More action needed to prevent stomach problems in NSAID users, despite recent progress

Four out of ten high-risk patients prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) also received appropriate measures to prevent upper-gastrointestinal (UGI) problems, but the remainder did not receive adequate protection, according to a study in the June issue of Alimentary Pharmacology and Therapeutics.

Although the number of patients receiving preventative strategies increased five-fold over the 11-year period studied by researchers in The Netherlands, greater steps need to be taken to protect patients who face a high risk of side effects.

“NSAIDs are among the world’s most frequently prescribed drugs for arthritis and inflammatory conditions, but their use can quadruple the risk of upper gastrointestinal problems” explains lead researcher Dr Vera Valkhoff from the Erasmus University Medical Centre in Rotterdam.

“These can range from mild symptoms like indigestion to more serious conditions like bleeding, perforation or obstructions, which can lead to hospital admissions or, in some cases, death.

“Preventative strategies include using a COX inhibitor NSAID instead of a nonselective NSAID and combining NSAIDs with gastroprotective agents. However international studies suggest that as many as three-quarters of high- risk patients are not receiving adequate protection from the side effects of NSAIDs.”

The research team looked at the records of 50,126 NSAID users aged 50 or over from the Integrated Primary Care Database, using the latest figures available (1996 to 2006).

This showed that just under seven per cent of high-risk patients had been correctly prescribed preventative strategies in 1996, but by 2006 this had risen to over 39 per cent. However, the latest figure was nine per cent higher for patients who had a medical history of UGI problems.

A correct prescription was defined as a patient receiving a preventative strategy if they were defined as high risk because of a history of UGI bleeding/ulceration, being 65 or over or using anticoagulants, aspirin or corticosteroids. This category also included low-risk patients who were not receiving a preventative strategy, as there is no indication that this is necessary in such cases.

Under-prescription was defined as a high-risk patient not receiving a strategy and over prescription as a low-risk patient receiving a strategy.

Key findings of the study include:

• Just over 43 per cent of NSAID users were defined as high-risk because of at least one risk factor. Being aged 65 or over was the most frequent risk factor (40 per cent) followed by use of anticoagulants (nine per cent) and having diabetes mellitus (eight per cent).

• The researchers found that the remaining 57 per cent of the study population had no NSAID-related upper-gastrointestinal (UGI) risk factors and were therefore deemed as low risk.

• Correct prescriptions among high-risk users rose from seven per cent in 1996 to 39 per cent in 2006. But the number of low-risk users who received unnecessary preventative strategies also rose, from three per cent in 1996 to 12 per cent in 2006.

• Preventative strategies for patients with a medical history of UGI events rose from 27 per cent in 1996 to 48 per cent in 2006. When older age was factored in (75 plus) these figures rose from nine per cent in 1996 to 49 per cent in 2006.

• High-risk patients had a higher average age than low-risk patients (73 versus 55.6 years) and were more likely to be female than male (60 per cent versus 54 per cent).

“Our study shows that, although considerable improvements have been made in prescribing preventative strategies for people taking NSAIDs, the majority of high-risk users, including those with a history of UGI events, are not receiving adequate protection from side effects.

“We hope that our study will draw attention to the international need for patient risk to be evaluated and appropriate action taken to ensure that NSAID use does not lead to UGI problems.”

The article can be accessed free at

Notes to editors

Time-trends in gastroprotection with nonsteroidal anti-inflammatory drugs (NSAIDS). Valkhoff et al. Alimentary Pharmacology & Therapeutics. 31, pp1218-1228. (June 2010). DOI: 10.1111/j.1365-2036.2010.04281.x

Alimentary Pharmacology & Therapeutics is an international journal of Gastroenterology and Hepatology. The journal accepts original papers and systematic reviews concerned with clinical Gastroenterology, Hepatology and Endoscopy. AP&T is particularly interested in therapies and diagnostics, including all aspects of translation from bench to bedside: identification of novel therapeutic targets, epidemiology, clinical trials, drug safety and meta-analyses.

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