Giustino Varrassi1, Magdi Hanna2, Giorgos Macheras3, Antonio Montero4, Antonio Montes Perez5,6, Winfried Meissner7, Serge Perrot8, Carmelo Scarpignato9. 1. a European League Against Pain, Zurich and Rome , Switzerland and Italy. 2. b Analgesics and Pain Research Unit (APRU), King's College Hospital , London , UK. 3. c 4th Orthopaedic Department , KAT Hospital , Athens , Greece. 4. d Anaesthesiology & Surgery Department , Hospital Arnau de Vilanova , Lleida , Spain. 5. e Anaesthesiology Department , Hospitales Mar-Eseranza , Barcelona , Spain ; 6. f Universitat Autonoma de Barcelona. 7. g Department of Anaesthesiology and Intensive Care , Jena University Hospital , Jena , Germany. 8. h Centre de la Douleur, Université Paris Descartes, INSERM U987, Hopital Cochin , Paris , France. 9. i Clinical Pharmacology & Digestive Pathophysiology Unit, Department of Clinical & Experimental Pharmacology , University of Parma , Parma , Italy.
Abstract
BACKGROUND: Untreated and under-treated pain represent one of the most pervasive health problems, which is worsening as the population ages and accrues risk for pain. Multiple treatment options are available, most of which have one mechanism of action, and cannot be prescribed at unlimited doses due to the ceiling of efficacy and/or safety concerns. Another limitation of single-agent analgesia is that, in general, pain is due to multiple causes. Combining drugs from different classes, with different and complementary mechanism(s) of action, provides a better opportunity for effective analgesia at reduced doses of individual agents. Therefore, there is a potential reduction of adverse events, often dose-related. Analgesic combinations are recommended by several organizations and are used in clinical practice. Provided the two agents are combined in a fixed-dose ratio, the resulting medication may offer advantages over extemporaneous combinations. CONCLUSIONS: Dexketoprofen/tramadol (25 mg/75 mg) is a new oral fixed-dose combination offering a comprehensive multimodal approach to moderate-to-severe acute pain that encompasses central analgesic action, peripheral analgesic effect and anti-inflammatory activity, together with a good tolerability profile. The analgesic efficacy of dexketoprofen/tramadol combination is complemented by a favorable pharmacokinetic and pharmacodynamic profile, characterized by rapid onset and long duration of action. This has been well documented in both somatic- and visceral-pain human models. This review discusses the available clinical evidence and the future possible applications of dexketoprofen/tramadol fixed-dose combination that may play an important role in the management of moderate-to-severe acute pain.
BACKGROUND: Untreated and under-treated pain represent one of the most pervasive health problems, which is worsening as the population ages and accrues risk for pain. Multiple treatment options are available, most of which have one mechanism of action, and cannot be prescribed at unlimited doses due to the ceiling of efficacy and/or safety concerns. Another limitation of single-agent analgesia is that, in general, pain is due to multiple causes. Combining drugs from different classes, with different and complementary mechanism(s) of action, provides a better opportunity for effective analgesia at reduced doses of individual agents. Therefore, there is a potential reduction of adverse events, often dose-related. Analgesic combinations are recommended by several organizations and are used in clinical practice. Provided the two agents are combined in a fixed-dose ratio, the resulting medication may offer advantages over extemporaneous combinations. CONCLUSIONS:Dexketoprofen/tramadol (25 mg/75 mg) is a new oral fixed-dose combination offering a comprehensive multimodal approach to moderate-to-severe acute pain that encompasses central analgesic action, peripheral analgesic effect and anti-inflammatory activity, together with a good tolerability profile. The analgesic efficacy of dexketoprofen/tramadol combination is complemented by a favorable pharmacokinetic and pharmacodynamic profile, characterized by rapid onset and long duration of action. This has been well documented in both somatic- and visceral-painhuman models. This review discusses the available clinical evidence and the future possible applications of dexketoprofen/tramadol fixed-dose combination that may play an important role in the management of moderate-to-severe acute pain.
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