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A pooled analysis evaluating the efficacy and tolerability of tapentadol extended release for chronic, painful diabetic peripheral neuropathy.

Schwartz S, Etropolski MS, Shapiro DY, Rauschkolb C, Vinik AI, Lange B, Cooper K, Van Hove I, Haeussler J - Clin Drug Investig (2015)

Bottom Line: No clinically relevant differences were observed in the efficacy of tapentadol ER across patient subgroups divided by age, sex, race, opioid experience and pain intensity.Incidences of treatment-emergent adverse events were 56.0 % (192/343) with placebo and 74.7 % (269/360) with tapentadol ER during maintenance.Results of this pooled analysis indicate that tapentadol ER was effective for managing DPN-related pain, and provided consistent analgesic efficacy across different patient subgroups.

View Article: PubMed Central - PubMed

Affiliation: Cetero Research, San Antonio, TX, USA.

ABSTRACT

Background and objective: Data from two similarly designed studies of tapentadol extended release (ER) for managing neuropathic pain associated with diabetic peripheral neuropathy (DPN; NCT00455520, NCT01041859) in adults were pooled for this analysis, allowing a detailed evaluation of efficacy in patient subgroups and secondary endpoints.

Methods: In each study, patients were titrated to their optimal dose of open-label tapentadol ER [100-250 mg twice daily (bid)] over 3 weeks. Patients with ≥1-point improvement in average pain intensity [11-point numerical rating scale (NRS)] were randomized (1:1) to receive placebo or tapentadol ER during a 12-week, double-blind maintenance period.

Results: Mean (standard deviation [SD]) changes in pain intensity from baseline to week 12 of maintenance in the placebo (n = 343) and tapentadol ER (n = 360) groups, respectively, were 1.28 (2.41) and 0.08 (1.87) [least squares mean difference (LSMD): -1.14 (95 % confidence interval [CI]: -1.435, -0.838); P < 0.001, in favour of tapentadol ER]. Significant between-group differences were also observed in changes from the start of the double-blind treatment period to the double-blind endpoint for the Short Form-36 physical functioning, role-physical, bodily pain, social functioning and role-emotional subscale and physical component summary scores, and the EuroQol 5-Dimension health status index (all P < 0.05, in favour of tapentadol ER). No clinically relevant differences were observed in the efficacy of tapentadol ER across patient subgroups divided by age, sex, race, opioid experience and pain intensity. Incidences of treatment-emergent adverse events were 56.0 % (192/343) with placebo and 74.7 % (269/360) with tapentadol ER during maintenance.

Conclusion: Results of this pooled analysis indicate that tapentadol ER was effective for managing DPN-related pain, and provided consistent analgesic efficacy across different patient subgroups.

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Related in: MedlinePlus

Mean [standard error (SE)] pain intensity over time [intent-to-treat (ITT) population]. Values during the OL titration period are based on observed-case analysis, and values during the DB maintenance period are based on the last observation carried forward (LOCF). Patients were required to have ≥1-point improvement in pain intensity during the OL titration period to be eligible for randomization to treatment during the DB maintenance period. BL baseline, DB double-blind, ER extended release, OL open-label. aOL tapentadol ER population: start OL, n = 1,034; week 1, n = 1,038; week 2, n = 951; week 3, n = 869. bValue for week 3 of the OL titration period is also shown at this timepoint
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Fig1: Mean [standard error (SE)] pain intensity over time [intent-to-treat (ITT) population]. Values during the OL titration period are based on observed-case analysis, and values during the DB maintenance period are based on the last observation carried forward (LOCF). Patients were required to have ≥1-point improvement in pain intensity during the OL titration period to be eligible for randomization to treatment during the DB maintenance period. BL baseline, DB double-blind, ER extended release, OL open-label. aOL tapentadol ER population: start OL, n = 1,034; week 1, n = 1,038; week 2, n = 951; week 3, n = 869. bValue for week 3 of the OL titration period is also shown at this timepoint

Mentions: Mean (standard error) pain intensity scores over the course of the study are shown in Fig. 1. For the open-label ITT population, mean [standard deviation (SD)] pain intensity (observed-case analysis) was 7.29 (1.38) at the start of the open-label titration period and 4.15 (2.10) at week 3 of the open-label titration period; the mean change from the start to week 3 of the open-label titration period was −3.19 (2.00). For patients who tolerated tapentadol ER, had at least a 1-point improvement in pain intensity during the open-label titration period and were randomized to treatment in the double-blind maintenance period, mean (SD) pain intensity scores (LOCF) were 3.48 (2.02) in the placebo group and 3.67 (1.84) in the tapentadol ER group at baseline (average pain over the 3 days prior to the start of the double-blind maintenance period), and 4.76 (2.52) in the placebo group and 3.77 (2.19) in the tapentadol ER group at week 12 of the double-blind maintenance period. The mean (SD) change from baseline to week 12 of the maintenance period was 1.28 (2.41) in the placebo group and 0.08 (1.87) in the tapentadol ER group [LSMD for tapentadol ER vs placebo (95 % confidence interval [CI]) −1.14 (−1.435, −0.838); P < 0.001]. These results indicate that pain intensity worsened upon switching from open-label tapentadol ER treatment to placebo during the double-blind maintenance period but was relatively unchanged with continued treatment with tapentadol ER.Fig. 1


A pooled analysis evaluating the efficacy and tolerability of tapentadol extended release for chronic, painful diabetic peripheral neuropathy.

