RESEARCH - Blood pressure destabilization and edema among 8538 users of Celebrex, Vioxx, and NS NSAIDs and nonusers of NSAIDs receiving ordinary clinical care

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J Rheumatol. 2004 Jun;31(6):1143-51.

Blood pressure destabilization and edema among 8538 users of celecoxib,

rofecoxib, and nonselective nonsteroidal antiinflammatory drugs (NSAID)

and nonusers of NSAID receiving ordinary clinical care.

Wolfe F, Zhao S, Pettitt D.

National Data Bank for Rheumatic Diseases, Arthritis Research Center

Foundation, Wichita, KS 67214, USA. fwolfe@...

OBJECTIVE: To investigate the relationship between nonselective

nonsteroidal antiinflammatory drugs (NS NSAID), rofecoxib, celecoxib,

and risk of edema and blood pressure destabilization in patients with

rheumatoid arthritis (RA) and osteoarthritis (OA) receiving ordinary

clinic care. METHODS: Patients participating in a longterm outcome study

reported drug use, as well as the presence of edema and blood pressure

increases occurring during the previous 6 months. To measure pure drug

effect, analyses were restricted to 8538 patients who exclusively used a

NS NSAID, rofecoxib, or celecoxib, and compared to nonusers of NS NSAID,

rofecoxib, or celecoxib. We evaluated blood pressure destabilization

using patient-reported increases in blood pressure and/or difficulty in

controlling blood pressure. RESULTS: Compared with nonusers, after

adjusting for age, sex, presence of RA, and history of heart disease and

hypertension, patients using rofecoxib, but not celecoxib or NS NSAID,

had an increased rate of edema (23.3% vs 18.0%), while the rates for

celecoxib and NS NSAID were 17.5% and 18.2%, respectively. The adjusted

risk of edema was significantly increased for rofecoxib compared to

celecoxib (OR 1.33, 95% CI 1.08-1.64). For blood pressure increases,

among patients who did not report having hypertension, no significant

increase was noted for NS NSAID and celecoxib compared with nonusers.

However a significant increased risk of blood pressure increase was seen

for rofecoxib (OR 2.08, 95% CI 1.41-3.06). Among patients who reported

having hypertension, patients taking rofecoxib had a significant

increase

ed risk of blood pressure increase compared to nonusers (OR 1.55, 95% CI

1.23-1.96), while the risks of blood pressure increase for users of

celecoxib and NS NSAID were not significantly different than among

nonusers. After controlling for age, sex, RA, and new starts on NSAID,

the risk of blood pressure increase was significantly higher for users

of rofecoxib than celecoxib (OR 1.21, 95% CI 1.03-1.61) among patients

with hypertension, and numerically higher for nonhypertensives (OR 1.42,

95% CI 0.96-2.22). The increased risk for hypertension and edema of

rofecoxib compared to celecoxib users was further confirmed by analysis

of specific reported side effects during 2 separate 6-month periods

(July 1 to December 31, 1999, and January 1 to June 30, 2000). During

these 2 periods, rofecoxib-treated patients were 2.16 to 3.82 times more

likely to report edema or blood pressure increase side effects compared

to celecoxib-treated patients.

CONCLUSION: Rofecoxib, but not celecoxib and NS NSAID, is associated

with an increased risk of edema and blood pressure increase compared to

nonusers of NSAID.

PMID: 15170928

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

5170928 & dopt=Abstract

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