A double-blind, randomized, placebo-controlled clinical trial on benfotiamine treatment in patients with diabetic nephropathy.
OBJECTIVE
To investigate the effect of benfotiamine on urinary albumin excretion (UAE) and the tubular damage marker kidney injury molecule-1 (KIM-1) in patients with type 2 diabetes and nephropathy.


METHODS
Patients with type 2 diabetes and UAE equivalent to 15-300 mg/24 h, despite ACE inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs), were randomly assigned to 12 weeks of benfotiamine (900 mg/day) (n = 39) or placebo (n = 43).


RESULTS
Compared with placebo, benfotiamine treatment resulted in significant improvement of thiamine status (P < 0.001). Benfotiamine treatment did not significantly decrease 24-h UAE or 24-h KIM-1 excretion.


CONCLUSIONS
In patients with type 2 diabetes and nephropathy, high-dose benfotiamine treatment for 12 weeks in addition to ACE-Is or ARBs did not reduce UAE or KIM-1 excretion, despite improvement of thiamine status.
Alkhalaf
Alaa
A
Department of Internal Medicine, University Medical Center Groningen, Groningen, the Netherlands. a.alkhalaf@int.umcg.nl
Klooster
Astrid
A
van Oeveren
Willem
W
Achenbach
Ulrike
U
Kleefstra
Nanne
N
Slingerland
Robbert J
RJ
Mijnhout
G Sophie
GS
Bilo
Henk J G
HJ
Gans
Reinold O B
RO
Navis
Gerjan J
GJ
Bakker
Stephan J L
SJ
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000419:Albuminuria / Q000188:drug therapy* / Q000652:urine; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D015415:Biomarkers / Q000652:urine; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000652:urine; D003928:Diabetic Nephropathies / Q000188:drug therapy* / Q000652:urine; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000072596:Hepatitis A Virus Cellular Receptor 1; D006801:Humans; D007684:Kidney Tubules / Q000187:drug effects; D008297:Male; D008562:Membrane Glycoproteins / Q000652:urine; D008875:Middle Aged; D010919:Placebos; D011991:Receptors, Virus; D013831:Thiamine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood
D000276:Adjuvants, Immunologic; D047228:Angiotensin II Type 1 Receptor Blockers; D000806:Angiotensin-Converting Enzyme Inhibitors; D015415:Biomarkers; C491143:HAVCR1 protein, human; D000072596:Hepatitis A Virus Cellular Receptor 1; D008562:Membrane Glycoproteins; D010919:Placebos; D011991:Receptors, Virus; D013831:Thiamine; C013835:benphothiamine