A 35 y/o male patient presents to your clinic. He was on rofecoxib [Vioxx®], prescribed for some 'aches and pains' after running and/or exercising. This is the only NSAID he's tried for this complaint and has had good results. He has no other significant medical history and no allergies. His labs are WNL and he's on no other medications. He wants to know what formulary COXII alternatives you have for Vioxx®.

What do you choose to prescribe - another formulary COXII NSAID? A non-selective NSAID? An OTC analgesic? Why or why not?

SELECT  here for discussion

I can only hope you choose NOT to give him another COXII NSAID. In this case, with no risk factors or prior history, I'd strongly recommend an OTC analgesic (Tylenol, aspirin, etc) or a non-selective NSAID.

It's important to remember the COXII NSAIDs are no more effective than standard non-selective NSAIDs. They may be safer in selected populations (i.e. those at risk for significant GI events such as ulcers, significant GI bleeding, perforation). COXII NSAIDs have an equivalent risk of nephrotoxicity as non-selective NSAIDs.

At WHMC, we use the following criteria as guides for selecting those patients most likely to benefit from a COXII NSAID:

1)    Over 65 years of age
2)    History of a clinically significant GI event such as ulcer, significant GI bleeding, perforation
3)    Concurrent steroids (steroids decrease turnover of gastric mucosa, lowering defensive factors in the stomach)
4)    Concurrent anticoagulation (COX-2 agents may interact with warfarin)
5)    Post-op use (limited to 7 days post-op or less) - non-selective NSAIDs may inhibit platelet aggregation and prolong bleeding/oozing. Also, long-term use may inhibit bone healing and repair of tendon rupture.

Criteria for use in other institutions or healthcare plans may differ slightly but these are pretty standard. I didn't include familial adenomatous polyposis (FAP) as a criterion for celecoxib [Celebrex®] but this would also be included as an appropriate use.

Important note - Both celecoxib [Celebrex®] and valdecoxib [Bextra®] are CONTRAindicated in patients with sulfonamide allergy and patients with a history of allergic type reactions, urticaria, or asthma/bronchospasm secondary to aspirin or other NSAIDs.

The withdrawal of Vioxx® should prompt providers to re-assess the need of patients for a COXII NSAID. The patient described above probably shouldn't have been prescribed a COXII in the first place. He exhibits NO risk factors for GI events and is unlikely to benefit from the potential safety benefits of the COXII NSAIDs. Had this patient been 70 years old on concurrent steroids for COPD, then the answer would have been different. The question everyone should ask in this situation (and all prescribing decisions between two or more agents) is, "Is the incremental benefit worth the incremental cost?" Would this patient benefit enough to warrant spending significantly more per dose for the COXII agent? I think most folks would agree this 35 y/o patient would not. I'd suggest the 70 y/o patient described above would warrant the additional expense of the COXII agent.

Some other agents that may be considered include:

-    non acetylated salicylates - ex. Salsalate

-    meloxicam [Mobic®] - a somewhat selective COXII NSAID, loses selectivity at higher doses, doers not have the COXII label from the FDA. FYI - Mobic® is a Basic Core Formulary (BCF) agent.

-    Etodolac [Lodine®], nabumetone [Relafen®] - also somewhat selective COXII NSAID, both are available generically and hence, somewhat less expensive

-    Sulindac [Clinoril®] - may (stress may!) be may be an attractive alternative in patients with impaired renal function due to its predominantly hepatic metabolic pathway.

Some situations to avoid when prescribing COXII agents:

- Concurrent aspirin therapy, as little as 50mg per day (probably removes any COX-2 GI safety benefit). FYI - A baby aspirin, often recommended for secondary prevention of heart attacks, contains 81mg.

- Concurrent Proton Pump Inhibitor (PPI) therapy (may not benefit from COX-2 GI safety benefit). Some authors suggest it's more cost-effective to treat patients with a non-selective NSAID and a PPI versus a COXII NSAID alone.

This Pearl is meant for academic and educational purposes only. This Pearl is meant to raise important points regarding the safe and cost-effective pharmacotherapy of patients. It is not meant to be the definitive reference for the treatment or prophylaxis of various diseases. Although every effort is taken to ensure this Pearl is correct and factual, errors may occur. The US Air Force, the 59th Medical Wing (MDW), and 59th MDW Pharmacy assume no liability for incorrect information or harm that may occur from the use of the information included in this Pearl.