Titration with oxymorphone extended release to achieve effective long-term pain relief and improve tolerability in opioid-naive patients with moderate to severe pain.

Abstract

OBJECTIVE:

Assess the effectiveness and tolerability of a program of gradual dose titration with oxymorphone extended release (ER) for treatment of moderate to severe chronic pain in opioid-naive patients.

DESIGN:

Open-label, nonrandomized 6-month study with a titration/stabilization period of <or=1 month followed by a 5-month maintenance period.

SETTING:

Multidisciplinary pain centers in the United States.

PATIENTS:

Adult opioid-naive patients with moderate to severe chronic pain.

INTERVENTIONS:

Patients were gradually titrated from a 5-mg dose of oxymorphone ER (taken every 12 hours) to a stabilized dose that provided effective pain relief and was well tolerated.

OUTCOME MEASURES:

Brief Pain Inventory Short Form questions 5 and 9, patient and physician global assessments of pain relief, adverse events (AEs), and discontinuations.

RESULTS:

The majority (94/126; 75%) of patients were stabilized on a dose of oxymorphone ER that provided effective pain relief with tolerable AEs. Most (81/94; 86%) required <24 days to reach a stable dose. Sixteen percent of patients in the titration period and 17% of patients in the maintenance period discontinued because of AEs possibly or probably related to oxymorphone ER. Patients completing the entire 5-month maintenance period experienced effective pain relief with significant (>50%) reductions of pain interference with quality-of-life measures. There was minimal dose escalation over the 5 months and low use of rescue medication.

CONCLUSIONS:

Oxymorphone ER provided effective pain relief from moderate to severe chronic pain in opioid-naive patients. Gradual titration was well tolerated, with a low rate of discontinuations caused by AEs.

• Authors: Richard Rauck, Tina Ma, Rosemary Kerwin, Harry Ahdieh
• Journal: Pain medicine (Malden, Mass.) (Pain Med) Vol. 9 Issue 7 Pg. 777-85 (Oct 2008) ISSN: 1526-4637 [Electronic] England
• PMID: 18950436 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Delayed-Action Preparations
• Oxymorphone

Topics

• Adult
• Aged
• Aged, 80 and over
• Analgesics, Opioid (administration & dosage)
• Delayed-Action Preparations (administration & dosage)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug Tolerance
• Female
• Humans
• Longitudinal Studies
• Male
• Middle Aged
• Oxymorphone (administration & dosage, adverse effects)
• Pain (diagnosis, drug therapy)
• Pain Measurement (drug effects)
• Treatment Outcome
• United States