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Observational Study
. 2022 Jun 16;12(1):10126.
doi: 10.1038/s41598-022-13085-5.

Oxycodone/naloxone versus tapentadol in real-world chronic non-cancer pain management: an observational and pharmacogenetic study

Jordi Barrachina  1 , Cesar Margarit  1   2 , Javier Muriel  1   2 , Santiago López-Gil  3 , Vicente López-Gil  3 , Amaya Vara-González  3 , Beatriz Planelles  1   4 , María-Del-Mar Inda  1 , Domingo Morales  5 , Ana M Peiró  6   7   8   9
Affiliations
Observational Study

Oxycodone/naloxone versus tapentadol in real-world chronic non-cancer pain management: an observational and pharmacogenetic study

Jordi Barrachina et al. Sci Rep. .

Abstract

Tapentadol (TAP) and oxycodone/naloxone (OXN) potentially offer an improved opioid tolerability. However, real-world studies in chronic non-cancer pain (CNCP) remain scarce. Our aim was to compare effectiveness and security in daily pain practice, together with the influence of pharmacogenetic markers. An observational study was developed with ambulatory test cases under TAP (n = 194) or OXN (n = 175) prescription with controls (prescribed with other opioids (control), n = 216) CNCP patients. Pain intensity and relief, quality of life, morphine equivalent daily doses (MEDD), concomitant analgesic drugs, adverse events (AEs), hospital frequentation and genetic variants of OPRM1 (rs1799971, A118G) and COMT (rs4680, G472A) genes, were analysed. Test CNCP cases evidenced a significantly higher pain relief predictable due to pain intensity and quality of life (R2 = 0.3), in front of controls. Here, OXN achieved the greatest pain relief under a 28% higher MEDD, 8-13% higher use of pregabalin and duloxetine, and 23% more prescription change due to pain, compared to TAP. Whilst, TAP yielded a better tolerability due the lower number of 4 [0-6] AEs/patient, in front of OXN. Furthermore, OXN COMT-AA homozygotes evidenced higher rates of erythema and vomiting, especially in females. CNCP real-world patients achieved higher pain relief than other traditional opioids with a better tolerability for TAP. Further research is necessary to clarify the potential influence of COMT and sex on OXN side-effects.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Daily morphine equivalent dose (MEDD) (mean ± SD) depending on control and tapentadol (TAP) and oxycodone/naloxone (OXN) cases groups.
Figure 2
Figure 2
Percentage of patients with adverse events of patients (AEs) self-reported in in total population, control, tapentadol (TAP) and oxycodone/naloxone (OXN) cases groups.
Figure 3
Figure 3
Analgesic, opioid and coadjuvant treatment in total population, control, and case (tapentadol and oxycodone/naloxone) groups.
Figure 4
Figure 4
Difference of frequency of vomiting and erythema adverse events depending on COMT and OPRM1 gene variants in oxycodone/naloxone case groups.
Figure 5
Figure 5
Study flow chart of patients’ selection and controls.
See this image and copyright information in PMC

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