A Randomized, Double-Blind, Placebo-Controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients

Christie, Jennifer; Shroff, Sagar; Shahnavaz, Nikrad; Carter, Latoya A.; Harrison, Melanie S.; Dietz-Lindo, Karan A.; Hanfelt, John; Srinivasan, Shanthi

doi:10.1038/ajg.2016.531

Cited by 36 publications

(34 citation statements)

References 24 publications

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“…There were no safety concerns. There is, however, a lack of safety data of lubiprostone in PD patients, but because of the data available in the general and geriatric population, lubiprostone is considered to pose an “ acceptable risk without specialized monitoring .” Typical AEs of lubiprostone include nausea, diarrhea, and dyspnea …”

Section: Results and Conclusionmentioning

confidence: 99%

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Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

et al. 2019

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Objective To update evidence‐based medicine recommendations for treating nonmotor symptoms in Parkinson's disease (PD). Background The International Parkinson and Movement Disorder Society Evidence‐Based Medicine Committee's recommendations for treatments of PD were first published in 2002, updated in 2011, and now updated again through December 31, 2016. Methods Level I studies testing pharmacological, surgical, or nonpharmacological interventions for the treatment of nonmotor symptoms in PD were reviewed. Criteria for inclusion and quality scoring were as previously reported. The disorders covered were a range of neuropsychiatric symptoms, autonomic dysfunction, disorders of sleep and wakefulness, pain, fatigue, impaired olfaction, and ophthalmologic dysfunction. Clinical efficacy, implications for clinical practice, and safety conclusions are reported. Results A total of 37 new studies qualified for review. There were no randomized controlled trials that met inclusion criteria for the treatment of anxiety disorders, rapid eye movement sleep behavior disorder, excessive sweating, impaired olfaction, or ophthalmologic dysfunction. We identified clinically useful or possibly useful interventions for the treatment of depression, apathy, impulse control and related disorders, dementia, psychosis, insomnia, daytime sleepiness, drooling, orthostatic hypotension, gastrointestinal dysfunction, urinary dysfunction, erectile dysfunction, fatigue, and pain. There were no clinically useful interventions identified to treat non‐dementia‐level cognitive impairment. Conclusions The evidence base for treating a range of nonmotor symptoms in PD has grown substantially in recent years. However, treatment options overall remain limited given the high prevalence and adverse impact of these disorders, so the development and testing of new treatments for nonmotor symptoms in PD remains a top priority. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

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Section: Results and Conclusionmentioning

confidence: 99%

“…Typical AEs of lubiprostone include nausea, diarrhea, and dyspnea. 106,107 Probiotics and prebiotic fiber were evaluated in 1 high-quality, positive study. 40 The new conclusions are "efficacious" and "clinically useful."…”

Section: T R E a T M E N T O F T H E N O N M O T O R S Y M P T O M S mentioning

confidence: 99%

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

et al. 2019

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“…Both agents have been shown to stimulate intestinal fluid secretion and transit. Lubiprostone, a peripheral-acting derivative from prostaglandin E1 that activates CIC-2 chloride channels stimulating intraluminal fluid secretion, has been studied in a diabetic population [29••]. …”

Section: Treatment Considerations In Constipation (Table 1)mentioning

confidence: 99%

“…A recent randomized, double-blind controlled trial examined the effectiveness of lubiprostone on constipation symptoms and colonic transit time specifically in diabetics [29••]. In this trial, 76 diabetic patients were randomized with baseline measurements of spontaneous bowel movements (SBM), quality of life, and colon transit time (utilizing a wireless motility capsule).…”

Section: Treatment Considerations In Constipation (Table 1)mentioning

confidence: 99%

Diabetes Mellitus and the Colon

Piper

Saad

2017

Curr Treat Options Gastro

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Opinion statement Diabetes mellitus (DM) can affect the structure and function of the colon promoting commonly encountered lower gastrointestinal symptoms such as constipation, diarrhea, abdominal distention, bloating, and abdominal pain. Specific colonic disorders for which adults with DM are at greater risk include chronic constipation, enteropathic diarrhea, colorectal cancer (CRC), inflammatory bowel disease, microscopic colitis, and Clostridium difficile colitis. Smooth muscle structure and function, density of the interstitial cells of Cajal, and the health and function of the autonomic and enteric nerves of the colon are all potential affected by DM. These effects can in turn lead to alterations in colon motility, visceral sensation, immune function, endothelial function, and the colonic microbiome. The evaluation and treatment for slow transit constipation as well as pelvic floor dysfunction should be considered when constipation symptoms are refractory to initial treatment measures. DM-related medications and small bowel conditions such as celiac disease and small intestinal bowel overgrowth should be considered and excluded before a diagnosis of enteropathic diarrhea is made. Given the higher risk of CRC, adults with DM should be appropriately screened and may require a longer bowel preparation to ensure an adequate evaluation.

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“…This study does not address whether lubiprostone is effective and well tolerated in medically complex patients as the study design excluded patients with any significant co-morbid medical conditions, specifically in the diabetic population. The effect of lubiprostone in such populations was recently reported in a study by Christie et al [13] that addressed lubiprostone use in a diabetic population with CIC. The authors reported that lubiprostone improved complete spontaneous bowel movement (CSBM) without increasing nausea compared to placebo as assessed using wireless motility capsule and colon transit time, coupled with quality-of-life questionnaires.…”

mentioning

confidence: 81%

Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders

Gotfried

Schey

2017

Dig Dis Sci

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A Randomized, Double-Blind, Placebo-Controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients

Abstract: This study suggests that lubiprostone is a safe and effective treatment for increasing weekly SBMs and decreasing CTT in patients with DM and CIC.

Cited by 36 publications

References 24 publications

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

Diabetes Mellitus and the Colon

Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders

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