Amitriptyline vs. pregabalin in painful diabetic neuropathy: a randomized double blind clinical trial

Bansal, Dipika; Bhansali, Anil; Hota, Debasish; Chakrabarti, Amitava; Dutta, Pinaki

doi:10.1111/j.1464-5491.2009.02806.x

Cited by 109 publications

(69 citation statements)

References 25 publications

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“…Bansal et al reported in a head-tohead comparison that pregabalin was more effective in providing pain relief in DPN than amitriptyline [144]. In a large multicenter, double-blind, parallel-group study in over 800 patients, Tesfaye and colleagues found that 60 mg/day duloxetine was more effective than 300 mg/day pregabalin (p < 0.001) in the initial 8-week phase [145].…”

Section: Combination Therapy For Dpnmentioning

confidence: 99%

Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions

Javed¹,

Alam²,

Malik³

2015

Rev Diabet Stud

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■ AbstractDiabetic peripheral neuropathies (DPN) are a heterogeneous group of disorders caused by neuronal dysfunction in patients with diabetes. They have differing clinical courses, distributions, fiber involvement (large or small), and pathophysiology. These complications are associated with increased morbidity, distress, and healthcare costs. Approximately 50% of patients with diabetes develop peripheral neuropathy, and the projected rise in the global burden of diabetes is spurring an increase in neuropathy. Distal symmetrical polyneuropathy (DSPN) with painful diabetic neuropathy, occurring in around 20% of diabetes patients, and diabetic autonomic neuropathy (DAN) are the most common manifestations of DPN. Optimal glucose control represents the only broadly accepted therapeutic option though evidence of its benefit in type 2 diabetes is unclear. A number of symptomatic treatments are recommended in clinical guidelines for the management of painful DPN, including antidepressants such as amitriptyline and duloxetine, the γ-aminobutyric acid analogues gabapentin and pregabalin, opioids, and topical agents such as capsaicin. However, monotherapy is frequently not effective in achieving complete resolution of pain in DPN. There is a growing need for head-to-head studies of different single-drug and combination pharmacotherapies. Due to the ubiquity of autonomic innervation in the body, DAN causes a plethora of symptoms and signs affecting cardiovascular, urogenital, gastrointestinal, pupillomotor, thermoregulatory, and sudomotor systems. The current treatment of DAN is largely symptomatic, and does not correct the underlying autonomic nerve deficit. A number of novel potential candidates, including erythropoietin analogues, angiotensin II receptor type 2 antagonists, and sodium channel blockers are currently being evaluated in phase II clinical trials.

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Section: Combination Therapy For Dpnmentioning

confidence: 99%

Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions

Javed¹,

Alam²,

Malik³

2015

Rev Diabet Stud

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“…Therefore, it was recommend that a combination may be considered in patients who show a partial response to either drug given alone but who seek additional pain relief [Gilron et al 2009]. Bansal and colleagues recently reported in a head-to-head study that pregabalin may be more efficacious than amitriptyline in patients with PDN [Bansal et al 2009]. In a multicentre, double-blind, parallelgroup study of 805 patients with DPN in the initial 8-week therapy 60 mg/day duloxetine was found to be superior to 300 mg/day pregabalin (p < 0.001) and subsequently a 50% response rate for pain relief was shown in 52.1% for combination and 39.3% for high-dose monotherapy (p = 0.068) ].…”

Section: Future Directionsmentioning

confidence: 99%

Treatment of painful diabetic neuropathy

Javed

Petropoulos²,

Alam

et al. 2014

Therapeutic Advances in Chronic Disease

179

129

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Painful diabetic neuropathy (PDN) is a debilitating consequence of diabetes that may be present in as many as one in five patients with diabetes. The objective assessment of PDN is difficult, making it challenging to diagnose and assess in both clinical practice and clinical trials. No single treatment exists to prevent or reverse neuropathic changes or to provide total pain relief. Treatment of PDN is based on three major approaches: intensive glycaemic control and risk factor management, treatments based on pathogenetic mechanisms, and symptomatic pain management. Clinical guidelines recommend pain relief in PDN through the use of antidepressants such as amitriptyline and duloxetine, the γ-aminobutyric acid analogues gabapentin and pregabalin, opioids and topical agents such as capsaicin. Of these medications, duloxetine and pregabalin were approved by the US Food and Drug Administration (FDA) in 2004 and tapentadol extended release was approved in 2012 for the treatment of PDN. Proposed pathogenetic treatments include α-lipoic acid (stems reactive oxygen species formation), benfotiamine (prevents vascular damage in diabetes) and aldosereductase inhibitors (reduces flux through the polyol pathway). There is a growing need for studies to evaluate the most potent drugs or combinations for the management of PDN to maximize pain relief and improve quality of life. A number of agents are potential candidates for future use in PDN therapy, including Nav 1.7 antagonists, N-type calcium channel blockers, NGF antibodies and angiotensin II type 2 receptor antagonists.

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“…Both medications differ in cost, the latter being more expensive. A randomized double blind clinical trial conducted by Bhansal et al [4] has compared amitriptyline (n=22) and pregabalin (n=22) at average doses of 16 and 218 mg/d, respectively. This study found that there is no significant difference in pain relief between both groups but concluded that pregabalin is a good alternative for the treatment of DPN, especially in those who cannot tolerate amitriptyline [4] .…”

mentioning

confidence: 99%

“…A randomized double blind clinical trial conducted by Bhansal et al [4] has compared amitriptyline (n=22) and pregabalin (n=22) at average doses of 16 and 218 mg/d, respectively. This study found that there is no significant difference in pain relief between both groups but concluded that pregabalin is a good alternative for the treatment of DPN, especially in those who cannot tolerate amitriptyline [4] . In the network meta-analysis, which compared efficacy and safety of six antidepressants and anticonvulsants in DPN conducted by Neelima et al demonstrates that pregabalin precedes amitripyline based on most favourable balance between risk and benefit [5] .…”

mentioning

confidence: 99%

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Efficacy, Safety and Cost Effectiveness of Amitriptyline and Pregabalin in Patients with Diabetic Peripheral Neuropathy

Sankar¹,

Oommen²,

Thomas³

et al. 2017

pharmaceutical-sciences

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The tricyclic antidepressant, amitriptyline and the anticonvulsant, pregabalin are the most frequently used medications in general practice for diabetic peripheral neuropathy. This study compares the effectiveness of amitriptyline vs. pregabalin using neuropathic pain symptom inventory and visual analogue scale, the incidence of adverse drug reactions and the cost effectiveness. Effectiveness was measured using visual analogue scale and neuropathic pain symptom inventory scores both before and after therapy. Adverse drug reactions were documented after the therapy and cost effectiveness was measured using incremental cost effectiveness analysis ratio. Both drugs showed obvious pain relief. Visual analogue scale mean difference scores showed statistically significant difference in efficacy for amitriptyline and pregabalin. Incidences of adverse drug reactions were more or less similar in terms of magnitude. Furthermore the cost of amitriptyline is less than that of pregabalin. Hence we concluded that amitriptyline was a better choice of therapy than pregablin because it was well tolerated and has a lower cost for the additional effectiveness achieved.

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Amitriptyline vs. pregabalin in painful diabetic neuropathy: a randomized double blind clinical trial

Abstract: As there are few differences between the two treatments in efficacy, pregabalin 150 mg twice daily might be the alternative choice as it is associated with fewer adverse effects in our population.

Cited by 109 publications

References 25 publications

Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions

Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions

Treatment of painful diabetic neuropathy

Efficacy, Safety and Cost Effectiveness of Amitriptyline and Pregabalin in Patients with Diabetic Peripheral Neuropathy

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