Background Management of patients with rheumatic diseases and at risk for developing NSAID-associated gastrointestinal (GI) events (symptoms and/or complications) varies not only across Europe but also within each country.
Objectives The pan-European EVIDENCE study was designed to provide a real-life perspective of the current management of rheumatic diseases with NSAIDs in Europe, in terms of pain relief, side effects and preventive therapies among patients with GI risk factors.
Methods EVIDENCE was a multicentre, prospective, observational (non-interventional) study of adult patients receiving NSAID therapy for rheumatoid arthritis (RA), osteoarthritis (OA) or ankylosing spondylitis (AS) (NCT01176682; study code: NIS-GEU-DUM-2010/1) . Enrolled patients had at least one of the following GI risk factors (age >60 years, documented history of peptic ulcers or receiving concomitant treatment with any dose of acetylsalicylic acid [ASA], anticoagulants, selective serotonin reuptake inhibitors [SSRIs] or oral steroids) and had initiated NSAID therapy in the preceding 2-12 weeks. The primary endpoint was the incidence of pre-specified GI events (symptomatic and/or complicated) during 6 months’ follow-up. Complicated events were adjudicated and validated. Statistical analysis was descriptive.
Results A total of 4149 patients (65% female, mean age 66 years) were enrolled (RA, 11%; OA, 85%; AS, 3%). 34% of patients had a documented history of GI events (most commonly gastritis, esophagitis, dyspepsia and heartburn). Use of ASA, anticoagulants, SSRIs and oral steroids was noted for 23%, 5%, 12% and 10% of patients, respectively. Diclofenac and ibuprofen were the most common index NSAIDs (33% and 22%, respectively).
Among evaluable patients (n=4037), 9.9% (n=410) reported at least 1 GI event during 6 months’ follow-up, equating to an incidence rate of 16.9 events/100 patient-years. Incidence rates, by country, ranged from 8.3 (Switzerland) to 46.9 events/100 patient-years (Netherlands). Events were typically associated with the upper GI tract, most commonly dyspepsia, gastritis and heartburn (27%, 18% and 14% of events, respectively). Complicated GI events were uncommon (<1% of patients; incidence rate of 1.2 events/100 patient-years), as were cardiac events (<1%) and other complications (3.7%, including anaemia, pneumonia and osteoporosis). Overall, 62% of patients never received proton pump inhibitor therapy during follow-up.
Conclusions The EVIDENCE study provides a comprehensive real-life view of the current management of patients with rheumatic diseases treated with NSAIDs, including low use of prevention therapies and the ongoing risk for developing GI events.
Supported by AstraZeneca, Madrid, Spain
Lanas et al. Gut 2011;60 Suppl. 3:A153.
Disclosure of Interest M. Boers Consultant for: Mundi, Novartis, Speakers Bureau: Merck, J. Nuevo Employee of: AstraZeneca, A. Lanas Consultant for: AstraZeneca, Pfizer, Speakers Bureau: AstraZeneca, Pfizer