EFFICACY AND TOLERABILITY OF FLUPIRTINE MALEATE VERSUS DICLOFENAC IN MECHANICAL LOW BACK PAIN – A PROSPECTIVE COMPARATIVE STUDY

RAMYA R; RAJARAM S; LEENA RANJINI V; NATHIYA S

doi:10.22159/ajpcr.2024.v17i5.50317

Authors

RAMYA R Department of Pharmacology, Vinayaka Mission’s Kirupananda Variyar Medical College and Hospitals, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, India. https://orcid.org/0009-0007-4507-1135
RAJARAM S Department of Pharmacology, Vinayaka Mission’s Kirupananda Variyar Medical College and Hospitals, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, India.
LEENA RANJINI V Department of Pharmacology, Shri Sathya Sai Medical College and Research Institute, Chengalpattu, Tamil Nadu, India.
NATHIYA S Department of Pharmacology, KMCH Institute of Health Sciences and Research, Coimbatore, Tamil Nadu, India

DOI:

https://doi.org/10.22159/ajpcr.2024.v17i5.50317

Keywords:

Flupirtine, Diclofenac, SNEPCO, Oswestry disability index, Visual analog scale, Pain relief rate, Numerical rating scale

Abstract

Objective: Low back pain (LBW) is one of the most common reasons for adults visiting orthopedic outpatient clinics in our country. The objective of the study was to compare the safety and efficacy of flupirtine, a selective neuronal potassium channel opener, with diclofenac, a widely used NSAIDs analgesic, in patients with mechanical LBW (MLBP).

Methods: This prospective, open-labeled, and randomized comparative clinical study included 100 patients with MLBP for more than 6 weeks. Fifty patients received flupirtine 100 mg, and 50 patients received diclofenac 100 mg for 7 days. Follow-up was done on day 8 and day 30. Assessments of functional improvement by the Oswestry Disability Index (ODI), pain relief by the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), and Pain Relief Rate (PRR) were recorded. Safety and tolerability were also assessed. Data were analyzed using the Chi-square and Paired student t-tests.

Results: VAS, NRS, and ODI scores were assessed for each visit (0, 1, and 2), and PRR was assessed on visits 1 and 2. VAS (p<0.05), NRS (p<0.05) scores, and sustained effect after stoppage of the drug were found to be better in the flupirtine group compared to the diclofenac group. Flupirtine was well tolerated. More patients reported adverse events in diclofenac than in the flupirtine group.

Conclusion: Flupirtine may have a superior sustained effect compared to diclofenac in MLBP.

Downloads

Download data is not yet available.

References

Banerjee M, Bhattacharyya K, Sarkar RN, Ghosh B. Comparative study of efficacy and tolerability of flupirtine versus tramadol in non-steroidal anti-inflammatory drug intolerant mechanical low back pain. Indian J Rheumatol. 2012;7(3):135-40. doi: 10.1016/j.injr.2012.06.002

Bhattarai S, Chhetri HP, Alam K, Thapa P. A study on factors affecting low back pain and safety and efficacy of NSAIDs in acute low back pain in a Tertiary Care Hospital of Western Nepal. J Clin Diagn Res. 2013;7(12):2752-8. doi: 10.7860/JCDR/2013/6520.3752, PMID 24551630

Canto MG, Andreu I, Fernandez J, Blanca M. Selective immediate hypersensitivity reactions to NSAIDs. Curr Opin Allergy Clin Immunol. 2009;9(4):293-7. doi: 10.1097/ACI.0b013e32832db943, PMID 19561490

Devulder J. Flupirtine in pain management: Pharmacological properties and clinical use. CNS Drugs. 2010;24(10):867-81. doi: 10.2165/11536230-000000000-00000, PMID 20839897

Dixit M, Doan T, Kirschner R, Dixit N. Significant acute kidney injury due to non-steroidal anti-inflammatory drugs: Inpatient setting. Pharmaceuticals (Basel). 2010;3(4):1279-85. doi: 10.3390/ph3041279, PMID 27713300

GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: A systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol 2023. 2021;5:e316-29.

Hörl WH. Nonsteroidal anti-inflammatory drugs and the kidney. Pharmaceuticals (Basel). 2010;3(7):2291-321. doi: 10.3390/ ph3072291, PMID 27713354

Kornhuber J, Bleich S, Wiltfang J, Maler M, Parsons CG. Flupirtine shows functional NMDA receptor antagonism by enhancing Mg2+ block via activation of voltage independent potassium channels. Rapid communication. J Neural Transm (Vienna). 1999;106(9-10):857-67. doi: 10.1007/s007020050206, PMID 10599868

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(12):3523-30. doi: 10.1185/03007990802579769, PMID 19032134

Nair AS, Ubale P. Flupirtine: A narrative review of its role in acute and chronic pain management. Med One. 2017;2:e170006. 11. Roelofs PD, Deyo RA, Koes BW, Scholten RJ, Van Tulder MW. Non-steroidal anti-inflammatory drugs for low back pain. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD000396. doi: 10.1002/14651858. CD000396.pub3, PMID 18253976

Rosado A, Vives R, González R, Rodríguez PP. Intolerance to non-steroidal anti-inflammatory drugs with respiratory reaction: Clinical and diagnostic features. Alergol Inmunol Clin. 2000;15:153-9.

Sharma A, Manjunath SM, Nagesh Raju G, Dharmaraj B, Nagendra Gowda MR. A comparative study of efficacy and safety of flupirtine versus piroxicamin patients with low back pain. Int J Res Med Sci. 2015;3:2337-41.

Singal R, Gupta P, Jain N, Gupta S. Role of flupirtine in the treatment of pain - chemistry and its effects. Maedica (Bucur). 2012;7(2):163-6. PMID 23401726

Khair-ul-Bariyah S, Shahid MT. Flupirtine: A review on its therapeutic potency. Int J Pharm Sci Rev Res. 2013;22(1):231-5.

Ueberall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and tolerability of flupirtine in subacute/chronic musculoskeletal pain - results of a patient level, pooled re-analysis of randomized, double-blind, controlled trials. Int J Clin Pharmacol Ther. 2011;49(11):637-47. doi: 10.5414/cp210000, PMID 22011688

Vohra F, Raut A. Comparative efficacy, safety, and tolerability of diclofenac and aceclofenac in musculoskeletal pain management: A systematic review. Indian J Pain. 2016;30(1):3-6. doi: 10.4103/0970- 5333.173431

Galasko CS, Courtenay PM, Jane M, Stamp TC. Trial of oral flupirtine maleate in the treatment of pain after orthopaedic surgery. Curr Med Res Opin. 1985;9(9):594-601. doi: 10.1185/03007998509109640, PMID 3902375

Goodchild CS, Nelson J, Cooke I, Ashby M, Jackson K. Combination therapy with flupirtine and opioid: Open-label case series in the treatment of neuropathic pain associated with cancer. Pain Med. 2008;9(7):939-49. doi: 10.1111/j.1526-4637.2008.00512.x, PMID 18950447

Mueller-Schwefe G. Flupirtine in acute and chronic pain associated with muscle tenseness. Results of a postmarket surveillance study. Fortschr Med Orig. 2003;121(1):11-8. PMID 15117064

Wladyka CL, Kunze DL. KCNQ/M-currents contribute to the resting membrane potential in rat visceral sensory neurons. J Physiol. 2006;575(1):175-89. doi: 10.1113/jphysiol.2006.113308, PMID 16777937