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Meta-analysis confirms rise in blood pressure from treatment with COX-2 inhibitors
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Selective COX-2 inhibitors appear to produce greater increases in both systolic and diastolic blood pressures compared to nonselective nonsteroidal anti-inflammatory drugs and placebos, according to recent a meta-analysis by researchers in Australia.
However, it remains uncertain whether the increases in blood pressure pose a clinically significant risk to patients.
"Although the incremental change in blood pressure is small, the potential widening of pulse pressure and widespread use of these agents may have significant public health implications," the authors said in the study. "Elevated systolic blood pressure is closely associated with increased cardiovascular events including heart failure, myocardial infarction and death."
The Arthritis Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) began a safety review of cyclooxygenase-2 (COX-2) inhibitors on February 16. The Archives of Internal Medicine had scheduled the meta-analysis to be published in the March 14 edition of its journal, but released it before the advisory meeting because of its relevance, according to the journal's Web site
Meta-analysis of 19 trials
Tai-Juan Aw, MBBS, FRACP, Steven Joseph Haas, BPharm, MSHPA, and colleagues at Monash University in Melbourne reviewed published studies evaluating COX-2 inhibitors that included blood pressure data. The researchers identified the studies through a search of MEDLINE and the Cochrane Database of Systematic Reviews. They also reviewed data from the FDA's Web site of currently licensed COX-2 inhibitors.
The authors included only prospective, randomized and controlled trials of parallel design published in English before May 2004. Studies also had to include at least 50 patients and four weeks of treatment.
After exclusion, the meta-analysis included 19 studies involving 45,451 arthritis patients - 29,824 with osteoarthritis and 15,627 with rheumatoid arthritis. The included trials evaluated the COX-2 inhibitors Vioxx (rofecoxib, Merck & Co.), Celebrex (celecoxib, Pfizer Inc.) and Arcoxia (etoricoxib, Merck & Co.). Nine trials compared a COX-2 inhibitor against the nonsteroidal anti-inflammatory drug (NSAID) Aleve (naproxen, Bayer), and 10 trials included a placebo group.
Increased blood pressures
The researchers found weighted mean differences (WMD) in systolic blood pressure increases of 3.85 mm Hg between COX-2 patients vs. placebo, 2.83 mm Hg between COX-2 patients vs. nonselective NSAIDs, and 2.83 mm Hg between rofecoxib vs. celecoxib patients. Regarding diastolic blood pressure, the researchers found a WMD of 1.06 mm Hg between COX-2 patients vs. placebo and 1.34 mm Hg between COX-2 patients vs. nonselective NSAIDs.
COX-2 patients also had a 1.61 relative risk for developing hypertension compared to placebo patients and a 1.25 relative risk compared to NSAID patients.
Rofecoxib produced a 1.59 mm Hg WMD increase in diastolic blood pressure compared to nonselective NSAIDs, while celecoxib produced a 0.15 mm Hg WMD increase compared to NSAIDs and a 0.99 mm Hg increase compared to placebo. Rofecoxib patients also had a 1.5 relative risk for developing a clinically important elevation in systolic blood pressure and a 1.55 relative risk for elevated diastolic blood pressure compared to celecoxib patients, according to the study.
For more information:
- Aw T, Haas SJ, Liew D, et. al. Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch Intern Med. 2005;165:1-7.