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Bernd Lange - One of the best experts on this subject based on the ideXlab platform.
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Tapentadol prolonged-release for moderate-to-severe chronic osteoarthritis knee pain: a double-blind, randomized, placebo- and oxycodone controlled release-controlled study
Current Medical Research and Opinion, 2017Co-Authors: Alain Serrie, Bernd Lange, A SteupAbstract:AbstractObjective: To assess efficacy and safety of tapentadol prolonged release (PR) for moderate-to-severe chronic osteoarthritis knee pain.Methods: Patients (n = 990) were randomized (1:1:1) to tapentadol PR, oxycodone controlled release (CR; reference compound for assay sensitivity), or placebo for a double-blind 3-week titration and 12-week Maintenance Period. Primary efficacy end-points were change from baseline in average pain intensity at week 12 of Maintenance (US end-point) and over the entire Maintenance Period (non-US end-point) with “last observation carried forward” as imputation method for missing scores.Results: Both primary end-points were not significantly different for tapentadol PR nor for oxycodone CR vs placebo at week 12 (least squares [LS] mean difference = –0.3 [95% CI = –0.61–0.09]; p = 0.152 and 0.2 [95% CI = –0.16–0.54]; p = 0.279, respectively) and over the Maintenance Period (LS mean difference = –0.2 [95% CI = –0.55–0.07]; p = 0.135 and 0.1 [95% CI = –0.18–0.44]; p = 0.421, ...
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Efficacy and safety of tapentadol prolonged release for moderate-to-severe chronic osteoarthritis knee pain: a pooled analysis of two double-blind, randomized, placebo- and oxycodone controlled release-controlled studies
Current Medical Research and Opinion, 2017Co-Authors: Bernd Lange, Christian Elling, Detlef Von Zabern, Cecile DuboisAbstract:AbstractObjective: To compare efficacy and safety of tapentadol prolonged-release (PR) and oxycodone-controlled release (CR) in moderate-to-severe chronic osteoarthritis knee pain.Methods: Data from two double-blind, randomized, placebo- and oxycodone CR-controlled phase 3 studies with a 3-week titration Period and 12-week controlled dose adjustment Maintenance Period were pooled. Primary efficacy end-points were change from baseline in average pain intensity at week 12 (US end-point) and over the entire Maintenance Period (non-US end-point).Results: A total of 2,010 patients were assessed. For both primary end-points, tapentadol PR was significantly more effective than oxycodone CR (LS mean difference of –0.41 [95% CI = –0.65, –0.16; p = 0.001] at week 12 and –0.35 [95% CI = –0.58, –0.12; p = 0.003] over 12 weeks of Maintenance [last observation carried forward]). Significantly better outcomes than for oxycodone CR were also observed for patient global impression of change, both Short Form-36 component s...
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Efficacy and Safety of Tapentadol Extended Release Compared with Oxycodone Controlled Release for the Management of Moderate to Severe Chronic Pain Related to Osteoarthritis of the Knee
Clinical Drug Investigation, 2010Co-Authors: Marc Afilalo, Mila Etropolski, Bernd Lange, Brigitte Kuperwasser, A Steup, Christine Rauschkolb, Kathy Kelly, Ilse Van Hove, A. Okamoto, Juergen HaeusslerAbstract:Background: Tapentadol is a novel, centrally acting analgesic with μ-opioid receptor agonist and norepinephrine reuptake inhibitor activity. Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for management of moderate to severe chronic osteoarthritis-related knee pain. Methods: This was a randomized, double-blind, active- and placebo-controlled, parallel-arm, multicentre, phase III study during which patients received tapentadol ER, oxycodone CR or placebo for a 3-week titration Period followed by a 12-week Maintenance Period. The study was carried out at sites in Australia, Canada, New Zealand and the US. A total of 1030 patients with chronic osteoarthritis-related knee pain were randomized to receive tapentadol ER 100–250 mg twice daily, oxycodone HCl CR 20–50 mg twice daily or placebo. Primary endpoints (as determined prior to initiation of the study) were the changes from baseline in average daily pain intensity (rated by patients on an 11-point numerical rating scale) over the last week of Maintenance and over the entire 12-week Maintenance Period; last observation