A comparative study of efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery

Abstract

BackgroundEffective control of pain postoperatively is essential in providing enhanced patient care and a cost-effective hospital stay. Though many treatment modalities exist for postoperative pain management in orthopedic surgeries they are often accompanied by adverse effects. This study was carried out to assess the efficacy of flupirtine and piroxicam in postoperative pain reduction using visual analog scale (VAS) score.Materials and methodsAn open-label, parallel group, comparative study was conducted on patients undergoing lower limb orthopedic surgery, randomized into two groups of 38 patients each. They received either flupirtine 100 mg or piroxicam 20 mg 6 hours after surgery and then twice daily orally for 5 days. Pain was measured using VAS score, total pain relief score (TOTPAR24), and patient satisfaction score (PSS); the other scales used were behavioral pain assessment scale (BPAS) and functional activity score (FAS). Rescue medication used was tramadol 100 mg intravenously. WHO causality scale was used for assessing adverse effects. Descriptive and inferential statistics were used for assessment of various parameters.ResultsA total of 76 patients with mean ± standard deviation age of 35.08±10.3 years were recruited; 34 in the flupirtine and 37 in the piroxicam groups completed the study. Patients in both groups were comparable in baseline characteristics. Flupirtine and piroxicam reduced VAS score 48 hours postoperatively compared to baseline (p=0.006 and 0.001) and piroxicam produced significant reduction in pain at 8, 12, and 120 hours compared to flupirtine (p=0.028, 0.032, 0.021). TOTPAR24 and PSS at 24 hours were comparable between the treatments. BPAS scores at 24 hours were reduced significantly in patients receiving either drug (p=0.001). FAS improved at 72 hours in patients receiving piroxicam. Adverse effects were similar with both the medications.ConclusionFlupirtine and piroxicam reduced pain effectively but the onset of pain relief was earlier with piroxicam.

Randomized controlled trial about pain medication flupirtine ignores recent pharmacovigilance warnings

“…On October 16, 2017 in the Journal of Pain Research , a randomized controlled trial (RCT) comparing efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery was published. 1 However, this paper fails to report important information.…”

“…The recommendation also states that flupirtine should not be given to people with preexisting liver disease, alcohol abuse, or other hepatotoxic drugs: This has been mentioned as part of the exclusion criteria stated on page 2472 (lines 33 and 38). 1 The literature search done before the commencement of our study revealed that short-term therapy usually did not elevate the liver enzymes, and so we highlighted only the advantages and safety features of flupirtine over piroxicam in the “Introduction” section. We missed directly pointing out the hepatotoxic potential of flupirtine on long-term administration in the introduction; although it was unintentional, we regret the error.…”

“…Considering all these information about potential severe liver toxicity induced by flupirtine, it is surprising that a new RCT being published does not even mention flupirtine’s potential to induce hepatotoxicity, and that measurements of liver enzymes were also not reported. The only information in the “Introduction” section regarding flupirtine safety is “It is devoid of adverse effects like gastritis, renal compensation, and respiratory depression and therefore found to be safe in most patients.” 1 …”

“…As per the 2013 European Medicines Agency recommendations stated in the letter, flupirtine-containing medications need to be used only for short-term pain when other analgesics are contraindicated, for not more than 14 days: We have used flupirtine only for a short duration of 5 days as mentioned in the paper on page 2472 (lines 9 and 10). 1 We have adhered to the guidelines for the use of flupirtine as per the drug regulatory board in our country. 2…”

Flupirtine as a Potential Treatment for Fibromyalgia

“…21,22 Flupirtine as a treatment of pain Effective analgesia has been reported in a range of acute and chronic pain conditions, such as musculoskeletal pain, postoperative pain, migraine and neuralgia following treatment with flupirtine. 5,23, 24 Restoration of the normal sensitivity of over-excitable nociceptive pathways and inhibition of the stimulation of nociceptive neurons by factors such as inflammatory mediators (e.g. bradykinin) have been suggested to be responsible for the effects of flupirtine.…”