Oxycodone Hydrochloride Controlled-Release Tablet for Cancer Pain
Oxycodone Hydrochloride Controlled-Release Tablet for Cancer Pain
Background and Objective: Oxycodone is a semisynthetic opioid analgesic drug classed as a strong opioid. The controlled-release oxycodone tablet formulation (OCRT) was approved in China in 2004 for management of moderate to severe cancer pain. Few data about the efficacy of OCRT and clinical outcomes in Chinese patients taking this drug are available. The purpose of this study was to evaluate the efficacy and tolerability of this drug for relief of moderate to severe cancer pain in Chinese patients.
Methods: This was a prospective, open-label, multicentre clinical trial carried out in ten hospitals in Zhejiang Province, China. Patients with cancer pain with a score ≥4 (numerical rating scale) were enrolled. They received oral OCRT at an initial dosage of 5mg every 12 hours for patients scoring 4-6 and 10mg every 12 hours for patients scoring ≥7. Doses were then titrated on an individual basis. Onset of analgesic action, pain score and quality-of-life (QOL) scores–including items measuring family understanding and support, sleep, mental state, appetite, fatigue, and activities of daily life–were evaluated. Adverse effects were also documented.
Results: 216 patients (126 males and 90 females) aged 22-84 years were enrolled. The total mean OCRT dosage was 445.2 ± 361.6mg (range 130-2320mg). The daily dosages of the vast majority of cases (89%) were between 10mg and 30mg. Onset of analgesic action occurred within 1 hour in 198 cases (91.7%) following administration of OCRT. 82.4% of cases were titrated to a steady dosage level within 2 days following administration of the first dose of medication. Pain score decreased significantly (p < 0.01) from 7.1 ± 1.2 at baseline to 2.3 ± 1.2 one week after starting medication and 1.8 ± 0.9 four weeks after starting medication. Scores on all six QOL items increased significantly (p < 0.01) compared with baseline but showed varying rates of improvement. Adverse events included constipation, nausea, vomiting, drowsiness and dysuria. These were noted most frequently in the first week (25.5% of patients) and lessened over time. No severe adverse events were noted.
Conclusion: We conclude that OCRT is well tolerated and effective in controlling moderate to severe cancer pain in Chinese patients.
Pain continues to be a prevalent symptom experienced by cancer patients. It occurs in approximately one-quarter of patients with newly diagnosed malignancies, and in one-third of patients undergoing treatment. The prevalence of pain in patients with advanced cancer is about 70-80%. Pain relief is an important challenge for oncology doctors and an important factor in the quality of life of cancer patients.
Oxycodone is a semisynthetic strong opioid analgesic drug, useful for the treatment of moderate or severe pain. However, when formulated as immediate-release oxycodone, frequent administration of the medication is needed to sustain adequate pain control. One study showed that oral controlled-release oxycodone administered every 12 hours achieved analgesia comparable to that achieved with immediate-release oxycodone given every 6 hours. This formulation can maintain stable serum concentrations and avoid the erratic fluctuations that characterise use of immediate-release formulations. Oxycodone hydrochloride controlled-release tablet (OCRT) was approved by the US FDA in 1995 as a sustained-release form of oxycodone. It is indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Clinical studies have proved that OCRT delivers effective pain relief with tolerable adverse effects in patients with cancer pain, chronic non-cancer pain and acute post-surgical pain. Furthermore, because of the reduced need to take medications and fewer reports of adverse events, OCRT is associated with greater compliance than immediate-release oxycodone.
OCRT was approved for use in China in 2004. However, although it has been used throughout the world for several years and been the focus of a number of clinical studies, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. No published multicentre clinical trial of OCRT in Chinese patients is yet available. Since there are differences in background, religion, nationality and economic status between the Chinese population and people of other countries that may lead to different responses to this drug in Chinese patients, investigations of OCRT in this population are necessary. We therefore conducted this clinical trial to evaluate the efficacy and tolerability of OCRT in the management of cancer pain in Chinese patients.
