Research Summary: 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.


Methods and Findings

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.


Trial Registration

ClinicalTrials.gov NCT00974740

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Publisher: Public Library of Science

Date Published: 11-March-2011

Author(s): Martin S., Herder C., Schloot N., Koenig W., Heise T., Heinemann L., Kolb H., Song Y.

Link: https://doi.org/10.1371/journal.pone.0017554

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