Clinical Usefulness of Hydromorphone-OROS in Improving Sleep Disturbances in Korean Cancer Patients: A Multicenter, Prospective, Open-Label Study.
- Author:
Seong Hoon SHIN
1
;
Ho Sup LEE
;
Yang Soo KIM
;
Young Jin CHOI
;
Sung Hyun KIM
;
Hyuk Chan KWON
;
Sung Yong OH
;
Jung Hun KANG
;
Chang Hak SOHN
;
Sang Min LEE
;
Jin Ho BAEK
;
Young Joo MIN
;
Choongrak KIM
;
Joo Seop CHUNG
Author Information
- Publication Type:Multicenter Study ; Original Article
- Keywords: Cancer pain; Sleep disturbance; Hydromorphone-OROS (HM-OROS)
- MeSH: Analgesics, Opioid; Asthenia; Breakthrough Pain; Constipation; Dizziness; Humans; Incidence; Nausea; Prospective Studies*
- From:Cancer Research and Treatment 2014;46(4):331-338
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: To evaluate the efficacy of hydromorphone-OROS (HM-OROS) in reducing sleep disturbance and relieving cancer pain. MATERIALS AND METHODS: One hundred twenty cancer patients with pain (numeric rating scale [NRS] > or = 4) and sleep disturbance (NRS > or = 4) were evaluated. The initial HM-OROS dosing was based on previous opioid dose (HM-OROS:oral morphine=1:5). Dose adjustment of the study drug was permitted at the investigator\'s discretion. Pain intensity, number of breakthrough pain episodes, and quality of sleep were evaluated. RESULTS: A total of 120 patients received at least one dose of HM-OROS; 74 of them completed the final assessment. Compared to the previous opioids, HM-OROS reduced the average pain NRS from 5.3 to 4.1 (p < 0.01), worst pain NRS from 6.7 to 5.4 (p < 0.01), sleep disturbance NRS from 5.9 to 4.1 (p < 0.01), incidence of breakthrough pain at night from 2.63 to 1.53 times (p < 0.001), and immediate-release opioids use for the management of breakthrough pain from 0.83 to 0.39 times per night (p = 0.001). Of the 74 patients who completed the treatment, 83.7% indicated that they preferred HM-OROS to the previous medication. The adverse events (AEs) were somnolence, asthenia, constipation, dizziness, and nausea. CONCLUSION: HM-OROS was efficacious in reducing cancer pain and associated sleep disturbances. The AEs were manageable.
