Opioid titration with sustained-release oxycodone and immediate-release morphine for moderate/severe cancer pain: A pilot assessment of the CoDem protocol

Dekel, Boaz Gedaliahu Samolsky; Tomasi, Marco; Vasarri, Alessio; Gori, Alberto; Adversi, Marco; Castagnoli, Anna; Nino, Gianfranco Di; Melotti, Rita Maria

doi:10.5055/jom.2014.0189

Cited by 11 publications

(3 citation statements)

References 20 publications

(45 reference statements)

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“…There was a significant improvement in sleep scores compared with baseline in both treatment groups, with no significant intergroup difference. The type and incidence of adverse events did not differ greatly from previous reports ( 15 – 19 ).…”

Section: Discussioncontrasting

confidence: 58%

A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients

Inoue

Saito

Tsuneto

et al. 2018

Japanese Journal of Clinical Oncology

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Section: Discussioncontrasting

confidence: 58%

A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients

Inoue

Saito

Tsuneto

et al. 2018

Japanese Journal of Clinical Oncology

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“…In addition, the most common AEs identified and their incidence rates did not greatly differ from previous reports. 17 – 21 …”

Section: Discussionmentioning

confidence: 99%

A randomized, double-blind study of hydromorphone hydrochloride extended-release tablets versus oxycodone hydrochloride extended-release tablets for cancer pain: efficacy and safety in Japanese cancer patients (EXHEAL: a Phase III study of EXtended-release HydromorphonE for cAncer pain reLief)

Inoue

Saito

Tsuneto

et al. 2017

JPR

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BackgroundIn Japan, there are limited options for switching opioid analgesics. Hydromorphone is an opioid analgesic that is routinely used instead of morphine for cancer pain; however, it is not yet available in Japan. The aim of this study was to assess the efficacy and safety of hydromorphone (DS-7113b) extended-release tablets in opioid-naïve patients with cancer pain not relieved by non-opioid analgesics.Subjects and methodsThis was a multicenter, randomized, double-blind, parallel-group trial. A double-dummy method was used for blinding. Each randomized subject received either hydromorphone extended-release tablets plus placebo oxycodone hydrochloride extended-release tablets 4 mg/day (n=88) or placebo hydromorphone extended-release tablets plus oxycodone hydrochloride extended-release tablets 10 mg/day (n=93) orally for 7 days (once-daily dosing for hydromorphone and twice-daily dosing for oxycodone). The doses were adjusted as necessary. Efficacy was evaluated by change in visual analog scale (VAS) score from baseline to completion of treatment.ResultsThe between-group difference in least squares mean changes in VAS score from baseline to completion or discontinuation of treatment was −0.4 mm (95% CI −5.9 to 5 mm) by analysis of covariance where the baseline VAS score was used as a covariate. The upper limit of the 95% CI was below 10 mm, which was predefined as the noninferiority limit. This verified the noninferiority of hydromorphone tablets relative to oxycodone tablets. The incidence of adverse events was 80.7% (71 of 88) in the hydromorphone group and 83.7% (77 of 93) in the oxycodone group. The most common adverse events were nausea, vomiting, somnolence, diarrhea, and constipation, most of which are commonly observed with opioid analgesics.ConclusionThe efficacy and safety of hydromorphone extended-release tablets were equivalent to those of the oxycodone extended-release formulation.

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“…Finally, rotation can restore the decrease in opioid analgetic efficiency. 12 This approach has been used for over 20 years and is regarded as the standard-of-care in the field. 13 According to Mercadante et al, 13 the new opioid is administered at a safe dose, which maintains the balance between analgetic and adverse side effects.…”

Section: Introductionmentioning

confidence: 99%

The use of rotation to fentanyl in cancer-related pain

Dima

Tomuleasa

Frinc

et al. 2017

JPR

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Pain is commonly diagnosed with respect to cancer and heart diseases, being a major symptom in most neoplastic diseases. Uncontrolled pain leads to a decrease in the quality of life and an increase in the morbidity of the patient. Opioids represent the best analgetic supportive therapy and are frequently used in patients suffering from cancer and experiencing a high level of pain. Opioid treatment starts with a gradual titration of the dose until the minimum effective dose and the maximum tolerated dose are determined. Opioid rotation refers to the switch from one opioid to another in order to get a better response to analgetic therapy and reduce side effects. Fentanyl therapy is recommended to be continued during chemotherapy, radiotherapy, or in the case of surgical intervention. Rotation to fentanyl patches is an efficient and elegant solution for cancer patients, with reduced side effects. Opioid rotation, especially to fentanyl, was shown to increase the quality of life in patients with malignant disease. Finally, rotation to fentanyl is also advantageous from an economic point of view.

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Opioid titration with sustained-release oxycodone and immediate-release morphine for moderate/severe cancer pain: A pilot assessment of the CoDem protocol

Cited by 11 publications

References 20 publications

A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients

A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients

A randomized, double-blind study of hydromorphone hydrochloride extended-release tablets versus oxycodone hydrochloride extended-release tablets for cancer pain: efficacy and safety in Japanese cancer patients (EXHEAL: a Phase III study of EXtended-release HydromorphonE for cAncer pain reLief)

The use of rotation to fentanyl in cancer-related pain

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