Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain : A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE)
Varrassi, G. (Paolo Procacci Foundation)
Hanna, M. (Analgesics and Pain Research (APR) Ltd)
Coaccioli, S. (European League Against Pain)
Fabrizzi, P. (A. Menarini Industrie Farmaceutiche Riunite S.r.l.)
Baldini, S. (A. Menarini Industrie Farmaceutiche Riunite S.r.l.)
Kruljac, I. (Poliklinika SOLMED d.o.o.)
Brotons, Carlos (Institut de Recerca Sant Pau)
Perrot, S. (Pain Center. INSERM U987. Hôpital Cochin. University of Paris)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	Introduction: Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE). Methods: A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61). Results: The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46. 1% vs. 42. 6%, respectively; hazard ratio 1. 11; 95% confidence interval 0. 775, 1. 595; p = 0. 566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0. 05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0. 05). Overall, DKP/TRAM was well tolerated. Conclusion: Although the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP. Dante Study Registration: EudraCT number: 2019-003656-37; ClinicalTrials. gov Identifier: NCT05170841.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Acute low back pain ; Clinical trial ; Dexketoprofen trometamol ; Fixed-dose combination ; Tramadol hydrochloride
Publicat a:	Pain and Therapy, Vol. 13 Núm. 4 (august 2024) , p. 1007-1022, ISSN 2193-651X

DOI: 10.1007/s40122-024-00623-4
PMID: 38922520

16 p, 1.3 MB

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