Prucalopride-associated acute tubular necrosis

Sivabalasundaram, Vithika; Habal, Flavio; Cherney, David Z.I.

doi:10.12998/wjcc.v2.i8.380

Cited by 9 publications

(5 citation statements)

References 27 publications

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“…Single case reports have described a serious neuro-psychiatric event 65 and acute tubular necrosis 66 in patients prescribed prucalopride; a causal relationship has not been established in either case.…”

Section: Safety and Tolerability Of Prucalopridementioning

confidence: 99%

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An update on prucalopride in the treatment of chronic constipation

Aras

Quigley

2017

Therap Adv Gastroenterol

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Chronic constipation (CC) is a highly prevalent and often under-appreciated gastrointestinal disorder associated with significant impairment in quality of life. Symptoms of constipation are typically present for a number of years prior to a patient seeking help. Lifestyle modifications followed by, or coupled with, over-the-counter laxatives represent the initial treatment option; however, relief for many is limited and dissatisfaction rates for these approaches remain high. Over recent years, therefore, considerable effort has been exerted on the development of novel pharmacological approaches. Two major targets have emerged, motility and secretion. Research on the former led to the development of a number of prokinetic agents capable of stimulating colonic motility and, thus, accelerating colonic transit. Of these, earlier prototypes such as cisapride and tegaserod, though effective, were ultimately withdrawn due to cardiovascular adverse events due in part to receptor nonselectivity. Highly selective serotonergic receptor agonists have since emerged which appear to be equally effective in stimulating gut motility but are devoid of cardiac side effects. One such agent is prucalopride, which has now been approved for the management of chronic idiopathic constipation in several countries, but not in the United States. Multiple multicenter, randomized placebo-controlled clinical trials have demonstrated superiority for prucalopride compared to placebo in the short to medium term in relieving the major symptoms of constipation in both men and women across a broad spectrum of ages, ethnicities and geographic locations. To date, prucalopride has enjoyed a favorable safety profile and there have been no signals to suggest arrythmogenicity. Efficacy over longer periods of treatment remains to be confirmed. Evidence for efficacy in other forms of constipation, such as opioidinduced constipation and that related to Parkinson's disease is beginning to emerge; its status in the management of constipation-predominant irritable bowel syndrome or foregut motility disorders, such as gastroparesis, remains to be established.

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Section: Safety and Tolerability Of Prucalopridementioning

confidence: 99%

“…62 Prucalopride does not interfere with the bioavailability of oral contraceptive medications. 64 Single case reports have described a serious neuro-psychiatric event 65 and acute tubular necrosis 66 in patients prescribed prucalopride; a causal relationship has not been established in either case.…”

Section: Safety and Tolerability Of Prucalopridementioning

confidence: 99%

An update on prucalopride in the treatment of chronic constipation

Aras

Quigley

2017

Therap Adv Gastroenterol

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“… 224 Acute tubular necrosis has been reported in patients treated with prucalopride, although the causal relationship remains unclear. 225 Similarly, caution should be taken when administering this drug to patients with progressive hepatic impairment (Child–Pugh class C) and the elderly (> 65 years). Therefore, it is recommended to reduce the dose of prucalopride to 1 mg once a day in patients with severe renal or advanced hepatic impairment and the elderly population.…”

Section: Managementmentioning

confidence: 99%

2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation

Cho

Lee

Shin

et al. 2023

J Neurogastroenterol Motil

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Chronic constipation is one of the most common digestive diseases encountered in clinical practice. Constipation manifests as a variety of symptoms, such as infrequent bowel movements, hard stools, feeling of incomplete evacuation, straining at defecation, a sense of anorectal blockage during defecation, and use of digital maneuvers to assist defecation. During the diagnosis of chronic constipation, the Bristol Stool Form Scale, colonoscopy, and a digital rectal examination are useful for objective symptom evaluation and differential diagnosis of secondary constipation. Physiological tests for functional constipation have complementary roles and are recommended for patients who have failed to respond to treatment with available laxatives and those who are strongly suspected of having a defecatory disorder. As new evidence on the diagnosis and management of functional constipation emerged, the need to revise the previous guideline was suggested. Therefore, these evidence-based guidelines have proposed recommendations developed using a systematic review and meta-analysis of the treatment options available for functional constipation. The benefits and cautions of new pharmacological agents (such as lubiprostone and linaclotide) and conventional laxatives have been described through a meta-analysis. The guidelines consist of 34 recommendations, including 3 concerning the definition and epidemiology of functional constipation, 9 regarding diagnoses, and 22 regarding managements. Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding the management of functional constipation.

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“…Acute tubular necrosis has been reported in a single case treated with prucalopride, 65 although the causal relationship has not been established. Given these findings, the dose of prucalopride should be reduced to 1 mg once daily for patients with CKD (glomerular filtration rate less than 30 mL/min/1.73 m 2 ), as recommended in the FDA prescriber information.…”

Section: Management Of Constipation In Patients With Chronic Kidney D...mentioning

confidence: 99%

Constipation in Patients With Chronic Kidney Disease

Cha,

Park,

Camilleri

2023

J Neurogastroenterol Motil

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Constipation is a frequent symptom in patients with chronic kidney disease (CKD). This review outlines the mechanisms and management of constipation in patients with CKD from a physician’s perspective. Common causes of constipation in patients with CKD include concomitant medications, low dietary fiber intake, water-restricted diet, lack of physical activity, altered gut microbiota, and reduced gastrointestinal motility. Constipation has a negative impact on overall health, and, in particular, the presence of constipation has been associated with worsening kidney function and increased risk of developing advanced stages of CKD. Although lifestyle and dietary modifications may not always be practical for patients with CKD, they are recommended because they are beneficial as they lower mortality in patients with CKD. The use of laxatives containing magnesium salts, bulking agents, and osmotic laxatives may have insufficient efficacy and may be associated with adverse effects. In contrast, lactulose and lubiprostone have been shown to exhibit reno-protective effects. Linaclotide and plecanatide have very limited systemic absorption and appear safe in patients with CKD. Tenapanor reduces paracellular intestinal phosphate absorption in addition to blocking sodium uptake by enterocytes, and provides additional benefit in patients patients with CKD who have hyperphosphatemia and constipation. Prucalopride leads to improvements in bowel function and constipation-related symptoms in cases in which response to conventional laxatives are inadequate. However, the dose of prucalopride should be reduced to 1 mg once daily for patients with CKD. In conclusion, there are important advances on the impact and treatment of constipation in patients with CKD.

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Prucalopride-associated acute tubular necrosis

Cited by 9 publications

References 27 publications

An update on prucalopride in the treatment of chronic constipation

An update on prucalopride in the treatment of chronic constipation

2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation

Constipation in Patients With Chronic Kidney Disease

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