Oral prolonged-release Oxycodone-Naloxone: analgesic response, safety profile, and factors influencing the response in advanced cancer patients.

Oxycodone-Naloxone analgesia cancer patients constipation factors influencing the response

Journal

Pain practice : the official journal of World Institute of Pain
ISSN: 1533-2500
Titre abrégé: Pain Pract
Pays: United States
ID NLM: 101130835

Informations de publication

Date de publication:
27 Mar 2019
Historique:
entrez: 28 3 2019
pubmed: 28 3 2019
medline: 28 3 2019
Statut: aheadofprint

Résumé

Oxycodone-Naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic. We evaluated the analgesic response, prevalence, and severity of side effects in 176 cancer patients with moderate to severe pain and treated with OXN. Patients were followed for 28 days and evaluated every seven. Pain intensity, changes of therapy, and adverse drug reactions were recorded at each visit. The primary efficacy endpoint was the proportion of responders (≥30% reduction of pain intensity from baseline to final) and final average pain score ≤4 on a 0-10 scale. Average and worst pain intensity, and breakthrough pain (BTP) prevalence decreased over time and 81.3% of patients were responders. The starting daily dose of OXN was raised from 25.1±13.0 mg to 44.1±29.9 mg, and dose escalation >5%/day was observed in 19.4% of patients; 40.8-46.2% and 11.0-17.0% experienced any and severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk of analgesic non-response. OXN had strong analgesic effect in moderate to severe cancer pain patients: the safety profile is in line with the common adverse effects of opioids and severe constipation was uncommon. This article is protected by copyright. All rights reserved.

Sections du résumé

BACKGROUND BACKGROUND
Oxycodone-Naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic.
METHODS METHODS
We evaluated the analgesic response, prevalence, and severity of side effects in 176 cancer patients with moderate to severe pain and treated with OXN. Patients were followed for 28 days and evaluated every seven. Pain intensity, changes of therapy, and adverse drug reactions were recorded at each visit. The primary efficacy endpoint was the proportion of responders (≥30% reduction of pain intensity from baseline to final) and final average pain score ≤4 on a 0-10 scale.
RESULTS RESULTS
Average and worst pain intensity, and breakthrough pain (BTP) prevalence decreased over time and 81.3% of patients were responders. The starting daily dose of OXN was raised from 25.1±13.0 mg to 44.1±29.9 mg, and dose escalation >5%/day was observed in 19.4% of patients; 40.8-46.2% and 11.0-17.0% experienced any and severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk of analgesic non-response.
CONCLUSIONS CONCLUSIONS
OXN had strong analgesic effect in moderate to severe cancer pain patients: the safety profile is in line with the common adverse effects of opioids and severe constipation was uncommon. This article is protected by copyright. All rights reserved.

Identifiants

DOI: 10.1111/papr.12784 PMID: 30917409
pubmed: 30917409
doi: 10.1111/papr.12784
doi:

Types de publication

Journal Article

Langues

eng

Investigateurs

Silvia Natoli (S)
Gaspare Lipari (G)
Marta Luzi (M)
Giovanna Palumbo (G)
Leonardo Trentin (L)

Informations de copyright

This article is protected by copyright. All rights reserved.

Auteurs

Oscar Corli (O)

Pain and Palliative Care Research Unit, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

Vittorio Iorno (V)

Centre for Pain Medicine M. TIENGO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.

Lorenzo Legramandi (L)

Methodology for Clinical Research Laboratory, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

Eliana Rulli (E)

Methodology for Clinical Research Laboratory, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

Anna Roberto (A)

Methodology for Clinical Research Laboratory, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

Giuseppe Azzarello (G)

U.O.C. Oncology and Oncologic Hematology, ASL 13, Mirano, Venice Italy.

Stefania Schiavon (S)

Pain Therapy and Palliative Care Unit, Veneto Institute of Oncology IOV-IRCSS, Padua, Italy.

Luigi Cavanna (L)

Oncohematology Department, U.O. Oncology, Guglielmo da Saliceto Hospital, Piacenza, Italy.

Stefano De Santis (S)

Palliative Care and Oncologic Pain Service, S. Camillo-Forlanini Hospital, Rome, Italy.

Claudio Cartoni (C)

U.O. Ematology, Policlinico Umberto I, Rome Italy.

Pierangelo Di Marco (P)

Department of Cardiovascular Surgery, Respiratory Medicine, Nephrology, Anesthesiology and Geriatrics, Faculty of Medicine and Dentistry, Sapienza University, Rome, Italy.

Mario Dauri (M)

Department of Anesthesia and Intensive Care, PTV (Tor Vergata Policlinic Foundation), Rome, Italy.

Rosario Mistretta (R)

Hospice Raggio di sole, Salemi-ASP 9, Trapani, Italy.

Roberto Bortolussi (R)

Palliative Care and Pain Therapy Unit, Aviano National Cancer Institute, Aviano, Italy.

Mario Clerico (M)

Department of Medical Oncology, Hospital of Biella, Biella, Italy.

Manuela Pacchioni (M)

Department of Oncology, Ospedale San Raffaele IRCCS, Milan, Italy.

Carlo Crispino (C)

UOSD Treatment of Lung Cancer Complications, AO Dei Colli Monaldi Cotugno CTO Ospedale Monaldi, Napoli, Italy.

Mirko Marabese (M)

Molecular Genetics Unit, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

Nicole Corsi (N)

Pain and Palliative Care Research Unit, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

Classifications MeSH