Clinical studies of AGE-RAGE inhibitory effects of vitamins B and its derivatives.

Table 5: Clinical studies of AGE-RAGE inhibitory effects of vitamins B and its derivatives.

Therapeutic drug	Experimental design	Patient characteristics and treatment groups	Treatment duration	Major findings	Reference
Benfotiamine	Non-randomised crossover study	T2DM (n = 13) • High AGE content meal with and without 1050 mg benfotiamine pre-treatment	3 days	• High AGE content meal increased AGE level, endothelial dysfunction and oxidative stress markers which were reduced by benfotiamine.	[125]
Benfotiamine	Single-arm	T1DM (n = 9) • 600 mg benfotiamine-1200 mg α-lipoic acid	28 days	• Benfotiamine treatment together with α-lipoic acid normalised angiopoietin-2, monocyte hexosamine-modified proteins, prostacyclin synthase activity and AGE formation.	[126]
Benfotiamine	Double-blind RCT	T2DM, microalbuminuria (n = 82) • Placebo (n = 43) • 900 mg benfotiamine (n = 39)	12 weeks	• Benfotiamine did not decrease urinary albumin excretion and tubular damage marker, kidney injury molecule-1.	[128]
Benfotiamine	Double-blind RCT	T2DM, microalbuminuria (n = 82) • Placebo (n = 43) • 900 mg benfotiamine (n = 39)	12 weeks	• Benfotiamine had no effect on plasma and urinary CML, CEL and MG-H1 as well as other endothelial dysfunction and low-grade inflammatory markers.	[129]
Pyridoxamine	Double-blind RCT	DM, overt nephropathy (n = 212) • Placebo (n = 90) • 100-500 mg pyridoxamine (n = 122)	24 weeks	• Pyridoxamine reduced serum creatinine, urinary TGF-β1, CML and CEL.	[127]
Thiamine- Pyridoxine combined therapy	RCT	On haemodialysis (n = 50) • Placebo (n = 25) • 250 mg thiamine-200 mg pyridoxine combined therapy (n = 25)	8 weeks	• No beneficial treatment effect was observed in the serum albumin, plasma hsCRP, IL-6, AOPP, pentosidine and 8-hydroxy-2’-deoxyguanosine of the combined treatment.	[130]

AGE: Advanced Glycation End Product; AOPP: Advanced Oxidation Protein Product; CEL: Carboxyethyllysine; CML: Carboxymethyllysine; DM: Diabetes Mellitus; hsCRP: High Sensitive C-Reactive Protein; IL-6: Interleukin-6; MG-H1: Methylglyoxal-Derived Hydroimidazolone 1; RCT: Randomised Controlled Trial; T1DM: Type 1 Diabetes Mellitus; T2DM: Type 2 Diabetes Mellitus; TGF-β1: Transforming Growth Factor-β1.