carried forward was used to impute missing values after early treatment discontinuation. Results: Efficacy and safety were evaluated for 1023 patients. Tapentadol ER significantly reduced average pain intensity from baseline to week 12 of the Maintenance Period versus placebo (least squares mean [LSM] difference [95% CI], −0.7 [−1.04, −0.33]), and throughout the Maintenance Period (−0.7 [−1.00, −0.33]). Oxycodone CR significantly reduced average pain intensity from baseline throughout the Maintenance Period versus placebo (LSM difference [95% CI], −0.3 [−0.67, −0.00]) but not at week 12 (−0.3 [−0.68, 0.02]). A significantly higher percentage of patients achieved ≥50% improvement in pain intensity in the tapentadol ER group (32.0% [110/344]) compared with the placebo group (24.3% [82/337]; p = 0.027), indicating a clinically significant improvement in pain intensity, while a significantly lower percentage of patients achieved ≥50% improvement in pain intensity in the oxycodone CR group (17.3% [59/342]; p = 0.023 vs placebo). In the placebo, tapentadol ER and oxycodone CR groups, respectively, 61.1% (206/337), 75.9% (261/344) and 87.4% (299/342) of patients reported at least one treatment-emergent adverse event (TEAE); incidences of gastrointestinal-related TEAEs were 26.1% (88/337), 43.0% (148/344) and 67.3% (230/342). Conclusion: Treatment with tapentadol ER 100–250 mg twice daily or oxycodone HCl CR 20–50 mg twice daily was effective for the management of moderate to severe chronic osteoarthritis-related knee pain, with substantially lower incidences of gastrointestinal-related TEAEs associated with treatment with tapentadol ER than with oxycodone CR. [Trial registration number: NCT00421928 (ClinicalTrials.gov Identifier)]
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efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P<0.001). For both primary endpoints, the efficacy of tapentadol PR was noninferior to oxycodone CR (P<0.001), and tapentadol PR had superior gastrointestinal tolerability compared with oxycodone CR (P<0.001). Results of analyses of responders, patient global impression of change, Short Form-36 domains (except general health), and the EuroQol 5-Dimension health status index were significantly better for tapentadol PR than oxycodone CR (all P≤0.048); these results may have been affected by the worse tolerability profile of oxycodone CR. A higher percentage of patients discontinued treatment with oxycodone CR (61.7% [616/999]) compared with tapentadol PR (43.5% [425/978]). Tapentadol PR (100-250 mg twice daily) was efficacious and provided efficacy that was similar to oxycodone HCl CR (20–50 mg twice daily) for the management of chronic osteoarthritis knee and low back pain, with a superior gastrointestinal tolerability profile and fewer treatment discontinuations.
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Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain.
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P
A Steup - One of the best experts on this subject based on the ideXlab platform.
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Tapentadol prolonged-release for moderate-to-severe chronic osteoarthritis knee pain: a double-blind, randomized, placebo- and oxycodone controlled release-controlled study
Current Medical Research and Opinion, 2017Co-Authors: Alain Serrie, Bernd Lange, A SteupAbstract:AbstractObjective: To assess efficacy and safety of tapentadol prolonged release (PR) for moderate-to-severe chronic osteoarthritis knee pain.Methods: Patients (n = 990) were randomized (1:1:1) to tapentadol PR, oxycodone controlled release (CR; reference compound for assay sensitivity), or placebo for a double-blind 3-week titration and 12-week Maintenance Period. Primary efficacy end-points were change from baseline in average pain intensity at week 12 of Maintenance (US end-point) and over the entire Maintenance Period (non-US end-point) with “last observation carried forward” as imputation method for missing scores.Results: Both primary end-points were not significantly different for tapentadol PR nor for oxycodone CR vs placebo at week 12 (least squares [LS] mean difference = –0.3 [95% CI = –0.61–0.09]; p = 0.152 and 0.2 [95% CI = –0.16–0.54]; p = 0.279, respectively) and over the Maintenance Period (LS mean difference = –0.2 [95% CI = –0.55–0.07]; p = 0.135 and 0.1 [95% CI = –0.18–0.44]; p = 0.421, ...
