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COX2 inhibitor could offer benefits over other anti-inflammatory drugs for osteoarthritis (pp 639, 665, 675)
August 18, 2004Results of an international multi-centre study in this week's issue of THE LANCET suggest that the COX2 inhibitor lumiracoxib could be an effective treatment for osteoarthritis-its use was associated with an 80% reduction in gastric complications compared with other conventional anti-inflammatory drugs.
The use of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) is widespread to reduce the pain associated with osteoarthritis; however the side-effects of these drugs can be severe, sometimes leading to gastro-intestinal ulcer complications which account for around 7000 US and 1000 UK deaths each year. The development of Cyclo-oxygenase 2 (COX2)-selective inhibitors should reduce these ulcer complications, but evidence is limited, and the possibility that COX2 inhibitors increase cardiovascular events has been raised.
TARGET (The Therapeutic Arthritis Research and Gastrointestinal Event Trial) assessed gastrointestinal and cardiovascular safety of the COX2 inhibitor lumiracoxib compared with the NSAIDs naproxen and ibuprofen. 18325 osteoarthritis patients (aged 50 years or older) were randomised to receive either lumiracoxib (9156 patients), naproxen (4754 patients), or ibuprofen (4415 patients) for1 year. The risk of ulcer complications was reduced among patients given lumiracoxib (0"˘25%) compared with patients using non-selective NSAIDs (1"˘09%); however this benefit did not apply for patients who were also taking aspirin.
TARGET also demonstrated that the incidence of non-fatal and silent myocardial infarction, stroke, or cardiovascular death, which was low in the population, did not differ significantly between treatment groups (lumiracoxib 0"˘65% vs NSAIDs 0"˘55%), or when analysed by aspirin use, age, sex, high cardiovascular risk, or cerebrovascular history. "The fact that we enrolled osteoarthritis patients in the study who already had high blood pressure or other risk factors for coronary heart disease was important," says Dr. Michael E Farkouh, lead author on the cardiovascular outcomes paper (New York University School of Medicine, USA).
Investigator Michael Doherty (University of Nottingham, UK) comments: "Lumiracoxib showed a three to four-fold reduction in ulcer complications compared with non-steroidal anti-inflammatory drugs without an increase in the rate of serious cardiovascular events, suggesting that lumiracoxib is an appropriate treatment for patients with osteoarthritis".
The TARGET study is critically evaluated in an accompanying commentary by Eric J Topol and Gary W Falk (Cleveland Clinic Foundation, USA - see p 639). With regard to cardiovascular outcomes they comment: 'The overall low frequency of myocardial events is important to put in context. Patients in TARGET were 50 years or older and nearly all those with myocardial infarction, stroke, coronary artery bypass surgery, or congestive heart failure were excluded. Less than 2% of the patients had a previous myocardial infarction or a revascularisation procedure. Unfortunately, this trial, like all others in the clinical development of coxibs, purposefully excluded patients with known and significant pre-existing coronary artery disease'.
Topol and Falk also highlight concerns about lumiracoxib's liver toxicity and potential increase in heart attack if lumiracoxib is compared with naproxen alone: 'TARGET quantifies lumiracoxib's narrow benefit over two NSAIDs with a trade-off. For patients not taking aspirin, there is an absolute reduction of 0"˘72% in ulcer complications, with an excess of 2"˘0% of liver function test abnormalities. The putative benefit is further compromised if naproxen is the NSAID, with a 0"˘17% excess of myocardial infarction. For patients taking low-dose aspirin, it is hard to justify the coxib: there is no benefit in ulcer complication reduction, but the risk of myocardial infarction and hepatotoxicity persist.'
Lancet
TARGET also demonstrated that the incidence of non-fatal and silent myocardial infarction, stroke, or cardiovascular death, which was low in the population, did not differ significantly between treatment groups (lumiracoxib 0"˘65% vs NSAIDs 0"˘55%), or when analysed by aspirin use, age, sex, high cardiovascular risk, or cerebrovascular history. "The fact that we enrolled osteoarthritis patients in the study who already had high blood pressure or other risk factors for coronary heart disease was important," says Dr. Michael E Farkouh, lead author on the cardiovascular outcomes paper (New York University School of Medicine, USA).
