oxymorphone and Low-Back-Pain

Opioids are recommended for control of moderate-to-severe, chronic, malignant, and nonmalignant pain. A controlled-release formulation of the opioid oxymorphone has recently been launched. The aim of this review was to assess the effectiveness of oxymorphone as an analgesic in chronic pain. A systematic search for published studies of oral oxymorphone in the management of chronic pain was conducted. The studies were evaluated for their internal validity according to standard criteria. They were also evaluated for their external validity and research ethic aspects. A meta-analysis was performed to examine the effect of oxymorphone compared with placebo. Nine studies were evaluated; three were excluded because of low quality. Six controlled studies (duration 2-12 weeks) included a total of 1489 subjects suffering from chronic low back pain, chronic pain from osteoarthritis, and chronic cancer pain. Three of the studies were of high quality and three of medium quality. External validity was assessed to be high, medium, and low (in one, three, and two studies, respectively). The meta-analysis suggests that daily doses of 40-100mg are superior to placebo; however, the estimate (reduction of pain intensity compared with placebo) of the treatment effect is imprecise (95% confidence interval -17.08, -8.69). Limited evidence suggests that oxymorphone is effective for pain control in patients with cancer. No significant differences between oxymorphone and oxycodone at equipotent doses were found. In conclusion, oxymorphone is superior to placebo. There is no evidence that the efficacy of oxymorphone differs from other opioids.

Topics: Analgesics, Opioid; Chronic Disease; Humans; Low Back Pain; Neoplasms; Osteoarthritis; Oxymorphone; Pain; Randomized Controlled Trials as Topic

Opioids and antidepressants are frequently prescribed for chronic low back pain (cLBP). This post hoc analysis was conducted to assess the tolerability of oxymorphone extended release (ER) for cLBP in patients taking selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) compared with patients not taking SSRIs/SNRIs.. Patients in 2 clinical trials (NCT00225797, November 22, 2004 to July 18, 2005; NCT00226421, October 13, 2004 to August 19, 2005) aged ≥ 18 years with moderate to severe cLBP were titrated to a stabilized dose of oxymorphone ER during an open-label titration phase and then randomized to treatment with this dose or placebo every 12 hours for 12 weeks. In a post hoc analysis, adverse events (AEs) were compared between patients taking versus not taking SSRIs/SNRIs. Treatment efficacy was assessed as change from baseline in average daily pain intensity on a 100-mm visual analog scale.. Of 575 patients enrolled, 45 of 89 (50.6%) taking SSRIs/SNRIs and 303 of 486 (62.3%) not taking SSRIs/SNRIs successfully titrated to oxymorphone ER. The frequency of any AE did not differ significantly between the 2 subpopulations. During the titration phase, serious AEs occurred more frequently in patients taking SSRIs/SNRIs (3/89; 3.4%) compared with those not taking SSRIs/SNRIs (4/486; 0.8%; P = 0.04); however, during the double-blind treatment phase, there was no significant difference in the frequency of serious AEs in patients treated with oxymorphone ER taking (1/29; 3.4%) versus those not taking (3/146; 2.0%) SSRIs/SNRIs. Visual analog scale scores were similar in patients taking versus those not taking SSRIs/SNRIs throughout the study.. The concomitant use of oxymorphone ER with SSRIs or SNRIs was well tolerated in patients with cLBP.

Topics: Adolescent; Adrenergic Uptake Inhibitors; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Anxiety; Chronic Pain; Delayed-Action Preparations; Depression; Double-Blind Method; Female; Humans; Low Back Pain; Male; Middle Aged; Oxymorphone; Pain Measurement; Selective Serotonin Reuptake Inhibitors; Treatment Outcome; Young Adult

In controlled trials of analgesics, the primary outcome variable is most often a measure of global pain intensity. However, because pain is associated with a variety of pain sensations, the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed. This study sought to evaluate the utility of assessing the multiple components of non-neuropathic pain in an analgesic clinical trial.. A secondary analysis was performed using data from a clinical trial involving 140 individuals with low back pain who were converted from prestudy opioids to an equianalgesic dose of an extended release (ER) formulation of oxymorphone (OPANA ER), which was then titrated to a stable dose [defined as visual analog scale

