The string of bad news for HDL-related therapies continues. Resverlogix yesterday announced that the ASSURE clinical trial had failed to meet its primary endpoint. RVX-208, the drug being studied in the trial, is a novel small molecule that increases production of ApoA-1, which raises HDL levels and is thought to enhance reverse cholesterol transport.
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Another large study has failed to find any benefits for fish oil supplements. The Italian Risk and Prevention Study, published in the New England Journal of Medicine, enrolled 12,513 people who had not had a myocardial infarction but had evidence of atherosclerosis or had multiple cardiovascular risk factors. The patients were randomized to either a fish oil supplement (1 gram daily of n-3 fatty acids) or placebo.
After 5 years of followup, the primary endpoint– the time to death from cardiovascular causes or admission to the hospital for cardiovascular causes– had occurred in 11.7% of the fish oil group versus 11.9% of the placebo group (adjusted hazard ratio 0.97, CI 0.88-1.08, p=0.58). There were no significant differences in any of the prespecified secondary endpoints.
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A new line of preliminary research has turned up a novel pathway linking atherosclerosis to red meat and a common supplement contained in energy drinks. If the research is upheld, the findings may have important implications for dietary recommendations and our understanding of atherosclerosis. The research also provides a quite surprising example of the previously unsuspected health effects of bacteria in the intestine.
Published online in Nature Medicine, the new studies suggest a possible major role in atherosclerosis for carnitine, which is commonly added to energy drinks and is found naturally in high concentrations in red meat. The new theory combines several lines of evidence from studies in both animals and humans.
Led by Stanley Hazen, researchers at the Cleveland Clinic and elsewhere found that digestive tract bacteria metabolize carnitine into trimethylamine-N-oxide (TMAO), which has previously been linked to atherosclerosis in mice, though the exact mechanism is still unknown. The researchers found that these bacteria were able to flourish, and produce large amounts of TMAO, only in an environment of a carnitine-rich diet. For instance, after taking carnitine supplements, or eating a steak rich in carnitine, vegetarians produced far less TMAO than omnivores.
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Service members who died over the past decade were far less likely to have atherosclerosis than service members who died in Korea or Vietnam, according to a new study published in JAMA. Although it is impossible to fully understand the causes and implications of the finding, the results provide powerful new evidence pointing toward a very long term, enormous reduction in the prevalence of coronary disease, especially in younger people, though an aging population and disturbing trends in obesity and diabetes mean that cardiovascular disease will continue to be a major public health problem for the foreseeable future.
Bryant Webber and colleagues analyzed autopsy reports and available health data from 3,832 service members who died of combat or unintentional injuries in Afghanistan and Iraq and compared their findings to similar studies performed during the Korean and Vietnam wars. 8.5% of the newest group had evidence of coronary atherosclerosis, compared with 77% in the Korean War group and 45% in the Vietnam War group. The authors acknowledge that there are many reasons why the groups should not be directly compared but conclude that the overall trend in the reduced prevalence of atherosclerosis is undoubtedly true.
As might be expected, service members with atherosclerosis were older and more likely to have dyslipidemia, hypertension, or obesity than service members without atherosclerosis. Surprisingly, cigarette smoking was not significantly associated with atherosclerosis in this study.
In an accompanying editorial, the Framingham Study’s Daniel Levy writes that “the main finding of this study is valid: the prevalence of atherosclerosis in young men today is much lower than the prevalence in the Korean or Vietnam War eras. If these findings are generalizable to the US population as a whole, then the cardiovascular health of the US population may have improved appreciably over the past 6 decades.”
Levy writes that the concurrent decline in mortality from cardiovascular disease is likely the result of advances in both prevention and treatment, but only advances in primary prevention can explain the trend found in the autopsy studies. Nevertheless, he notes, cardiovascular disease is still the leading cause of death in the US: “The national battle against heart disease is not over; increasing rates of obesity and diabetes signal a need to engage earlier and with greater intensity in a campaign of preemption and prevention.”
Click here to read the JAMA press release…