Investigator Michael Doherty (University of Nottingham, UK) comments: "Lumiracoxib showed a three to four-fold reduction in ulcer complications compared with non-steroidal anti-inflammatory drugs without an increase in the rate of serious cardiovascular events, suggesting that lumiracoxib is an appropriate treatment for patients with osteoarthritis".
The TARGET study is critically evaluated in an accompanying commentary by Eric J Topol and Gary W Falk (Cleveland Clinic Foundation, USA - see p 639). With regard to cardiovascular outcomes they comment: 'The overall low frequency of myocardial events is important to put in context. Patients in TARGET were 50 years or older and nearly all those with myocardial infarction, stroke, coronary artery bypass surgery, or congestive heart failure were excluded. Less than 2% of the patients had a previous myocardial infarction or a revascularisation procedure. Unfortunately, this trial, like all others in the clinical development of coxibs, purposefully excluded patients with known and significant pre-existing coronary artery disease'.
Topol and Falk also highlight concerns about lumiracoxib's liver toxicity and potential increase in heart attack if lumiracoxib is compared with naproxen alone: 'TARGET quantifies lumiracoxib's narrow benefit over two NSAIDs with a trade-off. For patients not taking aspirin, there is an absolute reduction of 0"˘72% in ulcer complications, with an excess of 2"˘0% of liver function test abnormalities. The putative benefit is further compromised if naproxen is the NSAID, with a 0"˘17% excess of myocardial infarction. For patients taking low-dose aspirin, it is hard to justify the coxib: there is no benefit in ulcer complication reduction, but the risk of myocardial infarction and hepatotoxicity persist.'
Lancet
AIDS Current Events and AIDS News RSSU.S. and European Experts Applaud Creation of New Transatlantic Task Force on Global Antibiotic Resistance Threat
Experts on both sides of the Atlantic applaud President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt, representing the European Union (EU) Presidency, for establishing a transatlantic task force to address antibiotic resistance, an urgent and growing problem that threatens patient safety and public health worldwide.
1930s drug slows tumor growth
Drugs sometimes have beneficial side effects. A glaucoma treatment causes luscious eyelashes. A blood pressure drug also aids those with a rare genetic disease.
Pathogen protection and virulence: Dark side of fungal membrane protein revealed
Researchers at the Virginia Bioinformatics Institute (VBI) at Virginia Tech and Montana State University have discovered a fungal protein that plays a key role in causing disease in plants and animals and which also shields the pathogen from oxidative stress.
Global challenges and opportunities in fighting HIV/AIDS and neglected diseases
Responding to the HIV/AIDS pandemic and tackling so-called neglected tropical diseases are the focus of the November/December 2009 edition of Health Affairs.
Losing your tongue
Elder Tommy George has not spoken his aboriginal language of Kuku Thaypan for three years, since his brother died. "It might die in the throat, but it stays alive in the heart," he said to the Queensland Courier-Mail in June, 2009.
Placental precursor stem cells require testosterone-free environment to survive
Trophoblast stem cells (TSCs), cells found in the layer of peripheral embryonic stem cells from which the placenta is formed, are thought to exhibit "immune privilege" that aids cell survivability and is potentially beneficial for cell and gene therapies.
Propolis has proved to be a product with ability to have beneficial effects for health
Growing concerns about health has caused the scientific community to focus their interest on investigating functional foods which contribute to boosting the prevention and reduction of the risk of suffering from certain illnesses.
Endocrine Society calls for expanded scope and funding for stem cell research
Stem cell research holds great promise for the treatment of millions of Americans with debilitating and possibly fatal diseases.
Scientists use world's fastest supercomputer to create the largest HIV evolutionary tree
Supporting Los Alamos National Laboratory's role in the international Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium, researchers are using the Roadrunner supercomputer to analyze vast quantities of genetic sequences from HIV infected people in the hope of zeroing in on possible vaccine target areas.
Will genomics help prevent the next pandemic?
This week, the Public Library of Science, an open-access publisher, presents the "Genomics of Emerging Infectious Disease," a collection of essays, perspectives, and reviews that explores how genomics-with all its associated tools and techniques-can provide insights into our understanding of emerging infectious disease.
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