Author’s Reply to Zekry and Inderjeeth: “Pain in the Frail or Elderly Patient: Does Tapentadol Have a Role?”

Excerpt

We consider and respond to the comments by Zekry and Inderjeeth [1]. The suggestion that we have been unfair in applying a different set of rules and standards to a newer agent represents an interesting interpretation. We have clearly discussed the deficiencies in the literature pertaining to all opioids, particularly with regard to the paucity of data on their long-term efficacy and safety, and use in the elderly. Our concluding statement (“better the devil you know than the devil you don’t”) reflects concern over the lack of ideal analgesics, new or old, for use in the frail elderly [2]. A new drug can only be judged using the contemporary and recognized scientific approach prevailing at the time of its introduction. For instance, should the new antiplatelet drugs be judged according to the (lack of) safety and efficacy standards applicable at the time of introduction of aspirin? Tapentadol, being a new agent, must be judged using the current evidence-based criteria. We believe that our assessment of the drug against those standards is accurate and fair. As we also noted, we are not alone in that assessment of the published data relating to the drug. The correspondents state that older, frailer patients require agents that are more effective with fewer side effects. More precisely, what is required are agents that are safer and cost effective, as determined through sound scientific evidence and analyses. If tapentadol really is at least as effective, with fewer side effects and drug interactions than other opioids, this should be relatively easy to demonstrate in well-designed and adequately powered clinical trials. Once proven, the use of a high-cost medication, relative to older agents from the same pharmacological group, might then be justifiable. …