906 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Lubiprostone for the Treatment of Opioid-Induced Bowel Dysfunction in Patients With Chronic, Non-Cancer Pain

Cryer, Byron; Katz, Seymour; Vallejo, Ricardo; Scott, Charles; Joswick, Taryn; Dolecek, Gayle; Ueno, Ryuji

doi:10.1016/s0016-5085(10)60591-4

Cited by 10 publications

(14 citation statements)

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“…Lubiprostone was just recently approved in 2012 for the treatment of chronic constipation in Japan. Although its safety and efficacy in elderly patients still require further research (36), this drug has shown efficacy in small studies of constipation due to Parkinson's disease or opioid use (37,38), two situations that are frequently encountered in elderly populations. The most common adverse effects are diarrhea and nausea (39).…”

Section: Discussionmentioning

confidence: 99%

Obstructive Uropathy Caused by Chronic Constipation

2015

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We herein report a case regarding a 90-year-old woman with a history of recurrent episodes of urinary tract infections presenting with fever. Urinalysis revealed bacteria and white blood cells. Computed tomography showed dilated and fecally loaded rectum and colon with signs of obstructive uropathy. The patient was treated for urinary tract infection and constipation. Her bowel habits were controlled with lubiprostone, and she was discharged in good medical condition. This case highlights the importance of considering fecal impaction as a cause of urinary tract obstruction or infection.

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Section: Discussionmentioning

confidence: 99%

Obstructive Uropathy Caused by Chronic Constipation

2015

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“…An extension study of this trial determined lubiprostone to be safe and well tolerated over 52 weeks, with the most common adverse effects of diarrhea (11%), nausea (11%), urinary tract infection (9%) and sinusitis (9%). 41 Side effects seem to be dose dependent; with considerably more gastrointestinal adverse events (specifically nausea at 44%) observed at higher doses compared to the 24 μg once daily regimen (17%). Frequency of administration was not found to affect therapeutic outcomes.…”

Section: Lubiprostonementioning

confidence: 98%

“…Benefits in patients with opioid-induced constipation have also been reported. 41,42 Drossman et al 38 evaluated over 1100 IBS-C patients in a placebo-controlled RCT, demonstrating that lubiprostone 8 μg twice daily resulted in significantly higher overall response compared to placebo (17.9% vs. 10.1%, P = 0.001) over 12 weeks of treatment. An extension study of this trial determined lubiprostone to be safe and well tolerated over 52 weeks, with the most common adverse effects of diarrhea (11%), nausea (11%), urinary tract infection (9%) and sinusitis (9%).…”

Section: Lubiprostonementioning

confidence: 99%

Emerging Pharmacologic Therapies for Constipation-predominant Irritable Bowel Syndrome and Chronic Constipation

Eswaran¹,

Guentner²,

Chey³

2014

J Neurogastroenterol Motil

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Irritable bowel syndrome with constipation and chronic functional constipation are common digestive disorders that negatively impact quality of life and account for billions of dollars in health care costs. Related to the heterogeneity of pathogenesis that underlie these disorders and the failure of symptoms to reliably predict underlying pathophysiology, traditional therapies provide relief to only a subset of affected individuals. The evidence surrounding new and emerging pharmacologic treatments, which include both luminally and systemically acting drugs, is discussed here. These include agents such as lubiprostone, bile acid modulations, guanylate cyclase-C receptor agonists, serotonin receptor modulators and herbal therapies.

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“…However, authors used different terms in their inclusion criteria and for outcome analysis. For example, the expression rescue-free bowel movement (RFBM) was chosen in two studies [35,36] and was defined by BMs that occurred without using any laxatives in the prior 24 h. Though, the expression spontaneous bowel movement (SBM) was more common [11,12,31,32,[37][38][39][40][41]. Interestingly, SBM was defined exactly the same as RFBM by authors who gave a definition for SBM [11,12,31,32,[37][38][39].…”

Section: Bm Measuresmentioning

confidence: 99%