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Oxycodone/naloxone combination produces a stronger reduction of pain intensity and pain-related functional impairment vs. other opioids

Written by | 2 May 2014 | All Medical News

Strong opioids including oxycodone are amongst the most effective analgesics to  combat  moderate  to  severe  pain  of  various  aetiologies,  but  opioid-induced  bowel  dysfunction  (OIBD) represents  a  relevant  problem.  The  rationale  for  development  of  a  prolonged-release  (PR)  fixed  combination  of  oxycodone  and  naloxone  was  to  counteract  OIBD.  Due  to  its  negligible  oral  bioavailability, the  -opioid  receptor  antagonist  naloxone  is  able  to  selectively  displace  opioids  from  local  -receptors in  the  gastrointestinal  tract  without  affecting  central  opioid  binding  sites.  Pivotal  trials  of  PR  oxy-codone/naloxone  not  only  demonstrated  improved  bowel  function  but  also  equivalent  analgesic  efficacy compared  to  PR  oxycodone  alone.  Controlled  clinical  trials  comparing  PR  oxycodone/naloxone  with strong  opioids  other  than  oxycodone  are  not  available.  The  present  study  is  the  first  data  set  aimed at  comparing  pain  control,  bowel  function,  and  quality  of  life  (QoL)  in  patients  newly  treated  with  or switched  to  PR  oxycodone/naloxone  or  other  strong  opioids  during  routine  clinical  practice.

The study design included a  three-arm,  prospective  observational  study,  588  patients  with  moderate  to  severe  pain of  varying  aetiologies  received  either  PR  oxycodone/naloxone  (OXN  group  and  OXN  40/20  group  with indicated  use  of  the  40  mg/20  mg  dose  strength  at  baseline)  or  other  strong  opioids  (control  group),  patients were dosed according  to  pain  severity,  for  4–6  weeks.  Data  documented  include  pain  intensity  (NRS),  bowel  function (Bowel  Function  Index,  BFI),  pain-related  functional  impairment  (BPI-SF),  QoL  (EuroQol  EQ-5D-3L),  and a  global  assessment  of  treatment.

The study results showed that patients  receiving  PR  oxycodone/naloxone  experienced  a  clinically  important  reduction  in  pain intensity  and  pain-related  functional  impairment  of  approximately  40%.  The  reductions  of  pain  intensity (−2.9  ±  2.3)  and  pain-related  functional  impairment  (−2.4  ±  2.3)  in  the  OXN  group  were  significantly more  pronounced  than  in  the  control  group  (−2.1  ±  2.1  and  −1.8  ±  1.7).  In  the  control  group,  mean reductions  in  pain  intensity  did  not  reach  the  threshold  of  ≥30%  for  at  least  moderate  clinically  important  differences,  although  patients  were  prescribed  higher  doses  of  morphine  equivalents  than  OXN group  patients.  Improvements  in  bowel  function  (OXN:  −16.0  ±  27.6;  control:  3.1  ±  24.4)  and  QoL  (OXN: 20.8  ±  24.2;  control:  13.2  ±  23.1)  were  also  significantly  more  pronounced  in  the  OXN  group,  with  BFI scores  reduced  to  a  level  that  reflects  normal  bowel  function.  Results  for  the  OXN  40/20  group  receiving higher  doses  of  PR  oxycodone/naloxone  were  in  line  with  those  for  the  OXN  group.  In  the  control  group, more  frequent  gastrointestinal  adverse  events  and  less  favourable  ratings  of  tolerability  resulted  in  a higher  rate  of  treatment  discontinuations  due  to  adverse  events.

The authors concluded that in patients receiving PR oxycodone/naloxone, more favourable outcomes compared with other strong opioids regarding pain control, bowel function, and QoL were observed.

The authors went on to note that the implications of the  present  findings  underline  the  value  of  PR  oxycodone/naloxone  in  the  management of  patients  with  moderate  to  severe  chronic  pain.  The  data  set  further  adds  to  our  understanding  of  the benefits  and  risks  of  opioid  treatment  in  routine  clinical  practice.

©  2014  Published  by  Elsevier  B.V.  on  behalf  of  Scandinavian  Association  for  the  Study  of  Pain

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