Comparison of Efficacy and Tolerability of Immediate Release Glucosamine HCL And Glucosamine HCL Sustained Release Formulation in the Treatment of Knee Osteoarthritis; A Randomised Clinical Trial

  • Nusrat Nabi Tutor SR, Department of Pharmacology, Hamdard Institute of Medical Sciences & Research, New Delhi
  • Shalini Gupta Assistant Professor, department of pharmacology, Rama Medical College, Kanpur
  • Deepak Kumar Associate Professor, department of orthopedics, Rama Medical College, Kanpur
  • Nasir Nabi Naikoo Senior Resident, department of pathology, ESIC Medical College, Kolkatta
  • Himika Mukhopadhyay Senior Resident, department of pathology, Apollo Hospital, Kolkatta.
Keywords: Glucosamine, sustained release, immediate release, osteoarthritis, visual analogue scale, Western Ontario and McMaster Universities Osteoarthritis Index

Abstract

Background: Osteoarthritis (OA) is the most common form of and a leading cause of chronic disability between fourth and fifth decade of life, with a prevalence ranging between 17-60.6% in India. Objective: To compare the efficacy and safety profile of glucosamine HCl- sustained release (GLU-SR) with that of Glucosamine HCl- immediate release (GLU-IR) in patients with knee osteoarthritis (OA). Methods: This was an open labelled, randomised, controlled trial conducted in a tertiary care hospital at Kanpur. The study involved 60 patients with knee OA, randomised to receive single oral dose of 1,500 mg GLU-SR and GLU-IR for 60 days with 30 patients in each group. The primary efficacy being reduction in pain and improvement in function was assessed using visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Intention-to-treat principle, repeated measure of ANOVA and mixed model analysis were used for statistical analysis. The history of adverse reactions experienced was collected throughout the study period. Results: There was a significant reduction in algo functional indices as primary outcome measure in both the groups (P < 0.001). A significant difference (P < 0.05) in the number of patients reporting ADR in the GLU-SR arm (38% lesser) was noted as compared to GLU-IR arm, with no difference in the use of rescue medications in both arms. Conclusions: From the observations made in this study it is concluded that GLU-SR is as effective as GLU-IR in the management of knee OA; with an advantage of having a better safety profile.

Downloads

Download data is not yet available.

