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Multicenter, open-label, prospective evaluation of the conversion from previous opioid analgesics to extended-release hydromorphone hydrochloride administered every 24 hours to patients with persistent moderate to severe pain.
Clin Ther. 2006 Jan; 28(1):86-98.CT

Abstract

BACKGROUND

Hydromorphone hydrochloride is a mu-opioid agonist with dose-dependent analgesic properties. Extended-release hydromorphone hydrochloride (ER hydromorphone HCl) capsules have been developed for administration every 24 hours.

OBJECTIVES

This prospective evaluation focused on the first (ie, conversion) phase of 2 identically designed, randomized, controlled studies that compared the safety and efficacy of once-daily ER hydromorphone HCl capsules with immediate-release hydromorphone hydrochloride (IR hydromorphone HCl) tablets administered 4 times daily in the treatment of persistent moderate to severe cancer- and noncancer-related pain.

METHODS

Patients being treated with opioid analgesics for persistent moderate to severe pain were converted to ER hydromorphone HCl using an 8:1 conversion ratio. The dose was titrated to attain an average pain intensity (API) score < or = 4 on a 0- to 10-point numeric rating scale. Supplemental oral IR hydromorphone HCl tablets were used as rescue medication at a dose of one eighth to one sixth of the daily ER hydromorphone HCl dose.

RESULTS

A total of 343 patients (272 [79%] with cancer pain; mean age, 57.8 years) were enrolled and converted to ER hydromorphone HCl from their previous opioids. About half (51%) were women. At baseline, the mean (SD) API score was 5.3 (2.1). Mean (SD) API scores were 4.7 (2.0) after the first 48 hours and 3.4 (2.1) by the end of titration. After 4 to 21 days of titration, 239 (70%) patients reached stabilization defined as a > or = 48-hour period with an API score of < or =4, unchanged ER hydromorphone HCl dose, and < or = 2 rescue doses per day. The stabilized patients had mean (SD) API scores of 2.7 (1.1) at the end of titration. At stabilization, 102 (43%) of 239 patients remained at their initial conversion dose, 129 (54%) had a dose increase, and 8 (3%) had a dose decrease. Frequent (> or =10% of patients) adverse events that occurred within the first 48 hours after conversion and during the entire titration phase were nausea, somnolence, headache, constipation, vomiting, and dizziness.

CONCLUSION

In this prospective evaluation of the conversion and titration phase of 2 randomized, controlled studies, a conversion ratio of 8:1 mg of oral morphine to oral ER hydromorphone HCl was found to be clinically useful in patients with persistent moderate to severe cancer-related or noncancer-related pain.

Authors+Show Affiliations

MD Anderson Cancer Center, University o f Texas, Houston, Texas, USA. sharon.weinstein@hci.utah.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16490582

Citation

Weinstein, Sharon M., et al. "Multicenter, Open-label, Prospective Evaluation of the Conversion From Previous Opioid Analgesics to Extended-release Hydromorphone Hydrochloride Administered Every 24 Hours to Patients With Persistent Moderate to Severe Pain." Clinical Therapeutics, vol. 28, no. 1, 2006, pp. 86-98.
Weinstein SM, Shi M, Buckley BJ, et al. Multicenter, open-label, prospective evaluation of the conversion from previous opioid analgesics to extended-release hydromorphone hydrochloride administered every 24 hours to patients with persistent moderate to severe pain. Clin Ther. 2006;28(1):86-98.
Weinstein, S. M., Shi, M., Buckley, B. J., & Kwarcinski, M. A. (2006). Multicenter, open-label, prospective evaluation of the conversion from previous opioid analgesics to extended-release hydromorphone hydrochloride administered every 24 hours to patients with persistent moderate to severe pain. Clinical Therapeutics, 28(1), 86-98.
Weinstein SM, et al. Multicenter, Open-label, Prospective Evaluation of the Conversion From Previous Opioid Analgesics to Extended-release Hydromorphone Hydrochloride Administered Every 24 Hours to Patients With Persistent Moderate to Severe Pain. Clin Ther. 2006;28(1):86-98. PubMed PMID: 16490582.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter, open-label, prospective evaluation of the conversion from previous opioid analgesics to extended-release hydromorphone hydrochloride administered every 24 hours to patients with persistent moderate to severe pain. AU - Weinstein,Sharon M, AU - Shi,Minggao, AU - Buckley,Barbara J, AU - Kwarcinski,Monica A, PY - 2005/09/06/accepted PY - 2006/2/24/pubmed PY - 2006/5/26/medline PY - 2006/2/24/entrez SP - 86 EP - 98 JF - Clinical therapeutics JO - Clin Ther VL - 28 IS - 1 N2 - BACKGROUND: Hydromorphone hydrochloride is a mu-opioid agonist with dose-dependent analgesic properties. Extended-release hydromorphone hydrochloride (ER hydromorphone HCl) capsules have been developed for administration every 24 hours. OBJECTIVES: This prospective evaluation focused on the first (ie, conversion) phase of 2 identically designed, randomized, controlled studies that compared the safety and efficacy of once-daily ER hydromorphone HCl capsules with immediate-release hydromorphone hydrochloride (IR hydromorphone HCl) tablets administered 4 times daily in the treatment of persistent moderate to severe cancer- and noncancer-related pain. METHODS: Patients being treated with opioid analgesics for persistent moderate to severe pain were converted to ER hydromorphone HCl using an 8:1 conversion ratio. The dose was titrated to attain an average pain intensity (API) score < or = 4 on a 0- to 10-point numeric rating scale. Supplemental oral IR hydromorphone HCl tablets were used as rescue medication at a dose of one eighth to one sixth of the daily ER hydromorphone HCl dose. RESULTS: A total of 343 patients (272 [79%] with cancer pain; mean age, 57.8 years) were enrolled and converted to ER hydromorphone HCl from their previous opioids. About half (51%) were women. At baseline, the mean (SD) API score was 5.3 (2.1). Mean (SD) API scores were 4.7 (2.0) after the first 48 hours and 3.4 (2.1) by the end of titration. After 4 to 21 days of titration, 239 (70%) patients reached stabilization defined as a > or = 48-hour period with an API score of < or =4, unchanged ER hydromorphone HCl dose, and < or = 2 rescue doses per day. The stabilized patients had mean (SD) API scores of 2.7 (1.1) at the end of titration. At stabilization, 102 (43%) of 239 patients remained at their initial conversion dose, 129 (54%) had a dose increase, and 8 (3%) had a dose decrease. Frequent (> or =10% of patients) adverse events that occurred within the first 48 hours after conversion and during the entire titration phase were nausea, somnolence, headache, constipation, vomiting, and dizziness. CONCLUSION: In this prospective evaluation of the conversion and titration phase of 2 randomized, controlled studies, a conversion ratio of 8:1 mg of oral morphine to oral ER hydromorphone HCl was found to be clinically useful in patients with persistent moderate to severe cancer-related or noncancer-related pain. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/16490582/Multicenter_open_label_prospective_evaluation_of_the_conversion_from_previous_opioid_analgesics_to_extended_release_hydromorphone_hydrochloride_administered_every_24_hours_to_patients_with_persistent_moderate_to_severe_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(06)00024-5 DB - PRIME DP - Unbound Medicine ER -