Long term efficacy and safety of combined prolonged-release
oxycodone and naloxone in the management of non-cancer pain

J 2010

Long term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer pain

SANDER-KIESILING, A., P. LEYENDECKER, M. HOPP, L. TARAU, J. LEJCKO et. al.

Základní údaje

Originální název

Long term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer pain

Autoři

SANDER-KIESILING, A. (40 Rakousko, garant), P. LEYENDECKER (276 Německo), M. HOPP (276 Německo), L. TARAU (276 Německo), J. LEJCKO (203 Česká republika), Pavel ŠEVČÍK (203 Česká republika, domácí), Marek HAKL (203 Česká republika, domácí), Radovan HŘIB (203 Česká republika, domácí), R. UHL (276 Německo), H. DUERR (276 Německo), K. REIMER (276 Německo) a W. MEISSNER (276 Německo)

Vydání

International Journal of Clinical Practice, 2010, 1368-5031

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 2.309

Kód RIV

RIV/00216224:14110/10:00051722

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1111/j.1742-1241.2010.02360.x

UT WoS

000276490600016

Klíčová slova anglicky

RANDOMIZED CONTROLLED-TRIAL; OPIOID-INDUCED CONSTIPATION; DIABETIC-NEUROPATHY; BOWEL DYSFUNCTION; CANCER PAIN; COMBINATION; MODERATE; PREVALENCE

Příznaky

Mezinárodní význam

Změněno: 20. 4. 2012 11:35, Mgr. Michal Petr

Anotace

V originále

The aim of this study was to assess safety and efficacy of fixed combination oxycodone prolonged release (PR)/naloxone PR in terms of both analgesia and improving opioid-induced bowel dysfunction (OIBD) and associated symptoms, such as opioid-induced constipation (OIC), in adults with chronic non-cancer pain. Study design: These were open-label extension studies in which patients who had previously completed a 12-week, double-blind study received oxycodone PR /naloxone PR for up to 52 weeks. The analgesia study assessed pain using the modified Brief Pain Inventory-Short Form (BPI-SF). The bowel function study assessed improvements in constipation using the Bowel Function Index (BFI). Results: At open-label baseline in the analgesia study (n = 379), mean score [+/- standard deviation (SD)] for the BPI-SF item 'average pain over the last 24 h' was 3.9 +/- 1.52, and this remained low at 6 months (3.7 +/- 1.59) and 12 months (3.8 +/- 1.72). Mean scores for BPI-SF item 'sleep interference', and the BPI-SF 'pain' and 'interference with activities' subscales also remained low throughout the 52-week study. In the bowel function study (n = 258), mean BFI score (+/- SD) decreased from 35.6 +/- 27.74 at the start of the extension study to 20.6 +/- 24.01 after 12 months of treatment with oxycodone PR/naloxone PR. Pain scores also remained low and stable during this study. Adverse events in both extension phases were consistent with those associated with opioid therapy; no additional safety concerns were observed. Conclusion: Results from these two open-label extension studies demonstrate the long-term efficacy and tolerability of fixed combination oxycodone PR/naloxone PR in the treatment of chronic pain. Patients experienced clinically relevant improvements in OIBD while receiving effective analgesic therapy.

Citovat

SANDER-KIESILING, A., P. LEYENDECKER, M. HOPP, L. TARAU, J. LEJCKO, Pavel ŠEVČÍK, Marek HAKL, Radovan HŘIB, R. UHL, H. DUERR, K. REIMER a W. MEISSNER. Long term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer pain. International Journal of Clinical Practice. 2010, roč. 64, č. 6, s. 763-774. ISSN 1368-5031. Dostupné z: https://dx.doi.org/10.1111/j.1742-1241.2010.02360.x.

@article{920773,
   author = {SanderandKiesiling, A. and Leyendecker, P. and Hopp, M. and Tarau, L. and Lejcko, J. and Ševčík, Pavel and Hakl, Marek and Hřib, Radovan and Uhl, R. and Duerr, H. and Reimer, K. and Meissner, W.},
   article_number = {6},
   doi = {http://dx.doi.org/10.1111/j.1742-1241.2010.02360.x},
   keywords = {RANDOMIZED CONTROLLED-TRIAL; OPIOID-INDUCED CONSTIPATION; DIABETIC-NEUROPATHY; BOWEL DYSFUNCTION; CANCER PAIN; COMBINATION; MODERATE; PREVALENCE},
   language = {eng},
   issn = {1368-5031},
   journal = {International Journal of Clinical Practice},
   title = {Long term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer pain},
   volume = {64},
   year = {2010}
}

TY  - JOUR
ID  - 920773
AU  - Sander-Kiesiling, A. - Leyendecker, P. - Hopp, M. - Tarau, L. - Lejcko, J. - Ševčík, Pavel - Hakl, Marek - Hřib, Radovan - Uhl, R. - Duerr, H. - Reimer, K. - Meissner, W.
PY  - 2010
TI  - Long term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer pain
JF  - International Journal of Clinical Practice
VL  - 64
IS  - 6
SP  - 763-774
EP  - 763-774
SN  - 13685031
KW  - RANDOMIZED CONTROLLED-TRIAL
KW  - OPIOID-INDUCED CONSTIPATION
KW  - DIABETIC-NEUROPATHY
KW  - BOWEL DYSFUNCTION
KW  - CANCER PAIN
KW  - COMBINATION
KW  - MODERATE
KW  - PREVALENCE
N2  - The aim of this study was to assess safety and efficacy of fixed combination oxycodone prolonged release (PR)/naloxone PR in terms of both analgesia and improving opioid-induced bowel dysfunction (OIBD) and associated symptoms, such as opioid-induced constipation (OIC), in adults with chronic non-cancer pain. Study design: These were open-label extension studies in which patients who had previously completed a 12-week, double-blind study received oxycodone PR /naloxone PR for up to 52 weeks. The analgesia study assessed pain using the modified Brief Pain Inventory-Short Form (BPI-SF). The bowel function study assessed improvements in constipation using the Bowel Function Index (BFI). Results: At open-label baseline in the analgesia study (n = 379), mean score [+/- standard deviation (SD)] for the BPI-SF item 'average pain over the last 24 h' was 3.9 +/- 1.52, and this remained low at 6 months (3.7 +/- 1.59) and 12 months (3.8 +/- 1.72). Mean scores for BPI-SF item 'sleep interference', and the BPI-SF 'pain' and 'interference with activities' subscales also remained low throughout the 52-week study. In the bowel function study (n = 258), mean BFI score (+/- SD) decreased from 35.6 +/- 27.74 at the start of the extension study to 20.6 +/- 24.01 after 12 months of treatment with oxycodone PR/naloxone PR. Pain scores also remained low and stable during this study. Adverse events in both extension phases were consistent with those associated with opioid therapy; no additional safety concerns were observed. Conclusion: Results from these two open-label extension studies demonstrate the long-term efficacy and tolerability of fixed combination oxycodone PR/naloxone PR in the treatment of chronic pain. Patients experienced clinically relevant improvements in OIBD while receiving effective analgesic therapy.
ER  -

SANDER-KIESILING, A., P. LEYENDECKER, M. HOPP, L. TARAU, J. LEJCKO, Pavel ŠEVČÍK, Marek HAKL, Radovan HŘIB, R. UHL, H. DUERR, K. REIMER a W. MEISSNER. Long term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer pain. \textit{International Journal of Clinical Practice}. 2010, roč.~64, č.~6, s.~763-774. ISSN~1368-5031. Dostupné z: https://dx.doi.org/10.1111/j.1742-1241.2010.02360.x.

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