Key result
Simvastatin plus omega-3 PUFAs improves lipids and reduces insulin resistance ~39% in T2D with CAN.
Why the study?
There is currently no unified treatment algorithm for cardiac autonomic neuropathy in patients with type 2 diabetes mellitus.
Does the addition of simvastatin and/or omega-3 PUFAs to standard therapy improve lipid profiles and insulin resistance in patients with T2DM and definite cardiac autonomic neuropathy?
RCT (n=72)
Open-label
randomized
No
Does the addition of simvastatin and/or omega-3 PUFAs to standard therapy improve lipid profiles and insulin resistance in patients with T2DM and definite cardiac autonomic neuropathy?
The combination of simvastatin and omega-3 PUFAs improves lipid profiles and insulin resistance more effectively than either agent alone in patients with T2DM and cardiac autonomic neuropathy.
May support additive lipid and insulin benefits in T2DM with neuropathy; leaves open need for RCTs before practice change.
Background: Currently, there is no unified treatment algorithm of cardiac autonomic neuropathy (CAN) in patients with type 2 diabetes mellitus (T2DM).The aim of this study was to investigate the effects of simvastatin (SIM) and ω-3 polyunsaturated fatty acids (ω-3 PUFAs) on blood lipid profile and insulin resistance (IR) in patients with T2DM and definite CAN.Methods: The study involved 72 patients with T2DM and definite CAN.Patients were divided into four groups: 1st -received standard hypoglycemic therapycontrol (n = 15); 2nd (n = 22) -in addition SIM 20 mg/q.d.; 3rd (n = 18) -in addition 1 capsule/q.d. of the ω-3 PUFAs; 4th (n = 17) -in addition SIM 10 mg/ q.d and 1 capsule/q.d of the ω-3 PUFAs for three months.The concentration of glucose, glycated hemoglobin A1c, immunoreactive insulin (IRI), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) in the blood were determined.Homeostasis model assessment IR (HOMA-IR), atherogenic coefficient (AC), TG/LDL-C, TG/TC, TG/LDL-C and TG glucose (TyG) were calculated.Results: Prescription of SIM was accompanied by a statistically significant decrease in TC, LDL-C, TG concentrations.In parallel, SIM induced a decrease of AC, TG/HDL-C, increase in HDL-C, and does not affect the IRI, HOMA-IR, TG/LDL-C, TG/TC, TC/LDL-C/HDL-C, TyG.The use of ω-3 PUFAs has contributed to a significant reduction in TG, AC, TG/LDL-C, TG/TC, TG/HDL-C, TyG index, increase in HDL-C, and was not accompanied by changes in IRI content, HOMA-IR, TC, LDL-C, and TC/LDL-C/HDL-C.The combined prescription of SIM and ω-3 PUFAs was accompanied by more pronounced, statistically significant changes in the blood lipid spectrum, as well as a decrease in the IRI and HOMA-IR. Conclusion:Obtained results justify the appropriateness of combined SIM and ω-3 PUFAs prescription to patients with T2DM and definite CAN.
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Serhiyenko et al. (2019) conducted an RCT in Type 2 diabetes mellitus with definite cardiac autonomic neuropathy (n=72). Simvastatin and omega-3 polyunsaturated fatty acids vs. Standard hypoglycemic therapy was evaluated on HOMA-IR (p=<0.05). The combined prescription of simvastatin and omega-3 polyunsaturated fatty acids significantly improved the blood lipid profile and reduced insulin resistance in patients with type 2 diabetes and cardiac autonomic neuropathy.
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