Abstract
BackgroundA recent randomized placebo-controlled trial of the effect of atorvastatin treatment on the progression of newly diagnosed type 1 diabetes suggested a slower decline of residual beta cell function with statin treatment. Aim of this secondary analysis was to identify patient subgroups which differ in the decline of beta cell function during treatment with atorvastatin.Methodology/Principal FindingsThe randomized placebo-controlled Diabetes and Atorvastatin (DIATOR) Trial included 89 patients with newly diagnosed type 1 diabetes and detectable islet autoantibodies (mean age 30 years, 40% females), in 12 centers 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. For this secondary analysis patients were stratified by single baseline characteristics which were considered to possibly be modified by atorvastatin treatment. Subgroups defined by age, sex or by baseline metabolic parameters like body mass index (BMI), total serum cholesterol or fasting C-peptide did not differ in C-peptide outcome after atorvastatin treatment. However, the subgroup defined by high (above median) baseline C-reactive protein (CRP) concentrations exhibited higher stimulated C-peptide secretion after statin treatment (p = 0.044). Individual baseline CRP levels correlated with C-peptide outcome in the statin group (r2 = 0.3079, p<0.004). The subgroup with baseline CRP concentrations above median differed from the corresponding subgroup with lower CRP levels by higher median values of BMI, IL-6, IL-1RA, sICAM-1 and E-selectin.Conclusions/SignificanceAtorvastatin treatment may be effective in slowing the decline of beta cell function in a patient subgroup defined by above median levels of CRP and other inflammation associated immune mediators.Trial RegistrationClinicalTrials.gov NCT00974740
Highlights
Treatment with statins has been found to dampen inflammatory reactions and immune activation in general, and some positive results have been reported for intervention trials in rheumatoid arthritis [1,2,3]
Patients were stratified by single baseline characteristics which were considered to possibly associate with atorvastatin treatment
C-peptide outcome was dependent on some baseline metabolic parameters, i.e., significantly higher median stimulated C-peptide concentrations at 18 months were observed in subgroups defined by lower body mass index (BMI), higher fasting or higher stimulated C-peptide levels at baseline (Table 1)
Summary
Treatment with statins has been found to dampen inflammatory reactions and immune activation in general, and some positive results have been reported for intervention trials in rheumatoid arthritis [1,2,3]. In a recent trial of atorvastatin in patients with newly diagnosed type 1 diabetes (Diabetes and Atorvastatin, DIATOR) the primary analysis did not show a significant effect of statin treatment on the progressive loss of beta cell function at 18 months, as determined from serum C-peptide concentrations after a standardized liquid mixed meal [9]. A recent randomized placebo-controlled trial of the effect of atorvastatin treatment on the progression of newly diagnosed type 1 diabetes suggested a slower decline of residual beta cell function with statin treatment. Aim of this secondary analysis was to identify patient subgroups which differ in the decline of beta cell function during treatment with atorvastatin
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