Dr Vivek Baliga - PRECISION: Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis

Dr Vivek Baliga, Consultant at Baliga Diagnostics discusses a recent paper.

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OBJECTIVE: To assess cardiovascular, gastrointestinal, renal, and other outcomes with moderate dose celecoxib Vs ibuprofen and Naproxen in arthritis patients with high CV risk

METHODS:

• Patients who required NSAIDs for osteoarthritis or rheumatoid arthritis and were at increased CV risk were randomised to receive celecoxib, ibuprofen, or naproxen.
  
• Patients initially received celecoxib (100 mg BD), ibuprofen (600 mg TDS), or naproxen (375 mg BD) with matching placebo.
  
• Dosage can be increased upto: celecoxib -200 mg BD,  Ibuprofen 800 mg TDS, or  naproxen 500 mg BD for the treatment of symptoms
• Esomeprazole (20 to 40 mg) was provided to all patients for gastric protection.
• Low-dose aspirin (≤325 mg daily) was permitted to patients if required.
  
• Primary Composite Outcome :  Cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke
• Analysis was done on both ITT (intention to treat) and on treatment population
  

Results

• Total 24081 patients were initially randomized,
  
• Baseline Characters:Mean Age 63 years, 23% patients had established CVD, 90% had osteoarthritis, 10% had rheumatoid arthritis
• Mean treatment duration: 20.3 months; Mean followup period of 34.1 months.
• During the trial, 68.8% of the patients stopped taking the study drug, and 27.4% of the patients discontinued follow-up
  
• No difference in primary end point between 3 drugs. Celecoxib was non-inferior to naproxen and ibuprofen in both ITT and on treatment analysis  (as shown in figure)

Conclusion:
At moderate doses, celecoxib was found to be noninferior to ibuprofen or naproxen with regard to cardiovascular safety

Link to the article
http://www.nejm.org/doi/full/10.1056/NEJMoa1611593