Efficacy and tolerability of advanced glycation end-products inhibitor in osteoarthritis: a randomized, double-blind, placebo-controlled study.
OBJECTIVE
Advanced glycation end-products (AGEs) play an important role in pathogenesis of osteoarthritis (OA). The objective of this study was to evaluate the efficacy and tolerability of AGEs inhibitor (benfotiamine [50 mg]+pyridoxamine [50 mg]+methylcobalamin [500 µg]; Vonder [Cosme Farma Laboratories Limited, Goa, India]) in OA patients.


METHODS
A 24-week, double-blind, randomized placebo-controlled study in primary OA patients (n=30 [F/M=26/4; mean age, 57.26±2.16 y]) meeting the classification criteria of American College of Rheumatology, was conducted. Inflammatory disease activity scores on the Western Ontario and McMaster University (WOMAC) Osteoarthritis Index, Lequesne Index, and Pain scores were analyzed. Biomarkers: serum nitrite, AGEs, thiobarbituric acid reactive substances, C-reactive protein, erythrocyte sedimentation rate, were also measured. Time taken to walk 20 m was also recorded. Patients were randomized to either AGEs inhibitor or placebo tablets as thrice-daily regimen.


RESULTS
At 24 weeks, net decrease in pain score, -6.64±2.71 versus -8.20±1.28, P=0.003; total WOMAC score, -5.88±0.84 versus -8.26±1.24, P=0.013; Lequesne Index score, -0.60±0.06 versus -0.84±0.09, P=0.05; time taken for 20-m walk test, -5.0±1.39 versus -5.0±0.92 s, P=1.00, were observed in the placebo versus drug group, respectively. Net change in serum nitrite, -0.15±0.01 versus -0.79±0.12 µmol/L, P<0.001; AGEs, -0.12±0.02 versus -0.99±0.09, arbitrary florescence units, P=0.001; thiobarbituric acid reactive substances, -0.69±0.12 versus -1.80±0.12 nmol/L, P<0.01; C-reactive protein, -0.12±0.35 versus -2.45±0.60 mg/L, P<0.01, were observed in the placebo versus drug group, respectively.


CONCLUSIONS
This study shows the efficacy of an AGE inhibitor on decreasing pain and inflammation, and increasing daily activity and mobility in OA patients.
Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, India.
Shabnam
S
Garg
Ashit
A
Syngle
Kanchan
K
Vohra
D000328:Adult; D000368:Aged; D001799:Blood Sedimentation / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D017127:Glycation End Products, Advanced / Q000037:antagonists & inhibitors* / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010147:Pain Measurement; D011733:Pyridoxamine / Q000627:therapeutic use; D013831:Thiamine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome; D014805:Vitamin B 12 / Q000031:analogs & derivatives / Q000627:therapeutic use; D016138:Walking
D017127:Glycation End Products, Advanced; D011733:Pyridoxamine; D002097:C-Reactive Protein; C019476:mecobalamin; D014805:Vitamin B 12; D013831:Thiamine; C013835:benphothiamine