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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 RSSMultiple health concerns surface as winter, vitamin D deficiences arrive
A string of recent discoveries about the multiple health benefits of vitamin D has renewed interest in this multi-purpose nutrient, increased awareness of the huge numbers of people who are deficient in it, spurred research and even led to an appreciation of it as "nature's antibiotic."
AIDS research reveals a lack of family-planning programs in Uganda
University of Alberta graduate student Jennifer Heys wants to make her message clear: there needs to be more education in Ugandan communities about contraception.
Many pregnant women avoid HIV screening in Africa
'Prevention is the best cure' is a common expression, but what happens if preventative measures are not used? A large proportion of pregnant Ugandan women are going out of their way not to be HIV tested, increasing the risk of mother-to-child transmission.
An atomic-level look at an HIV accomplice
Since the discovery in 2007 that a component of human semen called SEVI boosts infectivity of the virus that causes AIDS, researchers have been trying to learn more about SEVI and how it works, in hopes of thwarting its infection-promoting activity.
UAB Researchers Discover Antibody Receptor Identity, Propose Renaming Immune-System Gene
Researchers at the University of Alabama at Birmingham (UAB) have uncovered the genetic identity of a cellular receptor for the immune system's first-response antibody, a discovery that sheds new light on infection control and immune disorders.
UCLA study shows brain's ability to reorganize
Visually impaired people appear to be fearless, navigating busy sidewalks and crosswalks, safely finding their way using nothing more than a cane as a guide.
Research calls for better assessment of tests for tuberculosis, HIV/AIDS and malaria
A rapid and accurate diagnosis is the first step towards treatment in the fight against infectious disease.
Prioritizing low-cost, simple health measures would save 2.5 million child lives a year
Almost a third of the children under age five who die each year could be saved if governments rebalance health spending to ensure low-cost, simple interventions such as safe water and hygiene, bed nets and basic maternal and newborn care, leading aid agency World Vision said today. Currently, 8.8 million children a year die before age five, most of preventable causes.
No-entry zones for AIDS virus
The AIDS virus inserts its genetic material into the genome of the infected cell. Scientists of the German Cancer Research Center have now shown for the first time that the virus almost entirely spares particular sites in the human genetic material in this process. This finding may be useful for developing new, specific AIDS drugs.
Hoping for a fluorescent basket case
Although recent advances have raised hopes that a protective vaccine can be developed, acquired immunodeficiency syndrome (AIDS) remains a major public health problem.
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