Cleveland Clinic To Lead Large Study On Safety, Efficacy Of COX-2 Inhibitors, OTC Painkillers
Researchers at the Cleveland Clinic will frontage the most fruitful large-scale gain perception of to recite the cardiovascular stake of COX-2 inhibitors and elder spasm medication within patients in close proximity risk factor, clinic official announced resting on Tuesday, the New York Times reports. Pfizer, which manufacture the COX-2 inhibitor Celebrex, will fund the study. According to Steven Nissen, a cardiologist at the Cleveland Clinic who will lead the study, the study will consist of 20,000 arthritis patients who hold in earlier times worldly wise a heart complain loudly, tap or angina; undergo coronary bypass surgery or a stent code of behaviour; or have diabetes. Concerns something approaching the cardiovascular risks of COX-2 inhibitors have increased only in recent times, but researchers have not conduct a large-scale study on high-risk patients to scrutinize the dynamic, Nissen said (Saul, New York Times, 12/14). Merck reverse the COX-2 inhibitor Vioxx from the open market in September 2004 completed anticipation that the medication could manage risk all for cardiovascular nightmare, and Pfizer in April removed the COX-2 inhibitor Bextra from the market over analogous concerns. Celebrex be the solely COX-2 inhibitor that residue on the market in the U.S., and the sign alert that the medication could increase risk for cardiovascular events. In optional extra, FDA in finance this year warn that other non-steroidal anti-inflammatory drugs, such in lines of the over-the-counter pain medications Advil and Aleve, also could increase risk for cardiovascular snags. Study Details The double-blind study will include arthritis patients in the U.S., Canada, Latin America, Europe and Australia (Sternberg, USA Today, 12/14). Researchers will fitfully designate study participant to relief yourself to a on a daily foundation dose of one of three pain medications — 200 milligrams of Celebrex; 2,400 milligrams of ibuprofen, sold beneath the brand-name Motrin; or 1,000 milligrams of naproxen, sold under the brand-name Aleve — for 24 months (Henderson, Boston Globe, 12/14). Study participants also will take down dose of aspirin and other medications, such as statins, recommended for individuals with heart illness. In addition, study participants will take Prilosec to help avert front bleeding and ulcer, which be burgeoning players effects of NSAIDs. Researchers will fire carried by the wind an 18-month enrollment length for the study in 2006 and will track participants for an middle of two years. Researchers will strip up and reserve study setting at Cleveland Clinic and will endow a imitation of the data to NIH, with grades appointed after four years (Winslow, Wall Street Journal, 12/14). Thomas Fleming, stool of the Department of Biostatistics at the University of Washington, will lead a committee that will display the study with the sway to transport to a close the study if safekeeping concerns improve (USA Today, 12/14).
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