Keeping you up to date on recent headlines in cardiovascular healthcare:
ADHD drugs linked to unexplained deaths, dysrhythmias .... New research supports the view that stimulants prescribed for attention deficit hyperactive disorder (ADHD) may increase the risk of sudden unexplained death in children. The study found the rate of stimulant use in children and adolescents who died suddenly or from cardiac dysrhythmias was 1.8% vs. 0.4% for youths who died in motor vehicle accidents. The researchers collected information from autopsy reports, toxicology results and interviews with parents. Of the final sample of 564 cases, 10 (1.8%) of the sudden unexplained death cases were being treated with a stimulant at the time of death, as compared with only two (0.4%) of the accident victims. The research appears in a June 15 online posting of the American Journal of Psychiatry. (doi:10.1176/appi.ajp.2009.09050619)
FDA urges caution concerning stimulants/child death link .... The study linking ADHD medications with sudden death in children and adolescents (referenced above) was funded by the FDA and the National Institute of Mental Health. But a follow-on statement by the FDA cited the study's limitations – acknowledged by the researchers. And the agency said it was "unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication." Robert Temple, MD, director of medical policy for the FDA's Center for Drug Evaluation, said, "I don't think it makes the case that there is real risk here." He noted that the study relies on just 10 sudden death events of those children on stimulants and the memories of their parents. (Agency perspective: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165858.htm)
Physio-Control named medical device Excellence Award winner .... Physio-Control (Redmond, Washington), a subsidiary of Medtronic (Minneapolis), received a gold Medical Design Excellence Award (MDEA) for its Lifepak 15 monitor/defibrillator at the MDEA ceremony held last week at the Medical Design & Manufacturing East 2009 conference and exposition in New York. The MDEA program recognizes both the design achievements and healthcare contributions of medical product manufacturers. Judges evaluate nominees based on product innovation, overcoming developmental challenges, design and engineering features and the impact made on improving healthcare.
New support for controversial mechanism underlying AF .... Researchers at Baylor College of Medicine (Houston) and Dresden University of Technology (Dresden, Germany) have developed data supporting the hypothesis that the protein CaMKII can enhance RyR2-mediated calcium leak, promoting atrial fibrillation (AF) in mice. The team studied mice engineered to express a mutant form of RyR2 associated with calcium leak; these mice did not spontaneously develop AF but were more likely to develop AF than normal mice if their heart rate was forced up. This was related to the functional interaction of CaMKII with RyR2, and blocking CaMKII function in these mice prevented them from developing atrial fibrillation when their heart rate was forced up. The study appears in the June 15 issue of the Journal of Clinical Investigation. (https://www.the-jci.org/article.php?id=37059)
Psoriasis linked to vascular diseases and death .... Patients with psoriasis are at risk for atherosclerosis and vascular diseases, according to a study analyzing mostly male patients at the Miami Veterans Affairs Medical Center. Researchers looked at 3,236 patients with psoriasis and 2,500 control patients, finding that skin disease was associated with a greater likelihood of ischemic heart disease, cerebrovascular disease, peripheral arterial disease and death. Robert Kirsner, MD, PhD, of the University of Miami, said the result "is not surprising, given the systemic nature of atherosclerosis," The researchers said studies are needed to determine if aggressive treatment of psoriasis or traditional cardiovascular risk factors will improve the total atherosclerotic burden associated with the condition. The study appears in the June issue of Archives of Dermatology (2009; 145: 700-703). (http://archderm.ama-assn.org/cgi/content/short/145/6/700)
Improving uptake in cardiac rehabilitation .... The particular wording of invitations to cardiac rehabilitation can greatly improve the low rate of participation. Two letters were developed, one to influence acceptance and the second to influence attendance. For both, a strategy called the Theory of Planned Behavior was used to develop wording intended to increase attendance at cardiac rehab. Attendance 86% among those receiving the reworded letters compared with 59% in the control group (p<0.002). The effective invitation letters tackled these by promoting the benefits of cardiac rehab, letting the recipients know that influential people (especially their doctors) were keen for them to attend, and emphasizing the ease of taking part. It also helped patients to plan their attendance. The study appears in the British Journal of Cardiology (2009;16(2):57-59).
Phone internet use reduces heart disease risk factors .... A new study indicates that phone and Internet communication between patients and providers reduces the risk factors for heart disease. The study analyzed all published randomized trials evaluating a telephone or internet-based intervention whose end-points were a measure of mortality, changes in levels of risk factors for heart disease, or quality of life. Telehealth interventions were associated with a 30% lower rate of mortality than non-intervention controls, a 1% risk reduction that was not statistically significant. However, there were significant findings in the effect of telehealth on modifiable risk factors for coronary disease, the researchers said, including lower total cholesterol levels in the telehealth patients, lower levels of systolic BP, and fewer people continuing to smoke. There also were favorable effects in levels of physical activity and quality of life. The research appears in the June issue of the European Journal of Cardiovascular Prevention & Rehabilitation (2009; 16; 281-289). (abstract: www.ejcpr.com/pt/re/ejcpr/abstract.00149831-900000000-99916.htm;jsessionid=K5fSy6SMV9qvSZqRJTnB1vnVtzHpLmtjbmQBN5JTpFr16qnphcvT!-514211921!181195628!8091!-1)
Study shows how stroke affects hand function .... A person whose hand function has been impaired by stroke can release an object more quickly when the affected arm is supported on a platform, but the support does not make it easier to grip the object, according to a new study. The study also found that active muscle-stretching exercises improved how quickly the stroke survivor could grip an object, but made release of the object more difficult. The researchers hypothesize that the exercises activate muscles, making it easier to grip but more difficult to relax the muscles, which makes it harder to release. The study, "Delays in grip initiation and termination in persons with stroke: Effects of arm support and active muscle stretch exercise," appears in the current online edition of the Journal of Neurophysiology.
First subject enrolled in second Phase II venous leg ulcer trial ... Healthpoint (Fort Worth, Texas) reported enrolling the first of 235 subjects in a Phase II dose-response study investigating a cell-based wound therapy HP802-247 for the treatment of venous leg ulcers. HP802-247 is a topical spray 247 utilizing allogeneic cells, living human cells derived from an individual donor that are subsequently grown in a tissue culture, and then applied to an unrelated patient. The first patient was enrolled at the Center for Clinical Research (San Francisco). The trial is the second planned-dose response trial evaluating the benefits/safety of enhancing wound healing by using metabolically active donor cells. The cells are sprayed onto the wound surface in a self-polymerizing protein mesh intended to help the cells to adhere to the tissue. (www.healthpoint.com/)
— Compiled by Don Long, MDD National Editor