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Australian Journal of Pharmacy : February 2005
pharmacy pro pharmacy professional updates COX-2 cardio concern and confusion continues O NGOING concern about COX-2 inhibitors is causing confusion about the best treatment for arthritis, as more conflicting data about the drugs’ cardiovascular safety appears. Dr Jim Bertouch, chairman of the Aus- tralian Rheumatology Association’s ther- apeutics committee, and Professor Ric Day, a rheumatologist and clinical phar- macologist at St Vincent’s Hospital, Syd- ney, told Australian Doctor magazine that caution was required in the use of cele- coxib ‘until the picture became clearer’. They suggested keeping prescriptions at the lowest possible dose, and carefully monitoring patients’ cardiovascular health. Dr Bertouch said patients with two car- diovascular risk factors should not take celecoxib during the current uncertainty; while Professor Day put forward a ‘sliding scale’ approach, where increased con- cerns about a risk required more consid- eration about prescribing, and increased patient monitoring. Late last year three COX-2 trials were suspended after concerns were raised. The Adenoma Prevention with Celecoxib (APC) trial was suspended after patients on 400mg and 800mg daily doses of cele- coxib were found to be 2.5 times more likely than those on placebo to have a car- diovascular event. However, the Prevention of Sponta- neous Adenomatous Polyps (PreSAP) trial, also suspended, showed patients on Blood pressure trial stopped early A N international trial comparing blood-pressure lowering treatments has been stopped early due to signifi- cantly better outcomes observed with a newer treatment strategy, a result that could have major implications for the treatment of millions of patients world- wide. Launched in 1997, the Anglo-Scandi- navian Cardiac Outcomes Trial (ASCOT) involved 19,000 patients and compared a more recent treatment strategy for hyper- tension against an older one, to determine which is better at preventing various car- diovascular events such as heart attacks and strokes. The newer treatment strategy using the calcium channel blocker, amlodipine, and the angiotensin converting enzyme inhibitor, perindopril, was compared with an older treatment strategy based on the beta-blocker, atenolol and the thiazide diuretic, bendroflumethiazide. Professor of Cardiovascular Medicine and Epidemiology at the University of Sydney, Stephen MacMahon, said that this outcome provides further evidence of potentially important differences between 400mg celecoxib daily were slightly less likely to have a cardiovascular event than those on placebo. A third suspended trial, the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) showed an apparent increase in cardiovascular and cere- brovascular events in patients taking naproxen, but no increase in those taking celecoxib. In the meantime, the TGA has fast- tracked its review of all COX-2 inhibitors and deferred consideration of other COX- 2s—Novartis’ Prexige and Boehringer Inelheim’s Mobic—from PBS listing dis- cussions. ¦ antihypertensive treatment regimens in their effects on clinically important out- comes. ‘This is an important finding for Aus- tralian patients and doctors, since amlodipine and perindopril are two of the most widely prescribed antihypertensive drugs in this country. ‘Non-optimal blood pressure is now the leading cause of death worldwide and the third largest contributor to the total bur- den of disease. ‘This burden is avoidable through effective preventive intervention, but the main problem is that many high risk indi- viduals still do not receive adequate pre- ventive care. ‘The challenge today is not the devel- opment of new drugs; rather, it is to ensure the appropriately widespread use of drugs such as amlodipine and perindo- pril that we have already. ‘The use of these drugs together with other preventive strategies, such as cho- lesterol lowering and antiplatelet therapy, will reduce cardiovascular disease risk by as much as three-quarters,’ Professor MacMahon said. ¦ 82 ? THE AUSTRALIAN JOURNAL OF PHARMACY VOL 86 FEBRUARY 2005 Reducing C-reactive protein levels may provide CV benefits N analysis from the REVERSAL (REVERSing Atherosclerosis with Aggressive Lipid Lowering) trial, pub- lished in the New England Journal of Med- icine, suggests that reducing C-reactive protein (CRP) levels, a biomarker of artery inflammation, may have clinical importance in reducing the progression of plaque build-up. A Previously reported results of REVER- SAL showed that aggressive reductions of LDL with Lipitor (atorvastatin calcium) 80mg stopped the progression of athero- sclerosis in patients with heart disease. In the CRP analysis, the investigators found that decreases in both LDL-C and CRP levels were independently and sig- nificantly linked with slowing the pro- gression of plaque build-up. Overall, patients with LDL cholesterol and CRP levels that were below the median had significantly slower progression rates than patients with reductions in both effi- cacy parameters that were above the median. ¦