Oral Prolonged-Release Oxycodone-Naloxone: Analgesic Response, Safety Profile, and Factors Influencing the Response in Patients With Advanced Cancer

Good Response with Appropriate Treatment (GREAT) Collaborators

Research output: Contribution to journalArticle

Abstract

Background: Oxycodone-naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic. Methods: We evaluated the analgesic response, prevalence, and severity of side effects in 176 patients with cancer who had moderate to severe pain and were being treated with OXN. Patients were followed for 28 days and evaluated every 7 days. 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 scale of 0 to 10. 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% to 46.2% and 11.0% to 17.0% experienced any constipation and a severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk for analgesic nonresponse. Conclusions: OXN had a strong analgesic effect in patients with moderate to severe cancer pain; the safety profile is in line with the common adverse effects of opioids, and severe constipation was uncommon. Clinical Trial Registration: NCT02293785.

Original languageEnglish
JournalPain Practice
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

Oxycodone
Naloxone
Analgesics
Constipation
Safety
Pain
Breakthrough Pain
Neoplasms
Opioid Analgesics
Digestive System
Drug-Related Side Effects and Adverse Reactions
Thyroid Gland
Clinical Trials
Psychology

Keywords

  • analgesia
  • constipation
  • factors influencing the response
  • oxycodone-naloxone
  • patients with cancer

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

Oral Prolonged-Release Oxycodone-Naloxone : Analgesic Response, Safety Profile, and Factors Influencing the Response in Patients With Advanced Cancer. / Good Response with Appropriate Treatment (GREAT) Collaborators.

In: Pain Practice, 01.01.2019.

Research output: Contribution to journalArticle

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title = "Oral Prolonged-Release Oxycodone-Naloxone: Analgesic Response, Safety Profile, and Factors Influencing the Response in Patients With Advanced Cancer",
abstract = "Background: Oxycodone-naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic. Methods: We evaluated the analgesic response, prevalence, and severity of side effects in 176 patients with cancer who had moderate to severe pain and were being treated with OXN. Patients were followed for 28 days and evaluated every 7 days. 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 scale of 0 to 10. 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{\%} to 46.2{\%} and 11.0{\%} to 17.0{\%} experienced any constipation and a severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk for analgesic nonresponse. Conclusions: OXN had a strong analgesic effect in patients with moderate to severe cancer pain; the safety profile is in line with the common adverse effects of opioids, and severe constipation was uncommon. Clinical Trial Registration: NCT02293785.",
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author = "{Good Response with Appropriate Treatment (GREAT) Collaborators} and Oscar Corli and Vittorio Iorno and Lorenzo Legramandi and Eliana Rulli and Anna Roberto and Giuseppe Azzarello and Stefania Schiavon and Luigi Cavanna and {De Santis}, Stefano and Claudio Cartoni and {Di Marco}, Pierangelo and Mario Dauri and Rosario Mistretta and Roberto Bortolussi and Mario Clerico and Manuela Pacchioni and Carlo Crispino and Mirko Marabese and Nicole Corsi and Silvia Natoli and Gaspare Lipari and Marta Luzi and Giovanna Palumbo and Leonardo Trentin",
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AU - Good Response with Appropriate Treatment (GREAT) Collaborators

AU - Corli, Oscar

AU - Iorno, Vittorio

AU - Legramandi, Lorenzo

AU - Rulli, Eliana

AU - Roberto, Anna

AU - Azzarello, Giuseppe

AU - Schiavon, Stefania

AU - Cavanna, Luigi

AU - De Santis, Stefano

AU - Cartoni, Claudio

AU - Di Marco, Pierangelo

AU - Dauri, Mario

AU - Mistretta, Rosario

AU - Bortolussi, Roberto

AU - Clerico, Mario

AU - Pacchioni, Manuela

AU - Crispino, Carlo

AU - Marabese, Mirko

AU - Corsi, Nicole

AU - Natoli, Silvia

AU - Lipari, Gaspare

AU - Luzi, Marta

AU - Palumbo, Giovanna

AU - Trentin, Leonardo

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N2 - Background: Oxycodone-naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic. Methods: We evaluated the analgesic response, prevalence, and severity of side effects in 176 patients with cancer who had moderate to severe pain and were being treated with OXN. Patients were followed for 28 days and evaluated every 7 days. 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 scale of 0 to 10. 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% to 46.2% and 11.0% to 17.0% experienced any constipation and a severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk for analgesic nonresponse. Conclusions: OXN had a strong analgesic effect in patients with moderate to severe cancer pain; the safety profile is in line with the common adverse effects of opioids, and severe constipation was uncommon. Clinical Trial Registration: NCT02293785.

AB - Background: Oxycodone-naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic. Methods: We evaluated the analgesic response, prevalence, and severity of side effects in 176 patients with cancer who had moderate to severe pain and were being treated with OXN. Patients were followed for 28 days and evaluated every 7 days. 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 scale of 0 to 10. 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% to 46.2% and 11.0% to 17.0% experienced any constipation and a severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk for analgesic nonresponse. Conclusions: OXN had a strong analgesic effect in patients with moderate to severe cancer pain; the safety profile is in line with the common adverse effects of opioids, and severe constipation was uncommon. Clinical Trial Registration: NCT02293785.

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