[Celecoxib in the symptomatic treatment of active osteo- or rheumatoid arthritis. Results of a post-marketing surveillance].
OBJECTIVE
The introduction of cyclooxygenase (COX)-2 selective drugs now offers physicians the possibility of a adequate analgesic and anti-inflammatory therapy. Drug induced side effects typically associated with NSAIDs are reduced. Using a post-marketing surveillance study (PSS) efficacy and tolerability of the COX-2-selective drug Celecoxib was evaluated. Patients were not restricted in the use of other medication.


METHODS
By means of a prospective, non-intervening PSS patients mainly suffering from musculoskeletal conditions such as osteoarthritis (70.5 %) or rheumatoid arthritis (19.6 %) were examined by about 12,000 physicians. The median observation period was almost 5 weeks.


RESULTS
In total 70236 patients (42 % males, 58 % females, mean age 60.3 years) were assessed. About 87 % of the patients were adequately treated with a daily dose of 200 mg. The tolerability of the treatment was judged to be "good" to "very good" by the physicians in 97 % and by the patients in 96 % of the cases. The overall incidence of undesirable events (UE) with or without potential causal relationship with the study medication was 2.8 % (1,955 patients), severe UEs manifesting in 0.3 % (223) of all patients.


CONCLUSIONS
Overall, the PSS confirms the evident subjective efficacy and tolerability by both the physician's and the patient's overall assessment.
Wigand
R
R
Medizinische Klinik III, Zentrum für Innere Medizin, Klinikum der Johann-Wolfgang-Goethe-Universität, Frankfurt am Main. r.wigand@em.uni-frankfurt.de
Wehling
M
M
Brauer
H-G
HG
Stridde
E
E
Vergin
H
H
May
M
M
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011720:Pyrazoles; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib