Safety and Efficacy of Duloxetine in the Treatment of Diabetic Peripheral Neuropathic Pain in Older Patients

Wasan, Ajay D.; Ossanna, Melissa J.; Raskin, Joel; Wernicke, Joachim; Robinson, Michael J.; Hall, Jerry A.; Edwards, Sara; Lipsius, Sarah; Meyers, Adam L.; McCarberg, Bill

doi:10.2174/157488609787354404

Cited by 36 publications

(33 citation statements)

References 15 publications

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“…Safety and tolerability of duloxetine has been described previously (and will not be addressed here) in the individual publications cited above, and articles with a focus on safety [34-42]. …”

Section: Introductionmentioning

confidence: 99%

Efficacy of Duloxetine in Patients with Chronic Pain Conditions

Skljarevski¹,

Zhang²,

Iyengar³

et al. 2011

CDTH

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The primary objective of this study is to review the efficacy of duloxetine in treating chronic pain using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations for clinical significance across chronic pain states. These include pain intensity, patient ratings of overall improvement, physical functioning, and mental functioning. This review comprised the side-by-side analyses of 12 double-blind, placebo-controlled trials of duloxetine in patients with chronic pain (diabetic peripheral neuropathic pain, fibromyalgia, chronic pain due to osteoarthritis, and chronic low back pain). Patients received duloxetine (60 to 120 mg/day) or placebo. Average pain reduction was assessed over 3 months as the primary efficacy outcome. Other measures used were physical function and Patient Global Impression of Improvement. In 10 of the 12 studies, statistically significant greater pain reduction was observed for duloxetine- compared with placebo-treated patients. The response rates based on average pain reduction, improvement of physical function, and global impression were comparable across all 4 chronic pain states. Compared with patients on placebo, significantly more patients treated with duloxetine reported a moderately important pain reduction (≥30% reduction) in 9 of the 12 studies, a minimally important improvement in physical function in 8 of the 12 studies, and a moderately important to substantial improvement in Patient Global Impression of Improvement rating in 11 of the 12 studies. The analyses reported here show that duloxetine is efficacious in treating chronic pain as demonstrated by significant improvement in pain intensity, physical functioning, and patient ratings of overall improvement.

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Section: Introductionmentioning

confidence: 99%

Efficacy of Duloxetine in Patients with Chronic Pain Conditions

Skljarevski¹,

Zhang²,

Iyengar³

et al. 2011

CDTH

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“…The pooled data set was stratified by age (<65 years of age versus ≥65 years of age) to explore potential age-dependent effects in efficacy and safety parameters [21]. To compare the probability of response for both age groups, a logistic repeated measures model was used [21].…”

Section: Methodsmentioning

confidence: 99%

Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

Skljarevski

Frakes

Sagman

et al. 2012

Pain Research and Treatment

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We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect (MOE) study that examine duloxetine 40 and 60 mg once daily (QD) in patients with diabetic peripheral neuropathic pain (DPNP). In all placebo-controlled studies, duloxetine showed significantly (P ≤ .01) greater reduction in pain severity (weekly mean of 24-hour average pain severity ratings, primary outcome measure) compared with placebo. In all placebo-controlled studies, duloxetine showed significantly (P ≤ .05) greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo (P ≤ .01) for duloxetine patients in all placebo-controlled studies. Response rates (based on 30% pain reduction) ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different (P ≤ .01) between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events (placebo groups: 2.6% to 7.4%). Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.

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“…Patients receiving duloxetine (60 and 120 mg/day), regardless of age subgroup, had significantly greater improvement in Average Pain Severity than placebotreated patients beginning at week 1 and at each subsequent visit until study end point [46]. The incidence of treatment-emergent adverse events did not differ between the two age groups in the acute phase, but rates of discontinuation owing to adverse events were significantly higher in older patients regardless of treatment group [46]. Those who completed the 12-week acute phase of the DPNP studies were re-randomized to routine care or duloxetine 60 mg twice daily for a 52-week, open-label, safety extension phase [47][48][49].…”

Section: Use In Specific Populationsmentioning

confidence: 95%

“…A post hoc ana lysis of three 12-week, placebocontrolled trials of duloxetine (60 and 120 mg/ day) in the management of DPNP, which stratified the data by age (<65 and ≥65 years), was conducted to evaluate the safety and efficacy of duloxetine in the treatment of DPNP in older (≥65 years) adults [46]. Patients receiving duloxetine (60 and 120 mg/day), regardless of age subgroup, had significantly greater improvement in Average Pain Severity than placebotreated patients beginning at week 1 and at each subsequent visit until study end point [46].…”

Section: Use In Specific Populationsmentioning

confidence: 99%

Evaluation of Duloxetine for Chronic Pain Conditions

2011

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Summary Duloxetine hydrochloride (duloxetine) is used as a nonopioid analgesic for the treatment of certain chronic pain conditions. It is a serotonin and norepinephrine reuptake inhibitor and has been approved in the USA for the management of both diabetic peripheral neuropathic pain and fibromyalgia. In addition, based on several studies demonstrating that duloxetine was efficacious in the management of chronic low back pain and chronic pain caused by osteoarthritis, duloxetine was approved for the management of chronic musculoskeletal pain. Effect sizes in studies of each of the aforementioned chronic pain conditions are comparable with other commonly used pain medications. Treatment-emergent adverse events are generally mild to moderate in severity, and tend to occur early and transiently.

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Safety and Efficacy of Duloxetine in the Treatment of Diabetic Peripheral Neuropathic Pain in Older Patients

Abstract: 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>or=65.

Cited by 36 publications

References 15 publications

Efficacy of Duloxetine in Patients with Chronic Pain Conditions

Efficacy of Duloxetine in Patients with Chronic Pain Conditions

Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

Evaluation of Duloxetine for Chronic Pain Conditions

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