Correction to: Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy

Moore, Rachel A.; McQuay, HJ; Tomaszewski, Janusz; Raba, Grzegorz; Tutunaru, D.; Lietuviete, Nellija; Galad, J.; Hagymasy, L.; Melka, Dace; Kotarski, J; Rechberger, Tomasz; Fülesdi, Béla; Nizzardo, Andrea; Guerrero-Bayón, C.; Cuadripani, S.; Pizà-Vallespir, B.; Bertolotti, M.

doi:10.1186/s12871-017-0452-x

Cited by 3 publications

(1 citation statement)

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“…(16) No existen estudios comparativos con otras asociaciones de analgésicos, pero sí en monoterapia, logrando mejores resultados con la combinación tramadol/dexketoprofeno. (17,18) Además, se analizó la prescripción de tratamientos concomitantes. Se encontró que los analgésicos, AINE, antiepilépticos y opioides débiles eran los más recetados.…”

Section: Discussionunclassified

Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?

Viñas-Bastart,

Oms-Arias,

Pedraza-Gutiérrez

et al. 2022

Pharm Care Esp

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Introduction: The use of the fixed-dose combination of tramadol/dexketoprofen in Spain and in other countries has increased considerably. The authorized therapeutic indication for this medicinal product is the short-term symptomatic treatment of moderate to severe acute pain in adult patients. The objective of this study was to describe the pattern of use of tramadol/dexketoprofen in the field of primary health care. Method: A cross-sectional, descriptive and multicenter study was carried out. The study population included all patients from a Primary Care Department (53 Primary Care teams) with an active prescription of tramadol/dexketoprofen on March 28, 2018. The target population was those patients who were prescribed tramadol/dexketoprofen. dexketoprofen for >20 days. Results: A total of 176 patients had an active prescription for tramadol/dexketoprofen. All patients (100%) had a duration of treatment greater than 5 days and 72.7% (N=128) greater than 20 days. The mean duration of treatment was 14±160.9 days in patients who had less than 20 days of treatment and 224±160.8 days in patients who had more than 20 days of treatment. 35.1% of the patients were treated with >2 pain medications and concomitantly with tramadol/dexketoprofen. The general practitioner initiated 65.6% of the prescriptions. Conclusions: The fixed-dose combination of tramadol/dexketoprofen was frequently used off-label, according to the product characteristics and the available scientific evidence. This study warns about the potential risks associated with the use of this drug in clinical practice, such as lack of effectiveness and/or the appearance of adverse effects.

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Section: Discussionunclassified

Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?

Viñas-Bastart,

Oms-Arias,

Pedraza-Gutiérrez

et al. 2022

Pharm Care Esp

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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,

Hanna,

Coaccioli

et al. 2024

Pain Ther

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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. Supplementary Information The online version contains supplementary material available at 10.1007/s40122-024-00623-4.

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Analgesic Efficacy of Tramadol/Dexketoprofen vs Ibuprofen After Impacted Lower Third Molar Extraction: A Randomized Controlled Clinical Trial

Vallecillo

Vallecillo-Rivas

Gálvez

et al. 2021

Journal of Evidence Based Dental Practice

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Correction to: Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy

Cited by 3 publications

References 1 publication

Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?

Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?

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)

Analgesic Efficacy of Tramadol/Dexketoprofen vs Ibuprofen After Impacted Lower Third Molar Extraction: A Randomized Controlled Clinical Trial

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