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the 3 FDA-approved coxibs – rofecoxib, known to consumers as Vioxx, and valdecoxib, known to consumers as Bextra – were withdrawn from the market.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!
Rutgers-led innovation could spur faster, cheaper, nano-based manufacturing
14.02.2018 | Rutgers University
New study from the University of Halle: How climate change alters plant growth
12.01.2018 | Martin-Luther-Universität Halle-Wittenberg
A newly developed laser technology has enabled physicists in the Laboratory for Attosecond Physics (jointly run by LMU Munich and the Max Planck Institute of Quantum Optics) to generate attosecond bursts of high-energy photons of unprecedented intensity. This has made it possible to observe the interaction of multiple photons in a single such pulse with electrons in the inner orbital shell of an atom.
In order to observe the ultrafast electron motion in the inner shells of atoms with short light pulses, the pulses must not only be ultrashort, but very...
A group of researchers led by Andrea Cavalleri at the Max Planck Institute for Structure and Dynamics of Matter (MPSD) in Hamburg has demonstrated a new method enabling precise measurements of the interatomic forces that hold crystalline solids together. The paper Probing the Interatomic Potential of Solids by Strong-Field Nonlinear Phononics, published online in Nature, explains how a terahertz-frequency laser pulse can drive very large deformations of the crystal.
By measuring the highly unusual atomic trajectories under extreme electromagnetic transients, the MPSD group could reconstruct how rigid the atomic bonds are...
Quantum computers may one day solve algorithmic problems which even the biggest supercomputers today can’t manage. But how do you test a quantum computer to...
For the first time, a team of researchers at the Max-Planck Institute (MPI) for Polymer Research in Mainz, Germany, has succeeded in making an integrated circuit (IC) from just a monolayer of a semiconducting polymer via a bottom-up, self-assembly approach.
In the self-assembly process, the semiconducting polymer arranges itself into an ordered monolayer in a transistor. The transistors are binary switches used...
Breakthrough provides a new concept of the design of molecular motors, sensors and electricity generators at nanoscale
Researchers from the Institute of Organic Chemistry and Biochemistry of the CAS (IOCB Prague), Institute of Physics of the CAS (IP CAS) and Palacký University...
15.02.2018 | Event News
13.02.2018 | Event News
12.02.2018 | Event News
23.02.2018 | Physics and Astronomy
23.02.2018 | Health and Medicine
23.02.2018 | Physics and Astronomy