NSAIDs effect on blood pressure safe over 6 weeks in pediatric patients with JIA

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Synopsis
201 patients with juvenile idiopathic arthritis (JIA) were randomized to a naproxen group or a celecoxib group to compare the changes in systolic blood pressure (SBP) over 6 weeks, for the purpose of analyzing the safety and efficacy of NSAID treatment in pediatric patients. Results showed no Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Pfizer Inc.
Conflicts: Company Employee
CONTENT IS LOCKED
Why was this study needed now?
Hypertension in children is an increasing cause of morbidity that is expected to rise in the future due to its association with obesity. There have been studies that indicate non-selective non-steroidal anti-inflammatory drugs (NSAIDs) can cause hypertension or exacerbate hypertension in the adult population. However, other studies have contradicted this evidence in the adult population. There is a paucity of evidence when looking at the effect on blood pressure with chronic use of NSAIDS in the paediatric population.
What was the principal research question?
What effect does NSAID treatment for 6 weeks have on BP in children with juvenile idiopathic arthritis?
Population: 201 patients, aged 2-17 years with JIA (oligoarticular, polyarticular arthritis, and children with systemic onset disease, but inactive systemic features), were included. (182 completed follow-up)
Intervention: Celecoxib group: celecoxib capsules, 50 mg twice a day for patients weighing 10-25 kg, or 100 mg twice a day for patients weighing greater than 25 kg, for 6 weeks (n= 101, 88 completed follow-up, Mean age: 11.1).
Comparison: Naproxen group: naproxen suspension, 7.5 mg/kg twice a day, with a max dose of 500 mg twice a day, for 6 weeks (n=100, 94 completed follow-up, Mean age: 11.2).
Outcomes: In terms of safety, the primary endpoint was the change from baseline to week 6/final visit for systolic blood pressure (SBP) and secondary endpoints included the change from baseline to weeks 2 and 4 for SBP and the change from baseline to weeks 2, 4, and 6 for diastolic blood pressure (DBP). BP was measured by auscultation in triplicate. Other safety measures included overall safety and tolerability evaluated by clinical lab measurements, physical exam, vital signs, and monitoring of adverse events. Efficacy endpoints included the change from baseline to week 6 in parent's assessment of overall well-being, the number of patients at week 6 with a 30% or greater improvement in parent's global assessment of overall well-being, change from baseline to week 6 in the patient's assessment of overall well-being, and the number of patients at week 6 with a 30% or greater improvement in the patient's global assessment of overall well-being.
Methods: Prospective, double-blinded, multi-centered, RCT.
Time: Outcome measures were assessed over 5 study visits, with follow-up included at visits 2-5 over a 6 week period (treatment phase).
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.