What is the incidence of hypertension associated with Celebrex (Celecoxib)?

From the Guidelines

Celebrex (celecoxib) is known to cause hypertension in a significant number of patients, with a mean blood pressure increase of 5 mm Hg, as reported in a study published in the American Family Physician 1. This risk is particularly concerning for patients with pre-existing hypertension, heart disease, or kidney problems. The mechanism behind this effect involves the reduction of prostaglandins that help dilate blood vessels and promote sodium excretion by the kidneys, leading to sodium and water retention and increased peripheral vascular resistance. According to a scientific statement from the American Heart Association, the use of COX-2 inhibitors like Celebrex should be considered with caution, especially in patients at high risk of cardiovascular events 1. Key points to consider include:

• Monitoring blood pressure when starting Celebrex, especially during the first few weeks of treatment
• Using the lowest effective dose for the shortest duration possible in patients with cardiovascular risk factors
• Considering alternative pain medications if significant blood pressure elevation occurs
• Being aware of the potential for increased cardiovascular risk with COX-2 inhibitors, as highlighted by regulatory authorities and clinical trials. It is essential to weigh the benefits against the risks for individual patients and to consider their specific medical history and risk factors when prescribing Celebrex.

From the FDA Drug Label

The rates of hypertension from the CLASS trial in the celecoxib capsule, ibuprofen and diclofenac-treated patients were 2.4%, 4.2% and 2.5%, respectively. The incidence of hypertension in patients taking celecoxib is 2.4% as reported in the CLASS trial 2.

• This suggests that celecoxxib may cause hypertension in a small percentage of patients.
• It is essential to monitor blood pressure during the initiation of NSAID treatment and throughout the course of therapy, especially in patients with preexisting hypertension or those taking medications that may affect blood pressure, such as ACE inhibitors, thiazide diuretics, or loop diuretics 2.

From the Research

Celebrex and Hypertension

• The relationship between Celebrex (celecoxib) and hypertension has been studied in various research papers 3, 4, 5, 6, 7.
• A population-based cohort study found that patients on celecoxib had a similar rate of postexposure hypertension incidence compared to nonselective NSAID users (HR 1.013; 95% CI 0.862 to 1.190) 3.
• A randomized, double-blind, placebo-controlled trial found that high doses of celecoxib had no significant effect on the antihypertensive effect of the ACE inhibitor lisinopril, with mean changes from baseline in 24-hour systolic and diastolic BP being 2.6/1.5+/-0.9/0.6 mm Hg on celecoxib versus 1.0/0.3+/-1/0.6 mm Hg on placebo (P=0.34 for systolic BP; P=0.45 for diastolic BP) 4.
• Another study found that celecoxib caused a smaller increase in systolic BP compared to rofecoxib in patients with controlled hypertension on a fixed antihypertensive regimen, with 6.9% of patients in the celecoxib group developing increased systolic BP compared to 14.9% in the rofecoxib group (p <0.01) 5.
• A meta-analysis found a significantly higher incidence of serious vascular events in the celecoxib group compared to controls treated with placebo (rate ratio 1.598,95% CI: 1.048 to 2.438; P=0.029), but no significant difference in the incidence of nonfatal stroke and death from cardiovascular causes 6.
• A fixed-dose combination of amlodipine and celecoxib (Consensi) has been approved for the treatment of comorbid hypertension and osteoarthritis, highlighting the potential for celecoxib to be used in patients with hypertension 7.

Key Findings

• Celecoxib may not significantly increase the risk of hypertension compared to nonselective NSAID users 3.
• High doses of celecoxib do not appear to affect the antihypertensive effect of ACE inhibitors 4.
• Celecoxib may cause a smaller increase in systolic BP compared to other COX-2 inhibitors like rofecoxib 5.
• Celecoxib may be associated with an increased risk of serious vascular events, particularly myocardial infarction, compared to placebo 6.
• A fixed-dose combination of amlodipine and celecoxib is available for the treatment of comorbid hypertension and osteoarthritis 7.