January 25, 2012 (Dallas, Texas) - An analysis of 18 Postgrad confirm that the differences in risk factor burden in middle-aged translate into large differences in the lives of the risk of heart disease and blood vessels [1]."The current model when we think of prevention is to assess the risk over the next 10 years using something like the degree of risk Framingham ... and supposed to guide decision-making process," senior author Dr. Donald Lloyd-Jones (Northwestern University, said Chicago, IL) heartwire. "This approach is quite true, but this is an incomplete representation of the risk to our patients."New results of the project life risk of cardiovascular gathering, which was published in the January 26, 2012 issue of the New England Journal of Medicine, found that the risk in people in their 40s or 50S with risk factors and one or two, such as high blood pressure or high cholesterol in the blood ladders sharply over their lives. "So there is a separation between information risk in the short term that routinely calculate what we know, especially with this paper, is the long-term risks that are significantly higher."This is not necessarily news, but this is a new way to look at it that I hope to attract people's attention more," he said. "If I can tell you this, make sure you have 10-year risk may be low, but based on your personal data now, it may be at risk the lives of 50% or more of a heart attack or stroke a major before he died .... and I hope that it is a little more of a catalyst. "The study analyzed cohort studies 18 with 257 384 patients, including black and white men and women across a 50-year cohorts of birth. Important studies measuring cardiovascular risk factors at age 45.55, 65, and 75. Measuring risk factors include smoking, cholesterol levels, diabetes, and blood pressure.Account risks life events of the heart and blood vessels and shows that there is a risk factor and one even in middle age can increase significantly the risk of one in his life from cardiovascular disease compared with no risk factors, and risk rises with each risk factor further.In all parts of the meta-analysis, participants with no risk factors at the age of 55 (total cholesterol level in blood: <180 mg / dL, blood pressure <120 mm Hg systolic and diastolic 80 mm Hg, nondiabetic. Non-smokers) and was otherwise significantly better to avoid death from cardiovascular disease by the age of 80 of the participants with two or more of the major risk factors (4.7% versus 29.6% among men and 6.4% versus 20.5% among women).People with risk factor optimization has also risks a younger, fatal coronary heart disease or nonfatal MI (3.6% versus 37.5% among men, <1% versus 18.3% among women), and stroke, fatal or non-fatal (2.3% versus 8.3% between men and 5.3% versus 10.7% among women), compared with those with risk factors of two or more.A similar risk by raceThe risk of death from the age of cardiovascular disease and coronary heart disease or nonfatal MI is generally about twice that among men than among women, but risk a lifetime of blow fatal and nonfatal were similar for men and women.Also, the trends shown in a similar study from the people both white and black did not change across birth cohorts-year variety. "[We saw] similar results to striking black and white in the categories of risk factors the same, but there appeared a story that there is little accuracy, unfortunately, bad news," he said. Blacks, on average, a greater burden of cardiovascular risk factors than white people, but black people, especially men, are more likely to die at a younger age from other causes, and less likely to live out "the fate of the heart and blood vessels." "Thus, in the end of the day, we found that the risk for life for blacks and whites are similar significantly, but their access to these rates for various reasons, to some extent, and it is important to say that it is not 'Americaness African That's what created this situation. It pretty much of social and economic factors. "He said Lloyd Jones, studies of patients of Hispanic do not have enough follow-up so far to provide a strong risk of life data, but hoped that the data will be available at the end. He expects the long-term risk profile for heart and blood vessels to Asian Americans will be available shortly.Now is the time to address the risk factors"If we can get our young adults who live a healthier life styles and more of them in middle age with optimal [risk factors] levels, that would be fantastic news," said Lloyd Jones. "But if you are in middle age, and you have a risk factor or two or more, it is time to actually address this. You should get [in touch] with the doctor, they are your numbers, and understand where the danger is coming from, and almost certainly You will need to help to control these [risk factors], but no less important in a partnership lifestyle changes to control those things .... It's also a very important partnership .... You can not put horses can be completely in the barn, but you do much to mitigate these risks if you get serious about this matter. "Commenting on the study, said Dr. Aaron Epidemiology Folsum (University of Minnesota, Minneapolis) heartwire ", and the data indicate that the U.S. could eliminate coronary heart disease to a large extent if, through a pattern of life, we can help adults to avoid factors risk in the first place. cardiovascular diseases that are preventable, and we need to be more aggressive in promoting healthy lifestyles among young people, and this shows on the paper aimed at young people should be paid off in the long run, not only in less coronary artery disease , but, on the basis of induction, and also in reducing health care costs. "This study was supported by grants from the National Heart, Lung, and Blood Institute. One of the book does not have any
