Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial


  • Tanmoy Kanti Goswami Department of Pharmacology, NRS Medical College, Kolkata, West Bengal, India
  • Pradip Kumar Ghoshal Department of Cardiology, NRS Medical College, Kolkata, West Bengal, India
  • Avijit Hazra Department of Pharmacology, IPGME and R, Kolkata, West Bengal, India
  • Asish Biswas Department of Pharmacology, NRS Medical College, Kolkata, West Bengal, India




Flupirtine, Primary osteoarthritis, Tramadol


Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder responsible for considerable morbidity, particularly in old age. Flupirtine, a new centrally acting analgesic, is devoid of the adverse effects of NSAIDs and opioid analgesics. In this study author compared the effectiveness and safety of flupirtine with tramadol in knee OA.

Methods: An open label, randomized, controlled trial was done with patients of primary knee OA of both sexes, age >50 years. Patients were recruited from Rheumatology OPD of SSKM Hospital. A minimum WOMAC score of 35 was essential for recruitment. Patients with serious comorbidities were excluded. They were treated orally with either flupirtine (100mg thrice daily) or tramadol (50mg thrice daily) for 12 weeks.

Results: Ninety patients were recruited and data of 42 on flupirtine and 41 on tramadol were analysed. There was significant improvement in pain, stiffness and physical function compared to baseline in both the groups. However, there was no significant difference between groups at 4, 8 and 12 weeks. Responder rate (50% reduction in pain score from baseline) was 66.67% with flupirtine and 48.78% with tramadol (p = 0.122). Flupirtine caused 4 adverse events compared to 16 with tramadol. However, both the drugs were well-tolerated.

Conclusions: The effectiveness of flupirtine in knee OA is comparable to tramadol, while causing minimal adverse effects. Long-term benefits need to be explored.


Breedveld FC. Osteoarthritis - the impact of a serious disease. Rheumatol. 2004;43:i4-8.

Guccione AA, Felson DT, Anderson JJ, Anthony JM, Zhang Y, Wilson PW, et al. The effects of specific medical conditions on the functional limitation of elders in the Framingham study. Am J Public Health. 1994;84:35-8.

Dicesare PE, Abramson SB. Pathogenesis of osteoarthritis. In: Harris ED, Budd RC, Genovese MC, et al, editors. Kelley’s Textbook of Rheumatology. 7th Ed. Elsevier Saunders; 2005:1493-1513.

Doherty M, Ralston SH. Musculoskeletal diseases. In: Davidson’s principles and practice of medicine. Colledge NR, et al, editors. 21st Ed. Elsevier; 2010:1083-1103.

Hayami T. Osteoarthritis of the knee joint as a cause of musculoskeletal ambulation disability symptom complex (MADS). Clin Calcium. 2008;18:1574-80.

Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001;60:91-7.

Rintelen B, Neumann K, Leeb BF. A meta-analysis of controlled clinical studies with diacerein in the treatment of osteoarthritis. Arch Intern Med. 2006;166:1899-906.

Sun BH, Wu CW, Kalunian KC. New developments in osteoarthritis. Rheum Dis Clin North Am. 2007;33:135-48.

Fidelix TS, Soares BG, Trevisani VF. Diacerein for osteoarthritis. Cochrane database Syst Rev. 2006;25:CD005117.

McMahon FG, Arndt WF Jr, Newton JJ, Montgomery PA, Perhach JL. Clinical experience with flupirtine in the US. Postgrad Med J. 1987;63(3):81-5.

Müller-Limmroth W. The effect of a new analgesic, flupirtine, on psychomotor performance in humans. Arzneimittelforschung. 1985;35:1089-92.

Heusinger JH. Efficacy and tolerance of flupirtine and pentazocine in two multicentre trials. Postgrad Med J. 1987;63:71-9.

List of approved drugs from 01 January 2010 to 31st December 2010. Available at: http://cdsco.nic.in /list%20of%20approved%20drug%20from%2001.htm. Accessed 30 September 2012.

Li C, Ni J, Wang Z, Li M, Gasparic M, Terhaag B, et al. Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial. Curr Med Res Opin. 2008;24:3523-30.

Überall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo-and active-controlled parallel-group phase IV study. Curr Med Res Opin. 2012;28(10):1617-34.




How to Cite

Goswami, T. K., Ghoshal, P. K., Hazra, A., & Biswas, A. (2018). Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial. International Journal of Basic & Clinical Pharmacology, 7(3), 381–385. https://doi.org/10.18203/2319-2003.ijbcp20180484



Original Research Articles