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Efficacy and Safety of Tapentadol Extended Release Compared with Oxycodone Controlled Release for the Management of Moderate to Severe Chronic Pain Related to Osteoarthritis of the Knee
Clinical Drug Investigation, 2010Co-Authors: Marc Afilalo, Mila Etropolski, Bernd Lange, Brigitte Kuperwasser, A Steup, Christine Rauschkolb, Kathy Kelly, Ilse Van Hove, A. Okamoto, Juergen HaeusslerAbstract:Background: Tapentadol is a novel, centrally acting analgesic with μ-opioid receptor agonist and norepinephrine reuptake inhibitor activity. Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for management of moderate to severe chronic osteoarthritis-related knee pain. Methods: This was a randomized, double-blind, active- and placebo-controlled, parallel-arm, multicentre, phase III study during which patients received tapentadol ER, oxycodone CR or placebo for a 3-week titration Period followed by a 12-week Maintenance Period. The study was carried out at sites in Australia, Canada, New Zealand and the US. A total of 1030 patients with chronic osteoarthritis-related knee pain were randomized to receive tapentadol ER 100–250 mg twice daily, oxycodone HCl CR 20–50 mg twice daily or placebo. Primary endpoints (as determined prior to initiation of the study) were the changes from baseline in average daily pain intensity (rated by patients on an 11-point numerical rating scale) over the last week of Maintenance and over the entire 12-week Maintenance Period; last observation carried forward was used to impute missing values after early treatment discontinuation. Results: Efficacy and safety were evaluated for 1023 patients. Tapentadol ER significantly reduced average pain intensity from baseline to week 12 of the Maintenance Period versus placebo (least squares mean [LSM] difference [95% CI], −0.7 [−1.04, −0.33]), and throughout the Maintenance Period (−0.7 [−1.00, −0.33]). Oxycodone CR significantly reduced average pain intensity from baseline throughout the Maintenance Period versus placebo (LSM difference [95% CI], −0.3 [−0.67, −0.00]) but not at week 12 (−0.3 [−0.68, 0.02]). A significantly higher percentage of patients achieved ≥50% improvement in pain intensity in the tapentadol ER group (32.0% [110/344]) compared with the placebo group (24.3% [82/337]; p = 0.027), indicating a clinically significant improvement in pain intensity, while a significantly lower percentage of patients achieved ≥50% improvement in pain intensity in the oxycodone CR group (17.3% [59/342]; p = 0.023 vs placebo). In the placebo, tapentadol ER and oxycodone CR groups, respectively, 61.1% (206/337), 75.9% (261/344) and 87.4% (299/342) of patients reported at least one treatment-emergent adverse event (TEAE); incidences of gastrointestinal-related TEAEs were 26.1% (88/337), 43.0% (148/344) and 67.3% (230/342). Conclusion: Treatment with tapentadol ER 100–250 mg twice daily or oxycodone HCl CR 20–50 mg twice daily was effective for the management of moderate to severe chronic osteoarthritis-related knee pain, with substantially lower incidences of gastrointestinal-related TEAEs associated with treatment with tapentadol ER than with oxycodone CR. [Trial registration number: NCT00421928 (ClinicalTrials.gov Identifier)]
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efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P<0.001). For both primary endpoints, the efficacy of tapentadol PR was noninferior to oxycodone CR (P<0.001), and tapentadol PR had superior gastrointestinal tolerability compared with oxycodone CR (P<0.001). Results of analyses of responders, patient global impression of change, Short Form-36 domains (except general health), and the EuroQol 5-Dimension health status index were significantly better for tapentadol PR than oxycodone CR (all P≤0.048); these results may have been affected by the worse tolerability profile of oxycodone CR. A higher percentage of patients discontinued treatment with oxycodone CR (61.7% [616/999]) compared with tapentadol PR (43.5% [425/978]). Tapentadol PR (100-250 mg twice daily) was efficacious and provided efficacy that was similar to oxycodone HCl CR (20–50 mg twice daily) for the management of chronic osteoarthritis knee and low back pain, with a superior gastrointestinal tolerability profile and fewer treatment discontinuations.
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Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain.
