In the trial, the difference was driven by a decrease in hemoglobin and/or hematocrit of defined or presumed GI origin.
Pfizer claimed that Condor (Celecoxib vs Omeprazole and Diclofenac for at-risk Osteoarthritis and Rheumatoid arthritis patients) is the first large-scale study to use this composite GI endpoint.
The Condor trial showed the need for a more comprehensive assessment of NSAID-associated GI adverse events by evaluating both the upper and lower GI tract.
Condor is a double-blind, randomised study using this composite endpoint to assess two common treatment strategies for arthritis patients at increased GI risk – Celebrex alone, or treatment with diclofenac plus omeprazole.
Francis Chan, lead investigator and professor of medicine and therapeutics, chief of gastroenterology and hepatology at the Chinese University of Hong Kong, said: “Hemoglobin was included in the primary endpoint of Condor because a drop in hemoglobin can indicate blood loss from the upper or lower GI tract and have important clinical implications, such as requiring early discontinuation of treatment and the need for further clinical investigation.”
Briggs Morrison, senior vice president of clinical development of primary care business unit at Pfizer, said: “We intend to continue to sponsor important outcomes studies like Condor, which can give health care providers information when making treatment decisions.”