Abstract

BackgroundPrescription of non-steroidal anti-inflammatory drugs (NSAIDs) should be based on the assessment of both gastrointestinal (GI) and cardiovascular (CV) risk for the individual patient. We aimed to assess the GI/CV risk profile and the pharmacological management of patients with osteoarthritis (OA) in clinical practice.MethodsWe conducted a cross-sectional, multicentre, observational study of consecutive OA patients that visited 1,760 doctors throughout the Spanish National Health System (NHS) in a single day. The presence of GI risk factors, CV histories, hypertension and current pharmacological treatments was recorded.ResultsOf the 60,868 patients, 17,105 had a diagnosis of OA and were evaluable. The majority (93.4%) had more than one GI risk factor and 60.3% were defined to be at high-GI risk. Thirty-two percent had a history of CV events, 57.6% were treated with anti-hypertensive therapy and 22.6% had uncontrolled hypertension. One-fifth of patients were treated with non-NSAID therapies, whereas the remaining patients received NSAIDs. Non-selective NSAIDs (nsNSAID) plus proton pump inhibitor (PPI) or cyclooxigenase-2 (COX-2)-selective NSAIDs alone were more frequently prescribed in patients at increased GI risk. Patients with a positive CV history received nsNSAIDs or COX-2-selective NSAIDs in 41.3% and 31.7% of cases, respectively. When both the GI and CV histories were combined, 51% of the overall population was being prescribed drugs that were either not recommended or contraindicated.ConclusionsOver 90% of patients with OA are at increased GI and/or CV risk. In over half of these patients, the prescription of NSAIDs was not in accordance with current guidelines or recommendations made by regulatory agencies.

Highlights

  • Prescription of non-steroidal anti-inflammatory drugs (NSAIDs) should be based on the assessment of both gastrointestinal (GI) and cardiovascular (CV) risk for the individual patient

  • A COX-2-selective agent plus a proton pump inhibitor (PPI) is recommended in those with the highest GI risk, whereas Non-selective NSAIDs (nsNSAID) and COX-2-selective inhibitors should be avoided in patients with high GI and CV risks [11,12,13,14,15,16]

  • Of 17,105 patients with information regarding OA therapy, 20.4% were prescribed non-NSAID therapies including paracetamol

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Summary

Introduction

Prescription of non-steroidal anti-inflammatory drugs (NSAIDs) should be based on the assessment of both gastrointestinal (GI) and cardiovascular (CV) risk for the individual patient. All NSAIDs are associated with other side effects, including hypertension, water retention, heart failure and renal insufficiency [9]. Based on these findings, the Food and Drug Administration (FDA) [10], the European Medicines Agency (EMA) [11], and different scientific societies [12,13,14] agree that the medical management of patients who require NSAIDs must be based upon the previous assessment of GI and CV risk factors in the individual patient. Guidelines recommend the use of nsNSAIDs plus a gastroprotectant or a COX-2-selective NSAID alone in patients with one or more GI risk factors [15,16]. The EMA contraindicates the use of etoricoxib in the presence of uncontrolled hypertension [11]

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