Clinical Usefulness of Hydromorphone-OROS in Improving Sleep Disturbances in Korean Cancer Patients: A Multicenter, Prospective, Open-Label Study

다국어 초록 (Multilingual Abstract)

PurposeTo evaluate the efficacy of hydromorphone-OROS (HM-OROS) in reducing sleep disturbanceand relieving cancer pain.

Materials and MethodsOne hundred twenty cancer patients with pain (numeric rating scale [NRS] ≥ 4) and sleepdisturbance (NRS ≥ 4) were evaluated. The initial HM-OROS dosing was based on previousopioid dose (HM-OROS:oral morphine=1:5). Dose adjustment of the study drug waspermitted at the investigator’s discretion. Pain intensity, number of breakthrough painepisodes, and quality of sleep were evaluated.

ResultsA total of 120 patients received at least one dose of HM-OROS; 74 of them completed thefinal assessment. Compared to the previous opioids, HM-OROS reduced the average painNRS from 5.3 to 4.1 (p < 0.01), worst pain NRS from 6.7 to 5.4 (p < 0.01), sleep disturbanceNRS from 5.9 to 4.1 (p < 0.01), incidence of breakthrough pain at night from 2.63 to 1.53times (p < 0.001), and immediate-release opioids use for the management of breakthroughpain from 0.83 to 0.39 times per night (p = 0.001). Of the 74 patients who completed thetreatment, 83.7% indicated that they preferred HM-OROS to the previous medication. Theadverse events (AEs) were somnolence, asthenia, constipation, dizziness, and nausea.

ConclusionHM-OROS was efficacious in reducing cancer pain and associated sleep disturbances. TheAEs were manageable.

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