Topics: Adult; Aged; Analgesics, Opioid; Drug Administration Schedule; Drug Delivery Systems; Factor Analysis, Statistical; Female; Humans; Low Back Pain; Male; Middle Aged; Oxymorphone; Pain Measurement; Pain Threshold; Patient Satisfaction; Psychometrics; Reproducibility of Results; Treatment Outcome; Young Adult

Opioid-experienced (N = 250) patients with chronic, moderate to severe low back pain (LBP) were converted from their prestudy opioid(s) to an approximately equianalgesic dose of OPANA ER (oxymorphone extended release). Patients continued slow titration, with 56% stabilized within 1 month to a dose of OPANA ER that reduced average pain to <40 mm on a visual analog scale with good tolerability. Stabilized patients (n = 143) were randomized to placebo or their stabilized dose of OPANA ER every 12 hours for a 12-week double-blind period. Pain intensity increased significantly more for patients randomized to placebo than for patients who continued their stabilized dose of OPANA ER; the increase from baseline (at randomization) to final visit was 31.6 mm for placebo versus 8.7 mm with OPANA ER (P < .0001). During double-blind treatment, placebo patients were approximately 8-fold more likely than OPANA ER patients to discontinue because of lack of efficacy (P < .001). Discontinuations as a result of adverse events were similar between groups, 10% with placebo and 11% with OPANA ER. Opioid-related adverse events included constipation (6%), somnolence (3%), and nausea (3%). Fifty-seven percent of opioid-experienced patients with chronic, moderate to severe LBP achieved a stable dose of OPANA ER that was efficacious and generally well-tolerated for up to 12 weeks.. In a 12-week, double-blind, randomized, placebo-controlled trial in opioid-experienced patients with chronic, moderate to severe LBP, OPANA ER provided efficacious, long-term analgesia and was generally well-tolerated. OPANA ER may provide clinicians with a new treatment option for patients experiencing suboptimal analgesic responses or poor tolerability with other opioids.

Topics: Adult; Analgesics, Opioid; Chronic Disease; Delayed-Action Preparations; Double-Blind Method; Female; Humans; Low Back Pain; Male; Middle Aged; Morphine Derivatives; Oxymorphone; Pain Measurement; Patient Satisfaction; Placebos; Severity of Illness Index; Treatment Outcome

Determine the efficacy and tolerability of oxymorphone extended release (OPANA ER) in opioid-naive patients with moderate to severe chronic low back pain (CLBP).. Patients > or = 18 years of age were titrated with oxymorphone ER (5- to 10-mg increments every 12 h, every 3-7 days) to a well-tolerated, stabilized dose. Patients were then randomized to continue their oxymorphone ER dose or receive placebo every 12 h for 12 weeks. Oxymorphone immediate release was available every 4-6 h, as needed, for the first 4 days and twice daily thereafter.. Sixty-three percent of patients (205/325) were titrated to a stabilized dose of oxymorphone ER, most (203/205) within 1 month. During titration, 18% discontinued from adverse events (AEs) and 1% from lack of efficacy. For patients completing titration, average pain intensity decreased from 69.4 mm at screening to 22.7 mm (p < 0.0001). After randomization, 68% of oxymorphone ER and 47% of placebo patients completed 12 weeks of double-blind treatment. Approximately 8% of patients in each group discontinued because of AEs. Placebo patients discontinued significantly sooner from lack of efficacy than those receiving oxymorphone ER (p < 0.0001). Pain intensity increased significantly more in the placebo group (least squares [LS] mean change 26.9 +/- 2.4 [median 28.0]) than in the oxymorphone ER group (LS mean change 10.0 +/- 2.4 [median 2.0]; p < 0.0001). Oxymorphone ER was generally well tolerated without unexpected AEs. Although limitations of a randomized withdrawal study include the potential for unblinding and opioid withdrawal in placebo patients, opioid withdrawal was limited to two patients in the placebo group and one in the oxymorphone ER group.. Stabilized doses of oxymorphone ER were generally safe and effective over a 12-week double-blind treatment period in opioid-naive patients with CLBP.

