Once-Daily OROS Hydromorphone for Management of Cancer Pain: an Open-Label, Multi-Center, Non-Interventional Study.
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.
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Cheol Kyu
0000-0001-8701-0786
CK
Park
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Hyun Wook
0000-0002-0454-3278
HW
Kang
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea. droij@chonnam.ac.kr.
In Jae
0000-0003-4837-1321
IJ
Oh
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Young Chul
0000-0001-7019-7687
YC
Kim
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Yeo Kyeoung
0000-0001-5447-4285
YK
Kim
Department of Thoracic and Cardiovascular surgery, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Kook Joo
0000-0003-4111-5181
KJ
Na
Department of Radiation Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Sung Ja
0000-0002-3066-2617
SJ
Ahn
Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Tae Ok
0000-0002-0922-9472
TO
Kim
Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
Young Jin
0000-0003-0263-9302
YJ
Choi
Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
Geun Am
0000-0003-2100-8522
GA
Song
Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
Min Ki
0000-0002-0163-115X
MK
Lee
D000368:Aged; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D000072716:Cancer Pain / Q000188:drug therapy* / Q000473:pathology; D003248:Constipation / Q000209:etiology; D004244:Dizziness; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D059408:Pain Management; D017060:Patient Satisfaction; D011446:Prospective Studies; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000517:prevention & control; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D004091:Hydromorphone
Chronic Pain; Hydromorphone; Opioids; Pain Management