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.; P. LEYENDECKER; M. HOPP; L. TARAU; J. LEJCKO; Pavel ŠEVČÍK; Marek HAKL; Radovan HŘIB; R. UHL; H. DUERR; K. REIMER a W. MEISSNER

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

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/10:00051722

Organizační jednotka

Lékařská fakulta

DOI

UT WoS

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.