To assess efficacy and safety of pharmacological pain treatment in patients with inflammatory arthritis (IA) and gastrointestinal (GI) or liver comorbidities.
A systematic literature search was performed using Medline, Embase, and Cochrane Controlled Trial Register up to June 2010, as well as American College of Rheumatology and European League Against Rheumatism meeting abstracts (2007-2010). The population investigated was defined as patients with IA and existing or prior reported GI or liver disease treated with nonsteroidal antiinflammatory drugs (NSAID), opioids or opioid-like drugs, paracetamol, antidepressants, neuromodulators, or muscle relaxants. Outcomes of interest were defined as efficacy evaluated by common pain measures and safety evaluated by withdrawals due to adverse events, worsening of comorbidity, and mortality.
Out of 2869 identified studies only a single open-arm trial fulfilled inclusion criteria assessing the safety and efficacy of naproxen in 58 patients with active rheumatoid arthritis and GI comorbidities. The presence of fecal occult blood was reported in 1/58 participants tested between Weeks 1 to 26 and 2/32 participants tested between Weeks 27 to 52. Over the course of the study, 7 participants (12.1%) withdrew due to adverse events; no serious adverse events were reported. Among the 14 studies excluded due to inclusion of a mixed population (osteoarthritis or other rheumatic conditions) or an intervention that was already withdrawn, 5 trials reported a higher risk of developing GI events in patients with prior GI events when treated with NSAID.
Very little evidence regarding safety and efficacy of pain treatment in patients with IA and GI or hepatic comorbidities was found. In patients with a history of GI events, extrapolating from other studies, NSAID should be used cautiously since there is evidence that these patients are at a higher risk of developing adverse events.