Missing Data Lead FDA Panel to Vote Against Rivaroxaban for ACS May 23, 2012 (Updated May 24, 2012) (Silver Spring, Maryland) — The missing data issues plaguing the ATLAS ACS 2 TIMI 51 trial of the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the FDA Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting, the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus clopidogrel, or ticlopidine. Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the ATLAS ACS TIMI 46 phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the risk of bleeding and intracranial hemorrhage, but the studies were hindered by early patient withdrawals and missing data. We Don't Know What We're Missing Based on the ATLAS ACS 2 results, FDA reviewer Dr Karen Hicks recommended approval of rivaroxaban for the requested indications except all-cause mortality. However, another FDA reviewer, Dr Thomas Marciniak, was adamant that the trial results are not interpretable because about 12% of the patients had incomplete follow-up, far higher than the 1% to 1.5% differences in the end-point rates between rivaroxaban and placebo. A total of 1294 subjects discontinued the trial prematurely, and the company was only able to contact 183, of which 177 were confirmed to be alive. Because of the patient dropouts, the company adopted a "modified intention-to-treat analysis," whereby patients were observed for 30 days after randomization or the global end date for the trial, instead of observing all the patients until the end of the trial as the FDA originally suggested. Marciniak criticized the sponsor's efforts to follow the patients and said that three patient deaths not counted in the modified intention-to-treat analysis may just be the "tip of the iceberg." Because the percentage of patients whose ultimate vital status remains unknown is much greater than the reported differences in mortality rates, the claimed mortality benefits are not reliable. The majority of the panel sided with Marciniak. For example, Dr Sanjay Kaul (University of California, Los Angeles) voted "no" because "there was enough uncertainty in the quality and robustness of the data that dissuaded me from voting yes. . . . The 'missingness' of the data doesn't invalidate it, but it certainly makes it hard to infer [the conclusion]." Dr Steven Nissen (Cleveland Clinic, OH) said that the decision to use the modified intention-to-treat analysis had a "profound impact" on the interpretability of the data. "It's saying we don't care what happens after 30 days, [and] that colored the trial in ways we couldn't recover from." Given the risk of major bleeding, "I want to see better evidence that this strategy of adding an Xa inhibitor or a direct thrombin inhibitor or something else to a good antiplatelet agent is robustly better for the patient," Nissen said. He recommends that the companies run a new trial of the 2.5 twice-daily dose of rivaroxaban using a strict intention-to-treat approach, but, he said, "I don't expect the death benefit to be too robust." Several panelists said they were concerned that the patients who dropped out of the trial were disproportionately likely to have a bleeding event, which led them to quit the trial, or a "protopathic" event, as statistician Dr Scott Emerson (University of Washington, Seattle) put it. "We're worried that an impending event is what is changing their behavior. We see that all the time in clinical trials--that regularly measured end points do not pick up [all of] the events," he said. He said that since the company was only able to contact 183 of the over 1200 patients who dropped out, it is possible that the dropouts skew the outcomes comparison of the trial. "Differential event rates after dropout are the number-one thing we're afraid of, so you have to explore it" in a statistical sensitivity analysis of the potential impact of these unknown outcomes. "It would not surprise me if, at the end of the day, these data did not hold up under a proper sensitivity analysis," he said. "What I want to know is, among the people who had events, how differential was the follow-up, but I can tell you by just looking at it, there was a very slightly different amount of follow-up of the people in the treatment arm. But I don't know whether everyone in the treatment arm was cured and they were trekking in the Himalayas and everyone in the placebo arm went home to die. I don't know that that's not the case." Dr Maury Krantz (University of Colorado, Denver) voted in favor of approval but said he does not know how rivaroxaban would perform in general clinical practice, especially when used with aspirin and clopidogrel. "I felt very much torn by this. This isn't a simple paradigm shift. It means going to triple therapy, which is really a three-headed monster in many ways. I think that what you're going to see in practice, if this is not done carefully with the proper labeling and secondary studies, is really dramatic magnification of bleeding and perhaps minimization of the efficacy benefit."
May 23, 2012 (Updated May 24, 2012) (Silver Spring, Maryland) — The missing data issues plaguing the ATLAS ACS 2 TIMI 51 trial of the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the FDA Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting , the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus clopidogrel , or ticlopidine . Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the ATLAS ACS TIMI 46 phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the ri...
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