Celebrex Clinical Pharmacology

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Celebrex - Clinical Pharmacology [celecoxib]

One area in the rectum and up to four areas in the colon were identified at baseline for specific follow-up, and polyps were counted at baseline and following six months of treatment. The mean reduction in the number of colorectal polyps was 28% for CELEBREX 400 mg BID, 12% for CELEBREX 100 mg BID and 5% for placebo. The reduction in polyps observed with CELEBREX 400 mg BID was statistically superior to placebo at the six-month timepoint (p=0.003). (See Figure 1.)

Figure 1 Figure 1
Percent Change from Baseline inPercent Change from Baseline in
Number of Colorectal PolypsNumber of Colorectal Polyps
(FAP Patients)(FAP Patients)

-50-50
-45-45
-40-40
-35-35
-30-30
-25-25
-20-20
-15-15
-10-10
-5-5
00
-50-50
-45-45
-40-40
-35-35
-30-30
-25-25
-20-20
-15-15
-10-10
-5-5

Placebo
-4.5%
100 mg BID
-11.9%
400 mg BID*
-28.0%

N=15 N=32 N=30

Percent Change from BaselinePercent Change from Baseline

* p=0.003 versus placebo

Special Studies

Endoscopic Studies:

Scheduled upper GI endoscopic evaluations were performed in over 4,500 arthritis patients who were enrolled in five controlled randomized 12-24 week trials using active comparators, two of which also included placebo controls. There was no consistent relationship between the incidence of gastroduodenal ulcers and the dose of CELEBREX over the range studied.

Table 2 summarizes the incidence of endoscopic ulcers in two 12-week studies that enrolled patients in whom baseline endoscopies revealed no ulcers.

Table 2
Incidence of Gastroduodenal Ulcers from Endoscopic Studies in OA and RA Patients
3 Month Studies

Study 1 (n = 1108) Study 2 (n= 1049)

Placebo 2.3% (5/217) 2.0% (4/200)
Celebrex 50 mg BID 3.4% (8/233) ---
Celebrex 100 mg BID 3.1% (7/227) 4.0% (9/223)
Celebrex 200 mg BID 5.9% (13/221) 2.7% (6/219)
Celebrex 400 mg BID --- 4.1% (8/ 197)
Naproxen 500 mg BID 16.2% (34/210)* 17.6% (37/210)*

*p 0.05 vs all other treatments

Table 3 summarizes data from two 12-week studies that enrolled patients in whom baseline endoscopies revealed no ulcers. Patients underwent interval endoscopies every 4 weeks to give information on ulcer risk over time.

Table 3
Incidence of Gastroduodenal Ulcers from 3-Month Serial Endoscopy Studies in OA and RA Patients
Week 4 Week 8 Week 12 Final
Study 3 (n=523)
Celebrex 4.0% 2.2% 1.5% 7.5%
200 mg BID (10/252)* (5/227)* (3/196)* (20/266)*
----------------------------------------------------------------------------------------
Naproxen 19.0% 14.2% 9.9% 34.6%
500 mg BID (47/247) (26/182) (14/141) (89/257)
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