Cancer Res Treat.  2014 Oct;46(4):331-338. 10.4143/crt.2013.130.

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

• Shin SH
• Lee HS
• Kim YS
• Choi YJ
• Kim SH
• Kwon HC
• Oh SY
• Kang JH
• Sohn CH
• Lee SM
• Baek JH
• Min YJ
• Kim C
• Chung JS

• KMID: 2380370
• DOI: http://doi.org/10.4143/crt.2013.130

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.

Keyword

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

MeSH Terms

Analgesics, Opioid
Asthenia
Breakthrough Pain
Constipation
Dizziness
Humans
Incidence
Nausea
Prospective Studies*
Analgesics, Opioid

Figure

• 

  Fig. 1. Summary of study design and patient disposition. ITT, intent-to-treat; PP, per-protocol. a)±2 days.

Reference

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