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P
Mila Etropolski - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Tapentadol Extended Release Compared with Oxycodone Controlled Release for the Management of Moderate to Severe Chronic Pain Related to Osteoarthritis of the Knee
Clinical Drug Investigation, 2010Co-Authors: Marc Afilalo, Mila Etropolski, Bernd Lange, Brigitte Kuperwasser, A Steup, Christine Rauschkolb, Kathy Kelly, Ilse Van Hove, A. Okamoto, Juergen HaeusslerAbstract:Background: Tapentadol is a novel, centrally acting analgesic with μ-opioid receptor agonist and norepinephrine reuptake inhibitor activity. Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for management of moderate to severe chronic osteoarthritis-related knee pain. Methods: This was a randomized, double-blind, active- and placebo-controlled, parallel-arm, multicentre, phase III study during which patients received tapentadol ER, oxycodone CR or placebo for a 3-week titration Period followed by a 12-week Maintenance Period. The study was carried out at sites in Australia, Canada, New Zealand and the US. A total of 1030 patients with chronic osteoarthritis-related knee pain were randomized to receive tapentadol ER 100–250 mg twice daily, oxycodone HCl CR 20–50 mg twice daily or placebo. Primary endpoints (as determined prior to initiation of the study) were the changes from baseline in average daily pain intensity (rated by patients on an 11-point numerical rating scale) over the last week of Maintenance and over the entire 12-week Maintenance Period; last observation carried forward was used to impute missing values after early treatment discontinuation. Results: Efficacy and safety were evaluated for 1023 patients. Tapentadol ER significantly reduced average pain intensity from baseline to week 12 of the Maintenance Period versus placebo (least squares mean [LSM] difference [95% CI], −0.7 [−1.04, −0.33]), and throughout the Maintenance Period (−0.7 [−1.00, −0.33]). Oxycodone CR significantly reduced average pain intensity from baseline throughout the Maintenance Period versus placebo (LSM difference [95% CI], −0.3 [−0.67, −0.00]) but not at week 12 (−0.3 [−0.68, 0.02]). A significantly higher percentage of patients achieved ≥50% improvement in pain intensity in the tapentadol ER group (32.0% [110/344]) compared with the placebo group (24.3% [82/337]; p = 0.027), indicating a clinically significant improvement in pain intensity, while a significantly lower percentage of patients achieved ≥50% improvement in pain intensity in the oxycodone CR group (17.3% [59/342]; p = 0.023 vs placebo). In the placebo, tapentadol ER and oxycodone CR groups, respectively, 61.1% (206/337), 75.9% (261/344) and 87.4% (299/342) of patients reported at least one treatment-emergent adverse event (TEAE); incidences of gastrointestinal-related TEAEs were 26.1% (88/337), 43.0% (148/344) and 67.3% (230/342). Conclusion: Treatment with tapentadol ER 100–250 mg twice daily or oxycodone HCl CR 20–50 mg twice daily was effective for the management of moderate to severe chronic osteoarthritis-related knee pain, with substantially lower incidences of gastrointestinal-related TEAEs associated with treatment with tapentadol ER than with oxycodone CR. [Trial registration number: NCT00421928 (ClinicalTrials.gov Identifier)]
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efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P<0.001). For both primary endpoints, the efficacy of tapentadol PR was noninferior to oxycodone CR (P<0.001), and tapentadol PR had superior gastrointestinal tolerability compared with oxycodone CR (P<0.001). Results of analyses of responders, patient global impression of change, Short Form-36 domains (except general health), and the EuroQol 5-Dimension health status index were significantly better for tapentadol PR than oxycodone CR (all P≤0.048); these results may have been affected by the worse tolerability profile of oxycodone CR. A higher percentage of patients discontinued treatment with oxycodone CR (61.7% [616/999]) compared with tapentadol PR (43.5% [425/978]). Tapentadol PR (100-250 mg twice daily) was efficacious and provided efficacy that was similar to oxycodone HCl CR (20–50 mg twice daily) for the management of chronic osteoarthritis knee and low back pain, with a superior gastrointestinal tolerability profile and fewer treatment discontinuations.
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Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain.
