Top-Line Data Show Celecoxib Met Primary Objective In Clinical Trial To
Evaluate The Effects On Blood Pressure In Pediatric Patients With Juvenile
NEW YORK -- April 25, 2013
Pfizer Inc. (NYSE: PFE) today announced top-line results for a Phase 4
clinical trial in which the primary objective was to measure blood pressure
(hypertension) among pediatric patients with Juvenile Idiopathic Arthritis
(JIA; also known as Juvenile Rheumatoid Arthritis or JRA) taking celecoxib
(Celebrex) capsules or naproxen.
The results demonstrated there was virtually no difference in changes to
systolic blood pressure, the primary endpoint, and diastolic blood pressure,
the secondary endpoint, between the celecoxib and naproxen treatment groups.
The safety profile was similar in both groups.
It is well-known that both selective and nonselective nonsteroidal
anti-inflammatory drugs (NSAIDs) may lead to new-onset hypertension or
worsening of underlying hypertension in adults, but little is known about the
impact of NSAID therapy on blood pressure in children.
The purpose of the study was to determine the effect of six weeks of treatment
with Celebrex or naproxen on blood pressure in patients aged two to 17 years
with JRA. Since 2006, Celebrex has been approved by the U.S. Food and Drug
Administration for the relief of the signs and symptoms of JRA in pediatric
patients two years of age and older.
Juvenile Idiopathic Arthritis is a chronic and long-term disease that results
in joint pain and swelling. It is the most common form of arthritis in
children. According to the Centers for Disease Control and Prevention,
estimates of prevalence range from 11,700 – 69,000 children under age 18 in
About the Study
The 6-week study was a randomized, double-blind, multicenter,
active-controlled trial conducted to evaluate the effects of Celecoxib (50 mg
or 100 mg twice daily, determined by patient’s weight) or naproxen (7.5 mg/kg
twice daily, maximum dose of 500 mg twice daily) on blood pressure in
pediatric patients with JIA.
A total of 201 patients were included in the study from 10 different
countries. All patients were diagnosed with JIA, including patients with
disease types where few joints are affected (oligoarticular JIA) and where
many joints are affected (polyarticular JIA). Children with systemic onset
disease – a form characterized by high fevers and rash – were included only if
they still had arthritis, but no longer had systemic features like fever.
The primary endpoint analysis for the change from baseline to week 6 in
systolic blood pressure (SBP) showed a 90% confidence that the true difference
of the change from baseline in SBP between the celecoxib and naproxen groups
was between -0.56 and 2.76, with 0 (no difference) being a possibility.
Similar results were observed for the diastolic blood pressure where the 95%
confidence interval was (-1.69, 1.33).
The adverse event profile was similar for the two treatment groups. The only
Serious Adverse Event occurred in the naproxen group and was not treatment
related. The most common adverse events reported in both treatment groups were
headache, nausea and joint aches. For patients receiving celecoxib, only
headache occurred in more than 5% of patients. For patients receiving
naproxen, nausea and joint aches occurred in more than 5% of patients. These
adverse events are consistent with what is already known about these
The study was conducted as part of a post-marketing commitment to the U.S.
Food and Drug Administration for Celebrex. Results from this study will be
submitted for presentation at upcoming scientific congresses and for
publication in a peer-reviewed medical journal.
CELEBREX is one of most studied drugs in arthritis treatment and is approved
in 134 countries. CELEBREX is approved in the U.S. for the relief of the signs
and symptoms of osteoarthritis, rheumatoid arthritis in adults, juvenile
rheumatoid arthritis in patients two years and older, ankylosing spondylitis,
for the management of acute pain in adults and for the treatment of primary
dysmenorrhea (menstrual cramps).
CELEBREX may cause an increased risk of serious cardiovascular (CV) thrombotic
events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may
have a similar risk. This risk may increase with duration of use. Patients
with CV disease or risk factors for CV disease may be at greater risk.
CELEBREX is contraindicated for the treatment of perioperative pain in
coronary artery bypass graft (CABG) surgery.
NSAIDs, including CELEBREX, cause an increased risk of serious
gastrointestinal adverse events including bleeding, ulceration, and
perforation of the stomach or intestines, which can be fatal. These events can
occur at any time during use and without warning symptoms. Elderly patients
are at greater risk for serious gastrointestinal (GI) events.
NSAIDs, including CELEBREX, should be used with caution in pediatric patients
with systemic onset JRA, due to the risk of disseminated intravascular
For Celebrex prescribing information in the United States visit
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Jennifer Kokell (media), (212) 733-2596
Suzanne Harnett (investors), (212) 733-8009
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