanoic Acids; D008055:Lipids; D011758:Pyrroles