Safety and adverse event profile of duloxetine

Wernicke, Joachim; Gahimer, James; Yalcin, Ilker; Wulster-Radcliffe, Meghan; Viktrup, Lars

doi:10.1517/14740338.4.6.987

Cited by 52 publications

(30 citation statements)

References 26 publications

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“…There were no significant differences in the laboratory parameters before and after the treatment, suggesting the safety of both drugs. Adverse events with both drugs were comparable with those reported in the previous studies (5,13,14,17,20,21,25). …”

Section: Discussionsupporting

confidence: 88%

A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy

et al. 2011

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OBJECTIVETo compare the efficacy and safety of duloxetine and amitriptyline in painful diabetic neuropathy (PDN).RESEARCH DESIGN AND METHODSIn this randomized, double-blind, cross-over, active-control trial, 58 patients received amitriptyline and duloxetine orally once daily at bedtime, each for 6 weeks with optional dose uptitration fortnightly. Single-blinded placebo washout was given for 2 weeks between the two treatments and a single-blinded placebo run-out phase of 4 weeks was given at the end of the treatment period. Pain relief was measured by the patient’s global assessment of efficacy, using a visual analog scale (0–100) as a primary end point, and overall improvement and adverse events were assessed as secondary outcome measures. Median pain score reductions of >50%, 25–50%, and <25% were considered good, moderate, and mild responses, respectively.RESULTSThere was a significant improvement in pain with both treatments compared with their baseline values (P < 0.001 for both). Good, moderate, and mild pain relief was achieved in 55, 24, and 15% of patients, respectively, on amitriptyline and 59, 21, and 9% of patients, respectively, on duloxetine. There were no significant differences in various other outcome measures between the groups. Of the reported adverse events, dry mouth was significantly more common with amitriptyline than duloxetine (55 vs. 24%; P < 0.01). Although, numerically, more patients preferred duloxetine, overall this was not statistically significant (48 vs. 36%; P = 0.18).CONCLUSIONSBoth duloxetine and amitriptyline demonstrated similar efficacy in PDN. A large, multicentric clinical trial in other populations could possibly demonstrate the superiority of either drug.

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Section: Discussionsupporting

confidence: 88%

A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy

et al. 2011

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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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“…Although the new generation is devoid of the anticholinergic and antihistaminic activity of the old TCAs, the increased NE tone still represents an increased risk of side effects, primarily blood pressure changes. This is also seen in clinical studies [52,56], and for new derivatives of this kind the challenge is to find the right balance between increased efficacy, putatively greater response and remission rates and, on the other side, norepinephrine-related side effects. Duloxetine might be the first compound of this type on the market with relatively modest effect on heart rate and blood pressure.…”

Section: Sert/net and Sert/net/dat Inhibitorsmentioning

confidence: 98%

Serotonin Reuptake Inhibitors: The Corner Stone in Treatment of Depression for Half a Century – A Medicinal Chemistry Survey

Moltzen

Bang‐Andersen

2006

CTMC

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Inhibition of serotonin (5-HT) reuptake has been a central theme in the therapy of depression for half a century. Through the years these therapies have improved, particularly with regard to side effects, and today's selective serotonin reuptake inhibitors (SSRIs) constitute a reasonably effective offer for the patients. However, there is still room for major improvement and considering that almost 20% of the population in the western world will experience a depressive period in their lifetime, there is a large need for improved therapies. A large spectrum of targets and strategies are currently being pursued, but so far none of these new approaches have been successful, mainly due to lack of a deeper understanding of the disease biology. Since inhibition of 5-HT reuptake ensures a certain degree of antidepressant efficacy, there has been a large interest in various combinations with serotonin reuptake inhibitors (SRIs) in order to improve on the shortcomings of treatment with SSRIs. Some of these approaches have resulted in marketed antidepressants, eg combinations of SRI with norepinephrine (NE) reuptake inhibition, whereas other approaches are still at an experimental stage. This review attempts to present the current status of these add-on/combination approaches with particular focus on the medicinal chemistry aspects.

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Safety and adverse event profile of duloxetine

Cited by 52 publications

References 26 publications

A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy

A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy

Efficacy of Duloxetine in Patients with Chronic Pain Conditions

Serotonin Reuptake Inhibitors: The Corner Stone in Treatment of Depression for Half a Century – A Medicinal Chemistry Survey

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