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Prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal mucosal injury: risk factors for serious complications.
- Source :
-
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver [Dig Liver Dis] 2000 Mar; Vol. 32 (2), pp. 138-51. - Publication Year :
- 2000
-
Abstract
- Background: 1-2% of all patients under non-steroidal anti-inflammatory drug therapy are exposed to serious upper gastrointestinal complications. The policy of prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal mucosal injury by using misoprostol or suppressing acid secretion is still a matter of debate.<br />Aims: To discuss the effectiveness of prophylaxis of a gastrointestinal complication during non-steroidal anti-inflammatory drug treatment, according to the number and relevance of risk factors.<br />Patients: A total of 8.843 patients with rheumatoid arthritis, admitted to the widest prospective multicentre mega-trial, on 6-month complication prevention of non-steroidal anti-inflammatory drug-induced ulcers.<br />Methods: The results are presented in terms of the number of patients to be treated (number needed to treat) in order to prevent one serious upper gastrointestinal complication, and corrected for the number of patients, that receiving the prophylaxis therapy, would lead to one additional withdrawal (number needed to harm).<br />Results: The base-line risk for a complication strongly depended on the number and relevance of risk factors: history of peptic ulcer disease, of gastrointestinal bleeding, of cardiovascular disease, and age. In the general study population, the relative risk reduction of gastrointestinal complications with misoprostol was 40%: thus the number needed to treat to prevent 1 event was 250 in the experimental period (6 months) or 125 when normalized at one-year treatment (1 year number needed to treat]. When considering the prophylaxis gain in intermediate (risk 1-2%) or high risk subjects (patients with a probability of an event over 2%, for the presence of 1 important risk factor or multiple factors), the 1-year number needed to treat rapidly drops from about 100 to about 17. The number needed to harm for one withdrawal was 18. The number needed to treat corrected for withdrawals in order to avoid major complications rises from 125 to 132 in the general population of non-steroidal anti-inflammatory drug users; from 102 to 105 in subjects at intermediate risk, such as patients with history of cardiovascular disease; in the groups at high risk, from 26 to 27 (patients with history of peptic ulcer disease), and from 16 to 17 (patients with history of peptic ulcer disease, cardiovascular disease and aged over 65 years).<br />Conclusions: Patients at intermediate and high risk for complications from non-steroidal anti-inflammatory drug-induced ulcers should be considered for prophylaxis. In this group of patients, misoprostol prevention of severe complications is effective, and its clinical relevance similar to that of other preventive measures in medical practice.
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Arthritis, Rheumatoid drug therapy
Double-Blind Method
Duodenal Ulcer chemically induced
Duodenal Ulcer pathology
Duodenal Ulcer prevention & control
Endoscopy, Gastrointestinal
Female
Gastrointestinal Diseases chemically induced
Gastrointestinal Diseases pathology
Humans
Male
Middle Aged
Prospective Studies
Risk Factors
Stomach Ulcer chemically induced
Stomach Ulcer pathology
Stomach Ulcer prevention & control
Anti-Inflammatory Agents, Non-Steroidal adverse effects
Anti-Ulcer Agents therapeutic use
Gastrointestinal Diseases prevention & control
Intestinal Mucosa drug effects
Misoprostol therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1590-8658
- Volume :
- 32
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
- Publication Type :
- Academic Journal
- Accession number :
- 10975790
- Full Text :
- https://doi.org/10.1016/s1590-8658(00)80402-8