Topics: Analgesics, Opioid; Analysis of Variance; Delayed-Action Preparations; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Low Back Pain; Male; Middle Aged; Oxymorphone; Pain Measurement; Statistics, Nonparametric; Treatment Outcome; United States

This multicenter, randomized, double-blind, placebo- and active-controlled trial was conducted to compare the analgesic efficacy and safety of oxymorphone extended release (ER) with placebo and oxycodone controlled release (CR) in ambulatory patients with moderate to severe chronic low back pain requiring opioid therapy. Patients (N = 213) aged 18 to 75 years were randomized to receive oxymorphone ER (10 to 110 mg) or oxycodone CR (20 to 220 mg) every 12 hours during a 7- to 14-day dose-titration phase. Patients achieving effective analgesia at a stable opioid dose entered an 18-day double-blind treatment phase and either continued opioid therapy or received placebo. With stable dosing throughout the treatment phase, oxymorphone ER (79.4 mg/day) and oxycodone CR (155 mg/day) were superior to placebo for change from baseline in pain intensity as measured on a visual analog scale; the LS mean differences were -18.21 and 18.55 (95% CI, -25.83 to -10.58 and -26.12 to -10.98, respectively; P = .0001). Use of rescue medication was 20 mg per day. Adverse events for the active drugs were similar; the most frequent were constipation and sedation. Oxymorphone ER and oxycodone CR were generally safe and effective for controlling low back pain. Oxymorphone ER was equianalgesic to oxycodone CR at half the milligram daily dosage, with comparable safety.. Definitive studies of long-acting opioids in patients with chronic low back pain are lacking. We report the results of a multicenter, randomized, placebo-controlled, double-blind study evaluating the analgesic efficacy and safety of oxymorphone ER and oxycodone CR in opioid-experienced patients with chronic low back pain.

Topics: Adolescent; Adult; Aged; Analgesics, Opioid; Chronic Disease; Constipation; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Low Back Pain; Male; Middle Aged; Oxycodone; Oxymorphone; Pain Measurement; Placebo Effect; Placebos; Sleep Stages; Treatment Outcome

To evaluate the influence of age, sex, and previous opioid experience on the likelihood of successfully titrating opioid-naive and experienced patients with chronic low back pain (CLBP) to an effective and well-tolerated dose of oxymorphone extended release (ER).. Post hoc analysis of open-label titration phases of two enriched-enrollment randomized-withdrawal phase III trials in 575 adults with moderate-to-severe CLBP. Opioid-naive patients (n = 325) initiated oxymorphone ER at 10 mg/day (5 mg q12 h). Opioid-experienced patients (n = 250) initiated at a dose equianalgesic to their previous opioid and were allowed doses of 5 mg oxymorphone immediate-release rescue medication every 4-6 h, as needed. Oxymorphone ER was gradually titrated to a dose that reduced pain to or=65 years were less likely than patients aged <65 years to complete titration (45 vs. 63%; p = 0.002; 95% CI, -0.30 to -0.06) and more likely to discontinue owing to adverse events (40 vs. 15%; p < 0.001; 95% CI, 0.14-0.36). Oxycodone-experienced patients were less likely than hydrocodone-experienced patients to complete titration (46 vs. 62%, p = 0.03; 95% CI,-0.30 to -0.02). Among successfully titrated patients, pain decreased regardless of prior opioid therapy, sex, or age.. Most patients with CLBP were titrated to an effective, generally well-tolerated oxymorphone ER dose. Older patients and those converted from oxycodone may require more gradual titration. A study limitation is that patients initiated oxymorphone ER to comply with protocol, whereas treatment failure typically motivates opioid initiation or switching in clinical practice.

