Clinical and economic evaluation of tapentadol extended release and oxycodone/naloxone extended release in comparison with controlled release oxycodone in musculoskeletal pain

Abstract

Both tapentadol ER and oxycodone/naloxone ER are cost effective interventions compared with CR oxycodone; however, tapentadol ER was shown to provide better clinical outcomes at lower costs.

Appropriate use of information in therapeutic decision-making: reflections on indirect comparisons

“…Another example involving an economic model was published evaluating the relative cost effectiveness of two strong analgesics, recently published in this journal 17 . The economic model itself was robust and appeared to give valid conclusions, but derived some of its key efficacy inputs from an indirect comparison.…”

Comparing tapentadol to oxycodone/naloxone combination: building castles in the air

“…Indeed, RCTs might be performed in different populations, with different concomitant treatments, different overall management of disease, and, last but not least, different outcomes. Coluzzi and Ruggeri 13 included three RCTs that compared oxycodone/naloxone CR with oxycodone CR. The first study 14 enrolled patients with a documented history of moderate to severe chronic non-malignant lower back pain adequately managed by an opioid analgesic, and the aim was to demonstrate the superiority of oxycodone/ naloxone CR formulation over placebo with respect to analgesic efficacy.…”

“…The main aim of those studies was to evaluate the efficacy of oxycodone/naloxone CR compared to oxycodone CR in relieving constipation. On the contrary, all the trials [17][18][19] evaluating tapentadol ER and included in the analysis of Coluzzi and Ruggeri 13 had as primary goal the assessment of the efficacy and safety of this new medication compared to oxycodone CR. Furthermore, while patients of the oxycodone/naloxone trials [14][15][16] were all on opioid therapy at the time of recruitment, between 44.0 and 49.8% of those belonging to the tapentadol studies [17][18][19] were opioid naïve.…”

“…An example of this approach is presented in Table 1. If one evaluates four variables selected from the studies Coluzzi and Ruggeri 13 included in their analysis, it appears that oxycodone/naloxone CR has a significantly better profile than tapentadol ER. Nevertheless, this kind of unadjusted indirect comparison has been criticized for discarding within trial comparisons, increasing the liability of bias and over-precise estimates 22 .…”

“…Adverse event and post-randomization withdrawal rates were taken from each study [14][15][16][17][18][19] . Proportions, their differences, and 95% confidence intervals (CIs) were calculated using the method recommended by Newcombe and Altman improvement in BFI and, therefore, the data regarding constipation presented in the forest plot ( Figure 5 of the Coluzzi and Ruggeri paper 13 ) do not reflect the aim of the studies and -when included in an economic model -could produce ambiguous findings.…”