Analgesic efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients with chronic pain from spinal disorders

Chang Ju Hwang, Sung Soo Chung, Kyu Yeol Lee, Jae Hyup Lee, Seong Hwan Moon, Jin Hyok Kim, Kyu Jung Cho, Jae Sung Ahn, Dong Soo Kim, Ye Soo Park, Hye Jeong Park

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain. Methods: In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0–10) and the Korean-language EuroQol-five dimensions questionnaire, respectively. Results: Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7%, the most common being nausea, constipation, and dizziness; 77.9% of these adverse drug reactions had resolved or were resolving at the end of the study. Conclusions: Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders.

Original languageEnglish
Pages (from-to)33-40
Number of pages8
JournalCiOS Clinics in Orthopedic Surgery
Volume10
Issue number1
DOIs
Publication statusPublished - 2018 Mar

Fingerprint

Oxycodone
Somatoform Disorders
Naloxone
Chronic Pain
Analgesics
Safety
Pain
Quality of Life
Drug-Related Side Effects and Adverse Reactions
Dizziness
Constipation
Nausea
Opioid Analgesics
Anti-Inflammatory Agents
Language
Incidence
Pharmaceutical Preparations
Population

All Science Journal Classification (ASJC) codes

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

Hwang, Chang Ju ; Chung, Sung Soo ; Lee, Kyu Yeol ; Lee, Jae Hyup ; Moon, Seong Hwan ; Kim, Jin Hyok ; Cho, Kyu Jung ; Ahn, Jae Sung ; Kim, Dong Soo ; Park, Ye Soo ; Park, Hye Jeong. / Analgesic efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients with chronic pain from spinal disorders. In: CiOS Clinics in Orthopedic Surgery. 2018 ; Vol. 10, No. 1. pp. 33-40.
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title = "Analgesic efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients with chronic pain from spinal disorders",
abstract = "Background: A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain. Methods: In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0–10) and the Korean-language EuroQol-five dimensions questionnaire, respectively. Results: Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9{\%} between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7{\%}, the most common being nausea, constipation, and dizziness; 77.9{\%} of these adverse drug reactions had resolved or were resolving at the end of the study. Conclusions: Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders.",
author = "Hwang, {Chang Ju} and Chung, {Sung Soo} and Lee, {Kyu Yeol} and Lee, {Jae Hyup} and Moon, {Seong Hwan} and Kim, {Jin Hyok} and Cho, {Kyu Jung} and Ahn, {Jae Sung} and Kim, {Dong Soo} and Park, {Ye Soo} and Park, {Hye Jeong}",
year = "2018",
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Analgesic efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients with chronic pain from spinal disorders. / Hwang, Chang Ju; Chung, Sung Soo; Lee, Kyu Yeol; Lee, Jae Hyup; Moon, Seong Hwan; Kim, Jin Hyok; Cho, Kyu Jung; Ahn, Jae Sung; Kim, Dong Soo; Park, Ye Soo; Park, Hye Jeong.

In: CiOS Clinics in Orthopedic Surgery, Vol. 10, No. 1, 03.2018, p. 33-40.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Analgesic efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients with chronic pain from spinal disorders

AU - Hwang, Chang Ju

AU - Chung, Sung Soo

AU - Lee, Kyu Yeol

AU - Lee, Jae Hyup

AU - Moon, Seong Hwan

AU - Kim, Jin Hyok

AU - Cho, Kyu Jung

AU - Ahn, Jae Sung

AU - Kim, Dong Soo

AU - Park, Ye Soo

AU - Park, Hye Jeong

PY - 2018/3

Y1 - 2018/3

N2 - Background: A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain. Methods: In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0–10) and the Korean-language EuroQol-five dimensions questionnaire, respectively. Results: Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7%, the most common being nausea, constipation, and dizziness; 77.9% of these adverse drug reactions had resolved or were resolving at the end of the study. Conclusions: Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders.

AB - Background: A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain. Methods: In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0–10) and the Korean-language EuroQol-five dimensions questionnaire, respectively. Results: Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7%, the most common being nausea, constipation, and dizziness; 77.9% of these adverse drug reactions had resolved or were resolving at the end of the study. Conclusions: Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders.

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U2 - 10.4055/cios.2018.10.1.33

DO - 10.4055/cios.2018.10.1.33

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JO - Clinics in Orthopedic Surgery

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