Vioxx increases risk of edema, loss of hypertension control, but not celecoxib or NSAIDs

[Guest guest]

Rofecoxib increases risk of edema, loss of hypertension control, but not

celecoxib or NSAIDs

Rheumawire

Jun 25, 2004 Janis

Wichita, KS - Hypertension and arthritis occur concurrently in many

patients, and several arthritis drugs can interfere with blood-pressure

control or even cause de novo hypertension.

Dr Frederick Wolfe (National Data Bank for Rheumatic Diseases, Wichita,

KS) reports that rofecoxib (Vioxx®, Merck) was associated with an

increased risk of edema and with increased blood pressure, but not

celecoxib (Celebrex®, Pfizer) or nonselective nonsteroidal

anti-inflammatory drugs (NSAIDs), in an analysis of patients from the

National Data Bank for Rheumatic Diseases [1].

" Be careful! " Wolfe tells rheumawire. " Monitor blood pressure. " In an

accompanying editorial, Dr Janet E Pope (University of Western Ontario,

London) notes that a recent study of rheumatoid arthritis (RA) patients

found that 19% had no blood-pressure reading recorded in their charts

and that 37% had hypertension that was not being effectively treated

[2].

Wolfe's analysis, which is in the June 2004 issue of the Journal of

Rheumatology, found no increased risk of hypertension or edema with the

use of celecoxib or NSAIDs but increased rates associated with rofecoxib

of 23.3% for edema (vs 18.0% in nonusers) and 23.2% for blood-pressure

increase (vs 15.2% for nonusers). These effects were greater in

hypertensive patients (including those with controlled hypertension)

than in normotensives.

This Pfizer-supported study was based on data from patients

participating in a long-term outcome study. The analysis included 8538

patients (77.9% RA, 22.1% osteoarthritis) who had exclusively used an

NSAID (n=2863), rofecoxib (n=991), or celecoxib (n=1525), compared with

2863 nonusers of these agents. The investigators evaluated

blood-pressure destabilization using patient-reported increases in blood

pressure and/or difficulty in controlling blood pressure. (Blood

pressures were not actually measured. Data were from questionnaires that

asked patients, " Did you become aware of any increase in your blood

pressure? " and " Did you have any problem controlling your high blood

pressure? " Validation was conducted by examining the hypertensive

medications patients were taking and comparing the use of such

medications with the report of hypertension.)

" The purpose of the study was to investigate the properties of the

COX-2-specific inhibitors celecoxib and rofecoxib, compared with

patients who received nonselective NSAIDs and nonusers of nonselective

NSAIDs, " Wolfe writes. The analysis showed that rofecoxib users were

1.37 times more likely to report edema than nonusers (p<0.001). There

was no significant difference in edema rates between the nonusers and

the NSAID or celecoxib users. The odds ratio differed significantly

between the rofecoxib and celecoxib groups, indicating a greater risk of

edema with rofecoxib.

Among either hypertensive or normotensive patients, rofecoxib was

significantly associated with a reported blood-pressure increase, with

an odds ratio of 1.55 for rofecoxib vs nonusers among hypertensive

patients and 2.08 for rofecoxib vs nonusers in the normotensive

population. However, the increases in blood pressures occurred mainly in

patients with a history of hypertension. Wolfe tells rheumawire that the

increase in blood pressure was small and that no increase in congestive

heart failure was observed.

" As all patients receiving NSAID therapy may be at risk for edema and

hypertension, it is important that they be evaluated for this

possibility during the time of NSAID therapy, " Wolfe concludes.

In an editorial that accompanies the article, Dr Janet E Pope agrees.

" We must be aware that hypertension is common and underdiagnosed and

undertreated in our patients and that in hypertensive patients NSAIDs

may aggravate their hypertension control. One can decide that some drugs

are more or less apt to destabilize blood pressure, but good clinical

practice would warrant a commonsense approach: being aware, monitoring

blood pressure, particularly early in chronic NSAID users, and

responding to significant elevations of blood pressure, " Pope says.

Sources

Wolfe F, Zhao S, Reynolds M, et al Blood pressure

destabilization and edema among 8538 users of celecoxib, rofecoxib, and

nonselective nonsteroidal anti-inflammatory drugs (NSAID) and nonusers

of NSAID receiving ordinary clinical care J Rheumatol 2004;

31:1143-1151

Pope JE Hypertension, nonsteroidal anti-inflammatory

drugs, and lessons learned J Rheumatol 2004; 31:1035-1037

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org