Prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal mucosal injury: risk factors for serious complications

Background. 1-2% of all patients under non-steroidal anti-inflammatory drug therapy are exposed to serious upper gastrointestinal complications. The p olicy of prevention of non-steroidal anti-inflammatory drug-induced gastroi ntestinal mucosal injury by using misoprostol or suppressing acid secretion is still a matter of debate. Aims. To discuss the effectiveness of prophylaxis of a gastrointestinal com plication during non-steroidal anti-inflammatory drug treatment, according to the number and relevance of risk factors. Patients. A total of 8.843 patients with rheumatoid arthritis, admitted to the widest prospective multicentre mega-trial, on 6-month complication prev ention of nonsteroidal anti-inflammatory drug-induced ulcers. 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 gas trointestinal complication, and corrected for the number of patients, that receiving the prophylaxis therapy, would lead to one additional withdrawal (number needed to harm). Results. The base-line risk for a complication strongly depended on the num ber and relevance of risk factors: history of peptic ulcer disease, of gast rointestinal bleeding, of cardiovascular disease, and age. In the general s tudy population, the relative risk reduction of gastrointestinal complicati ons 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 (patien ts with a probability of an event over 2%, for the presence of ? 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 withdr awal was 18. The number needed to treat corrected for withdrawals in order to avoid major complications rises from 125 to 132 in the general populatio n of non-steroidal anti-inflammatory drug users; from 102 to 105 in subject s at intermediate risk, such as patients with history of cardiovascular dis ease; in the groups at high risk, from 26 to 27 (patients with history of p eptic ulcer disease), and from 16 to 1 7 (patients with history of peptic u lcer disease, cardiovascular disease and aged over 65 years). Conclusions. Patients at intermediate and high risk for complications from non-steroidal anti-inflammatory drug-induced ulcers should be considered fo r prophylaxis. In this group of patients, misoprostol prevention of severe complications is effective, and its clinical relevance similar to that of o ther preventive measures in medical practice.