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Efficacy and Tolerability of Advanced Glycation End-Products Inhibitor in Osteoarthritis: A Randomized, Double-Blind, Placebo-controlled Study

Garg, Shabnam B. Pharm*; Syngle, Ashit MD; Vohra, Kanchan M. Pharm*

Clinical Journal of Pain:
doi: 10.1097/AJP.0b013e318272ebec
Original Articles
Abstract

Objectives: 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.

Discussion: This study shows the efficacy of an AGE inhibitor on decreasing pain and inflammation, and increasing daily activity and mobility in OA patients.

Author Information

*Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala

Fortis Multispecialty Hospital, Mohali, Punjab, India

The authors declare no conflict of interest. The academic institute, Punjabi University, Patiala, provided all the necessary financial support to K.V. for completing the dissertation work. Cosme Farma Laboratories Limited, Goa, India, provided drug and placebo tablets (Vonder) as gift samples for research purpose only.

Reprints: Kanchan Vohra, M. Pharm, Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab 147002, India (e-mail: kanchan_vohra23@yahoo.com).

Received January 5, 2012

Accepted September 5, 2012

© 2013 by Lippincott Williams & Wilkins