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Cancer Res Treat. 2014 Oct;46(4):331-8. doi: 10.4143/crt.2013.130. Epub 2014 Jul 21.

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

Author information

1
Division of Hemato-Oncology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.
2
Division of Hemato-Oncology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.
3
Division of Hemato-Oncology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Korea.
4
Division of Hemato-Oncology, Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea.
5
Division of Hemato-Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea.
6
Division of Hemato-Oncology, Department of Internal Medicine, Inje University Paik Hospital, Inje University College of Medicine, Busan, Korea.
7
Division of Hemato-Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
8
Departments of Statistics, National Research Laboratory for Computational Proteomics and Biophysics, Pusan National University, Busan, Korea ; Departments of Physics, National Research Laboratory for Computational Proteomics and Biophysics, Pusan National University, Busan, Korea ; Interdisciplinary Research Program of Bioinformatics, Pusan National University, Busan, Korea.

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] ≥ 4) and sleep disturbance (NRS ≥ 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.

KEYWORDS:

Cancer pain; Hydromorphone-OROS (HM-OROS); Sleep disturbance

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