International expert group discusses alternatives to COX-2 inhibitors

Mar 7 2005

International group of pain specialists meets to develop recommendations for the treatment of chronic moderate-to-severe pain in the wake of the global withdrawal of rofecoxib (Vioxx) and concerns regarding use of other COX-2 inhibitors.

Given uncertainty over the continuing safety and utility of coxibs, and the lack of clear interim guidance from national and international regulatory agencies, societies and organisations, physicians and their patients face a dilemma. Should they revert to the use of traditional NSAIDS, with their associated serious side-effect profiles (a cause of 16,500 deaths each year in the USA alone), or should they be looking to adopt more flexible approaches? An expert panel of pain specialists met in UK to discuss this issue and to attempt to formulate guidance for physicians.

After discussing the safety data for both NSAIDs and the COX-2 inhibitors, the group endorsed an expanded role for weak opioids, which are more effective in moderate-to-severe pain than NSAIDs, and possess other significant advantages included titratability, reversibility and lack of prostaglandin-associated side effects. The role of combinations of weak opioids and other analgesic agents - in particular, tramadol plus paracetamol - merits particular attention.

The group considered that tramadol and tramadol combinations offered a useful advantage in that they were 'NSAID-sparing'; i.e., they could be used in combination with lower-than-usual doses of NSAIDs. Use of tramadol is recommended by medical societies.

Hurdles to proper utilisation of weak opioids were also addressed by the panel. Side-effects are a common reason given for non-compliance. The panel agreed that a policy of 'go low, go slow' - starting with a low dose and increasing it gradually - should be used to achieve good analgesia without intolerable side-effects.

The meeting concluded with a discussion on the importance of communicating clear guidance to physicians on appropriate prescribing of analgesics in this new climate of uncertainty regarding the continuing use of COX-2 inhibitors.

In light of the recent decision of the NIH to suspend use of the COX-2 inhibitor celecoxib in the Adenoma Prevention with Celecoxib (APC) trial - and the likelihood that elevated cardiovascular risk may indeed be a class effect - physicians and other healthcare providers are now faced with significant treatment and ethical challenges. The need for prompt and clear guidance to physicians is immediate and urgent.

The discussions at the meeting and recommendations of the panel will be written up and submitted for publication in the peer-reviewed literature.