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M Etropolski - One of the best experts on this subject based on the ideXlab platform.

  • tolerability and efficacy of tapentadol extended release in elderly patients 75 years of age with Chronic Osteoarthritis knee or low back pain
    Journal of opioid management, 2015
    Co-Authors: David M Biondi, Jim Xiang, M Etropolski, Bruce L Moskovitz
    Abstract:

    Objective: Management of Chronic pain in elderly adult patients is often complicated by analgesic medication–related side effects. This post hoc analysis of pooled data evaluated the tolerability and analgesic efficacy of tapentadol extended release (ER) compared with oxycodone controlled release (CR) in elderly adult patients ( ≥ 75 years of age) with moderate to severe, Chronic Osteoarthritis knee or low back pain. Methods: Data were pooled from three similarly designed, randomized, double-blind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate to severe, Chronic Osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain, and data for patients ≥ 75 years of age were evaluated. Each study consisted of a 3-week titration and 12-week maintenance period. Patients received placebo, tapentadol ER (100-250 mg bid), or oxycodone HCl CR (20-50 mg bid). Tolerability was evaluated using adverse event reporting. Efficacy was evaluated using pain intensity ratings (11-point numerical rating scale). Results: For patients ≥ 75 years of age (n = 210), incidences of gastrointestinal treatment-emergent adverse events (TEAEs) overall and TEAEs of vomiting and the composite of nausea and/or vomiting were significantly lower in the tapentadol ER group compared with the oxycodone CR group (all p ≤ 0.0206). Tapentadol ER treatment was associated with significant reductions in pain intensity from baseline to week 15 compared with placebo (p = 0.0075); differences between the oxycodone CR and placebo groups failed to reach statistical significance (p = 0.1195), likely related to a higher treatment discontinuation rate in the oxycodone CR group. No significant differences were observed between the tapentadol ER and oxycodone CR groups in the change in pain intensity from baseline to week 15 (p = 0.2135). Conclusions: In elderly adult patients ≥ 75 years of age with moderate to severe, Chronic Osteoarthritis knee or low back pain, tapentadol ER (100-250 mg bid) provided significant pain relief compared with placebo and had a better overall gastrointestinal tolerability profile than oxycodone CR.

  • Tolerability and efficacy of tapentadol extended release in elderly patients ≥75 years of age with Chronic Osteoarthritis knee or low back pain
    Journal of opioid management, 2015
    Co-Authors: David M Biondi, Jim Xiang, M Etropolski, Bruce L Moskovitz
    Abstract:

    Objective: Management of Chronic pain in elderly adult patients is often complicated by analgesic medication–related side effects. This post hoc analysis of pooled data evaluated the tolerability and analgesic efficacy of tapentadol extended release (ER) compared with oxycodone controlled release (CR) in elderly adult patients ( ≥ 75 years of age) with moderate to severe, Chronic Osteoarthritis knee or low back pain. Methods: Data were pooled from three similarly designed, randomized, double-blind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate to severe, Chronic Osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain, and data for patients ≥ 75 years of age were evaluated. Each study consisted of a 3-week titration and 12-week maintenance period. Patients received placebo, tapentadol ER (100-250 mg bid), or oxycodone HCl CR (20-50 mg bid). Tolerability was evaluated using adverse event reporting. Efficacy was evaluated using pain intensity ratings (11-point numerical rating scale). Results: For patients ≥ 75 years of age (n = 210), incidences of gastrointestinal treatment-emergent adverse events (TEAEs) overall and TEAEs of vomiting and the composite of nausea and/or vomiting were significantly lower in the tapentadol ER group compared with the oxycodone CR group (all p ≤ 0.0206). Tapentadol ER treatment was associated with significant reductions in pain intensity from baseline to week 15 compared with placebo (p = 0.0075); differences between the oxycodone CR and placebo groups failed to reach statistical significance (p = 0.1195), likely related to a higher treatment discontinuation rate in the oxycodone CR group. No significant differences were observed between the tapentadol ER and oxycodone CR groups in the change in pain intensity from baseline to week 15 (p = 0.2135). Conclusions: In elderly adult patients ≥ 75 years of age with moderate to severe, Chronic Osteoarthritis knee or low back pain, tapentadol ER (100-250 mg bid) provided significant pain relief compared with placebo and had a better overall gastrointestinal tolerability profile than oxycodone CR.

  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain.

