Context: Cardiovascular disease is a major cause of mortality in Type 1 Diabetes (TIDM). TIDM is a pro-inflammatory state. Whilst there is consensus on lipid management in Type 2 diabetes (T2DM), there is a lack of data in Type 1 diabetes. In addition to benefits on the lipid profile, statin therapy is anti-inflammatory

Objective: There is scanty data on statin therapy in T1DM. Thus, we tested the effect of simvastatin compared to Placebo (P) on biomarkers of inflammation and monocyte function in TIDM patients.

Design: Double-blind, randomized, placebo-controlled study of T1DM patients, randomized to Placebo or simvastatin, 20 mg/day for 3 months.

Setting: UC Davis Medical Center

Participants: Patients with T1DM.

Methods and Results: Analytes measured at baseline and 3 months included liver function tests, creatinine, HbAIC, hsCRP, sCD40L, monocyte O₂^-, cytokines, NFkb. Simvastatin therapy resulted in significant reduction in LDL and non-HDL cholesterol, hs-CRP (18% reduction, p < 0.001) and sCD40L (22% reduction, P<0.05) compared to P. Simvastatin therapy significantly inhibited LPS-activated monocyte release of O₂^- (p<0.0005), IL-8 (p<0.03) and TNF (p<0.02). S therapy significantly inhibited monocyte IL-6 release compared to baseline (P = 0.02). S therapy also significantly reduced monocytic nuclear NFKb p65 activity compared to placebo (p<0.01).

Conclusions: This study demonstrates that simvastatin (20 mg/d) is safe in T1DM patients and has concomitant benefits on the lipid profile and biomarkers of inflammation. These novel findings could have implications for developing policy guidelines for statin therapy in forestalling vascular complications in young T1DM.