
pmid: 21586743
Atherosclerosis and its thrombotic complications are the leading cause of morbidity and mortality in developed countries, and the burden of atherosclerotic disease is expected to increase even further in the coming decades due to soaring obesity rates that feed the diabetes epidemic. There is, therefore, a clear need for new drugs targeting atherosclerosis to add to our current therapeutic armamentarium. Drug approval currently is based on multicenter, randomized, placebo-controlled trials with long-term follow-up in thousands of patients to demonstrate clear benefits in mortality and cardiovascular events and to allow adequate assessment of safety. Cardiovascular drug development has become a hostage to its own success. New drugs must be compared to placebo but on the background of highly effective standard therapy that lowers event rates and necessitates huge sample sizes and long follow-up. Failures of promising new cardiovascular drugs in large clinical trials1 have had catastrophic consequences for the sponsoring pharmaceutical and biotechnological companies. These conditions are inhibiting new drug development and are stimulating a search for alternate methods to assess new compounds. Cardiovascular imaging techniques have been used to fill this need.2 Cardiovascular imaging trials are shorter and require only a fraction of the patients needed for a large events trial because all patients who complete an imaging trial contribute to the end point. Thus, imaging trials are less expensive. By themselves, they are not sufficient for drug approval by regulatory agencies partly because of the limited safety data that can be generated with the study drug given the number of patients involved and duration of exposure. Nevertheless, imaging studies can provide evidence to inform the decision about whether a large outcome trial should proceed. They are therefore currently best suited in phase 2 of drug development. Ideally, imaging studies also should provide useful data regarding the mechanism …
Carotid Artery Diseases, Diagnostic Imaging, Spectroscopy, Near-Infrared, Atherosclerosis, Coronary Angiography, Magnetic Resonance Imaging, Molecular Imaging, Humans, Radionuclide Imaging, Tomography, X-Ray Computed, Tomography, Optical Coherence, Ultrasonography, Interventional
Carotid Artery Diseases, Diagnostic Imaging, Spectroscopy, Near-Infrared, Atherosclerosis, Coronary Angiography, Magnetic Resonance Imaging, Molecular Imaging, Humans, Radionuclide Imaging, Tomography, X-Ray Computed, Tomography, Optical Coherence, Ultrasonography, Interventional
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