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Oxycodone/naloxone versus Tapentadol in real-world chronic non-cancer pain management: a prospective controlled and pharmacogenetic study
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  • Jordi Barrachina,
  • Cesar Margarit,
  • Javier Muriel ,
  • Santiago López-Gil,
  • Vicente López-Gil,
  • Amaya Vara-González,
  • Beatriz Planelles,
  • Maria del Mar Inda,
  • Domingo Morales ,
  • Ana Peiró
Jordi Barrachina
Alicante Institute for Health and Biomedical Research
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Cesar Margarit
Alicante Institute for Health and Biomedical Research
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Javier Muriel
Alicante Institute for Health and Biomedical Research
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Santiago López-Gil
Miguel Hernandez University of Elche
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Vicente López-Gil
Miguel Hernandez University of Elche
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Amaya Vara-González
Miguel Hernandez University of Elche
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Beatriz Planelles
Alicante Institute for Health and Biomedical Research
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Maria del Mar Inda
Hospital General Universitari d'Alacant
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Domingo Morales
Universidad Miguel Hernandez de Elche
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Ana Peiró
Alicante Institute for Health and Biomedical Research

Corresponding Author:[email protected]

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Abstract

Background and purpose: Tapentadol (TAP) and oxycodone/naloxone (OXN) are available formulations that potentially offer improved gastrointestinal tolerability. However, real-world studies in chronic non-cancer pain (CNCP) remain scarce. The aim is to analyse their benefit/risk profiles and the influence of pharmacogenetic markers in daily pain practice. Experimental approach: A prospective, controlled study was developed with ambulatory CNCP patients. Cases were treated with TAP (n=204) or OXN (n=180) prescription, and controls other opioids (n=216). Pain intensity and relief, quality of life, morphine equivalent daily doses (MEDD), adverse events (AEs) and hospital admissions were registered. OPRM1 (rs1799971, A118G) and COMT (rs4680, G472A) gene variants were also analysed. Key Results: Cases evidenced a significantly higher pain relief than control did in real-world management. Here, pain intensity and quality of life were predictive values of relief (R2=0.3). OXN achieved greater pain relief under higher 28% MEDD, 15% pregabalin and 8% duloxetine than TAP. Additionally, OXN needed 15-23% more prescription changes. What´s more, OXN presented the highest rate of AEs at 6 (3-9) per person, including a 68% prevalence of constipation and 24% of erythema. COMT-AA showed higher rates of erythema and vomiting, especially in females. Conclusions and Implications: OXN and TAP exhibited optimal benefit/risk profiles for improving pain relief in real-world CNCP. However, increased OXN pain relief conditioned patients for higher MEDDs, constipation side-effects and drug prescription changes than TAP. Further research is necessary to clarify a potential sex-bias in and genetic influence on side-effects.