Parecoxib sodium demonstrates gastrointestinal safety comparable to placebo in healthy subjects.
BACKGROUND
The gastrointestinal safety of the novel injectable cyclooxygenase-2 selective inhibitor, parecoxib sodium, was compared with the nonselective nonsteroidal anti-inflammatory drug, ketorolac, and placebo in healthy subjects.


METHODS
In a multicenter, randomized, double-blind, placebo-controlled design, 123 adults with endoscopically-confirmed normal upper gastrointestinal mucosae received parecoxib sodium 40 mg twice daily (7 days); placebo (2 days) followed by ketorolac 30 mg 4 times daily (5 days); or placebo (7 days) (each group n = 41). Posttreatment endoscopy scores were analyzed at 3 levels of severity: ulcers (scores of 7), > or =11 erosions/ulcers (scores of 5-7), and any erosions/ulcers (scores of 3-7).


RESULTS
No subjects treated with parecoxib sodium or placebo developed gastroduodenal ulcers or > or =11 erosions/ulcers. Parecoxib sodium was comparable to placebo with respect to the combined incidence of erosions/ulcers (12% vs. 7%, P = 0.419). In contrast, in the ketorolac group, 11 (28%) subjects developed ulcers, 19 (48%) subjects developed > or =11 gastroduodenal erosions/ulcers, and the rate of combined ulcers/erosions was 85% (P < 0.001 vs. placebo and parecoxib sodium).


CONCLUSIONS
Parecoxib sodium 40 mg twice daily for 7 days has a gastrointestinal safety profile superior to ketorolac 30 mg 4 times daily for 5 days, and comparable to placebo.
Harris
Stuart I
SI
Seaview Research, Miami, Florida, USA.
Stoltz
Randall R
RR
LeComte
Dianne
D
Hubbard
Richard C
RC
D000328:Adult; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000139:chemically induced*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D020910:Ketorolac / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D016896:Treatment Outcome
D016861:Cyclooxygenase Inhibitors; D007555:Isoxazoles; C409945:parecoxib; D020910:Ketorolac