Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial

Schwartz, Sherwyn; Etropolski, Mila; Shapiro, Douglas Y.; Okamoto, Akiko; Lange, Robert; Häeussler, Jüergen; Rauschkolb, Christine

doi:10.1185/03007995.2010.537589

Cited by 219 publications

(127 citation statements)

References 46 publications

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“…First, pioglitazone and other PPARγ agonists reduce neuropathic pain-like behavior in normoglycemic animals after various routes of administration including: repeated oral 55, 63 or intraperitoneal 31, 55, 63, 96 ; local injection to the injured sciatic nerve 96 or incised paw 31 ; or a single spinal 11, 30, 62, 71 or brain 62 injection. Second, numerous drugs can reduce PDN without reducing hyperglycemia in patients with PDN, including tapentadol 88 or the FDA-approved PDN medications duloxetine and pregabalin 59, 90 . Furthermore, the antioxidant taurine 49 , aldose reductase inhibitors 9, 66, 75 , insulin growth factor 112, 113 , or poly-ADP-ribose inhibitors 21, 67, 68 reduce hyperalgesia in animal models of PDN without inhibiting hyperglycemia.…”

Section: Discussionmentioning

confidence: 99%

Pioglitazone Inhibits the Development of Hyperalgesia and Sensitization of Spinal Nociresponsive Neurons in Type 2 Diabetes

Griggs

Donahue

Adkins

et al. 2016

The Journal of Pain

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Thiazolidinedione drugs (TZDs) such as pioglitazone are FDA-approved for the treatment of insulin resistance in type 2 diabetes. However, whether TZDs reduce painful diabetic neuropathy (PDN) remains unknown. Therefore we tested the hypothesis that chronic administration of pioglitazone would reduce PDN in Zucker Diabetic Fatty (ZDFfa/fa) rats. Compared to Zucker Lean (ZLfa/+) controls, ZDF developed: (1) elevated blood glucose, HbA1c, methylglyoxal and insulin; (2) mechanical and thermal hyperalgesia at the hindpaw; (3) increased avoidance of noxious mechanical probes in a mechanical conflict avoidance behavioral assay, the first report of a measure of affective-motivational pain-like behavior in ZDF; and (4) exaggerated lumbar dorsal horn immunohistochemical expression of pressure-evoked phosphorylated extracellular signal-regulated kinase (pERK). Seven weeks of pioglitazone (30 mg · kg−1 · d−1 in food) reduced blood glucose, HbA1c, hyperalgesia, and pERK expression in ZDF. This is the first report to reveal hyperalgesia and spinal sensitization in the same ZDF animals, both evoked by a noxious mechanical stimulus that reflects pressure pain frequently associated with clinical PDN. As pioglitazone provides the combined benefit of reducing hyperglycemia, hyperalgesia, and central sensitization, we suggest that TZDs represent an attractive pharmacotherapy in patients with type 2 diabetes-associated pain.

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Section: Discussionmentioning

confidence: 99%

Pioglitazone Inhibits the Development of Hyperalgesia and Sensitization of Spinal Nociresponsive Neurons in Type 2 Diabetes

Griggs

Donahue

Adkins

et al. 2016

The Journal of Pain

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“…Tapentadol has been shown to be effective in the management of different types of chronic pain, including osteoarthritis knee pain, low back pain and DNP, with a tolerable safety profile [168,169] . Specifically concerning DNP, a randomizedwithdrawal, placebocontrolled trial reported reduction of at least 30% in pain intensity in about 50% of the patients that received tapentadol [170] . Similar data were obtained in a recent clinical trial in diabetic neuropathic patients with moderate to severe pain, which experienced nausea (21.1%) and vomiting (12.7%) as side effects [171] .…”

Section: Opioidsmentioning

confidence: 99%

Diabetic neuropathic pain: Physiopathology and treatment

Schreiber

Nones

Reis

et al. 2015

WJD

339

267

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Diabetic neuropathy is a common complication of both type 1 and type 2 diabetes, which affects over 90% of the diabetic patients. Although pain is one of the main symptoms of diabetic neuropathy, its pathophysiological mechanisms are not yet fully known. It is widely accepted that the toxic effects of hyperglycemia play an important role in the development of this complication, but several other hypotheses have been postulated. The management of diabetic neuropathic pain consists basically in excluding other causes of painful peripheral neuropathy, improving glycemic control as a prophylactic therapy and using medications to alleviate pain. First line drugs for pain relief include anticonvulsants, such as pregabalin and gabapentin and antidepressants, especially those that act to inhibit the reuptake of serotonin and noradrenaline. In addition, there is experimental and clinical evidence that opioids can be helpful in pain control, mainly if associated with first line drugs. Other agents, including for topical application, such as capsaicin cream and lidocaine patches, have also been proposed to be useful as adjuvants in the control of diabetic neuropathic pain, but the clinical evidence is insufficient to support their use. In conclusion, a better understanding of the mechanisms underlying diabetic neuropathic pain will contribute to the search of new therapies, but also to the improvement of the guidelines to optimize pain control with the drugs currently available.

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“…Tapentadol has been shown to be effective in the reduction of pain intensity 227,228 , Vinik et al 227 reported improvement in pain in PC-RCTs. The pain reduction occurs within 2–3 weeks 227 .…”

Section: Findings From Studies Grouped By Chronic Pain Syndromementioning

confidence: 99%

“…The pain reduction occurs within 2–3 weeks 227 . The minimal effective dose ranged from 100 mg/daily 227,228 . Tramadol has been shown to be effective in the reduction of pain intensity and improvement in social and physical functioning in a single PC-RCT 229 .…”

Section: Findings From Studies Grouped By Chronic Pain Syndromementioning

confidence: 99%

Alternatives to Opioids in the Pharmacologic Management of Chronic Pain Syndromes: A Narrative Review of Randomized, Controlled, and Blinded Clinical Trials

Nicol

Hurley

Benzon

2017

Anesthesia &Amp; Analgesia

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Chronic pain exerts a tremendous burden on individuals and societies. If one views chronic pain as a single disease entity, then it is the most common and costly medical condition. At present, medical professionals who treat patients in chronic pain are recommended to provide comprehensive and multidisciplinary treatments, which may include pharmacotherapy. Many providers employ non-opioid medications to treat chronic pain, however, for some patients, opioid analgesics are the exclusive treatment of chronic pain. However, there is currently an epidemic of opioid use in the United States, and recent guidelines from the Centers for Disease Control (CDC) have recommended that the use of opioids for non-malignant chronic pain be used only in certain circumstances. The goal of this review was to report the current body of evidence-based medicine gained from prospective, randomized-controlled, blinded studies on the use of non-opioid analgesics for the most common non-cancer chronic pain conditions. A total of 9566 studies were obtained during literature searches and 271 of these met inclusion for this review. Overall, while many non-opioid analgesics have been found to be effective in reducing pain for many chronic pain conditions, it is evident that the number of high-quality studies is lacking and the effect sizes noted in many studies is not considered to be clinically significant despite statistical significance. More research is needed to determine effective and mechanisms-based treatments for the chronic pain syndromes discussed in this review. Utilization of rigorous and homogeneous research methodology would likely allow for better consistency and reproducibility, which is of utmost importance in guiding evidence-based care.

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Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial

Abstract: Compared with placebo, tapentadol ER 100-250 mg bid provided a statistically significant difference in the maintenance of a clinically important improvement in pain 1 , 2 and was well-tolerated by patients with painful DPN.

Cited by 219 publications

References 46 publications

Pioglitazone Inhibits the Development of Hyperalgesia and Sensitization of Spinal Nociresponsive Neurons in Type 2 Diabetes

Pioglitazone Inhibits the Development of Hyperalgesia and Sensitization of Spinal Nociresponsive Neurons in Type 2 Diabetes

Diabetic neuropathic pain: Physiopathology and treatment

Alternatives to Opioids in the Pharmacologic Management of Chronic Pain Syndromes: A Narrative Review of Randomized, Controlled, and Blinded Clinical Trials

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