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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

Sensitivity analyses of the primary efficacy analysis [double-blind (DB) intent-to-treat (ITT) population]. BOCF baseline observation carried forward, CI confidence interval, ER extended release, LOCF last observation carried forward, PMI placebo mean imputation, WOCF worst observation carried forward
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Fig2: Sensitivity analyses of the primary efficacy analysis [double-blind (DB) intent-to-treat (ITT) population]. BOCF baseline observation carried forward, CI confidence interval, ER extended release, LOCF last observation carried forward, PMI placebo mean imputation, WOCF worst observation carried forward

Mentions: Sensitivity analyses using alternative imputation methods supported the results of the primary efficacy analysis. Statistically significant differences were observed between placebo and tapentadol ER for the change in average pain intensity from baseline to week 12 of the double-blind maintenance period, using all alternative imputation methods (P < 0.001, in favour of tapentadol ER for all comparisons; Fig. 2). The results of the post hoc MMRM analysis were consistent with those of the primary efficacy analysis using LOCF and the other imputation methods summarized in Fig. 2; using the MMRM, the estimated difference between the tapentadol ER and placebo groups for the change from baseline to week 12 of the double-blind maintenance period was −1.14 (95 % CI −1.47, −0.82; P < 0.001).Fig. 2


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)

Sensitivity analyses of the primary efficacy analysis [double-blind (DB) intent-to-treat (ITT) population]. BOCF baseline observation carried forward, CI confidence interval, ER extended release, LOCF last observation carried forward, PMI placebo mean imputation, WOCF worst observation carried forward
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig2: Sensitivity analyses of the primary efficacy analysis [double-blind (DB) intent-to-treat (ITT) population]. BOCF baseline observation carried forward, CI confidence interval, ER extended release, LOCF last observation carried forward, PMI placebo mean imputation, WOCF worst observation carried forward
Mentions: Sensitivity analyses using alternative imputation methods supported the results of the primary efficacy analysis. Statistically significant differences were observed between placebo and tapentadol ER for the change in average pain intensity from baseline to week 12 of the double-blind maintenance period, using all alternative imputation methods (P < 0.001, in favour of tapentadol ER for all comparisons; Fig. 2). The results of the post hoc MMRM analysis were consistent with those of the primary efficacy analysis using LOCF and the other imputation methods summarized in Fig. 2; using the MMRM, the estimated difference between the tapentadol ER and placebo groups for the change from baseline to week 12 of the double-blind maintenance period was −1.14 (95 % CI −1.47, −0.82; P < 0.001).Fig. 2

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