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P
Brigitte Kuperwasser - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Tapentadol Extended Release Compared with Oxycodone Controlled Release for the Management of Moderate to Severe Chronic Pain Related to Osteoarthritis of the Knee
Clinical Drug Investigation, 2010Co-Authors: Marc Afilalo, Mila Etropolski, Bernd Lange, Brigitte Kuperwasser, A Steup, Christine Rauschkolb, Kathy Kelly, Ilse Van Hove, A. Okamoto, Juergen HaeusslerAbstract:Background: Tapentadol is a novel, centrally acting analgesic with μ-opioid receptor agonist and norepinephrine reuptake inhibitor activity. Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for management of moderate to severe chronic osteoarthritis-related knee pain. Methods: This was a randomized, double-blind, active- and placebo-controlled, parallel-arm, multicentre, phase III study during which patients received tapentadol ER, oxycodone CR or placebo for a 3-week titration Period followed by a 12-week Maintenance Period. The study was carried out at sites in Australia, Canada, New Zealand and the US. A total of 1030 patients with chronic osteoarthritis-related knee pain were randomized to receive tapentadol ER 100–250 mg twice daily, oxycodone HCl CR 20–50 mg twice daily or placebo. Primary endpoints (as determined prior to initiation of the study) were the changes from baseline in average daily pain intensity (rated by patients on an 11-point numerical rating scale) over the last week of Maintenance and over the entire 12-week Maintenance Period; last observation carried forward was used to impute missing values after early treatment discontinuation. Results: Efficacy and safety were evaluated for 1023 patients. Tapentadol ER significantly reduced average pain intensity from baseline to week 12 of the Maintenance Period versus placebo (least squares mean [LSM] difference [95% CI], −0.7 [−1.04, −0.33]), and throughout the Maintenance Period (−0.7 [−1.00, −0.33]). Oxycodone CR significantly reduced average pain intensity from baseline throughout the Maintenance Period versus placebo (LSM difference [95% CI], −0.3 [−0.67, −0.00]) but not at week 12 (−0.3 [−0.68, 0.02]). A significantly higher percentage of patients achieved ≥50% improvement in pain intensity in the tapentadol ER group (32.0% [110/344]) compared with the placebo group (24.3% [82/337]; p = 0.027), indicating a clinically significant improvement in pain intensity, while a significantly lower percentage of patients achieved ≥50% improvement in pain intensity in the oxycodone CR group (17.3% [59/342]; p = 0.023 vs placebo). In the placebo, tapentadol ER and oxycodone CR groups, respectively, 61.1% (206/337), 75.9% (261/344) and 87.4% (299/342) of patients reported at least one treatment-emergent adverse event (TEAE); incidences of gastrointestinal-related TEAEs were 26.1% (88/337), 43.0% (148/344) and 67.3% (230/342). Conclusion: Treatment with tapentadol ER 100–250 mg twice daily or oxycodone HCl CR 20–50 mg twice daily was effective for the management of moderate to severe chronic osteoarthritis-related knee pain, with substantially lower incidences of gastrointestinal-related TEAEs associated with treatment with tapentadol ER than with oxycodone CR. [Trial registration number: NCT00421928 (ClinicalTrials.gov Identifier)]
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efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P<0.001). For both primary endpoints, the efficacy of tapentadol PR was noninferior to oxycodone CR (P<0.001), and tapentadol PR had superior gastrointestinal tolerability compared with oxycodone CR (P<0.001). Results of analyses of responders, patient global impression of change, Short Form-36 domains (except general health), and the EuroQol 5-Dimension health status index were significantly better for tapentadol PR than oxycodone CR (all P≤0.048); these results may have been affected by the worse tolerability profile of oxycodone CR. A higher percentage of patients discontinued treatment with oxycodone CR (61.7% [616/999]) compared with tapentadol PR (43.5% [425/978]). Tapentadol PR (100-250 mg twice daily) was efficacious and provided efficacy that was similar to oxycodone HCl CR (20–50 mg twice daily) for the management of chronic osteoarthritis knee and low back pain, with a superior gastrointestinal tolerability profile and fewer treatment discontinuations.
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Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain.
