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Gastrointestinal events in at-risk patients starting non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatic diseases: the EVIDENCE study of European routine practice
  1. Angel Lanas1,
  2. Maarten Boers2,
  3. Javier Nuevo3
  1. 1Servicio de Aparato Digestivo, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), University Clinic Hospital, University of Zaragoza, Zaragoza, Spain
  2. 2Departments of Epidemiology and Biostatistics and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands
  3. 3Observational Research Centre, Global Medicines Development, AstraZeneca, Madrid, Spain
  1. Correspondence to Dr Angel Lanas, Service of Digestive Diseases, University Hospital Lozano Blesa, C/Domingo Miral s/n, Zaragoza 50009, Spain; angel.lanas{at}


Objectives Data concerning rates of gastrointestinal (GI) events in non-steroidal anti-inflammatory drug (NSAID) users derive mainly from clinical trials. The EVIDENCE study quantified the incidence of symptomatic uncomplicated and/or complicated GI events in at-risk European patients treated with NSAIDs in real-life practice.

Methods This non-interventional study assessed 4144 adults with at least one GI risk factor who recently initiated NSAID therapy for osteoarthritis (85%), rheumatoid arthritis (11%), ankylosing spondylitis (3%) or a combination (1%). Patient characteristics and medical history were collected from medical records. GI events (upper and lower) were recorded at in-clinic visits during 6 months’ follow-up.

Results Mean time on index NSAID at enrolment was 33 days. The incidence (per 100 person-years) was 18.5 per 100 person-years for uncomplicated GI events and 0.7 per 100 person-years for complicated GI events. Upper GI events were far more common (12%) than lower GI events (1%) during study follow-up (median 182 days (range 61–320)). Other reported rates for cardiovascular, anaemia or non-GI events were much less frequent. A minority (28%) of patients had ongoing proton pump inhibitor use at enrolment, with strong variation by practice and country.

Conclusions EVIDENCE is the largest prospective study of the real-life management of European patients treated with NSAIDs for rheumatic diseases and at increased GI risk. It shows that GI events from the upper GI tract are far more common than those from the lower GI tract. It also shows adherence to guidelines for gastroprotection is generally low. identifier NCT01176682.

  • NSAIDs
  • Inflammation
  • Treatment

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