Multimodal analgesia in moderate-to-severe pain: a role for a new fixed combination of dexketoprofen and tramadol

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.

Keywords:

• Acute pain
• multimodal analgesia
• drug combination
• NSAIDs
• opioids
• dexketoprofen
• tramadol

Transparency

Declaration of funding

This work was carried out thanks to an unrestricted educational grant from MENARINI International.

Declaration of financial/other relationships

MENARINI did not have any role in design, planning, or execution of the review. The terms of the financial support from MENARINI included freedom for the authors to reach their own conclusions, and an absolute right to publish the results of this work, irrespective of any conclusions reached. WM reports personal fees from Menarini, during the conduct of the study; grants and personal fees from Grunenthal, Mundipharma, AcelRx Pharmaceuticals, BioQPharma, and Medicine Company, outside the submitted work. MH, GM, A. Montes, A. Montero, SP, CS, and GV are members of the Scientific Advisory Board and of the Speakers’ Bureau of MENARINI International. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.

Acknowledgments

We are indebted to Chiara Degirolamo, PhD (Letscom SRL, Scientific Division, Rome) for her invaluable help during the preparation of this manuscript.