Rofecoxib (Vioxx) Increases Systolic Blood Pressure in Hypertensives with Type 2 Diabetes
posted 05/23/03

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.

Source: Diabetes In Control Dot Com: 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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