Rofecoxib
(Vioxx) Increases Systolic Blood Pressure in Hypertensives
with Type 2 Diabetes
Rofecoxib significantly increased systolic blood
pressure, while celecoxib (Celebrex) and naproxen
did not.
Researchers
reported at the 18th Annual Scientific Meeting
of the American Society of Hypertension.
Dr.
James Sowers, with the State University of New
York, in Stony Brook, presented the results of
a study in which 404 patients were randomised
to celecoxib 200 mg QD, rofecoxib 25 mg QD, or
naproxen 500 mg BID for 12 weeks.
Prior
studies have shown that some nonsteroidal anti-inflammatory
drugs (NSAIDS) and the cyclooxigenase 2 (COX-2)
inhibitor rofecoxib may destabilise blood pressure
control in osteoarthritis patients with stable
treated hypertension, especially while on ACE-inhibitors
or beta blocker therapy. However, these trials
had significant limitations; notably, they lacked
a traditional NSAID comparator to rofecoxib.
Dr.
Sowers and colleagues compared the effects of
the traditional NSAID naproxen against the COX-2
inhibitors rofecoxib and celecoxib in patients
receiving angiotensin-converting enzyme (ACE)
inhibitor therapy.
Patients
were 40 years of age or older and had chronic
osteoarthritis of the hip or knee diagnosed by
American College of Rheumatology criteria. They
also had a clinical diagnosis of type 2 diabetes
and were on stable hypertensive ACE-inhibitor
treatment or angiotensin receptor blockers for
at least 6 weeks.
The
study's primary outcome measure was the mean change
in average 24-hour systolic blood pressure from
baseline to Week 6. disease-specific, self-administered,
health status measure. Patients were asked to
fill out the 24-question Western Ontario and McMaster
Universities Arthritis Index (WOMAC) to identify
clinically-important pain, stiffness and physical
function related to their hip or knee osteoarthritis
at baseline and Week 6 and 12 follow-up.
Rofecoxib
resulted in an increase in mean 24-hour systolic
blood pressure of 4.2 mm Hg at Week 6 versus celecoxib
and naproxen. This increase was sustained through
12 weeks of treatment. Celecoxib was associated
with a 0.1 mm Hg decrease and naproxen with a
0.8 mm Hg decrease (P=0.005).
Rofecoxib
was also associated with an increase in pulse
pressure at 6 and 12 weeks (P=0.4, P=0.39).
Changes
in total WOMAC scores were similar for all three
treatments at Weeks 6 and 12.
Dr.
Sowers said that the larger systolic blood pressure
increases with rofecoxib may reflect "relatively
greater" effects on renal or vascular COX
-2 inhibition.
Overall,
celecoxib 200 mg QD has a more favourable side
effect profile than rofecoxib 25 mg QD in high-risk
patients with hypertension and type 2 diabetes
using ACE-inhibitors, he added. The study was
sponsored by Pharmacia.
[Study
title: Rofecoxib, But Not Celecoxib or Naproxen,
Increases Mean 24-Hour Systolic Blood Pressure:
Results of a Randomized Double Blind controlled
Trial in Treated Hypertensive Patients with Osteoarthritis
(OA) and Type 2 Diabetes Mellitus. Abstract 25]
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