References

1. Lützner J, Kasten P, Günther KP, Kirschner S. Surgical options for patients with osteoarthritis of the knee. Nat Rev Rheumatol 2009;5:309-16
2. Sharma MK, Swami HM, Bhatia V, Verma A, Bhatia SP, Kaur G. An Epidemiological Study of Correlates of Osteo-Arthritis in Geriatric Population of UT Chandigarh. Indian J Community Med 2007;32:77-8
3. Salve H, Gupta V, Palanivel C, Yadav K, Singh B. Prevalence of knee osteoarthritis amongst perimenopausal women in an urban resettlement colony in South Delhi. Indian J Public Health 2010;54:155-7.
4. Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med 2010;26:355-69.
5. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum 2000; 43; 1905–15.
6. Felson DT, Lawrence RC, Hochberg MC, McAlindon T, Dieppe PA, Minor MA, et al. Osteoarthritis: New insights. Part 2: Treatment approaches. Ann Intern Med 2000;133:726-37.
7. Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, et al. EULAR recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis 2003; 62: 1145–55.
8. Richy F, Bruyere O, Ethgen O, Cucherat M, Henrotin Y, Reginster JY. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: A comprehensive meta-analysis. Arch Intern Med 2003;163:1514-22.
9. Unpublished preliminary data- Study No. GLU/2008/362, Synchron Research Services Pvt. Ltd. Ahmedabad. 2008
10. Persiani S, Roda E, Rovati LC, Locatelli M, Giacovelli G, Roda A. Glucosamine oral bioavailability and plasma pharmacokinetics after increasing doses of crystalline glucosamine sulfate in man. Osteoarthritis Cartilage 2005;13:1041-9.
11. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
12. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988; 15: 1833–40.
13. Teichtahl A, Wluka A, Proietto J, Cicuttini F. Obesity and the female sex, risk factors for knee osteoarthritis that may be attributable to systemic or local leptin biosynthesis and its cellular effects. Med Hypotheses 2005;65:312-5.
14. McAlindon TE, LaValley MP, Gulin JP, Felson DT. Glucosamine and chondroitin for treatment of osteoarthritis: A systematic quality assessment and metaanalysis. JAMA 2000;283:1469-75.
15. Holzer SS, Cuerdon T. Development of an economic model comparing acetaminophen to NSAIDs in the treatment of mild-to-moderate osteoarthritis. Am J Manag Care 1996;2(Suppl):S15-26.
16. Ray WA, Griffin MR, Stein CM. Cardiovascular. toxicity of valdecoxib. N Engl J Med 2004;351:2767.
17. Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Intraarticular corticosteroid for treatment of osteoarthritis of the knee. Cochrane Database Syst Rev 2006;2:CD005328.
18. Herrero-Beaumont G, Román JA, Trabado MC, Blanco FJ, Benito P, Martin-Mola E, et al. Effects of glucosamine sulfate on 6-month control of knee osteoarthritis symptoms vs. placebo and acetaminophen: results from the Glucosamine Unum In Die Efficacy (GUIDE) trial [abstract]. Arthritis Rheum 2005;9 Suppl: 1203.
19. Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, Blanco FJ, Benito P, Martín-Mola E, Paulino J, Marenco JL, Porto A, Laffon A, Araújo D, Figueroa M, Branco J. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. Arthritis Rheum. 2007 Feb;56(2):555-67.
20. Kulkarni C, Leena A, Lohit K, Mishra D, Saji MJ. A randomized comparative study of safety and efficacy of immediate release glucosamine HCL and glucosamine HCL sustained release formulation in the treatment of knee osteoarthritis: A proof of concept study. J Pharmacol Pharmacother 2012;3:48-54.
21. Persiani S, Rotini R, Trisolino G, Delliponti L, Rovati LC, Locatelli M, et al. Glucosamine plasma and synovial fluid concentrations before and after oral administration of crystalline glucosamine sulfate in knee osteoathritis patients [abstract]. Arthritis Rheum 2005;52 Suppl 9:S508.
22. Basak M, Joseph S, Joshi S, Sawant S. Comparative bioavailability of a novel timed release and powder-filled glucosamine sulfate formulation-a multidose, randomized, crossover study. Int J Clin Pharmacol Ther 2004;42: 597-601.
23. Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, Blanco FJ, Benito P, Martín-Mola E, et al. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms – A randomized, double blind, placebo controlled study using acetaminophen as a side comparator. Arthritis Rheum 2007;56:555-7.
24. Persiani S, Roda E, Rovati LC, Locatelli M, Giacovelli G, Roda A .Glucosamine oral bioavailability and plasma pharmacokinetics after increasing doses of crystalline glucosamine sulfate in man. Osteoarthritis Cartilage 2005;13:1041-9.
25. Talent TM, Gracy RW. Pilot study of oral polymeric N-acetyl-Dglucosamine as a potential treatment for patients with osteoarthritis. Clin Ther 1996;18:1184-90.
26. Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, et al. Glucosamine, chondroitin sulfate and the two in combination for painful knee osteoarthritis. N Engl J Med 2006; 354: 795–808
27. Sawitzke AD, Shi H, Finco MF, Dunlop DD, Bingham CO, Harris CL, et al. The effect of glucosamine and/or chondroitin sulfate on the progression of knee osteoarthritis. Arthritis Rheum 2008;58:3183-91.
28. Jackson CS, Plaas AH, Barkhill JG, Harris CL, Clegg DO. The pharmacokinetic of oral glucosamine and chondroitin sulfate in humans [abstract]. Arthritis Rheum 2005;52:4062-3.
29. Kelly GS. The role of glucosamine sulfate and chondroitin sulfates in the treatment of degenerative joint disease. Alt Med Rev 1998;3;27-39.
Published
2018-09-30
How to Cite
1.
Nabi N, Gupta S, Kumar D, Naikoo N, Mukhopadhyay H. Comparison of Efficacy and Tolerability of Immediate Release Glucosamine HCL And Glucosamine HCL Sustained Release Formulation in the Treatment of Knee Osteoarthritis; A Randomised Clinical Trial. IABCR [Internet]. 30Sep.2018 [cited 11Dec.2018];4(3):54-8. Available from: https://iabcr.org/index.php/iabcr/article/view/403