Brand Name Drug: Celebrex
Active Ingredient Drug: celecoxib
Indication: Newest indication is for patients with familial adenomatous polyposis; also indicated for osteoarthritis and rheumatoid arthritis
Company Name: Searle and Pfizer Inc
Availability: Approved by FDA for familial adenomatous polyposis on December 23, 1999
Familial adenomatous polyposis (FAP) is a hereditary disease characterized by the development of hundreds and even thousands of potentially precancerous adenomatous polyps in the colon and rectum, which typically first appear in adolescence and early adulthood. Left untreated, virtually all patients with FAP develop colorectal cancer by age 40 or 50. The mainstay of care for these patients has been endoscopic surveillance and surgery when necessary.
Now the first drug ever to be approved for treating FAP is available: Celebrex (celecoxib), manufactured by Searle and Pfizer. Celebrex has been available for patients with osteoarthritis and rheumatoid arthritis, and is now indicated for the treatment of patients with FAP. Celebrex works by inhibiting the COX-2 enzyme. The recommended dose for FAP patients is 400 mg twice daily. Celebrex is not meant to replace the usual endoscopic surveillance and surgeries that FAP patients currently undergo, but rather to supplement this care.
How It Works
Celebrex is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by inhibiting the enzyme cyclooxygenase-2 (COX-2). The polyps in patients with FAP express high levels of COX-2 compared to normal adjacent tissue.
Celebrex (celecoxib): Clinical Study Results
The efficacy of Celebrex in FAP was assessed in a 6-month randomized, double-blind, placebo-controlled clinical trial which included 83 patients with FAP. The number of adenomatous colorectal polyps was compared between patients who received 400 mg of Celebrex twice a day and another group of FAP patients who received a placebo. Celebrex was found to reduce the number of polyps by 28% — significantly greater than the 5% reduction observed in the patients who received a placebo.
Since the trial did not include cancer as an endpoint to be studied, the effect of Celebrex on cancer development has yet to be established. However, further studies will be conducted to assess this potential clinical benefit.
What the Patient Should Know
The most common side effects associated with Celebrex are diarrhea, abdominal pain, and dyspepsia. As with all NSAIDs, Celebrex has the potential to cause gastrointestinal bleeding, particularly in patients with bleeding disorders and those taking anticoagulants such as warfarin. Therefore, patients should be educated about the signs and symptoms of such bleeding and advised to seek medical attention promptly should it occur. Patients should also report any skin rash, unexplained weight gain, or edema to their health-care providers.
Patients with a known allergy to sulfonamides or to aspirin or other NSAIDs, particularly those who may develop aspirin-sensitive asthma, should not take Celebrex (celecoxib). The drug should be used with caution in patients with hepatic or renal impairment, and in those with fluid retention, hypertension, or heart failure (since some patients taking Celebrex have experienced fluid retention and edema). Celebrex may interact with ACE inhibitors, furosemide, fluconazole, and lithium. Patients taking these drugs should inform their physicians.