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• W1998932289 abstract "Patients with chronic pain that does not respond to nonopioid medications may switch to agents combining opioid and nonopioid analgesics. However, there is a therapeutic ceiling with such agents because the safe maximum daily dose is limited by the nonopioid component. For example, hydrocodone/acetaminophen induces abnormal liver enzyme elevations at ≥4 g/d acetaminophen. In this study we performed a subgroup analysis of hydrocodone-experienced patients who participated in a clinical trial of oxymorphone extended release (OPAN ER) for chronic lower back pain (CLBP). Among the 250 patients with moderate to severe CLBP enrolled in the study, 104 were receiving hydrocodone-based therapy at screening. Of these, 61% (n=63) were successfully converted and titrated (for ≤1 mo) to a stabilized oxymorphone ER dose (median = 30 mg every 12 h with ≤2 doses per day rescue medication). Median pain on a 100-mm Visual Analog Scale was reduced from 71 mm at screening to 23 mm following titration. After stabilization, 61 patients (59%) began double-blind treatment with oxymorphone ER (n=32) or placebo (n=29) for up to 12 weeks. Fewer oxymorphone ER patients than placebo patients discontinued treatment owing to lack of efficacy (12% vs 55%). Before titration, a minority (49%) of patients rated their previous hydrocodone-based therapy as Good to Excellent; after titration 99% rated oxymorphone ER Good to Excellent. At final visit, more oxymorphone ER patients than placebo patients rated their medication as Good to Excellent (78% vs 22%; P<0.001). Physician ratings followed a similar pattern and favored oxymorphone ER (P<0.001). Anxiety, bronchitis, and pain exacerbated were the most frequently reported adverse events during double-blind treatment with oxymorphone ER (2 patients each). In this study, the majority of hydrocodone-experienced patients with poorly controlled pain were titrated to an effective and well-tolerated dose of oxymorphone ER. This research was supported by Endo Pharmaceuticals Inc. Patients with chronic pain that does not respond to nonopioid medications may switch to agents combining opioid and nonopioid analgesics. However, there is a therapeutic ceiling with such agents because the safe maximum daily dose is limited by the nonopioid component. For example, hydrocodone/acetaminophen induces abnormal liver enzyme elevations at ≥4 g/d acetaminophen. In this study we performed a subgroup analysis of hydrocodone-experienced patients who participated in a clinical trial of oxymorphone extended release (OPAN ER) for chronic lower back pain (CLBP). Among the 250 patients with moderate to severe CLBP enrolled in the study, 104 were receiving hydrocodone-based therapy at screening. Of these, 61% (n=63) were successfully converted and titrated (for ≤1 mo) to a stabilized oxymorphone ER dose (median = 30 mg every 12 h with ≤2 doses per day rescue medication). Median pain on a 100-mm Visual Analog Scale was reduced from 71 mm at screening to 23 mm following titration. After stabilization, 61 patients (59%) began double-blind treatment with oxymorphone ER (n=32) or placebo (n=29) for up to 12 weeks. Fewer oxymorphone ER patients than placebo patients discontinued treatment owing to lack of efficacy (12% vs 55%). Before titration, a minority (49%) of patients rated their previous hydrocodone-based therapy as Good to Excellent; after titration 99% rated oxymorphone ER Good to Excellent. At final visit, more oxymorphone ER patients than placebo patients rated their medication as Good to Excellent (78% vs 22%; P<0.001). Physician ratings followed a similar pattern and favored oxymorphone ER (P<0.001). Anxiety, bronchitis, and pain exacerbated were the most frequently reported adverse events during double-blind treatment with oxymorphone ER (2 patients each). In this study, the majority of hydrocodone-experienced patients with poorly controlled pain were titrated to an effective and well-tolerated dose of oxymorphone ER. This research was supported by Endo Pharmaceuticals Inc." @default.
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• W1998932289 date "2008-04-01" @default.
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• W1998932289 title "(250) Oxymorphone extended release in hydrocodone-experienced patients with chronic low back pain: Subgroup analysis of a 12-week, randomized, double-blind, placebo-controlled study" @default.
• W1998932289 doi "https://doi.org/10.1016/j.jpain.2008.01.171" @default.
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