COX-2 inhibitors and arterial hypertension: an analysis of spontaneous case reports in the Pharmacovigilance database.
OBJECTIVE
To evaluate the main characteristics of case reports of arterial hypertension (AH) related to COX-2 inhibitor (coxib) use in real-life practice.


METHODS
This study was based on spontaneous reports of adverse drug reactions (ADRs) submitted to the French Pharmacovigilance system. Associations between AH and the different groups of those using non-steroidal anti-inflammatory drugs (NSAIDs: rofecoxib, celecoxib and non-selective NSAIDs) were compared using calculation of the odds ratio (OR) with 95% confidence intervals (CIs).


RESULTS
In France, between 1 April 2000 and 30 November 2003, 34 AH cases related to coxibs were reported. Case reports include predominantly patients older than 65 years, with a previous story of essential AH. Most AH (60%) occurred during the first 15 days of treatment. The AH was reported significantly more frequently for rofecoxib than celecoxib. The OR for development of AH with rofecoxib versus celecoxib was 3.3 (1.6-6.9). The AH was also reported more frequently with coxib (2.8%) than with non-selective NSAID (0.5%) use, OR = 5.9 (3.8-9.0).


CONCLUSIONS
This study shows that coxibs are associated with a risk of AH in real-life practice. More spontaneous reports of AH to the French Pharmacovigilance system concern rofecoxib than celecoxib (and coxibs than non-selective NSAIDs). This ADR is of special epidemiological importance due to both the risks of AH and the large use of coxibs.
Durrieu
G
G
Faculté de Médecine de Toulouse, Unité de Pharmacoépidémiologie UA 3696, IFR INSERM 126, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmaco épidémiologie et d'Informations sur le Médicament, Toulouse, France. durrieu@cict.fr
Olivier
P
P
Montastruc
J L
JL
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects*; D016208:Databases, Factual; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology; D007783:Lactones / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011720:Pyrazoles / Q000009:adverse effects*; D013449:Sulfonamides / Q000009:adverse effects*; D013450:Sulfones / Q000009:adverse effects*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D011720:Pyrazoles; D013449:Sulfonamides; D013450:Sulfones; C116926:rofecoxib; D000068579:Celecoxib