Residual beta cell function in newly diagnosed type 1 diabetes after treatment with atorvastatin: the Randomized DIATOR Trial

Background

Recent evidence suggests that the lipid-lowering agent atorvastatin is also apotent immunomodulator. The aim of this study was to investigate thepossible effect of atorvastatin on the decline of residual beta cellfunction in recent-onset type 1 diabetes.

Methods and Findings

The randomised placebo-controlled Diabetes and Atorvastatin (DIATOR) Trialincluded 89 patients with newly diagnosed type 1 diabetes and isletautoantibodies (mean age 30 years, 40% females), in 12 centres inGermany. Patients received placebo or 80 mg/d atorvastatin for 18 months. Asprimary outcome stimulated serum C-peptide levels were determined 90 minafter a standardized liquid mixed meal. An intent-to-treat analysis wasperformed. Fasting and stimulated C-peptide levels were not significantlydifferent between groups at 18 months. However, median fasting serumC-peptide levels dropped from baseline to 12 and 18 months in the placebogroup (from 0. 34 to 0.23 and 0.20 nmol/l, p<0.001) versus anonsignificant decline in the atorvastatin group (from 0.34 to 0.27 and 0.30nmol/l, ns). Median stimulated C-peptide concentrations declined betweenbaseline and 12 months (placebo from 0.89 to 0.71 nmol/l, atorvastatin from0.88 to 0.73 nmol/l, p<0.01 each) followed by a major loss by month 18 inthe placebo group (to 0.48 nmol/l, p = 0.047) but notin the atorvastatin group (to 0.71 nmol/l, ns). Median levels of totalcholesterol and C-reactive protein decreased in the atorvastatin group only(p<0.001 and p = 0.04). Metabolic control wassimilar between groups.

Conclusions

Atorvastatin treatment did not significantly preserve beta cell functionalthough there may have been a slower decline of beta-cell function whichmerits further study.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00974740","term_id":"NCT00974740"}}NCT00974740