The result was similar for patients taking meloxicam and two other commonly prescribed NSAIDs. Moreover, no effects on bleeding time were observed in healthy volunteers with meloxicam at higher than recommended doses.
These safety findings reassured meloxicam’s overall safety profile. The data are especially significant in view of the medical community’s concern about the gastrointestinal and cardiovascular side-effects of NSAIDs and selective COX-2 inhibitors.
Meloxicam (Mobic) is a NSAID indicated for the symptomatic treatment of painful steoarthritis, rheumatoid arthritis and ankylosing spondylitis.
The third of three recently approved NSAIDs in the US, Mobic has been available in the US since last year, and has been used by more than 45 million patients in 100 countries.
Traditional NSAIDs reduce inflammation and pain inhibiting the COX-2 enzyme responsible for inflammation. However, they also inhibit the COX-1 enzyme, which is responsible for general maintenance and protection of the organs, including the gastrointestinal tract.
Meloxicam selectively inhibits COX-2 to a greater degree than COX-1, resulting in reduced inflammation and pain but with less gastrointestinal events caused by COX-1 inhibition.
Dr. Gurkipal Singh of the Stanford University Medical Center in the US, who conducted the cardiovascular study, commented: "Meloxicam’s superior GI tolerability compared with traditional NSAIDs such as diclofenac, and its overall safety profile are well documented. Its overall safety profile is good news, as it suggests that the findings highlighted with rofecoxib are not class effect of selective COX-2 inhibitors."
Singh explained the data: "We examined all areas of cardiovascular risk and renal toxicity to ensure that meloxicam was safe at all dose levels. It is important to know that a drug has an overall tolerability and safety profile that goes further than ensuring fewer gastrointestinal events. These data clearly show that meloxicam has a commendable overall safety profile."
Commenting on the results, Dr. Henry Rinder of the Yale School of Medicine in the US, said: "These results are very reassuring. Meloxicam has been prescribed in overall 45 million cases worldwide and we are very pleased to see these new data on this selective COX-2 inhibitor."
Dr. Andres Barner, a member of the board of managing directors of Boehringer Ingelheim, responsible for pharma research, development and medicine, said: "Meloxicam was one of the first COX-2 selective drugs launched to help people with arthritis."