Celecoxib (Celebrex) without aspirin beats NSAIDS

A lower number of ulcer symptoms and complications has been monitored in patients being treated with celebrex compared to traditional NSAID therapy used for osteoarthritis or rheumatoid arthritis

However the difference practically disapears when aspirin is added to the traditional therapy, states a North American study.

The values are the following:

Gastroitnestinal ulcers occurred in 59% more case on patients treated with traditional therapy when compared to celecoxib treatment in dosage of 400mg twice a day. On the other hand in patients which were also give aspirin in dosage of 325mg or less aspirin a day the frequency of ulcer apparition was only by 2% higher then in those treated with celecoxib.

The difference in the effects of celebrex and traditional treatment are due to the fact the celebrex specifically inhibits cyclooxygenase type 2, without affecting the other isoforms and thus having no effect on the GI mucose. On the other hand Ibuprofen and diclofenac inhibit both isoforms of cyclooxygenase thus increasing the possibility of ulcer occurrence.

Ulcer complications developed 35 percent less frequently in celecoxib users who did not use aspirin than in patients who took an NSAID but not aspirin.

The incidence of adverse cardiovascular events, such as myocardial infarction, was similar in the celecoxib and NSAID groups, regardless of aspirin use.

These findings came from the Celecoxib Long-term Arthritis Safety Study (CLASS), which compared the safety of standard therapeutic dosages of ibuprofen or diclofenac with an intentionally high dosage of celebrex. CLASS data were obtained from 7,968 patients at 326 medical centers in the United States and Canada.

The authors noted that many of the osteoarthritis and rheumatoid arthritis patients typically treated in clinical practice would have been excluded from the study, which did not enroll patients with active GI disease. Other patients excluded from the study were those who had had cancer within the past five years and patients with kidney, liver, or clotting disorders. Patients who used glucocorticoids or disease-modifying antirheumatic drugs were eligible for the study.

During the trial, which ran from September 1998 to this past March, 3,987 adults age 18 and older were randomly assigned to the celecoxib group. A group of 3,981 adults with similar characteristics was assigned to NSAID treatment, with 1,985 patients randomly chosen to receive ibuprofen 800 mg three times a day and 1,996 to receive diclofenac 75 mg twice daily.

According to the package insert for celecoxib, the recommended daily dose of celebrex is 200 mg for osteoarthritis treatment and 200-400 mg for treatment of rheumatoid arthritis. CLASS enrollees in the celecoxib group received two to four times the recommended dosage. The study authors indicated that they selected this amount in order to assess the safety of celecoxib at a high dosage.

When given at a dosage higher than the recommended amount, celecoxib does not produce a better therapeutic response than when given at a lower dosage, the authors noted.

Patients who took less than 70 percent of their assigned medication were considered noncompliant and withdrawn from the study. Other patients withdrew from the study because their drug did not adequately control arthritis symptoms or adverse events occurred during treatment.

In all, 2,376 patients in the celecoxib group and 2,197 in the NSAID group completed at least six months of treatment.