CardioSource WorldNews December 2014 - Page 38

Positive News on Negative Trials It was a coincidence, but the day after AHA ended – with its surfeit of intriguing negative trials – the National Institutes of Health (NIH) and the US Department of Health and Human Services proposed new rules that would give more public access to data from clinical trials – even negative trials. The changes would expand the number of trials requiring investigators to publish summaries of their results to ClinicalTrials.gov. If you think of the website more as providing details of study design and methodology, you are not alone. Currently, there are 178,000 clinical trials registered on the website and, of those, just 15,000 include a summary of their results, according to the NIH. Margaret Hamburg, MD, commissioner of the US Food and Drug Administration, said the new rules would close an important gap and help eliminate unnecessary duplication of clinical trials. This is particularly important when negative results haven’t been published about a drug that may be unsafe or ineffective. Summaries of findings would generally be due within a year of an NIHfunded study’s end, including summaries even for unapproved, unlicensed, and uncleared products. (Phase I studies would be excluded, however.) Public comments on the proposed rule changes are being accepted through February 19, 2015. both lower-risk individuals as well as those at high risk of infective endocarditis (FIGURE).” Although there is a temporal association, for sure – the change point for the uptick in IE was 3 months after the guidelines were published in the U.K. -- Mark Dayer, MBBS, BSc, PhD, who presented the data, admitted “we cannot conclude there is a cause/effect relationship.” On the other hand, he added, “We have been unable to establish an alternative explanation.” Valentin Fuster, MD, PhD, editor-in-chief of the Journal of the American College of Cardiology, noted that this news is “a real hit in the head” and we should think again about the recommendations for antibiotic prophylaxis for IE prevention. No Go with Low-do(se) Aspirin in Primary Prevention Of all the negative trials, one of the most striking was the broad failure of low-dose aspirin for primary prevention. About 15,000 patients were randomized, but Kazuyuki Shimada, MD, Shinoyama City Hospital, Tokyo, Japan, said, “Primary prevention of atherosclerotic events with daily lowdose aspirin did not reduce the combined risk of death from cardiovascular causes, nonfatal stroke, and nonfatal MI in this elderly Japanese population, but it did increase the risk of serious extracranial hemorrhage.” The good news: the CV event rate was <1% per year, so “that means that the benefits of aspirin are likely to be low,” explained Dorairaj Prabhakaran, MD, Public Health Foundation of India. Save the Imaging: Screening for CAD in Patients with Diabetes Fails Given the added risk of diabetes in patients with coronary artery disease (CAD), it sure makes sense to see whether routine screening for CAD by cardiac computed tomography angiography (CCTA) in higher-risk patients with diabetes mellitus (DM) but no signs or symptoms of cardiovascular disease (CVD) improves upon guidelines-directed optimal diabetes care. “Among asymptomatic patients with type 1 or type 2 diabetes, screening for coronary artery disease by CCTA did not reduce the composite rates of all-cause mortality, nonfatal MI, or hospitalization for unstable angina at 4 years despite differential use of coronary interventions and favorable trends in lipids and blood pressure,” said Joseph Muhlstein, MD, University of Utah, Murray, Utah. The good news is that aggressive risk factor management works. Despite finding moderate-to- severe CAD in 1 of every 5 study participants as well as a high Agatston score in 4 out of 10 asymptomatic patients with DM, the event rates in both arms were low, approximately 0.5% annual rate of MI. Dr. Muh