NSAIDs Use in the Rheumatic Diseases (Opinions of a Multi-disciplinary Expert Panel 2010)

FIRST, DO NO HARM. This is one of the tenets in the practice of Medicine. It would really be tragic if a doctor’s intervention (i.e. NSAIDs) for a non-fatal disease (e.q. arthritis) would result in hospitalization (e.q. for GI bleeding) or, even worse, death. However, NSAID use is an important mainstay in the treatment of many rheumatic conditions.

Currently available NSAIDs demonstrate similar effectiveness. However, their safety profiles have pronounced differences. The use of non-selective NSAIDs (nsNSAIDs – Ibuprofen, Diclofenac and Naproxen) have been associated with increased risk for serious GI events while the use of COX-2 Selective Inhibitors (CSI – Celecoxib and Etoricoxib) carries some concern over cardiovascular safety. In fact, the US FDA had recommended that all NSAIDs and CSIs carry black box warnings regarding the potential increased cardiovascular risk. So when we use NSAIDs in the rheumatic diseases instead of Primum Non Nocere, what we actually practice is the LEAST HARM PRINCIPLE.

A European Panel of 18 experts from diverse fields – Rheumatology, Cardiology, Gastroenterology, Orthopedics, Clinical Pharmacology, Family Medicine and Geriatrics – were asked to individually assess the appropriateness of therapeutic options for a variety of mutually exclusive patient profiles. Using the RAND/ UCLA definition, a treatment was considered appropriate if the expected benefits exceeded the potential negative consequences by a sufficient margin. Spearman’s correlation coefficient for ordinal variables was then used to investigate agreement between the individual ratings. All experts were provided an electronic document that was an extensive data overview of evidence from 1998 to 2008.

The clinical variables used in the construction of patient profiles were:

  • Age (<65 or >65 years)

  • History of upper GI events – none, uncomplicated, complicated

    • Uncomplicated – previous uncomplicated esophageal, gastric or duodenal event (e.q. significant symptoms, ulcers discovered by a clinically indicated work-up)

    • Complicated – previous complicated esophageal, gastric or duodenal event (perforation, obstruction or bleeding)

  • Cardiovascular risk based on 10 year risk of fatal CV events based on the Heart Score of the European Society of Cardiology

  • Use of low dose aspirin in high CV risk patients

  • Use of anti-platelet and anticoagulants

  • Use of systemic steroids

  • NSAID treatment pattern – intermittent vs continuous

Global pattern of appropriate treatments in relation to

Appropriate therapy for different patient profiles were as follows:

  • Patient without unfavorable conditions – all NSAID (including CSI) without proton pump inhibitor (PPI) were deemed appropriate

  • Patient with low cardiovascular risk but with history of no or uncomplicated GI events – CSI alone or non-selective NSAID plus PPI

  • Patient with low cardiovascular risk but with history of complicated GI events – CSI with PPI or Diclofenac/ Ibuprofen with PPI

  • Patient with high cardiovascular risk but with history of no or uncomplicated GI events – Naproxen with PPI

  • Patient with high cardiovascular risk (therefore receiving aspirin) and history of complicated GI events – none of the options were deemed appropriate

The results of the panel recommendations were embedded in a program available at http://www.e-hims.com/Sensar.

As a side note, funding for the study was supported by an unrestricted educational grant from Pfizer. The sponsor was not involved in the panel process and the preparation of the manuscript.

Reference

Burmester G, Lanas A, Biasucci L, et al. The appropriate use of NSAIDs in rheumatic disease: opinions of a multidisciplinary European expert panel. Ann Rheum Dis 2010;

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