Background & Aims

Low Back Pain (LBP) is highly prevalent in India, adversely affecting QOL of patients significantly. LBP is a leading cause of activity limitation and work absence which has a huge impact on economic burden.
Current guidelines recommend the short-term use weak opioids (especially tramadol), for symptomatic pain relief in patients with chronic LBP; however, their use is associated with adverse effects, such as constipation, nausea, sedation, leading to treatment discontinuation.
Hence this meta-analysis was conducted to assess the efficacy and tolerability of flupirtine, a a non opioid, non NSAID analgesic with tramadol in patients with low back pain.

Methods

An electronic database search was carried out in EBM (Evidence Based Medicine) Reviews, Cochrane Library and PubMed using keywords Flupirtine, Tramadol, Low back pain based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guideline to include relevant randomized controlled trials (RCT)s. The meta-analysis was performed by Review Manager 5.4 (RevMan 5.4) software.

Results

Total 104 studies were identified out of which, 4 RCTs involving a total of 695 patients were eligible for analysis.
In comparison Tramadol, Flupirtine resulted in significantly more decrease in the pain intensity on both NRS (MD =-0.42; 95% CI: -0.67 to -0.17, P< 0.0001) and VAS score(MD =-0.23; 95% CI: -0.32 to -0.14, P< 0.0001). In terms of safety flupirtine was found to be significantly better tolerated than tramadol in terms of Total AEs (OR =0.49; 95% CI: O.35 to 0.68, P< 0.0001), nausea (OR =0.20; 95% CI: O.12 to 0.33, P< 0.0001), vomiting (OR =0.17; 95% CI: O.08 to 0.37, P< 0.0001), constipation(OR =0.37; 95% CI: O.17to 0.83, P=0.02) leading to significantly lower treatment discontinuations (OR =0.28; 95% CI: O.14 to 0.60, P=0.0009)

Conclusions

In patients with lower back pain, short term use of Flupirtine is associated superior improvement in pain intensity, along with a reduced incidence of adverse effects, such as nausea, vomiting, and constipation, thereby leading to less treatment discontinuation. Flupirtine appears to be a more efficacious alternative compared to Tramadol in the management of low back pain, given its favorable risk-benefit profile.

References

Current Medical Research and Opinion, 28:10, 1617-1634; Asian J Pharm Clin Res, Vol 12, Issue 4, 2019, 84-87; CURRENT MEDICAL RESEARCH AND OPINION 0300-7995 VOL. 24, NO. 12, 2008, 3523–3530; Indian Journal of Rheumatology 2012 September Volume 7, Number 3; pp. 135e140

Presenting Author

Sandesh Warudkar

Poster Authors

Sandesh Warudkar

MD

Intas Pharmaceuticals Ltd

Lead Author

Amit B Jain

Intas Pharmaceuticals Ltd

Lead Author

Nilanj Dave

Intas Pharmaceuticals Ltd

Lead Author

Alok Chaturvedi

Intas Pharmaceuticals Ltd

Lead Author

Topics

  • Systematic Reviews/Meta-Analysis