title: Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients.
abstract: OBJECTIVE
  To evaluate the effectiveness of OROS® hydromorphone in reducing breakthrough pain (BTP) medication frequency in Korean patients with chronic cancer pain.
  
  
  METHODS
  Multicenter, prospective, open-label, phase IV study.
  
  
  METHODS
  Patients with chronic malignant pain using immediate-release oxycodone more than two times per day for BTP.
  
  
  METHODS
  Patients were stabilized on their ongoing drug for 3 days immediately before baseline measurements (day 0). Medication was changed to OROS® hydromorphone at a dose equianalgesic to oxycodone using a 2.5:1 controlled-release oxycodone to hydromorphone hydrochloride conversion ratio; the patients were observed for 7 days. Dose was titrated, if required, and the patients were observed for another 7 days. Effectiveness and safety parameters were measured at baseline, day 7, and day 14.
  
  
  RESULTS
  BTP medication frequency on days 7 and 14, compared to baseline.
  
  
  RESULTS
  Of the 141 patients screened, 114 received study drug and 98 completed the study. Compared to day 0, daily BTP medication frequency on day 14 decreased from 2.93 to 2.00 (p > 0.0001), daily BTP frequency decreased from 3.67 to 2.44 (p > 0.0001), and end-of-dose pain frequency decreased by 44 percent. Pain was controlled adequately during daytime and night-time. Pain intensity decreased by 11 percent as assessed using the Korean Brief Pain Inventory and by 17 percent as assessed using the numerical rating scale. About 61.2 percent patients and 60.2 percent physicians were satisfied with the treatment. Common adverse events, which occurred in 91.2 percent patients, were constipation, somnolence, and dizziness.
  
  
  CONCLUSIONS
  Once-daily OROS® hydromorphone is efficient in the reduction of cancer pain-related BTP episodes, including end-of-dose pain.
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Min Kyoung
authors.initials: MK
authors.lastname: Kim
authors.forename: Myung Soo
authors.initials: MS
authors.lastname: Hyun
authors.forename: Jin Young
authors.initials: JY
authors.lastname: Kim
authors.forename: Keon Uk
authors.initials: KU
authors.lastname: Park
authors.forename: Hong Suk
authors.initials: HS
authors.lastname: Song
authors.forename: Sun Ah
authors.initials: SA
authors.lastname: Lee
authors.forename: Won Sik
authors.initials: WS
authors.lastname: Lee
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.forename: Hun Mo
authors.initials: HM
authors.lastname: Ryoo
authors.forename: Yoon Young
authors.initials: YY
authors.lastname: Cho
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010098:Oxycodone / Q000627:therapeutic use; D010147:Pain Measurement / Q000379:methods; D011446:Prospective Studies; D056910:Republic of Korea; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D010098:Oxycodone; D004091:Hydromorphone