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P
A. Okamoto - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Tapentadol Extended Release Compared with Oxycodone Controlled Release for the Management of Moderate to Severe Chronic Pain Related to Osteoarthritis of the Knee
Clinical Drug Investigation, 2010Co-Authors: Marc Afilalo, Mila Etropolski, Bernd Lange, Brigitte Kuperwasser, A Steup, Christine Rauschkolb, Kathy Kelly, Ilse Van Hove, A. Okamoto, Juergen HaeusslerAbstract:Background: Tapentadol is a novel, centrally acting analgesic with μ-opioid receptor agonist and norepinephrine reuptake inhibitor activity. Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for management of moderate to severe chronic osteoarthritis-related knee pain. Methods: This was a randomized, double-blind, active- and placebo-controlled, parallel-arm, multicentre, phase III study during which patients received tapentadol ER, oxycodone CR or placebo for a 3-week titration Period followed by a 12-week Maintenance Period. The study was carried out at sites in Australia, Canada, New Zealand and the US. A total of 1030 patients with chronic osteoarthritis-related knee pain were randomized to receive tapentadol ER 100–250 mg twice daily, oxycodone HCl CR 20–50 mg twice daily or placebo. Primary endpoints (as determined prior to initiation of the study) were the changes from baseline in average daily pain intensity (rated by patients on an 11-point numerical rating scale) over the last week of Maintenance and over the entire 12-week Maintenance Period; last observation carried forward was used to impute missing values after early treatment discontinuation. Results: Efficacy and safety were evaluated for 1023 patients. Tapentadol ER significantly reduced average pain intensity from baseline to week 12 of the Maintenance Period versus placebo (least squares mean [LSM] difference [95% CI], −0.7 [−1.04, −0.33]), and throughout the Maintenance Period (−0.7 [−1.00, −0.33]). Oxycodone CR significantly reduced average pain intensity from baseline throughout the Maintenance Period versus placebo (LSM difference [95% CI], −0.3 [−0.67, −0.00]) but not at week 12 (−0.3 [−0.68, 0.02]). A significantly higher percentage of patients achieved ≥50% improvement in pain intensity in the tapentadol ER group (32.0% [110/344]) compared with the placebo group (24.3% [82/337]; p = 0.027), indicating a clinically significant improvement in pain intensity, while a significantly lower percentage of patients achieved ≥50% improvement in pain intensity in the oxycodone CR group (17.3% [59/342]; p = 0.023 vs placebo). In the placebo, tapentadol ER and oxycodone CR groups, respectively, 61.1% (206/337), 75.9% (261/344) and 87.4% (299/342) of patients reported at least one treatment-emergent adverse event (TEAE); incidences of gastrointestinal-related TEAEs were 26.1% (88/337), 43.0% (148/344) and 67.3% (230/342). Conclusion: Treatment with tapentadol ER 100–250 mg twice daily or oxycodone HCl CR 20–50 mg twice daily was effective for the management of moderate to severe chronic osteoarthritis-related knee pain, with substantially lower incidences of gastrointestinal-related TEAEs associated with treatment with tapentadol ER than with oxycodone CR. [Trial registration number: NCT00421928 (ClinicalTrials.gov Identifier)]
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efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P<0.001). For both primary endpoints, the efficacy of tapentadol PR was noninferior to oxycodone CR (P<0.001), and tapentadol PR had superior gastrointestinal tolerability compared with oxycodone CR (P<0.001). Results of analyses of responders, patient global impression of change, Short Form-36 domains (except general health), and the EuroQol 5-Dimension health status index were significantly better for tapentadol PR than oxycodone CR (all P≤0.048); these results may have been affected by the worse tolerability profile of oxycodone CR. A higher percentage of patients discontinued treatment with oxycodone CR (61.7% [616/999]) compared with tapentadol PR (43.5% [425/978]). Tapentadol PR (100-250 mg twice daily) was efficacious and provided efficacy that was similar to oxycodone HCl CR (20–50 mg twice daily) for the management of chronic osteoarthritis knee and low back pain, with a superior gastrointestinal tolerability profile and fewer treatment discontinuations.
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Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain.
Advances in Therapy, 2010Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Steup, Thomas Haufel, Judy Ashworth, A. Okamoto, Mila EtropolskiAbstract:This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week Maintenance Period, preceded by a 3-week titration Period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the Maintenance Period and for the overall Maintenance Period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall Maintenance Period (all P
