J Korean Med Sci.  2016 Dec;31(12):1914-1921. 10.3346/jkms.2016.31.12.1914.

Once-Daily OROS Hydromorphone for Management of Cancer Pain: an Open-Label, Multi-Center, Non-Interventional Study

• Park CK
• Kang HW
• Oh IJ
• Kim YC
• Kim YK
• Na KJ
• Ahn SJ
• Kim TO
• Choi YJ
• Song GA
• Lee MK

• KMID: 2355619
• DOI: http://doi.org/10.3346/jkms.2016.31.12.1914

Abstract

Extended-release osmotic extended-release oral delivery system (OROS) hydromorphone is a strong synthetic opioid designed to maintain a constant blood concentration by once daily dosing. The objective of this observational study was to investigate the clinical usefulness of OROS hydromorphone in patients with cancer pain of moderate to severe intensity. Patients with cancer pain who required strong opioids were administered with OROS hydromorphone for 4 weeks. We assessed changes in pain intensity using a numerical rating scale (NRS) as well as levels of sleep disturbance, breakthrough pain, end-of-dose failure, patient satisfaction, and overall assessment of drug effectiveness based on investigator evaluation. Of the 648 enrolled patients, 553 patients were included in the full analysis set. The mean pain intensity was significantly decreased from the NRS value of 5.07 ± 1.99 to 2.75 ± 1.94 (mean % change of 42.13 ± 46.53, P < 0.001). The degree of sleep disturbance significantly improved (mean NRS change of 1.61 ± 2.57, P < 0.001), and the incidence of breakthrough pain was significantly decreased (mean NRS change of 1.22 ± 2.30, P < 0.001). The experience of end-of-dose failure also significantly decreased from 4.60 ± 1.75 to 3.93 ± 1.70, P = 0.007). The patient satisfaction rate was 72.7%, and 72.9% of investigators evaluated the study drug as effective. OROS hydromorphone was an effective and tolerable agent for cancer pain management. It effectively lowered pain intensity as well as improved sleep disturbance, breakthrough pain, and end-of-dose failure (Identifier: NCT 01273454).

Keyword

Chronic Pain; Hydromorphone; Opioids; Pain Management

MeSH Terms

Analgesics, Opioid
Breakthrough Pain
Chronic Pain
Humans
Hydromorphone*
Incidence
Observational Study
Pain Management
Patient Satisfaction
Research Personnel
Analgesics, Opioid
Hydromorphone

Figure

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  Fig. 1 Disposition of subjected patients. A total of 648 subjects were enrolled from June 2009 to December 2009.

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