A Double-Blind, Randomized Multicenter Trial Comparing Duloxetine with Placebo in the Management of Diabetic Peripheral Neuropathic Pain

Raskin, Joel; Pritchett, Yili; Wang, Fujun; D’Souza, Deborah N.; Waninger, A.; Iyengar, Smriti; Wernicke, Joachim

doi:10.1111/j.1526-4637.2005.00061.x

Cited by 468 publications

(365 citation statements)

References 26 publications

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“…Duloxetine is a selective serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor [40]. Duloxetine has been reported to be effective in diabetic neuropathic pain and recently in chronic orofacial pain disorders, such as burning mouth syndrome [41,42], suggesting other mechanisms of action. Indeed, duloxetine has been shown to act on certain sodium channels, blocking persistent late Nav1.7 currents.…”

Section: Discussionmentioning

confidence: 99%

SUNCT and SUNA: medical and surgical treatments

Lambru

Matharu

2013

Neurol Sci

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Short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA) are rare and often disabling primary headache disorders. Their management can be challenging. The abortive therapies are not generally useful as the attacks are relatively short lasting. A myriad of pharmacological preventive treatments have been tried in single case reports or small series in an openlabel fashion. Lamotrigine, as an oral preventive treatment, and lidocaine, as an intravenous transitional treatment, seem to be the most effective therapies. For medically intractable chronic forms of SUNCT and SUNA, several surgical approaches have been tried. These include ablative procedures involving the trigeminal nerve or the Gasserian ganglion, microvascular decompression of the trigeminal nerve, and neurostimulation techniques. This review provides an overview of the current pharmacological and surgical options for SUNCT and SUNA syndromes.

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Section: Discussionmentioning

confidence: 99%

SUNCT and SUNA: medical and surgical treatments

Lambru

Matharu

2013

Neurol Sci

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“…[27][28][29] In these studies, duloxetine 60 mg QD and 60 mg BID demonstrated significant improvement compared to placebo on the 24-hour average pain severity score. In addition, patients who completed one of the 12-week acute therapy phase studies were rerandomized to duloxetine 60 mg BID or routine care for 52 weeks of open-label treatment in order to evaluate the safety of duloxetine over long-term administration.…”

Section: Discussionmentioning

confidence: 99%

“…As detailed in Raskin et al, 29 patients were eligible for the study if they were 18 years or older, and presented with pain due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus. The pain had to begin in the feet and with relatively symmetrical onset.…”

Section: Entry Criteriamentioning

confidence: 99%

“…27 Based on this evidence, two more independent 12-week acute therapy studies were conducted, and these studies confirmed the safety and efficacy of duloxetine 60 mg QD and 60 mg BID in the management of patients with DPNP. 28,29 The study presented here was conducted in order to evaluate the safety, as well as the impact of therapy on patient-reported health outcomes with up to 65 weeks exposure with duloxetine 60 mg BID or routine care. It is a one-year extension of an acute study, the results of which were previously reported.…”

Section: Introduction Dmentioning

confidence: 99%

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Duloxetine versus Routine Care in the Long-Term Management of Diabetic Peripheral Neuropathic Pain

