Once-daily OROS hydromorphone for the management of chronic nonmalignant pain: a dose-conversion and titration study.
BACKGROUND
The use of opioid analgesics for patients with chronic nonmalignant pain is becoming more widely accepted, and long-acting formulations are an important treatment option.


OBJECTIVE
To assess conversion to extended-release OROS hydromorphone from previous stable opioid agonist therapy in patients with chronic nonmalignant pain of moderate-to-severe intensity.


METHODS
In this open-label multicentre trial, patients were stabilised on their previous opioid therapy before being switched to OROS hydromorphone at a ratio of 5 : 1 (morphine sulphate equivalent to hydromorphone hydrochloride). The OROS hydromorphone dose was titrated over 3-16 days to achieve effective analgesia, and maintenance treatment continued for 14 days.


RESULTS
Study medication was received by 336 patients; 66% completed all study phases. Stabilisation of OROS hydromorphone was achieved by 94.6% of patients, the majority in two or fewer titration steps (mean time, 4.2 days). Mean pain intensity scores, as determined by the Brief Pain Inventory, decreased during OROS hydromorphone treatment (p <or= 0.001). The percentage of patients rating their pain relief as 'good' or 'complete' increased, and the use of rescue analgesics for breakthrough pain decreased. The interference of pain with everyday activities (e.g. walking or work), and the effects on mood and enjoyment of life, also improved during the study (all p < 0.001). OROS hydromorphone was well tolerated, and adverse events were those expected for opioid agonist therapy.


CONCLUSIONS
Patients with chronic nonmalignant pain who had been receiving opioid therapy easily underwent conversion to OROS hydromorphone, with no loss of efficacy or increase in adverse events.
Wallace
M
M
San Diego Medical Center, University of California, La Jolla, CA, USA.
Rauck
R L
RL
Moulin
D
D
Thipphawong
J
J
Khanna
S
S
Tudor
I C
IC
D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires; D017186:Titrimetry; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004091:Hydromorphone