Health SystemOVERVIEW

Nonsteroidal anti-inflammatory drugs (NSAIDs) have served as the cornerstone of treatment for patients with many types of inflammatory and noninflammatory conditions. They are recommended for use in a wide variety of disease states, such as rheumatoid arthritis, systemic lupus erythematosus, and osteoarthritis, as well as nonsystemic conditions like acute and chronic muscle pain, joint pain, and ligamentous pain. With more than 100 million prescriptions written each year, NSAIDs represent the most commonly prescribed drug class. Concerns about their safety, however, have led to their limited use in older and high-risk patients, who are often the patients most in need of the drugs.

The use of the COX-l-sparing agents, with their improved gastrointestinal (GI) safety profile, has alleviated some of the concerns imposed by the older agents. Although these medications are now available for patients at a high risk for GI adverse drug events (ADEs), their significantly higher costs have led insurers to examine ways to control access to these agents. Consumer awareness of the COX-l-sparing medications, fueled partially by large direct marketing campaigns and possible misconceptions about their improved efficacy, has led patients, many of whom are at low risk for GI complications, to request prescriptions for these drugs.
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Traditional NSAIDs have been used to help reduce the signs and symptoms of arthritis and to diminish common aches and pains. More than $6 billion is spent each year on prescription NSAIDs; for every prescription written, almost l0 people obtain these medications over the counter.

Although the efficacy of NSAIDs, in terms of symptom relief, has not been questioned, significant morbidity and mortality rates related to these drugs (even in a nonprescribed form) have been reported. In l997, approximately l6,500 residents of the U.S. died as a result of NSAID-induced GI bleeding. This is equivalent to the number of patients who died as a result of human immunodeficiency virus (HIV) infection during the same year. In addition, more than l00,000 people were hospitalized.

More than 35% of the direct costs of treating patients with arthritis are related to NSAID-associated GI bleeding. Because none of these agents is considered to be a “disease-modifying drug,” these figures are even more disturbing. The average cost of hospitalization for a patient with GI bleeding in the federal health system is approximately $20,000, an expense that adds an enormous burden to an already strained health care budget. Theoretically, the careful use of COX-l-sparing agents can lower morbidity and mortality rates and reduce expenses in the long run.

Because NSAIDs effectively relieve the symptoms of the pain and stiffness of arthritis, and even though the need for these agents is clear (despite their significant side effects), searches for safer, equally effective agents have been undertaken. In the late 1980s, the COX-2 theory was advanced. The theory was that the pain and inflammation triggered by prostaglandins and other substances could be safely and effectively blocked by inhibiting the COX-2 enzyme while limiting any inhibition of COX-l activity. The COX-l enzyme is responsible for much of the “housekeeping” functions of the prostaglandins and thromboxanes, including protection of the gastric mucosa and maintenance of platelet function. The last several years have seen the development of more selective agents that preferentially bind to COX-2 without binding to COX-l. This has resulted in the availability of several new therapeutic regimens that appear to have safety advantages in the GI system.

The need for more than one agent in this new selective class is illustrated by the fact that approximately 30% of all patients who eventually find that NSAIDs are efficacious in relieving symptoms do not find success with the first agent. “Class switching” is common. In fact, many patients try two to four drugs before they find one that is effective for them; the reason might be related to differences in chemical structure or body composition, although the true answer to this question remains unknown.
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Approximately 20% of patients who take NSAIDs demonstrate an intolerance of the drug that is evidenced by GI symptoms, such as dyspepsia, reflux, and diarrhea. In addition, the rate of NSAID intolerance has been increasing by l% to 4% annually. These symptoms appear to be independent of the COX-2 mechanism of action, but they still cause patients to either stop or limit their intake of the medication.