Comparison of two dosing regimens of cisapride in the treatment of reflux oesophagitis

Schütze, K; Bigard, Marc‐André; Waes, Leen Van; Hinojosa, Joaquín; Bedogni, G.; Hentschel, E

doi:10.1046/j.1365-2036.1997.00180.x

Cited by 9 publications

(4 citation statements)

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“…In comparative studies, healing rates and symptomatic responses were shown to be similar to cimetidine 70 and ranitidine 71,72 and to be equivalent for cisapride in dosing schedules of 10 mg q.i.d. and 20 mg b.i.d 73 . Not all results were consistent, either between different dosing regimens or in terms of their relative impact on daytime and nocturnal heartburn.…”

Section: Pharmacodynamicsmentioning

confidence: 88%

“…and 20 mg b.i.d. 73 Not all results were consistent, either between different dosing regimens or in terms of their relative impact on daytime and nocturnal heartburn. The fact that the latter was more reproducible in the pivotal US studies led to the rather unusual and restrictive labeling for nocturnal heartburn.…”

Section: Gerdmentioning

confidence: 94%

“…In adults, initial studies were encouraging. Cisapride was found to heal and produce symptomatic improvement among patients with esophagitis [69][70][71][72][73] as well as improve symptoms among those with symptomatic heartburn, 74,75 prevent the provocation of heartburn by a fatty meal in susceptible individuals 76 and reduce relapse rates among those with healed esophagitis. 77 In comparative studies, healing rates and symptomatic responses were shown to be similar to cimetidine 70 and ranitidine 71,72 and to be equivalent for cisapride in dosing schedules of 10 mg q.i.d.…”

Section: Gerdmentioning

confidence: 99%

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Cisapride: What can we learn from the rise and fall of a prokinetic?

Quigley

2011

J of Digest Diseases

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Cisapride, the prototype serotonergic agent, evolved from a body of research that defined the key roles of serotonergic receptors in gastrointestinal motor and sensory function. Impressed by its in vitro properties and encouraged by clinical trial data, cisapride became the drug of choice for the treatment of a wide range of motility disorders and clinicians appeared impressed by its efficacy and comfortable with its side-effect profile. Once serious cardiac events began to be reported in association with cisapride therapy, dark clouds rapidly gathered and soon enveloped the drug, leading to its widespread withdrawal from markets. What lessons can we learn from the story of cisapride? How can its brief but spectacular rise and equally sensational demise inform the development of new drugs which are so sorely needed in the management of motility and functional gastrointestinal disorders? This review explores the background to the development of cisapride, its history in clinical trials and the experience with adverse events and, in so doing, attempts to identify lessons for the future in the therapeutics of enteric neuromodulatory drugs.KEY WORDS: cisapride, gastroesophageal reflux, gastrointestinal motility, gastroparesis, prokinetic, serotonin.Cisapride, introduced worldwide in the 1990s, is a serotonin 5-HT4 agonist with 5-HT3 antagonist activity that stimulates the release of acetylcholine from postsynaptic neurons in the enteric nervous system. It therefore had quite widespread prokinetic effects throughout the gastrointestinal tract: stimulating salivary secretion, increasing esophageal peristaltic amplitude, augmenting lower esophageal sphincter pressure, enhancing gastric emptying and stimulating small bowel and colonic transit. It was, however, devoid of antidopaminergic and direct cholinomimetic effects; the former avoiding the central nervous system and hyperprolactinemia-related side effects of metoclopramide, the latter avoiding the bladder and other side effects of traditional cholinergics, such as bethanechol. Though ultimately employed in a wide range of motility disorders from gastroparesis and pseudo-obstruction to colonic inertia, cisapride was actually approved by the Food and Drug Administration (FDA) in the USA for nocturnal heartburn based on the results of pivotal clinical trials. In primary care, cisapride soon came to be prescribed, either on its own or in combination with a histamine H2 receptor antagonist or a proton pump inhibitor, for a range of upper gastrointestinal symptoms including heartburn and dyspepsia. Its use was especially advocated for children with gastroesophageal reflux disease (GERD) based on the premise that dysmotility was predominant in the etiology of reflux in this patient population. Though trials in gastroparesis did not always show a consistent relationship between symptom improvement and an enhanced gastric emptying rate,

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Section: Pharmacodynamicsmentioning

confidence: 88%

Section: Gerdmentioning

confidence: 94%

Section: Gerdmentioning

confidence: 99%

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Cisapride: What can we learn from the rise and fall of a prokinetic?

Quigley

2011

J of Digest Diseases

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“…In short term treatment of GERD, cisapride (10 mg four times a day or 20 mg twice daily) has proved more effective than placebo and nearly as effective as H2-blockers in relieving symptoms and healing lesions in patients with grade 1 or 2 esophagitis at entry [24,25]. However, neither regimen has been demonstrated to be effective with higher grades of esophagitis [26].…”

Section: Therapymentioning

confidence: 99%

Gastroesophageal Reflux Disease (GERD): Current Agents and Future Perspective

Lanas

Santolaria²

2001

CPD

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The objectives of medical treatment of patients with gastroesophageal reflux disease (GERD) are relief of symptoms and healing of esophagitis, which can be achieved, at least in part, by drugs which suppress acid secretion. In patients with GERD symptoms and/or mild esophagitis, the best and most cost-effective therapeutic strategy is to start with a proton pump inhibitor with subsequent trial of step down of the intensity of therapy (e.g. H2-receptor antagonists). In patients with moderate or severe esophagitis, proton pump inhibitors are the mainstay of treatment and the most effective in preventing symptoms and esophagitis. In patients with mild disease, the recurrence of symptoms is less frequent and many patients may not need continuous maintenance therapy or may require treatment with either low dose proton pump inhibitors, H2-receptor antagonists or cisapride only. H. pylori eradication might be needed in GERD patients on long-term treatment with proton pump inhibitors, but the benefit of this strategy has not yet been adequately demonstrated. Antireflux surgery is a maintenance option for the young patient on long-term medical therapy. Improved medical therapy for GERD might depend on future agents with different therapeutic targets, including GABA inhibitors and nitric oxide modulating drugs in the control of the lower sphincter esophagus and in motility disorders, free radical scavengers in the prevention of mucosal damage and COX-2 specific inhibitors in the prevention of the progression of Barret's esophagus to adenocarcinoma. Finally, the modulation of some growth factors might have a potential role in delayed esophageal ulcer healing, refractory esophagitis and in Barrett's esophagus.

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