Large-scale study demonstrates celecoxib safe and effective osteoarthritis treatment with minimal gastrointestinal complications
Arthritis can be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) but the incidence of gastrointestinal problems is significant, resulting in approximately 103,000 hospitalizations and 16,500 deaths per year in the United States. The alternative COX-2 inhibitors may reduce these adverse events, but some have been withdrawn from the market due to cardiovascular complications and other adverse effects. Several questions remain about the safety advantage of COX-2 inhibitors compared with nonspecific NSAIDs.
In a report in the March 2006 issue of The American Journal of Medicine, researchers from eight university and hospital health centers and Pfizer Inc present the results of a large, multinational, “real-world,” controlled clinical trial in patients with osteoarthritis. Over 13,000 patients from 39 countries in six continents were randomly assigned for treatment with either celecoxib 100 mg twice daily (BID), celecoxib 200 mg BID, or nonselective NSAID therapy (diclofenac 50 mg BID or naproxen 500 mg BID) for 12 weeks.
Each patient was seen three times during the study and the efficacy of their treatment was assessed by three separate means. Any possible serious upper gastrointestinal adverse event had to be investigated by two independent committees (both blinded to patient randomization), using two different methodologies and definitions.
Results from all primary efficacy assessments showed that both dosages of celecoxib were as effective as NSAIDs in treating the signs and symptoms of osteoarthritis. The most commonly reported adverse events were abdominal pain and dyspepsia, both of which were experienced by significantly more NSAID patients than celecoxib patients. In addition, serious upper gastrointestinal events, such as gastric or duodenal perforations, gastric outlet obstruction, or upper gastrointestinal bleeding, occurred significantly less often with the celecoxib group than with NSAIDs.
There was no significant difference between celecoxib and the NSAID group in any cardiovascular adverse event rate, with the exception of investigator-reported cardiac failure. The rate of cardiac failure was 0.22/100 patient-years with celecoxib and 1.00/100 patient-years with the NSAID group. The incidence of cerebrovascular disorders was low and statistically similar between the groups. The risk of myocardial infarction (MI) was also low and statistically similar among the treatment groups.
Writing in the article, Gurkirpal Singh, MD, Adjunct Clinical Professor of Medicine at Stanford University, concludes, “Our study shows that the COX-2-specific inhibitor celecoxib is as effective as the nonspecific NSAIDs naproxen and diclofenac, but has significantly fewer serious upper gastrointestinal events. The number of cardiovascular thromboembolic events in our study was low and, although numerical differences were noted, these did not reach statistical significance. Because current clinical osteoarthritis treatment guidelines vary in their recommendations regarding the appropriate therapeutic role of COX-2-specific inhibitors, clinicians should consider a number of factors, including the risk for upper gastrointestinal events, duration of therapy, as well as costs, before deciding upon individual patient treatment.”
Pamela Poppalardo | alfa
The most recent press releases about innovation >>>
Die letzten 5 Focus-News des innovations-reports im Überblick:
Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.
As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...
Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.
Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...
For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.
While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...
An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.
The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...
A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.
Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...