Abstract
Objective: We present a post-hoc analysis of the safety and efficacy of duloxetine, a selective serotonin/ norepinephrine reuptake inhibitor, for treatment of diabetic peripheral neuropathic pain (DPNP) in older patients. Methods: Data from three double-blind, placebo-controlled trials in adult patients with DPNP were pooled and stratified by age ( < 65, ≥65 years). Patients were randomized to duloxetine (DLX) 60 mg once-daily, 60 mg twice-daily, or placebo for 12 weeks, followed by a 52-week extension phase (re-randomization to routine care or DLX 120 mg/day). Intent-totreat analyses were used for safety and efficacy assessment. Results: In the acute phase, overall TEAE rates did not differ significantly by age. A greater percentage of older patients discontinued due to TEAEs (P < 0.001), regardless of treatment group. Duloxetine improved weekly mean 24-hour average pain scores versus placebo in both age groups (P < 0.01). In the extension phase, a significant therapy-by-age interaction (P < 0.05) was observed in overall TEAE rate; with routine care, 86.6% of older patients had ≥1 TEAE versus 74.6% of younger patients. Conclusions: Although TEAEs more frequently lead to discontinuation in older patients, duloxetine was well tolerated and efficacious for treatment of DPNP regardless of age. These data suggest duloxetine may be beneficial for treatment of DPNP in patients ≥65.
Keywords: Diabetic peripheral neuropathic pain, duloxetine, older adults, tolerability
Current Drug Safety
Title: Safety and Efficacy of Duloxetine in the Treatment of Diabetic Peripheral Neuropathic Pain in Older Patients
Volume: 4 Issue: 1
Author(s): Ajay D. Wasan, Melissa J. Ossanna, Joel Raskin, Joachim F. Wernicke, Michael J. Robinson, Jerry A. Hall, Sara E. Edwards, Sarah Lipsius, Adam L. Meyers and Bill H. McCarberg
Affiliation:
Keywords: Diabetic peripheral neuropathic pain, duloxetine, older adults, tolerability
Abstract: Objective: We present a post-hoc analysis of the safety and efficacy of duloxetine, a selective serotonin/ norepinephrine reuptake inhibitor, for treatment of diabetic peripheral neuropathic pain (DPNP) in older patients. Methods: Data from three double-blind, placebo-controlled trials in adult patients with DPNP were pooled and stratified by age ( < 65, ≥65 years). Patients were randomized to duloxetine (DLX) 60 mg once-daily, 60 mg twice-daily, or placebo for 12 weeks, followed by a 52-week extension phase (re-randomization to routine care or DLX 120 mg/day). Intent-totreat analyses were used for safety and efficacy assessment. Results: In the acute phase, overall TEAE rates did not differ significantly by age. A greater percentage of older patients discontinued due to TEAEs (P < 0.001), regardless of treatment group. Duloxetine improved weekly mean 24-hour average pain scores versus placebo in both age groups (P < 0.01). In the extension phase, a significant therapy-by-age interaction (P < 0.05) was observed in overall TEAE rate; with routine care, 86.6% of older patients had ≥1 TEAE versus 74.6% of younger patients. Conclusions: Although TEAEs more frequently lead to discontinuation in older patients, duloxetine was well tolerated and efficacious for treatment of DPNP regardless of age. These data suggest duloxetine may be beneficial for treatment of DPNP in patients ≥65.
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Wasan D. Ajay, Ossanna J. Melissa, Raskin Joel, Wernicke F. Joachim, Robinson J. Michael, Hall A. Jerry, Edwards E. Sara, Lipsius Sarah, Meyers L. Adam and McCarberg H. Bill, Safety and Efficacy of Duloxetine in the Treatment of Diabetic Peripheral Neuropathic Pain in Older Patients, Current Drug Safety 2009; 4 (1) . https://dx.doi.org/10.2174/157488609787354404
DOI https://dx.doi.org/10.2174/157488609787354404 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
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