A randomized, double blind, placebo‐controlled pilot trial of the safety and efficacy of atorvastatin in children with elevated low‐density lipoprotein cholesterol (LDL‐C) and type 1 diabetes. Issue 2 (22nd November 2014) - Canas, Jose A
Abstract Background Children with type 1 diabetes (T1D) and elevated LDL‐C have an increased risk for cardiovascular disease, a process that can begin in childhood. Objective To assess the safety and efficacy of atorvastatin improving lipid profiles in children with T1D and elevated LDL‐C. Subjects Sixty children (31M/29F) with T1D, mean age: 15 ± 0.3 yr, mean diabetes duration: 6.8 ± 0.5 yr, HbA1c: 8.8 ± 0.2%, with mean LDL‐C 124 ± 4.0mg/dl were recruited. Methods After a 3‐month run‐in period, subjects were randomized double‐blindly to atorvastatin or placebo for 6 months. Lipoprotein subfractions were measured by ion mobility and glucose control by HbA1C; continuous glucose monitors were worn quarterly. Results After a run‐in period, 42 subjects were randomized. There were decreases in total cholesterol (−21%), LDL‐C (−32%), non‐HDL‐C (−31%) and apoB (−26%) in the atorvastatin group versus placebo (p < 0.001). Lipoprotein subparticles (LDL‐large 1 and 2A, IDL‐large and small, VLDL‐ medium and small) decreased with statins (p < 0.03 all). Insulin sensitivity scores remained constant in both groups and correlated inversely with apoB (r = −0.312 p = 0.039) and small LDL 3A (r = −0.404 p = 0.007). One subject had asymptomatic elevation of creatinine kinase which normalized after atorvastatin discontinuation. Conclusions Atorvastatin lowered LDL‐C, apoB, and atherogenic lipoprotein subparticles in children with T1D and elevated LDL‐C without worsening insulin resistance. The drug was well tolerated and safe. Long‐term studies would provide better insight on the impact of these interventions in the development of cardiovascular disease in children with diabetes.