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Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials.
J Pain Symptom Manage. 2005 Jun; 29(6):584-94.JP

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+Show Affiliations

North Idaho Cancer Center, Coeur d'Alene, Idaho 83814, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15963867

Citation

Grosset, Alan B., et al. "Comparative Efficacy of Oral Extended-release Hydromorphone and Immediate-release Hydromorphone in Patients With Persistent Moderate to Severe Pain: Two Randomized Controlled Trials." Journal of Pain and Symptom Management, vol. 29, no. 6, 2005, pp. 584-94.
Grosset AB, Roberts MS, Woodson ME, et al. Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials. J Pain Symptom Manage. 2005;29(6):584-94.
Grosset, A. B., Roberts, M. S., Woodson, M. E., Shi, M., Swanton, R. E., Reder, R. F., & Buckley, B. J. (2005). Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials. Journal of Pain and Symptom Management, 29(6), 584-94.
Grosset AB, et al. Comparative Efficacy of Oral Extended-release Hydromorphone and Immediate-release Hydromorphone in Patients With Persistent Moderate to Severe Pain: Two Randomized Controlled Trials. J Pain Symptom Manage. 2005;29(6):584-94. PubMed PMID: 15963867.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials. AU - Grosset,Alan B, AU - Roberts,Michael S, AU - Woodson,Mark E, AU - Shi,Minggao, AU - Swanton,Ruth E, AU - Reder,Robert F, AU - Buckley,Barbara J, PY - 2004/10/24/accepted PY - 2005/6/21/pubmed PY - 2005/9/1/medline PY - 2005/6/21/entrez SP - 584 EP - 94 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 29 IS - 6 N2 - 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. SN - 0885-3924 UR - https://www.unboundmedicine.com/medline/citation/15963867/Comparative_efficacy_of_oral_extended_release_hydromorphone_and_immediate_release_hydromorphone_in_patients_with_persistent_moderate_to_severe_pain:_two_randomized_controlled_trials_ DB - PRIME DP - Unbound Medicine ER -