Efficacy and safety profile of prolonged release oxycodone in combination with naloxone (OXN PR) in Parkinson’s disease patients with chronic pain

Graziella Madeo, Tommaso Schirinzi, Silvia Natoli, Mariangela Pierantozzi, Alessandro Stefani, Mario Dauri, Antonio Pisani

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Pain is a relevant and often underestimated non-motor symptom affecting the quality of life of patients with Parkinson’s disease (PD). Although some pain symptoms can be effectively treated by dopaminergic medication, a correct diagnosis of the different types and distribution of pain in PD is challenging, and accordingly, its treatment remains troublesome. We evaluated the efficacy and the safety of a prolonged release oral formulation of oxycodone hydrochloride combined with naloxone hydrochloride dehydrate, in a fixed ratio of 2:1 (OXN PR). A total of 16 PD patients with history of pain with a minimum intensity of four on numerical rating scale (NRS) received low-dose OXN PR (5/2.5 mg twice daily) and were observed for a period of 8 weeks. The primary efficacy measure was the pain severity measured with NRS and Brief Pain Inventory (BPI). Secondary efficacy measured the safety profile by recording the occurrence of side effects, clinical global impression of change (CGI-C), Parkinson’s disease sleep scale 2 (PDSS-2), Bowel function index (BFI). Data were collected and analyzed using descriptive statistics. Patients who completed the study (14 out of 16) reported a significant pain relief as observed by the reduction of NRS and BPI scores. No adjustment of dopaminergic therapy was required. No significant changes were observed in bowel function and constipation symptoms as measured by the BFI during the 8-week period. Similarly, no changes were observed in PDSS-2 score, whereas an improvement was recorded by CGI-C compared to baseline. Low-dose oral OXN PR was efficacious for the management of pain symptoms of patients with PD. More importantly, patients did not experience significant side effects, such as constipation or sedation. Our study provides evidence that opioids can be used to treat pain symptoms in PD patients.

Original languageEnglish
Pages (from-to)2164-2170
Number of pages7
JournalJournal of Neurology
Volume262
Issue number9
DOIs
Publication statusPublished - Sep 22 2015

Fingerprint

Oxycodone
Naloxone
Chronic Pain
Parkinson Disease
Safety
Pain
Constipation
Sleep
Social Adjustment
Equipment and Supplies
Pain Management
Opioid Analgesics
Quality of Life

Keywords

  • Non-motor symptoms
  • Opioid
  • Pain
  • Parkinson’s disease

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Efficacy and safety profile of prolonged release oxycodone in combination with naloxone (OXN PR) in Parkinson’s disease patients with chronic pain. / Madeo, Graziella; Schirinzi, Tommaso; Natoli, Silvia; Pierantozzi, Mariangela; Stefani, Alessandro; Dauri, Mario; Pisani, Antonio.

In: Journal of Neurology, Vol. 262, No. 9, 22.09.2015, p. 2164-2170.

Research output: Contribution to journalArticle

Madeo, Graziella ; Schirinzi, Tommaso ; Natoli, Silvia ; Pierantozzi, Mariangela ; Stefani, Alessandro ; Dauri, Mario ; Pisani, Antonio. / Efficacy and safety profile of prolonged release oxycodone in combination with naloxone (OXN PR) in Parkinson’s disease patients with chronic pain. In: Journal of Neurology. 2015 ; Vol. 262, No. 9. pp. 2164-2170.
@article{90f290615c8b493e9bec4b947137d757,
title = "Efficacy and safety profile of prolonged release oxycodone in combination with naloxone (OXN PR) in Parkinson’s disease patients with chronic pain",
abstract = "Pain is a relevant and often underestimated non-motor symptom affecting the quality of life of patients with Parkinson’s disease (PD). Although some pain symptoms can be effectively treated by dopaminergic medication, a correct diagnosis of the different types and distribution of pain in PD is challenging, and accordingly, its treatment remains troublesome. We evaluated the efficacy and the safety of a prolonged release oral formulation of oxycodone hydrochloride combined with naloxone hydrochloride dehydrate, in a fixed ratio of 2:1 (OXN PR). A total of 16 PD patients with history of pain with a minimum intensity of four on numerical rating scale (NRS) received low-dose OXN PR (5/2.5 mg twice daily) and were observed for a period of 8 weeks. The primary efficacy measure was the pain severity measured with NRS and Brief Pain Inventory (BPI). Secondary efficacy measured the safety profile by recording the occurrence of side effects, clinical global impression of change (CGI-C), Parkinson’s disease sleep scale 2 (PDSS-2), Bowel function index (BFI). Data were collected and analyzed using descriptive statistics. Patients who completed the study (14 out of 16) reported a significant pain relief as observed by the reduction of NRS and BPI scores. No adjustment of dopaminergic therapy was required. No significant changes were observed in bowel function and constipation symptoms as measured by the BFI during the 8-week period. Similarly, no changes were observed in PDSS-2 score, whereas an improvement was recorded by CGI-C compared to baseline. Low-dose oral OXN PR was efficacious for the management of pain symptoms of patients with PD. More importantly, patients did not experience significant side effects, such as constipation or sedation. Our study provides evidence that opioids can be used to treat pain symptoms in PD patients.",
keywords = "Non-motor symptoms, Opioid, Pain, Parkinson’s disease",
author = "Graziella Madeo and Tommaso Schirinzi and Silvia Natoli and Mariangela Pierantozzi and Alessandro Stefani and Mario Dauri and Antonio Pisani",
year = "2015",
month = "9",
day = "22",
doi = "10.1007/s00415-015-7823-3",
language = "English",
volume = "262",
pages = "2164--2170",
journal = "Journal of Neurology",
issn = "0340-5354",
publisher = "Dr. Dietrich Steinkopff Verlag GmbH and Co. KG",
number = "9",

