Efficacy and Safety of Tapentadol Immediate Release for Acute Pain: A Systematic Review and Meta-Analysis.

Abstract

Tapentadol (TAP) immediate release (IR) is a newer opioid option for acute pain. The aim of this systematic review was to examine the efficacy and safety of TAP IR compared with other opioids for acute pain. A systematic literature search as conducted using the Cochrane Library, Embase, International Pharmaceutical Abstracts, MEDLINE, PubMed, and Web of Science. The search included all randomized controlled trials and observational studies examining TAP IR versus other orally administered IR opioids for acute pain. The protocol for this study was registered on PROSPERO (CRD42018110267). Thirteen studies and 1 abstract were included in the systematic review (n=12,814 patients). Of these, 5 studies and 1 abstract were included in the qualitative review (n=9108 patients). Eight randomized controlled trials (n=3706 patients) comparing 50 to 100 mg TAP IR versus 5 to 15 mg oxycodone IR were included in the meta-analysis. The lowest dose of TAP IR (ie, 50 mg) was associated with less pain control compared with oxycodone IR (standardized mean difference=0.25, 95% confidence interval: 0.06-0.44, P<0.01). However, there were no significant differences at higher doses (ie, 75, 100 mg, or when a titration strategy was used). In the qualitative analysis, pain control with TAP IR was also similar to morphine IR and tramadol IR. TAP IR was less likely to have gastrointestinal adverse effects such as nausea and constipation compared with other opioids. TAP IR is as effective as other opioids at higher doses for acute pain and is associated with fewer gastrointestinal adverse effects. On the basis of these findings, TAP IR can be considered as a first-line opioid for acute pain.