title: Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials.
abstract: Two multicenter, randomized, double-blind, crossover studies with identical designs evaluated the efficacy of oral extended-release hydromorphone (HHER) administered q24h compared with immediate-release hydromorphone (HHIR) dosed four times daily in patients with persistent moderate to severe pain. Patients titrated to a stable HHER dose were randomized to individualized doses of HHER or HHIR for 3 to 7 days before crossover to the second treatment. Primary efficacy end point was the mean of average pain intensity (API) scores, rated on a 0- to 10-point numeric scale, over the last 2 days before the pharmacokinetics/pharmacodynamics day of each double-blind period. Difference between treatments (HHER - HHIR) in study 1 was 0.17 with a 90% confidence interval (CI) (-0.01, 0.34); in study 2, difference was 0.07 with a 90% CI (-0.12, 0.26). There were no significant differences between treatments in API scores or amount of rescue medication used at any time interval within the 24-hour dosing period. No reduction in pain control occurred in patients administered HHER at the end of the 24-hour dosing period. Most treatment-emergent adverse events were opioid-related. In these studies, HHER administered q24h and HHIR dosed four times daily provided comparable analgesia at an equivalent total daily dose.
authors.affiliation: North Idaho Cancer Center, Coeur d'Alene, Idaho 83814, USA.
authors.forename: Alan B
authors.initials: AB
authors.lastname: Grosset
authors.forename: Michael S
authors.initials: MS
authors.lastname: Roberts
authors.forename: Mark E
authors.initials: ME
authors.lastname: Woodson
authors.forename: Minggao
authors.initials: M
authors.lastname: Shi
authors.forename: Ruth E
authors.initials: RE
authors.lastname: Swanton
authors.forename: Robert F
authors.initials: RF
authors.lastname: Reder
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Buckley
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D013727:Terminal Care / Q000379:methods*
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004091:Hydromorphone