2020
DOI: 10.1080/03007995.2020.1814228
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Efficacy and tolerability of orally administered tramadol/dexketoprofen fixed-dose combination compared to diclofenac/thiocolchicoside in acute low back pain: experience from an Italian, single-centre, observational study

Abstract: Objectives: To compare the analgesic efficacy and tolerability of tramadol/dexketoprofen 75/25 mg (TRAM/DKP) versus diclofenac/thiocolchicoside 75/4 mg (DIC/THIO) in patients with moderate-to-severe acute low back pain (LBP). Methods: Single-centre, observational study in 82 adult outpatients with LBP due to disc herniation (!4 Numerical Rating scale, NRS) who received either oral TRAM/DKP (n ¼ 44) or intramuscular DIC/ THIO (n ¼ 38), both given every 12 h for 5 days. The primary endpoint was the change from b… Show more

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Cited by 12 publications
(19 citation statements)
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“…The dexketoprofen/tramadol 75/25 mg group also exhibited a significantly greater reduction in neuropathic pain. Both treatments were similarly well tolerated [36].…”
Section: Agentmentioning
confidence: 83%
See 1 more Smart Citation
“…The dexketoprofen/tramadol 75/25 mg group also exhibited a significantly greater reduction in neuropathic pain. Both treatments were similarly well tolerated [36].…”
Section: Agentmentioning
confidence: 83%
“…Examples of fixed-dose combination products include acetaminophen/oxycodone, dexketoprofen/tramadol, acetaminophen/hydrocodone, and diclofenac/thiocolchicoside. A study of 82 acute LBP outpatients compared the efficacy and tolerability of dexketoprofen/tramadol 75/25 mg to diclofenac/tiocolchisoide 75/4 mg [36]. In this study, patients had acute LBP caused by a herniated disc rated above four on a zero-ten pain scale.…”
Section: Agentmentioning
confidence: 99%
“…The main strengths of the DANTE study are the large sample size (larger than previous COX inhibitors and COX inhibitor/opioid combination study cohorts enrolling LBP patients) [33,34,44,45,50], the heterogeneity of the study population, resembling real-life conditions, the use of multiple analgesic and function assessments, and the comprehensive evaluation of patients' perspective, often neglected in previous clinical trials [28,33,34,50]. One limitation of the study is the lack of a treatment arm receiving a COX inhibitor/opioid combination; nevertheless, in a previous acute moderate-tosevere pain model, TRAM/DKP 75/25 mg demonstrated to be more effective than paracetamol/TRAM in the largest study so far performed in acute patients undergoing impacted third molar extraction [42].…”
Section: Discussionmentioning
confidence: 99%
“…Numerous clinical studies support the use of tramadol/dexketoprofen as a safe and effective analgesic [13,[20][21][22]. In a single-center observational study, tramadol/dexketoprofen 75/25 mg was compared head-tohead to diclofenac/thiocolchicoside 75/4 mg for moderate to severe acute LBP [23]. Tramadol/dexketoprofen provided significantly greater and longer-duration analgesia at day three (93.2% vs. 73.7%) and day seven and had more responders at all time points in the study.…”
Section: Assumption Challenge Commentsmentioning
confidence: 99%
“…Tramadol/dexketoprofen provided significantly greater and longer-duration analgesia at day three (93.2% vs. 73.7%) and day seven and had more responders at all time points in the study. Reductions in neuropathic pain as measured on the Douleur Neuropathique 4 (DN4) survey were significantly greater with tramadol/dexketoprofen as well (-62.7 vs. -39.7, p<0.0001) [ 23 ].…”
Section: Reviewmentioning
confidence: 99%