When selective cyclooxygenase 2 inhibitors (coxibs) were introduced a decade ago, they were widely hailed as a gastroprotective shield for NSAID users.
Eventually, they were incorporated into the treatment guidelines of both the American College of Rheumatology and the Arthritis Foundation for patients at increased risk of GI complications.. Two gastroprotective strategies for patients prescribed NSAIDs were recommended--either coprescription of a non-selective NSAID with an acid-reducing medication or selection of a COX-2 inhibitor NSAID. Then, clinical studies began to uncover evidence that COX-2 inhibitors and other non-selective NSAIDs may increase the risk of heart attack and stroke. Spurred by these findings and other safety concerns, 2 of the 3 FDA-approved coxibs – rofecoxib, known to consumers as Vioxx, and valdecoxib, known to consumers as Bextra – were withdrawn from the market. Questions regarding the appropriate use of COX-2 inhibitors for arthritis patients – and broader questions regarding prescribing patterns of novel drugs soon after FDA approval – remain.
For answers, a study published in the August 2006 issue of Arthritis Care & Research (http://www.interscience.wiley.com/journal/arthritiscare) examines the prescribing patterns of COX-2 inhibitors and other gastroprotective agents for arthritis patients with varying levels of GI risk. Using the Consortium of Rheumatology Researchers of North America (CORRONA) registry, a team of CORRONA investigators evaluated data on 2,690 rheumatoid arthritis (RA) patients treated between March 1, 2004 and September 30, 2004 – the last day rofecoxib was legally sold in the U.S.
Of the patient sample, 1,833 (68.1 percent) were prescribed NSAID agents, 538 (20 percent) were prescribed aspirin , and 319 (11.9 percent) were prescribed an NSAID and aspirin. In contrast to multiple earlier epidemiologic studies that observed that a minority of NSAID users were prescribed gastroprotection, the majority (75.3%) of the 1,833 patients prescribed NSAIDs in the study were prescribed a gastroprotective strategy; the most frequently prescribed gastroprotective strategy was COX-2 inhibitors (65.8%).
The researchers also stratified their analyses by the number of GI risk factors for each patient. For patients with two or more risk factors, 80.2% were prescribed a gastroprotective strategy, primarily using COX-2 inhibitors (68.6%). High rates of NSAID gastroprotection were also observed for patients with one major GI risk factor. However, the authors also observed that 72.0% without traditional GI risk factors were prescribed NSAID gastroprotection, including 64.1% using COX-2 inhibitors. As the authors pointed out, registries cannot identify all of the considerations and risk factors inherent in patient and physician decision-making.
"The relative GI safety of the COX-2 inhibitor class represented a major therapeutic advance for patients at increased GI risk who require long-term NSAID therapy," states its leading author, Jeffrey Greenberg, M.D., M.P.H. "The challenges associated with limiting diffusion of novel therapeutic agents to broader patient populations are likely to be challenges that cross subspecialty boundaries within the US health care system."
Clinical trials serve to determine the efficacy of a novel drug compound. However, the patient population for which a drug is prescribed frequently expands after FDA approval. This study underscores the potential value of post-marketing observational registries. "As novel therapeutic classes are introduced, early evaluation of prescribing patterns using arthritis registries can determine the appropriateness of prescribing patterns," Dr. Greenberg notes, "and may improve patient outcomes."
Amy Molnar | EurekAlert!
Europe’s Demographic Future. Where the Regions Are Heading after a Decade of Crises
10.08.2017 | Berlin-Institut für Bevölkerung und Entwicklung
Scientists reveal source of human heartbeat in 3-D
07.08.2017 | University of Manchester
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...
16.08.2017 | Event News
04.08.2017 | Event News
26.07.2017 | Event News
21.08.2017 | Medical Engineering
21.08.2017 | Materials Sciences
21.08.2017 | Life Sciences