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The Food and Drug Administration (FDA) has issued new guidance intended to assist sponsors in the clinical development of drugs for the treatment of HIV infection. Specifically, it addresses the FDAs current thinking regarding designs of clinical trials that use HIV ribonucleic acid (RNA) measurements to support accelerated and traditional approvals of antiretroviral drug products.
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The 12-month results of CREDO (clopidogrel for the Reduction of Events During Observation) were presented at AHA to coincide with the publication of this important clinical trial in the November 20, 2002, issue of JAMA.
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After years of legal wrangling, the FDA has approved loratadine (Claritin, Schering-Plough) as an over-the-counter (OTC) product for the treatment of seasonal rhinitis.
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Carotid artery stenting is an attractive concept for the treatment of patients with significant carotid stenoses who were at higher risk for carotid endarterectomy, but stroke rates in initial studies were unacceptably high.
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The pravastatin in elderly individuals at risk of vascular disease (PROSPER) trial is a study of statin therapy in high-risk elderly individuals. PROSPER tested the hypothesis that the benefits of statin therapy on cardiovascular disease, stroke, and cognitive decline would be seen in the elderly, which had not yet been rigorously investigated with respect to LDL lowering with a statin.
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Iwai and colleagues evaluated the effects of adenosine in 42 patients who underwent an electrophysiologic study and radiofrequency ablation for recurrent atrial tachycardias.
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The multicenter, unsustained tachycardia trial (MUSTT) was a randomized clinical trial designed to test whether antiarrhythmic therapy guided by electrophysiologic testing would reduce arrhythmic death and total mortality in high-risk patients.
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