  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain. Methods In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group. Results In the placebo ( n  = 993), tapentadol ER ( n  = 1,874), and oxycodone CR ( n  = 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively. Conclusion Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.

  • 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, 2010
    Co-Authors: Marc Afilalo, M Etropolski, Bernd Lange, Brigitte Kuperwasser, A Okamoto, A Steup, C. Rauschkolb, Kathy Kelly, Ilse Van Hove, Juergen Haeussler
    Abstract:

    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)]

Bernd Lange - One of the best experts on this subject based on the ideXlab platform.

  • 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, 2017
    Co-Authors: Alain Serrie, Bernd Lange, A Steup
    Abstract:

    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, ...

  • 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, 2017
    Co-Authors: Bernd Lange, Christian Elling, Detlef Von Zabern, Cecile Dubois
    Abstract:

    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...

  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain.

  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain. Methods In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group. Results In the placebo ( n  = 993), tapentadol ER ( n  = 1,874), and oxycodone CR ( n  = 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively. Conclusion Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.

  • 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, 2010
    Co-Authors: Marc Afilalo, M Etropolski, Bernd Lange, Brigitte Kuperwasser, A Okamoto, A Steup, C. Rauschkolb, Kathy Kelly, Ilse Van Hove, Juergen Haeussler
    Abstract:

    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)]

Ilona Steigerwald - One of the best experts on this subject based on the ideXlab platform.

  • Effectiveness and Tolerability of Tapentadol Prolonged Release Compared With Prior Opioid Therapy for the Management of Severe, Chronic Osteoarthritis Pain
    Clinical Drug Investigation, 2013
    Co-Authors: Ilona Steigerwald, Michael Schenk, Uwe Lahne, Peter Gebuhr, Dietmar Falke, Barbara Hoggart
    Abstract:

    Background Tapentadol prolonged release (PR; 100–250 mg twice daily) has been efficacious and well tolerated for managing moderate-to-severe, Chronic Osteoarthritis hip or knee pain in phase 3 studies with washout of previous analgesic treatment. Objective The objective of this study was to evaluate the effectiveness and tolerability of tapentadol PR (50–250 mg twice daily) after direct rotation from World Health Organization (WHO) step III opioids in patients with severe Osteoarthritis knee pain who previously responded to WHO step III therapy but showed poor tolerability. Methods This open-label, phase 3b study (NCT00982280) was conducted from October 2009 through June 2010 (prematurely terminated due to slow recruitment and study drug shortages) in clinical care settings in Europe and Australia. The study population included patients with severe, Chronic Osteoarthritis knee pain who had taken WHO step III opioids daily for ≥2 weeks before screening, responded to therapy (average pain intensity [11-point numerical rating scale-3 (NRS-3)] ≤5 at screening), and reported opioid-related adverse effects as their reason for changing analgesics. Patients switched directly from WHO step III therapy to tapentadol. Patients received oral tapentadol PR (50–250 mg twice daily) during 5-week titration and 7-week maintenance periods. Oral tapentadol immediate release (IR) was permitted (≤twice/day, ≥4 h apart) for acute pain episodes due to index pain or withdrawal symptoms following discontinuation of previous opioids (combined dose of tapentadol [PR and IR] ≤500 mg/day). This study was planned to evaluate conversion to tapentadol PR, based on responder rate 1 (percentage of patients with same/less pain [NRS-3] versus Week −1) at Week 6 (primary endpoint), adverse events (AEs), and discontinuation rates. Equianalgesic ratios were calculated for tapentadol prior to WHO step III opioids (PR and PR plus IR formulations). Results Of 82 patients enrolled, 63 received study medication. In the per-protocol population, responder rate 1 at Week 6 (last observation carried forward) was 94.3 % (50/53; P  

  • effectiveness and tolerability of tapentadol prolonged release compared with prior opioid therapy for the management of severe Chronic Osteoarthritis pain
    Clinical Drug Investigation, 2013
    Co-Authors: Ilona Steigerwald, Michael Schenk, Uwe Lahne, Peter Gebuhr, Dietmar Falke, Barbara Hoggart
    Abstract:

    Background Tapentadol prolonged release (PR; 100–250 mg twice daily) has been efficacious and well tolerated for managing moderate-to-severe, Chronic Osteoarthritis hip or knee pain in phase 3 studies with washout of previous analgesic treatment.

  • effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on demand for the management of severe Chronic Osteoarthritis related knee pain results of an open label phase 3b study
    Journal of Pain Research, 2012
    Co-Authors: Ilona Steigerwald, Matthias Muller, Jolanta Kujawa, Jeancharles Balblanc, Jaime Calvoalen
    Abstract:

    This open-label, phase 3b study (ClinicalTrials.gov Identifier: NCT00983073) evaluated the effectiveness, and tolerability of tapentadol for severe, Chronic Osteoarthritis knee pain that was inadequately managed with World Health Organization (WHO) Step I or II analgesics or co-analgesics, or that was not treated with regular analgesics. Prior to starting study treatment, patients discontinued any WHO Step II analgesics, while Step I analgesics and/or co-analgesics were continued at the same dose. Patients received tapentadol prolonged release (50–250 mg bid) during a 5-week titration period and a 7-week maintenance period. Doses of tapentadol immediate release 50 mg (≤twice/day; ≥4 hours apart) were permitted throughout the study (total daily dose of tapentadol prolonged and immediate release, ≤250 mg bid). The primary endpoint was the change in pain intensity on an 11-point numerical rating scale-3 (NRS-3; recalled average pain intensity [11-point NRS] during the last 3 days) from baseline to Week 6, using the last observation carried forward (LOCF) to impute missing pain intensity scores. The mean (standard deviation) change from baseline to Week 6 (LOCF) in pain intensity was −3.4 (2.10; P < 0.0001) for all patients evaluated for effectiveness (n = 195). Significant decreases in pain intensity were also observed at Weeks 6, 8, and 12 (all P < 0.0001) using observed-case analysis. Corresponding significant improvements from baseline to Weeks 6 and 12 were observed in the Western Ontario and McMaster Universities Osteoarthritis index, the EuroQol-5 Dimension health status questionnaire, the Short Form-36 health survey, and the Hospital Anxiety and Depression Scale (all P ≤ 0.0103). Treatment-emergent adverse events were in line with those observed in previous studies of tapentadol prolonged release. Overall, the results of this study indicate that tapentadol treatment results in significant improvements in pain intensity, health-related quality of life, and function in patients with inadequately managed, severe, Chronic Osteoarthritis knee pain.

Brigitte Kuperwasser - One of the best experts on this subject based on the ideXlab platform.

  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain.

  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain. Methods In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group. Results In the placebo ( n  = 993), tapentadol ER ( n  = 1,874), and oxycodone CR ( n  = 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively. Conclusion Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.

  • 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, 2010
    Co-Authors: Marc Afilalo, M Etropolski, Bernd Lange, Brigitte Kuperwasser, A Okamoto, A Steup, C. Rauschkolb, Kathy Kelly, Ilse Van Hove, Juergen Haeussler
    Abstract:

    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)]

  • efficacy and safety of tapentadol prolonged release for Chronic Osteoarthritis pain and low back pain
    Advances in Therapy, 2010
    Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Okamoto, A Steup, Thomas Haufel, Judy Ashworth, M Etropolski
    Abstract:

    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.

  • Efficacy and safety of tapentadol prolonged release for Chronic Osteoarthritis pain and low back pain.
    Advances in Therapy, 2010
    Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Okamoto, A Steup, Thomas Haufel, Judy Ashworth, M Etropolski
    Abstract:

    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

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  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain.

  • Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
    Advances in Therapy, 2014
    Co-Authors: M Etropolski, Bernd Lange, Brigitte Kuperwasser, Thomas Haufel, Maren Flügel, C. Rauschkolb, Frank Laschewski
    Abstract:

    Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with Chronic Osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, Chronic pain. Methods In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group. Results In the placebo ( n  = 993), tapentadol ER ( n  = 1,874), and oxycodone CR ( n  = 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively. Conclusion Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.

  • efficacy and safety of tapentadol prolonged release for Chronic Osteoarthritis pain and low back pain
    Advances in Therapy, 2010
    Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Okamoto, A Steup, Thomas Haufel, Judy Ashworth, M Etropolski
    Abstract:

    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.

  • Efficacy and safety of tapentadol prolonged release for Chronic Osteoarthritis pain and low back pain.
    Advances in Therapy, 2010
    Co-Authors: Bernd Lange, Brigitte Kuperwasser, A Okamoto, A Steup, Thomas Haufel, Judy Ashworth, M Etropolski
    Abstract:

    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