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CYTOTEC (misoprostol), prostaglandin
GASTROENTEROLOGY - focus
Opinions on drugs -
Posted on
Mar 14 2016
Reason for request
Renewal of inclusion and re-assessment of the actual benefit
No benefit over proton pump inhibitors for preventing gastroduodenal lesions and complications induced by essential NSAID treatment
- CYTOTEC has Marketing Authorisation in adults in preventive treatment of gastric and duodenal lesions and serious gastroduodenal complications induced by NSAIDs in at-risk patients (particularly age > 65 years, history of peptic ulcer or intolerance to NSAIDs) for whom anti-inflammatory treatment is essential.
- In old studies, misoprostol has demonstrated efficacy versus placebo in the prevention of gastroduodenal lesions and serious gastroduodenal complications induced by NSAIDs, with greater efficacy at the maximum dosage of 800 μg/day than at 400 or 600 μg/day. The 800 μg/day dosage is poorly tolerated (abdominal pain and diarrhoea). Its superiority to proton pump inhibitors (PPIs) has not been demonstrated. This is a second-line treatment.
- Vascular adverse effects, which are mainly coronary and cerebral, are rare and preventable. They have been observed in the case of overdose associated with off-label use in patients with cardiovascular risk factors.
Clinical Benefit
| Low |
- |
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