Abstract and Introduction
Abstract
Background and Objective: Oxycodone is a semisynthetic opioid analgesic drug classed as a strong opioid. The controlled-release oxycodone tablet formulation (OCRT) was approved in China in 2004 for management of moderate to severe cancer pain. Few data about the efficacy of OCRT and clinical outcomes in Chinese patients taking this drug are available. The purpose of this study was to evaluate the efficacy and tolerability of this drug for relief of moderate to severe cancer pain in Chinese patients.
Methods: This was a prospective, open-label, multicentre clinical trial carried out in ten hospitals in Zhejiang Province, China. Patients with cancer pain with a score ≥4 (numerical rating scale) were enrolled. They received oral OCRT at an initial dosage of 5mg every 12 hours for patients scoring 4-6 and 10mg every 12 hours for patients scoring ≥7. Doses were then titrated on an individual basis. Onset of analgesic action, pain score and quality-of-life (QOL) scores–including items measuring family understanding and support, sleep, mental state, appetite, fatigue, and activities of daily life–were evaluated. Adverse effects were also documented.
Results: 216 patients (126 males and 90 females) aged 22-84 years were enrolled. The total mean OCRT dosage was 445.2 ± 361.6mg (range 130-2320mg). The daily dosages of the vast majority of cases (89%) were between 10mg and 30mg. Onset of analgesic action occurred within 1 hour in 198 cases (91.7%) following administration of OCRT. 82.4% of cases were titrated to a steady dosage level within 2 days following administration of the first dose of medication. Pain score decreased significantly (p < 0.01) from 7.1 ± 1.2 at baseline to 2.3 ± 1.2 one week after starting medication and 1.8 ± 0.9 four weeks after starting medication. Scores on all six QOL items increased significantly (p < 0.01) compared with baseline but showed varying rates of improvement. Adverse events included constipation, nausea, vomiting, drowsiness and dysuria. These were noted most frequently in the first week (25.5% of patients) and lessened over time. No severe adverse events were noted.
Conclusion: We conclude that OCRT is well tolerated and effective in controlling moderate to severe cancer pain in Chinese patients.
Introduction
Pain continues to be a prevalent symptom experienced by cancer patients. It occurs in approximately one-quarter of patients with newly diagnosed malignancies, and in one-third of patients undergoing treatment. The prevalence of pain in patients with advanced cancer is about 70-80%. Pain relief is an important challenge for oncology doctors and an important factor in the quality of life of cancer patients.
Oxycodone is a semisynthetic strong opioid analgesic drug, useful for the treatment of moderate or severe pain. However, when formulated as immediate-release oxycodone, frequent administration of the medication is needed to sustain adequate pain control. One study showed that oral controlled-release oxycodone administered every 12 hours achieved analgesia comparable to that achieved with immediate-release oxycodone given every 6 hours. This formulation can maintain stable serum concentrations and avoid the erratic fluctuations that characterise use of immediate-release formulations. Oxycodone hydrochloride controlled-release tablet (OCRT) was approved by the US FDA in 1995 as a sustained-release form of oxycodone. It is indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Clinical studies have proved that OCRT delivers effective pain relief with tolerable adverse effects in patients with cancer pain, chronic non-cancer pain and acute post-surgical pain. Furthermore, because of the reduced need to take medications and fewer reports of adverse events, OCRT is associated with greater compliance than immediate-release oxycodone.
OCRT was approved for use in China in 2004. However, although it has been used throughout the world for several years and been the focus of a number of clinical studies, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. No published multicentre clinical trial of OCRT in Chinese patients is yet available. Since there are differences in background, religion, nationality and economic status between the Chinese population and people of other countries that may lead to different responses to this drug in Chinese patients, investigations of OCRT in this population are necessary. We therefore conducted this clinical trial to evaluate the efficacy and tolerability of OCRT in the management of cancer pain in Chinese patients.
