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

Cryer, Byron; Drossman, Douglas A.; Chey, William D.; Webster, Lynn R.; Habibi, Sepideh; Wang, Martin

doi:10.1007/s10620-017-4680-1

Cited by 36 publications

(22 citation statements)

References 32 publications

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“…73 Side effects, particularly nausea, are commoner with lubiprostone. 74 Treatment of CIC with 12 weeks of linaclotide was found to significantly reduce bowel and abdominal symptoms when compared with placebo in two RCTs. 75 Patients treated with linaclotide were also significantly more likely to reach the primary endpoint of three or more spontaneous bowel movements per week.…”

Section: Pharmacological Treatmentsmentioning

confidence: 99%

“…A meta‐analysis by Li and colleagues, 73 summarising data from nine RCTs of lubiprostone versus placebo in CIC and IBS‐C, found significant improvements in severity of constipation, stool consistency and degree of straining after one month, but there was no longer a significant difference between groups by 3 months 73 . Side effects, particularly nausea, are commoner with lubiprostone 74 …”

Section: Managementmentioning

confidence: 99%

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Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management

Black

Ford

2018

Medical Journal of Australia

132

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Chronic idiopathic constipation (CIC) is one of the most common gastrointestinal disorders, with a global prevalence of 14%. It is commoner in women and its prevalence increases with age. There are three subtypes of CIC: dyssynergic defaecation, slow transit constipation and normal transit constipation, which is the most common subtype. Clinical assessment of the patient with constipation requires careful history taking, in order to identify any red flag symptoms that would necessitate further investigation with colonoscopy to exclude colorectal malignancy. Screening for hypercalcaemia, hypothyroidism and coeliac disease with appropriate blood tests should be considered. A digital rectal examination should be performed to assess for evidence of dyssynergic defaecation. If this is suspected, further investigation with high resolution anorectal manometry should be undertaken. Anorectal biofeedback can be offered to patients with dyssynergic defaecation as a means of correcting the associated impairment of pelvic floor, abdominal wall and rectal functioning. Lifestyle modifications, such as increasing dietary fibre, are the first step in managing other causes of CIC. If patients do not respond to these simple changes, then treatment with osmotic and stimulant laxatives should be trialled. Patients not responding to traditional laxatives should be offered treatment with prosecretory agents such as lubiprostone, linaclotide and plecanatide, or the 5-HT4 receptor agonist prucalopride, where available. If there is no response to pharmacological treatment, surgical intervention can be considered, but it is only suitable for a carefully selected subset of patients with proven slow transit constipation.

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Section: Pharmacological Treatmentsmentioning

confidence: 99%

Section: Managementmentioning

confidence: 99%

Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management

Black

Ford

2018

Medical Journal of Australia

132

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“…The only symptom occurring more frequently amongst those on active treatment was diarrhea (NNH=10; 95% CI 5 to 25). Nausea is well-described in patients taking lubiprostone (256), but only one RCT reported these data (255), and there was no significant difference in rates.…”

Section: Quality Of Evidence: Moderatementioning

confidence: 99%

American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome

Ford

Martin

Chey

et al. 2018

American Journal of Gastroenterology

Self Cite

276

396

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IntroductionIrritable bowel syndrome (IBS) is the most prevalent of the functional gastrointestinal disorders (FGIDs). Current estimates are that IBS affects up to 10-12% of adults in North America (1,2). Although it can affect all individuals regardless of age, creed, or gender, IBS is more common among women and is most commonly diagnosed in younger individuals (< age 50) (2, 3). IBS is characterized by recurrent abdominal pain and altered bowel habits; bloating and distention frequently coexist. The diagnosis of IBS is made by taking a careful history, eliciting key symptoms, as well as performing a physical examination and limited diagnostic testing (4-6). IBS is categorized into four main subtypes based on the predominant bowel habit: IBS with constipation (IBC-C); IBS with diarrhea (IBS-D); IBS with mixed symptomology (IBS-M); and unclassified IBS (5).IBS imposes a significant burden to the health care system and to individuals.Direct medical costs attributed to IBS in the US, excluding prescription and over-thecounter medicines, were estimated at $1.5-$10 billion per year in 2005 (7). Patients with IBS enrolled in a large Health Maintenance Organization (HMO) had significantly more outpatient visits and incurred nearly 50% more in total costs than individuals without IBS (8). A retrospective case-control study from another large HMO reported that patients with IBS had significantly more diagnostic tests, imaging, and surgery compared with patients without a diagnosis of IBS (9). Significant variations in care across the United States related to the diagnosis and treatment of IBS also play a role in excessive health care costs (10). The burden of IBS on individuals can be measured in a number of ways. Studies have demonstrated consistently that IBS impairs work-related activities (e.g., lost work time, reduced productivity while at work) and also reduces quality of life (11,12). The development Ford et al.Page 3 of 91 of effective and efficient treatment strategies for IBS assumes considerable importance, therefore, not just for the individual sufferer, but for society at large.Given the clinical heterogeneity that is a hallmark of the disorder and the absence of a single effective therapy for all sufferers, available therapies tend to focus on predominant symptomatology at presentation (i.e., altered bowel habits, abdominal pain, or bloating) (4-6). Based on their purported mode of action, many pharmacological therapies for IBS developed in recent decades have been directed towards those with a particular bowel habit, whether diarrhea or constipation.However, treating IBS patients can be difficult as no validated treatment algorithm exists, not all patients respond to treatment, and patients with similar symptoms frequently respond to the same treatment differently. Fortunately, a variety of novel therapeutic strategies are being explored and new compounds have appeared since the last iteration of the ACG monograph on IBS (4). The goal of this document, therefore, is to provide an updated, evidence-based d...

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“…Nausea is the most common side effect, experienced by 8% of patients, but it is generally relatively mild and self-limited. 133…”

Section: Medications For Constipation (Table 1)mentioning

confidence: 99%

Management Options for Irritable Bowel Syndrome

Camilleri

2018

Mayo Clinic Proceedings

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Irritable bowel syndrome (IBS) is associated with diverse pathophysiological mechanisms. These include increased abnormal colonic motility or transit, intestinal or colorectal sensation, increased colonic bile acid concentration, superficial colonic mucosal inflammation, as well as epithelial barrier dysfunction, neurohormonal upregulation and activation of secretory processes in the epithelial layer. Novel approaches to treatment include lifestyle modification, changes in diet, probiotics and pharmacotherapy directed to the motility, sensation and intraluminal milieu of patients with IBS. Despite recent advances, there is a need for developing new treatments to relieve pain in IBS without deleterious central or other adverse effects.

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

Cited by 36 publications

References 32 publications

Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management

Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management

American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome

Management Options for Irritable Bowel Syndrome

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