Schwartz S, Etropolski MS, Shapiro DY, Rauschkolb C, Vinik AI, Lange B, Cooper K, Van Hove I, Haeussler J - Clin Drug Investig (2015)

Mean [standard error (SE)] pain intensity over time [intent-to-treat (ITT) population]. Values during the OL titration period are based on observed-case analysis, and values during the DB maintenance period are based on the last observation carried forward (LOCF). Patients were required to have ≥1-point improvement in pain intensity during the OL titration period to be eligible for randomization to treatment during the DB maintenance period. BL baseline, DB double-blind, ER extended release, OL open-label. aOL tapentadol ER population: start OL, n = 1,034; week 1, n = 1,038; week 2, n = 951; week 3, n = 869. bValue for week 3 of the OL titration period is also shown at this timepoint
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4300409&req=5

Fig1: Mean [standard error (SE)] pain intensity over time [intent-to-treat (ITT) population]. Values during the OL titration period are based on observed-case analysis, and values during the DB maintenance period are based on the last observation carried forward (LOCF). Patients were required to have ≥1-point improvement in pain intensity during the OL titration period to be eligible for randomization to treatment during the DB maintenance period. BL baseline, DB double-blind, ER extended release, OL open-label. aOL tapentadol ER population: start OL, n = 1,034; week 1, n = 1,038; week 2, n = 951; week 3, n = 869. bValue for week 3 of the OL titration period is also shown at this timepoint
Mentions: Mean (standard error) pain intensity scores over the course of the study are shown in Fig. 1. For the open-label ITT population, mean [standard deviation (SD)] pain intensity (observed-case analysis) was 7.29 (1.38) at the start of the open-label titration period and 4.15 (2.10) at week 3 of the open-label titration period; the mean change from the start to week 3 of the open-label titration period was −3.19 (2.00). For patients who tolerated tapentadol ER, had at least a 1-point improvement in pain intensity during the open-label titration period and were randomized to treatment in the double-blind maintenance period, mean (SD) pain intensity scores (LOCF) were 3.48 (2.02) in the placebo group and 3.67 (1.84) in the tapentadol ER group at baseline (average pain over the 3 days prior to the start of the double-blind maintenance period), and 4.76 (2.52) in the placebo group and 3.77 (2.19) in the tapentadol ER group at week 12 of the double-blind maintenance period. The mean (SD) change from baseline to week 12 of the maintenance period was 1.28 (2.41) in the placebo group and 0.08 (1.87) in the tapentadol ER group [LSMD for tapentadol ER vs placebo (95 % confidence interval [CI]) −1.14 (−1.435, −0.838); P < 0.001]. These results indicate that pain intensity worsened upon switching from open-label tapentadol ER treatment to placebo during the double-blind maintenance period but was relatively unchanged with continued treatment with tapentadol ER.Fig. 1

Bottom Line: No clinically relevant differences were observed in the efficacy of tapentadol ER across patient subgroups divided by age, sex, race, opioid experience and pain intensity.Incidences of treatment-emergent adverse events were 56.0 % (192/343) with placebo and 74.7 % (269/360) with tapentadol ER during maintenance.Results of this pooled analysis indicate that tapentadol ER was effective for managing DPN-related pain, and provided consistent analgesic efficacy across different patient subgroups.

View Article: PubMed Central - PubMed

Affiliation: Cetero Research, San Antonio, TX, USA.

ABSTRACT

Background and objective: Data from two similarly designed studies of tapentadol extended release (ER) for managing neuropathic pain associated with diabetic peripheral neuropathy (DPN; NCT00455520, NCT01041859) in adults were pooled for this analysis, allowing a detailed evaluation of efficacy in patient subgroups and secondary endpoints.

Methods: In each study, patients were titrated to their optimal dose of open-label tapentadol ER [100-250 mg twice daily (bid)] over 3 weeks. Patients with ≥1-point improvement in average pain intensity [11-point numerical rating scale (NRS)] were randomized (1:1) to receive placebo or tapentadol ER during a 12-week, double-blind maintenance period.

Results: Mean (standard deviation [SD]) changes in pain intensity from baseline to week 12 of maintenance in the placebo (n = 343) and tapentadol ER (n = 360) groups, respectively, were 1.28 (2.41) and 0.08 (1.87) [least squares mean difference (LSMD): -1.14 (95 % confidence interval [CI]: -1.435, -0.838); P < 0.001, in favour of tapentadol ER]. Significant between-group differences were also observed in changes from the start of the double-blind treatment period to the double-blind endpoint for the Short Form-36 physical functioning, role-physical, bodily pain, social functioning and role-emotional subscale and physical component summary scores, and the EuroQol 5-Dimension health status index (all P < 0.05, in favour of tapentadol ER). No clinically relevant differences were observed in the efficacy of tapentadol ER across patient subgroups divided by age, sex, race, opioid experience and pain intensity. Incidences of treatment-emergent adverse events were 56.0 % (192/343) with placebo and 74.7 % (269/360) with tapentadol ER during maintenance.

Conclusion: Results of this pooled analysis indicate that tapentadol ER was effective for managing DPN-related pain, and provided consistent analgesic efficacy across different patient subgroups.

Show MeSH
Related in: MedlinePlus