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- W1980883668 abstract "The safety and efficacy of oxymorphone extended release (ER) for chronic low back pain (CLBP) were established in 2 multicenter, enriched-enrollment, randomized-withdrawal trials. These trials were pooled in this post hoc subanalysis to examine the safety of oxymorphone ER in patients with comorbidities of hypertension, diabetes, and cardiovascular disease. During open-label titration of oxymorphone ER, 348 of 575 patients achieved an effective and generally well-tolerated dose (median stabilized dose 40 mg, all comorbidity subgroups); ≥1 adverse event (AE) was reported by a similar proportion of patients with and without hypertension (69.1% [141/204] vs 69.3% [257/371]), diabetes (73.8% [48/65] vs 68.6% [350/510]), and cardiovascular disease (73.8% [59/80] vs 68.5% [339/495]). During double-blind treatment with oxymorphone ER at the individually titrated dose, incidence of ≥1 AE was reported by a similar proportion of patients with and without diabetes (56.5% [13/23] vs 52.0% [79/152]), cardiovascular disease (72.7% [16/22] vs 49.7% [76/153]), and hypertension (58.5% [38/65] vs 49.1% [54/110]).The most frequent treatment-related AEs were nausea, constipation, somnolence, headache, and diarrhea, irrespective of comorbidity. A mean (SD) increase in visual analog scale pain intensity from baseline to final visit was observed for placebo patients, respectively, with and without hypertension (27.9 [29.8] vs 28.4 [26.7]), diabetes (26.6 [30.5] vs 28.4 [27.4]), and cardiovascular disease (30.3 [26.2] vs 28.0 [27.8]). In the oxymorphone ER group, a smaller increase was observed for patients with and without hypertension (9.8 [22.1] vs 9.6 [23.7]), diabetes (13.3 [25.0] vs 9.2 [22.8]), and cardiovascular disease (13.0 [24.5] vs 9.2 [22.9]). Oxymorphone ER was generally well tolerated and effective for CLBP in patients with or without hypertension, diabetes, and cardiovascular disease. (Supported by Endo Pharmaceuticals Inc.) (Hale, J Pain, 2007; Katz, Cur Med Res Opin, 2007.) The safety and efficacy of oxymorphone extended release (ER) for chronic low back pain (CLBP) were established in 2 multicenter, enriched-enrollment, randomized-withdrawal trials. These trials were pooled in this post hoc subanalysis to examine the safety of oxymorphone ER in patients with comorbidities of hypertension, diabetes, and cardiovascular disease. During open-label titration of oxymorphone ER, 348 of 575 patients achieved an effective and generally well-tolerated dose (median stabilized dose 40 mg, all comorbidity subgroups); ≥1 adverse event (AE) was reported by a similar proportion of patients with and without hypertension (69.1% [141/204] vs 69.3% [257/371]), diabetes (73.8% [48/65] vs 68.6% [350/510]), and cardiovascular disease (73.8% [59/80] vs 68.5% [339/495]). During double-blind treatment with oxymorphone ER at the individually titrated dose, incidence of ≥1 AE was reported by a similar proportion of patients with and without diabetes (56.5% [13/23] vs 52.0% [79/152]), cardiovascular disease (72.7% [16/22] vs 49.7% [76/153]), and hypertension (58.5% [38/65] vs 49.1% [54/110]).The most frequent treatment-related AEs were nausea, constipation, somnolence, headache, and diarrhea, irrespective of comorbidity. A mean (SD) increase in visual analog scale pain intensity from baseline to final visit was observed for placebo patients, respectively, with and without hypertension (27.9 [29.8] vs 28.4 [26.7]), diabetes (26.6 [30.5] vs 28.4 [27.4]), and cardiovascular disease (30.3 [26.2] vs 28.0 [27.8]). In the oxymorphone ER group, a smaller increase was observed for patients with and without hypertension (9.8 [22.1] vs 9.6 [23.7]), diabetes (13.3 [25.0] vs 9.2 [22.8]), and cardiovascular disease (13.0 [24.5] vs 9.2 [22.9]). Oxymorphone ER was generally well tolerated and effective for CLBP in patients with or without hypertension, diabetes, and cardiovascular disease. (Supported by Endo Pharmaceuticals Inc.) (Hale, J Pain, 2007; Katz, Cur Med Res Opin, 2007.)" @default.
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- W1980883668 date "2010-04-01" @default.
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- W1980883668 title "Safety and efficacy of oxymorphone extended release for chronic low back pain in patients with comorbidities" @default.
- W1980883668 doi "https://doi.org/10.1016/j.jpain.2010.01.199" @default.
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