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Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial

Abstract Objective: Painful diabetic peripheral neuropathy (DPN) may not be adequately managed with available therapeutic options. This phase III, randomized-withdrawal, placebo-controlled trial evaluated the safety and efficacy of tapentadol extended release (ER) for relieving painful DPN. Research... Full description

Journal Title: Current medical research and opinion 2011-01, Vol.27 (1), p.151-162
Main Author: Schwartz, Sherwyn
Other Authors: Etropolski, Mila , Shapiro, Douglas Y , Okamoto, Akiko , Lange, Robert , Haeussler, Juergen , Rauschkolb, Christine
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Informa UK Ltd
ID: ISSN: 0300-7995
Link: https://www.ncbi.nlm.nih.gov/pubmed/21162697
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recordid: cdi_informahealthcare_journals_10_1185_03007995_2010_537589
title: Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial
format: Article
creator:
  • Schwartz, Sherwyn
  • Etropolski, Mila
  • Shapiro, Douglas Y
  • Okamoto, Akiko
  • Lange, Robert
  • Haeussler, Juergen
  • Rauschkolb, Christine
subjects:
  • Adult
  • Aged
  • Aged, 80 and over
  • Algorithms
  • Analgesics, Opioid - administration & dosage
  • Analgesics, Opioid - adverse effects
  • Analgesics, Opioid - therapeutic use
  • Chronic pain
  • Delayed-Action Preparations
  • Diabetic Neuropathies - drug therapy
  • Diabetic peripheral neuropathy
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pain - drug therapy
  • Pain Measurement
  • Phenols - administration & dosage
  • Phenols - adverse effects
  • Phenols - therapeutic use
  • Placebos
  • Tapentadol ER
  • Treatment Outcome
  • Withholding Treatment - statistics & numerical data
ispartof: Current medical research and opinion, 2011-01, Vol.27 (1), p.151-162
description: Abstract Objective: Painful diabetic peripheral neuropathy (DPN) may not be adequately managed with available therapeutic options. This phase III, randomized-withdrawal, placebo-controlled trial evaluated the safety and efficacy of tapentadol extended release (ER) for relieving painful DPN. Research design and methods: Patients (n = 588) with at least a 3-month history of opioid and/or non-opioid analgesic use for DPN, dissatisfaction with current treatment, and an average pain intensity score of at least 5 on an 11-point numerical rating scale (NRS; 0 = 'no pain,' 10 = 'pain as bad as you can imagine') were titrated to an optimal dose of tapentadol ER (100-250 mg bid) during a 3-week open-label phase. Subsequently, patients (n = 395) with at least a 1-point reduction in pain intensity were randomized 1:1 to receive placebo or the optimal fixed dose of tapentadol ER determined during the open-label phase for a 12-week double-blind phase. Clinical trial registration: NCT00455520. Main outcome measures: The primary efficacy outcome was the change in average pain intensity from randomization, determined by twice-daily NRS measurements. Safety was assessed throughout the study. Results: The least-squares mean difference between groups in the change in average pain intensity from the start of double-blind treatment to week 12 was −1.3 (95% confidence interval, −1.70 to −0.92; p 
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0300-7995
fulltext: fulltext
issn:
  • 0300-7995
  • 1473-4877
url: Link


