January 19, 2012 (Houston, Texas) - A New advice suggests that sexual activity is safe for most patients with heart disease that doctors and patients and their partners should seek to debate the subject of sex [1]. The guidelines come from the first time, the American Heart Association (AHA) scientific statement on this issue, which is published online today in circulation.Lead author Dr Glenn N Levine (Baylor College of Medicine, Houston, TX) told heartwire that the guidelines are probably the most comprehensive on the subject to date and has been collected from various areas of expertise, including cardiology, exercise physiology, sexual counseling, and urology. Doctors, patients and partners do not want to talk about sexual activity, but it is something, which is an important quality of life for many people and we do not want to see patients to abstain from sex, from concern about the need to speed up the heart attack or sudden death, "- he notes.Only those patients who should abstain from sex with unstable heart disease or severe symptoms, they should be assessed and stabilized with appropriate treatment prior to sexual activity - Levine says. The drugs that can improve cardiovascular symptoms or survival should not be abandoned due to concerns that they may have an effect on sexual function - he notes.He also points out that while the use of phosphodiesterase-5 inhibitors (PDE-5), erectile dysfunction medications such as sildenafil (Viagra, Pfizer) is generally safe for men with stable cardiovascular disease, these drugs are absolutely contraindicated in patients taking nitrate therapy or long-acting preparations, or sublingual ones.Fear, anxiety and depression may lie to avoid GenderAHA recommendations are general guidelines of sexual activity and CVD, but also advice related to specific conditions: coronary artery disease, heart failure, valvular heart disease, those with heart rhythm and heart pacemakers or implantable cardioverter defibrillator ICDS) in patients with congenital heart disease and hypertrophic cardiomyopathy. And it includes the cardiovascular drugs and sexual function, as well as pharmacotherapy, sexual dysfunction.One of the main points of this statement, that doctors and health care providers know that this is a real problem that is not properly deal with the patient and partner and really should be, "- says Levine."At the same time, because we get a lot of unprofessional media attention to this problem - we hope that patients and their partners are aware that sexual activity is something they should feel free to visit the office to discuss with their health care providers, or until discharge from the hospital."It is important to emphasize is that the sexual intercourse the risk of heart attack is only a very slight increase in sexual activity and make only the minimum personal information overall level of risk.""Levine also want to emphasize the fact that anxiety and depression should be very important with regard to cardiovascular disease patients and may contribute to reduced or impaired sexual activity." Sexual counseling of compensating patients and their partners is an important component of recovery, unfortunately rarely, "- he and his co-authors to follow.Tips Help All doctors advise patients of compensation for sexThe scientific statement was published in the journal of cardiology, Levine noted cardiologist, because "going to be asked to comment on this, and often the GP will often refer to a cardiologist the patient deal with issues" related to sexual intercourse, he comments. For example, for one thing, it is often consulted by other physicians and patients can use in erectile dysfunction-drugs.However, Levine hopes that the new guidelines will encourage other professionals to ensure patient: "One of the goals is to allow general practitioners, family physicians, and others, at least for the majority of patients based guidelines."Another important aspect raised by the AHA statement, which was also confirmed by the American Urological Association, Society for Cardiovascular Angiography and interventions, Chest Surgery Society, the American heart and lung Rehabilitation Association, International Sexual Medicine Society, the American College of Cardiology Foundation, Heart Rate society, and heart failure Society of America - is that the heart of rehabilitation and regular physical activity can reduce cardiovascular complications in people with heart disease.Exercise testing can also provide additional information for an indefinite or uncertain-risk patients, the safety of sexual intercourse with the authors stress.They concluded that further research is needed on sexual activity in specific cardiovascular conditions, particularly in regard to women and older people.
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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