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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 change in Short Form-36 (SF-36) subscale and summary scale scores from the start of the double-blind (DB) treatment period to the DB endpoint. Negative values indicate deterioration. ER extended release. *P < 0.05 versus placebo. **P ≤ 0.001 versus placebo
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Fig4: Mean change in Short Form-36 (SF-36) subscale and summary scale scores from the start of the double-blind (DB) treatment period to the DB endpoint. Negative values indicate deterioration. ER extended release. *P < 0.05 versus placebo. **P ≤ 0.001 versus placebo

Mentions: For the SF-36 physical functioning, role-physical, bodily pain, social functioning and role-emotional subscale scores and the physical component summary score, significant differences were observed in the changes from the start of the double-blind treatment period to the double-blind endpoint between the placebo and tapentadol ER groups (P < 0.05, in favour of tapentadol ER; Fig. 4). A significant difference was also observed in the change from the start of the double-blind treatment period to the double-blind endpoint for the EQ-5D health status index between the placebo and tapentadol ER groups (LSMD for tapentadol ER vs placebo [95 % CI], 0.09 [0.056, 0.122]; P < 0.001), also in favour of tapentadol ER.Fig. 4


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 change in Short Form-36 (SF-36) subscale and summary scale scores from the start of the double-blind (DB) treatment period to the DB endpoint. Negative values indicate deterioration. ER extended release. *P < 0.05 versus placebo. **P ≤ 0.001 versus placebo
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig4: Mean change in Short Form-36 (SF-36) subscale and summary scale scores from the start of the double-blind (DB) treatment period to the DB endpoint. Negative values indicate deterioration. ER extended release. *P < 0.05 versus placebo. **P ≤ 0.001 versus placebo
Mentions: For the SF-36 physical functioning, role-physical, bodily pain, social functioning and role-emotional subscale scores and the physical component summary score, significant differences were observed in the changes from the start of the double-blind treatment period to the double-blind endpoint between the placebo and tapentadol ER groups (P < 0.05, in favour of tapentadol ER; Fig. 4). A significant difference was also observed in the change from the start of the double-blind treatment period to the double-blind endpoint for the EQ-5D health status index between the placebo and tapentadol ER groups (LSMD for tapentadol ER vs placebo [95 % CI], 0.09 [0.056, 0.122]; P < 0.001), also in favour of tapentadol ER.Fig. 4

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