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titleSafety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial
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creatorSchwartz, Sherwyn ; Etropolski, Mila ; Shapiro, Douglas Y ; Okamoto, Akiko ; Lange, Robert ; Haeussler, Juergen ; Rauschkolb, Christine
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descriptionAbstract Objective: Painful diabetic peripheral neuropathy (DPN) may not be adequately managed with available therapeutic options. This phase III, randomized-withdrawal, placebo-controlled trial evaluated the safety and efficacy of tapentadol extended release (ER) for relieving painful DPN. Research design and methods: Patients (n = 588) with at least a 3-month history of opioid and/or non-opioid analgesic use for DPN, dissatisfaction with current treatment, and an average pain intensity score of at least 5 on an 11-point numerical rating scale (NRS; 0 = 'no pain,' 10 = 'pain as bad as you can imagine') were titrated to an optimal dose of tapentadol ER (100-250 mg bid) during a 3-week open-label phase. Subsequently, patients (n = 395) with at least a 1-point reduction in pain intensity were randomized 1:1 to receive placebo or the optimal fixed dose of tapentadol ER determined during the open-label phase for a 12-week double-blind phase. Clinical trial registration: NCT00455520. Main outcome measures: The primary efficacy outcome was the change in average pain intensity from randomization, determined by twice-daily NRS measurements. Safety was assessed throughout the study. Results: The least-squares mean difference between groups in the change in average pain intensity from the start of double-blind treatment to week 12 was −1.3 (95% confidence interval, −1.70 to −0.92; p < 0.001, tapentadol ER vs. placebo). A total of 60.5% (356/588) of patients reported at least a 30% improvement in pain intensity from the start to the end of the open-label titration phase; of the patients who were randomized to tapentadol ER, 53.6% (105/196) reported at least a 30% improvement from pre-titration to week 12 of the double-blind phase. The most common treatment-emergent adverse events that occurred during double-blind treatment with tapentadol ER included nausea, anxiety, diarrhea, and dizziness. Potential limitations of this study are related to the enriched enrollment randomized-withdrawal trial design, which may result in a more homogeneous patient population during double-blind treatment and may present a risk of unblinding because of changes in side effects from the open-label to the double-blind phase. Conclusions: Compared with placebo, tapentadol ER 100-250 mg bid provided a statistically significant difference in the maintenance of a clinically important improvement in pain1,2 and was well-tolerated by patients with painful DPN.
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subjectAdult ; Aged ; Aged, 80 and over ; Algorithms ; Analgesics, Opioid - administration & dosage ; Analgesics, Opioid - adverse effects ; Analgesics, Opioid - therapeutic use ; Chronic pain ; Delayed-Action Preparations ; Diabetic Neuropathies - drug therapy ; Diabetic peripheral neuropathy ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Pain - drug therapy ; Pain Measurement ; Phenols - administration & dosage ; Phenols - adverse effects ; Phenols - therapeutic use ; Placebos ; Tapentadol ER ; Treatment Outcome ; Withholding Treatment - statistics & numerical data
ispartofCurrent medical research and opinion, 2011-01, Vol.27 (1), p.151-162
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12011 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 2011
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descriptionAbstract Objective: Painful diabetic peripheral neuropathy (DPN) may not be adequately managed with available therapeutic options. This phase III, randomized-withdrawal, placebo-controlled trial evaluated the safety and efficacy of tapentadol extended release (ER) for relieving painful DPN. Research design and methods: Patients (n = 588) with at least a 3-month history of opioid and/or non-opioid analgesic use for DPN, dissatisfaction with current treatment, and an average pain intensity score of at least 5 on an 11-point numerical rating scale (NRS; 0 = 'no pain,' 10 = 'pain as bad as you can imagine') were titrated to an optimal dose of tapentadol ER (100-250 mg bid) during a 3-week open-label phase. Subsequently, patients (n = 395) with at least a 1-point reduction in pain intensity were randomized 1:1 to receive placebo or the optimal fixed dose of tapentadol ER determined during the open-label phase for a 12-week double-blind phase. Clinical trial registration: NCT00455520. Main outcome measures: The primary efficacy outcome was the change in average pain intensity from randomization, determined by twice-daily NRS measurements. Safety was assessed throughout the study. Results: The least-squares mean difference between groups in the change in average pain intensity from the start of double-blind treatment to week 12 was −1.3 (95% confidence interval, −1.70 to −0.92; p < 0.001, tapentadol ER vs. placebo). A total of 60.5% (356/588) of patients reported at least a 30% improvement in pain intensity from the start to the end of the open-label titration phase; of the patients who were randomized to tapentadol ER, 53.6% (105/196) reported at least a 30% improvement from pre-titration to week 12 of the double-blind phase. The most common treatment-emergent adverse events that occurred during double-blind treatment with tapentadol ER included nausea, anxiety, diarrhea, and dizziness. Potential limitations of this study are related to the enriched enrollment randomized-withdrawal trial design, which may result in a more homogeneous patient population during double-blind treatment and may present a risk of unblinding because of changes in side effects from the open-label to the double-blind phase. Conclusions: Compared with placebo, tapentadol ER 100-250 mg bid provided a statistically significant difference in the maintenance of a clinically important improvement in pain1,2 and was well-tolerated by patients with painful DPN.
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titleSafety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial
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abstractAbstract Objective: Painful diabetic peripheral neuropathy (DPN) may not be adequately managed with available therapeutic options. This phase III, randomized-withdrawal, placebo-controlled trial evaluated the safety and efficacy of tapentadol extended release (ER) for relieving painful DPN. Research design and methods: Patients (n = 588) with at least a 3-month history of opioid and/or non-opioid analgesic use for DPN, dissatisfaction with current treatment, and an average pain intensity score of at least 5 on an 11-point numerical rating scale (NRS; 0 = 'no pain,' 10 = 'pain as bad as you can imagine') were titrated to an optimal dose of tapentadol ER (100-250 mg bid) during a 3-week open-label phase. Subsequently, patients (n = 395) with at least a 1-point reduction in pain intensity were randomized 1:1 to receive placebo or the optimal fixed dose of tapentadol ER determined during the open-label phase for a 12-week double-blind phase. Clinical trial registration: NCT00455520. Main outcome measures: The primary efficacy outcome was the change in average pain intensity from randomization, determined by twice-daily NRS measurements. Safety was assessed throughout the study. Results: The least-squares mean difference between groups in the change in average pain intensity from the start of double-blind treatment to week 12 was −1.3 (95% confidence interval, −1.70 to −0.92; p < 0.001, tapentadol ER vs. placebo). A total of 60.5% (356/588) of patients reported at least a 30% improvement in pain intensity from the start to the end of the open-label titration phase; of the patients who were randomized to tapentadol ER, 53.6% (105/196) reported at least a 30% improvement from pre-titration to week 12 of the double-blind phase. The most common treatment-emergent adverse events that occurred during double-blind treatment with tapentadol ER included nausea, anxiety, diarrhea, and dizziness. Potential limitations of this study are related to the enriched enrollment randomized-withdrawal trial design, which may result in a more homogeneous patient population during double-blind treatment and may present a risk of unblinding because of changes in side effects from the open-label to the double-blind phase. Conclusions: Compared with placebo, tapentadol ER 100-250 mg bid provided a statistically significant difference in the maintenance of a clinically important improvement in pain1,2 and was well-tolerated by patients with painful DPN.
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pmid21162697
doi10.1185/03007995.2010.537589