}

TY - JOUR

T1 - Efficacy and safety profile of prolonged release oxycodone in combination with naloxone (OXN PR) in Parkinson’s disease patients with chronic pain

AU - Madeo, Graziella

AU - Schirinzi, Tommaso

AU - Natoli, Silvia

AU - Pierantozzi, Mariangela

AU - Stefani, Alessandro

AU - Dauri, Mario

AU - Pisani, Antonio

PY - 2015/9/22

Y1 - 2015/9/22

N2 - Pain is a relevant and often underestimated non-motor symptom affecting the quality of life of patients with Parkinson’s disease (PD). Although some pain symptoms can be effectively treated by dopaminergic medication, a correct diagnosis of the different types and distribution of pain in PD is challenging, and accordingly, its treatment remains troublesome. We evaluated the efficacy and the safety of a prolonged release oral formulation of oxycodone hydrochloride combined with naloxone hydrochloride dehydrate, in a fixed ratio of 2:1 (OXN PR). A total of 16 PD patients with history of pain with a minimum intensity of four on numerical rating scale (NRS) received low-dose OXN PR (5/2.5 mg twice daily) and were observed for a period of 8 weeks. The primary efficacy measure was the pain severity measured with NRS and Brief Pain Inventory (BPI). Secondary efficacy measured the safety profile by recording the occurrence of side effects, clinical global impression of change (CGI-C), Parkinson’s disease sleep scale 2 (PDSS-2), Bowel function index (BFI). Data were collected and analyzed using descriptive statistics. Patients who completed the study (14 out of 16) reported a significant pain relief as observed by the reduction of NRS and BPI scores. No adjustment of dopaminergic therapy was required. No significant changes were observed in bowel function and constipation symptoms as measured by the BFI during the 8-week period. Similarly, no changes were observed in PDSS-2 score, whereas an improvement was recorded by CGI-C compared to baseline. Low-dose oral OXN PR was efficacious for the management of pain symptoms of patients with PD. More importantly, patients did not experience significant side effects, such as constipation or sedation. Our study provides evidence that opioids can be used to treat pain symptoms in PD patients.

AB - Pain is a relevant and often underestimated non-motor symptom affecting the quality of life of patients with Parkinson’s disease (PD). Although some pain symptoms can be effectively treated by dopaminergic medication, a correct diagnosis of the different types and distribution of pain in PD is challenging, and accordingly, its treatment remains troublesome. We evaluated the efficacy and the safety of a prolonged release oral formulation of oxycodone hydrochloride combined with naloxone hydrochloride dehydrate, in a fixed ratio of 2:1 (OXN PR). A total of 16 PD patients with history of pain with a minimum intensity of four on numerical rating scale (NRS) received low-dose OXN PR (5/2.5 mg twice daily) and were observed for a period of 8 weeks. The primary efficacy measure was the pain severity measured with NRS and Brief Pain Inventory (BPI). Secondary efficacy measured the safety profile by recording the occurrence of side effects, clinical global impression of change (CGI-C), Parkinson’s disease sleep scale 2 (PDSS-2), Bowel function index (BFI). Data were collected and analyzed using descriptive statistics. Patients who completed the study (14 out of 16) reported a significant pain relief as observed by the reduction of NRS and BPI scores. No adjustment of dopaminergic therapy was required. No significant changes were observed in bowel function and constipation symptoms as measured by the BFI during the 8-week period. Similarly, no changes were observed in PDSS-2 score, whereas an improvement was recorded by CGI-C compared to baseline. Low-dose oral OXN PR was efficacious for the management of pain symptoms of patients with PD. More importantly, patients did not experience significant side effects, such as constipation or sedation. Our study provides evidence that opioids can be used to treat pain symptoms in PD patients.

KW - Non-motor symptoms

KW - Opioid

KW - Pain

KW - Parkinson’s disease

UR - http://www.scopus.com/inward/record.url?scp=84941996828&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84941996828&partnerID=8YFLogxK

U2 - 10.1007/s00415-015-7823-3

DO - 10.1007/s00415-015-7823-3

M3 - Article

C2 - 26134157

AN - SCOPUS:84941996828

VL - 262

SP - 2164

EP - 2170

JO - Journal of Neurology

JF - Journal of Neurology

SN - 0340-5354

IS - 9

ER -