Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial

Hirayama, Yasuo; Ishitani, Kunihiko; Sato, Yasushi; Iyama, Satoshi; Takada, Kohichi; Murase, Kazuyuki; Kuroda, Hiroyuki; Nagamachi, Yukio; Konuma, Yuichi; Fujimi, Akihito; Sagawa, Tamotsu; Ono, Kaoru; Horiguchi, Hyogo; Terui, Takeshi; Koike, Kazuo; Kusakabe, Toshiro; Sato, Tsutomu; Takimoto, Rishu; Kobune, Masayoshi; Kato, Junji

doi:10.1007/s10147-015-0810-y

Cited by 90 publications

(64 citation statements)

References 18 publications

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“…Additionally, there are no medications currently available for the prevention of CIPN in patients undergoing treatment with neurotoxic chemotherapeutic agents . For patients who are experiencing CIPN, the antidepressant, duloxetine, is recommended although the magnitude of benefit is modest and much less than is desirable . In several case series, pregabalin reportedly alleviated CIPN with a relatively good safety profile .…”

Section: Introductionmentioning

confidence: 99%

Comparative analgesic efficacy of pregabalin administered according to either a prevention protocol or an intervention protocol in rats with cisplatin‐induced peripheral neuropathy

Han

Kuo

Nicholson

et al. 2018

Clin Exp Pharma Physio

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Chemotherapy-induced peripheral neuropathy (CIPN) is a type of peripheral neuropathic pain that may be dose-limiting in patients administered potentially curative cancer chemotherapy dosing regimens. In cancer survivors, persistent CIPN adversely affects patient quality of life and so adjuvant drugs (anticonvulsants eg pregabalin or antidepressants eg amitriptyline) are recommended for the relief of CIPN. However, most studies in rodent models of CIPN involve administration of single bolus doses of adjuvant drugs to assess pain-relieving efficacy. Hence this study was designed to assess the efficacy of pregabalin administered to CIPN-rats according to either a prevention or an intervention protocol. Groups of male Sprague-Dawley rats received four single intraperitoneal bolus doses of cisplatin at 3 mg/kg at once-weekly intervals to induce CIPN. For the prevention protocol, oral pregabalin (or vehicle) was administered to CIPN-rats once-daily for 21 consecutive days from day 0 to day 20 inclusive. For the intervention protocol, oral pregabalin was administered once-daily for 21 consecutive days from day 28 to day 48, inclusive. Mechanical allodynia and mechanical hyperalgesia in the bilateral hindpaws were assessed just prior to each dose of cisplatin and at least once weekly until study completion (day 27, prevention protocol; or day 48, intervention protocol). Mechanical allodynia and mechanical hyperalgesia were also determined at the time of peak effect at about 2 hours post pregabalin/vehicle administration, once weekly until study completion. For the prevention protocol in CIPN-rats, pregabalin alleviated mechanical hyperalgesia but not mechanical allodynia. For the intervention protocol, pregabalin alleviated both mechanical allodynia and mechanical hyperalgesia in the hindpaws.

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Section: Introductionmentioning

confidence: 99%

Comparative analgesic efficacy of pregabalin administered according to either a prevention protocol or an intervention protocol in rats with cisplatin‐induced peripheral neuropathy

Han

Kuo

Nicholson

et al. 2018

Clin Exp Pharma Physio

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“…A 2013 double-blinded, placebo-controlled, crossover trial found that duloxetine 60 mg daily had a beneficial effect on CIPN-related pain 52 . These findings were more recently confirmed in a study comparing duloxetine 40 mg daily and vitamin B12 53 .…”

Section: Treatmentmentioning

confidence: 60%

Chemotherapy-induced peripheral neuropathy: an update on the current understanding

2016

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Chemotherapy-induced peripheral neuropathy is a common side effect of selected chemotherapeutic agents. Previous work has suggested that patients often under report the symptoms of chemotherapy-induced peripheral neuropathy and physicians fail to recognize the presence of such symptoms in a timely fashion. The precise pathophysiology that underlies chemotherapy-induced peripheral neuropathy, in both the acute and the chronic phase, remains complex and appears to be medication specific. Recent work has begun to demonstrate and further clarify potential pathophysiological processes that predispose and, ultimately, lead to the development of chemotherapy-induced peripheral neuropathy. There is increasing evidence that the pathway to neuropathy varies with each agent. With a clearer understanding of how these agents affect the peripheral nervous system, more targeted treatments can be developed in order to optimize treatment and prevent long-term side effects.

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“…Recently, we reported the results of an open-label, pilot randomised trial wherein duloxetine was compared with vitamin B 12 in Japanese patients with CIPN. 8 Significant differences in improvement in numbness and pain were observed in the duloxetine group in comparison with those in the vitamin B 12 group. Adverse events (AE) including fatigue, somnolence, insomnia and nausea were observed, but all were grade 1 in common terminology criteria for AE (CTCAE) V.4.0.…”

Section: Discussionmentioning

confidence: 89%

Survey of the management of chemotherapy-induced peripheral neuropathy in Japan: Japanese Society of Medical Oncology

Hirayama¹,

Sasaki

Dosaka‐Akita

et al. 2016

ESMO Open

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BackgroundVarious drugs are administered for the management of chemotherapy-induced peripheral neuropathy (CIPN) in Japan. However, there have been no surveys undertaken to identify these drugs or their frequency of prescription. Therefore, we administered a questionnaire survey to the diplomates of the Subspecialty Board of Japanese Society of Medical Oncology (JSMO) to investigate the frequency of administration of different drugs for the management of CIPN in Japan.MethodsWe investigated the use of vitamin B12, antiepileptic agents such as pregabalin, duloxetine, antidepressants other than duloxetine, non-steroidal anti-inflammatory drugs (NSAIDs), opioids and the Kampo compound goshajinkigan in a questionnaire employing a three-step scale wherein A implies routine or prophylactic administration, B implies occasional administration and C implies infrequent administration.ResultsConsidering responses A and B together, the most frequently administered drugs for the treatment of numbness were antiepileptic drugs such as pregabalin (A+B=98.7%), vitamin B12 (74.7%), Kampo compounds (58.7%) and duloxetine (46.8%). The most frequently prescribed drugs for pain were NSAIDs (97.7%), followed by opioids (83.1%) and finally antiepileptic drugs (82.1%).ConclusionsVarious drugs are frequently administered for CIPN. In addition, it was found that marked differences exist between the drugs targeted on numbness and pain.

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Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial

Abstract: Our data suggests that duloxetine has a beneficial effect on CIPN caused by oxaliplatin, paclitaxel, vincristine, or bortezomib in Japanese patients.

Cited by 90 publications

References 18 publications

Comparative analgesic efficacy of pregabalin administered according to either a prevention protocol or an intervention protocol in rats with cisplatin‐induced peripheral neuropathy

Comparative analgesic efficacy of pregabalin administered according to either a prevention protocol or an intervention protocol in rats with cisplatin‐induced peripheral neuropathy

Chemotherapy-induced peripheral neuropathy: an update on the current understanding

Survey of the management of chemotherapy-induced peripheral neuropathy in Japan: Japanese Society of Medical Oncology

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