Raskin

Smith

Wong³

et al. 2006

Journal of Palliative Medicine

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Introduction: Duloxetine hydrochloride is a dual reuptake inhibitor of both serotonin and norepinephrine. In the present open-label study, the safety of duloxetine at a fixed-dose of 60 mg twice daily (BID) for up to 52 weeks was evaluated and compared to routine care in the therapy of patients diagnosed with diabetic peripheral neuropathic pain (DPNP).Methods: Patients who completed a 13-week, double-blind, duloxetine and placebo acute therapy period were rerandomly assigned in a 2:1 ratio to therapy with duloxetine 60 mg BID (N ‫؍‬ 161) or routine care (N ‫؍‬ 76) for an additional 52 weeks. Routine care consisted primarily of gabapentin, amitriptyline, and venlafaxine. The study included male or female outpatients 18 years of age or older with a diagnosis of DPNP caused by type 1 or type 2 diabetes.Results: A higher percentage of routine care-treated patients experienced 1 or more serious adverse events. No statistically significant therapy-group difference was observed in the overall incidence of treatment-emergent adverse events (TEAEs). The TEAEs reported by 10% or more of duloxetine 60 mg BID-treated patients were nausea, and by the routine care-treated patients were peripheral edema, pain in the extremity, somnolence, and dizziness. Duloxetine did not appear to adversely affect glycemic control, lipid profiles, nerve function, or the course of DPNP. There were no statistically significant therapy-group differences observed in the 36-item Short-Form Health Survey subscales or in the EuroQol 5-Dimension Questionnaire.Conclusions: In this study, duloxetine was safe and well tolerated compared to routine care in the long-term management of patients with DPNP.

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“…The literature regarding SNRI use for the prevention of chronic post-surgical pain is limited; however, given that the SNRI medication (duloxetine) is a firstline medication for the treatment of chronic neuropathic pain [67], its role in the prevention of chronic post-surgical pain should be further investigated. Duloxetine has been shown to be efficacious for the treatment of diabetic peripheral neuropathy and fibromyalgia [68][69][70][71]. Appropriately powered trials are necessary to examine the efficacy of the SNRIs in CPSP prevention, including dose-response studies and head-to-head comparisons with other drugs, such as pregabalin.…”

Section: Selective Norepinephrine and Serotonin Re-uptake Inhibitors mentioning

confidence: 99%

Preventive Analgesia and Novel Strategies for the Prevention of Chronic Post-Surgical Pain

Clarke

Poon

Weinrib

et al. 2015

Drugs

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Chronic post-surgical pain (CPSP) is a serious complication of major surgery that can impair a patient's quality of life. The development of CPSP is a complex process which involves biologic, psychosocial, and environmental mechanisms that have yet to be fully understood. Currently perioperative pharmacologic interventions aim to suppress and prevent sensitization with the aim of reducing pain and analgesic requirement in acute as well as long-term pain . Despite the detrimental effects of CPSP on patients, the body of literature focused on treatment strategies to reduce CPSP remains limited and continues to be understudied. This article reviews the main pharmacologic candidates for the treatment of CPSP, discusses the future of preventive analgesia, and considers novel strategies to help treat acute postoperative pain and lessen the risk that it becomes chronic. In addition, this article highlights important areas of focus for clinical practice including: multimodal management of CPSP patients, psychological modifiers of the pain experience, and the development of a Transitional Pain Service specifically designed to manage patients at high risk of developing chronic post-surgical pain. Key PointsThe development of chronic post-surgical pain (CPSP) is a complex process which involves biologic, psychosocial, and environmental mechanisms.Ketamine (an NMDA antagonist) appears to be the pharmacologic agent with the most consistent positive preventive analgesic results.The variation in patient response to pharmacologic agents can be explained, in part, by genetic polymorphisms.Understanding the heritability of CPSP will be useful when developing predictive algorithms to determine the preoperative risk for developing CPSP.Psychological treatments delivered before and after surgery have the potential to influence the trajectory of CPSP from the earliest days, in combination with multimodal, preventive analgesia.

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A Double-Blind, Randomized Multicenter Trial Comparing Duloxetine with Placebo in the Management of Diabetic Peripheral Neuropathic Pain

Abstract: In this clinical trial, duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the management of DPNP.

Cited by 468 publications

References 26 publications

SUNCT and SUNA: medical and surgical treatments

SUNCT and SUNA: medical and surgical treatments

Duloxetine versus Routine Care in the Long-Term Management of Diabetic Peripheral Neuropathic Pain

Preventive Analgesia and Novel Strategies for the Prevention of Chronic Post-Surgical Pain

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