Topics: Aged; Analgesics, Opioid; Chronic Disease; Clinical Trials, Phase III as Topic; Delayed-Action Preparations; Dose-Response Relationship, Drug; Female; Humans; Hydromorphone; Low Back Pain; Male; Middle Aged; Oxycodone; Oxymorphone; Pain Measurement; Patient Acceptance of Health Care; Randomized Controlled Trials as Topic; Substance Withdrawal Syndrome; Treatment Outcome

This study assessed the potential effects of age, sex, and prior opioid use on the response to oxymorphone extended release (ER) in patients with moderate to severe chronic low back pain.. Combined data from 2 placebo-controlled clinical trials with an enriched-enrollment, randomized-withdrawal design were analyzed. In patients aged > or =18 years with chronic low back pain, the dose of oxymorphone ER was titrated to a stable, tolerable, effective dose. Patients who completed titration were randomly assigned to a 12-week double-blind study period with oxymorphone ER or placebo. Oxymorphone immediate release 5 mg was permitted q4-6h, as needed for rescue medication or withdrawal symptoms, for 4 days after randomization and restricted to 10 mg/d thereafter. Pain intensity (100-mm visual analog scale [VAS]; 0 = no pain to 100 = worst pain imaginable) and time to study discontinuation due to lack of efficacy were compared with stratification by age (<65 vs > or =65 years), sex, and prior opioid use. Adverse events were categorized by severity and relation to study medication.. Of 575 patients, 348 completed titration and 347 entered the double-blind study phase. There were no significant between-group differences in demographic variables, except that the mean age in the oxymorphone ER group was significantly higher (P = 0.04), and the proportion of men was significantly lower (P = 0.01). There was no significant age difference between the oxymorphone ER and placebo groups stratified by age (<65 vs > or =65 years). Fewer patients aged > or =65 years versus <65 years completed titration (45.0% [36/80] vs 63.0% [312/495]; P = 0.002). The least-squares mean (SEM) differences in VAS pain scores between the oxymorphone ER (n = 174) and placebo (n = 169) groups were significant at each postbaseline assessment (P < 0.001) and at study completion (12.3 [2.8] mm; P < 0.001) and was not significantly affected by age, sex, or prior opioid use. Age and sex had no significant influence on adverse events or discontinuations due to lack of efficacy. More discontinuations due to lack of efficacy occurred among patients in the placebo group (hazard ratio, 5.01; P < 0.001) and among opioid-experienced patients. The latter effect was limited to opioid-experienced patients who received placebo. The rates of discontinuation due to lack of efficacy were similar between oxymorphone ER-treated opioid-naive and opioid-experienced patients (11.4% vs 11.6%). The proportion of patients who experienced opioid-related adverse events was significantly greater in the oxymorphone ER group compared with the placebo group (25.7% vs 16.3%; P = 0.03). The most frequent treatment-emergent adverse events in the oxymorphone ER group were nausea (8.0%), constipation (6.3%), vomiting (4.6%), and diarrhea (4.0%); in the placebo group were nausea (5.8%), diarrhea (4.7%), and increased sweating (2.3%).. In the enriched population of patients who successfully titrated to oxymorphone ER, oxymorphone ER was effective and generally well tolerated, independent of patients' age, sex, or previous opioid use.

Topics: Age Factors; Aged; Analgesics, Opioid; Chronic Disease; Delayed-Action Preparations; Double-Blind Method; Female; Follow-Up Studies; Humans; Low Back Pain; Male; Middle Aged; Oxymorphone; Pain Measurement; Randomized Controlled Trials as Topic; Retrospective Studies; Severity of Illness Index; Sex Factors

Topics: Administration, Oral; Analgesics, Opioid; Biological Availability; Clinical Trials as Topic; Delayed-Action Preparations; Drug Administration Schedule; Drug Interactions; Humans; Low Back Pain; Neoplasms; Opioid-Related Disorders; Osteoarthritis; Oxymorphone; Pain; Pain, Postoperative