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Discovery of blood pressure genes could help prevent cardiovascular disease

Findings, published today in Nature and Nature Genetics (11/9/2011) by the International Consortium for Blood Pressure Genome-Wide Association Studies represent a major advance in our understanding of the inherited influences on blood pressure and offer new potential therapeutic targets for prevention of heart disease and stroke – the biggest cause of death worldwide.

Research published in Nature and co-led by scientists from Queen Mary, University of London has discovered 16 new gene regions that influence blood pressure.

Toby Johnson, Patricia Munroe and Mark Caulfield from Barts and The London Medical School co-led with US and European colleagues an international collaborative study involving 351 scientists from 234 institutions based in 24 countries around the world. This study analysed data on over 270,000 people to find genetic variations in the DNA of each person that were associated with higher or lower blood pressure. This enabled them to identify 16 new gene regions influencing blood pressure and provided confirmation of 12 other gene regions that had previously been discovered by the Barts and The London team.

The researchers then combined the effects of genetic variation in all 28 gene regions and showed that these impact upon the risk of developing hypertension, stroke, coronary heart disease, and structural changes in the heart. The combined effect of these variations on blood pressure is similar to the effect of a standard blood pressure lowering medicine. Importantly, they showed that genetic effects on blood pressure are broadly similar in people of European, East Asian, South Asian, and African ancestries.

Blood pressure is influenced by a combination of lifestyle factors and genes which until now have proved challenging to identify. Even small changes in blood pressure can increase risk of stroke and heart attack and over one billion people worldwide have high blood pressure – hypertension.

Professor Mark Caulfield, who is also President of the British Hypertension Society, said: “High blood pressure affects a quarter of the adult population in the UK. These new gene regions we report today offer a major leap forward in our understanding of the inherited influences on blood pressure and offer new potential avenues for treatment which is particularly welcome for those who do not achieve optimal blood pressure control.”

Professor Patricia Munroe said: “This large multicentre collaboration has yielded many new genes for blood pressure, determining which gene and their function will improve our understanding of the basic architecture of hypertension, and should facilitate new therapeutic drug development.”

Dr Toby Johnson said: “There were enormous challenges to overcome in collecting and analysing the amount of data we needed for this study. Our discoveries illustrate the power of international collaborative research.”

A related study published today, in Nature Genetics and co- led by Louise Wain and Martin Tobin from the University of Leicester, and Paul Elliott from Imperial College London, reports on the identification of gene regions for two further types of blood pressure measurement; pulse pressure (PP) and mean arterial pressure (MAP). Both measurements can predict hypertension and cardiovascular disease. The research uncovered four new gene regions for pulse pressure and two for mean arterial pressure indicating novel genetic mechanisms underlying blood pressure variation.

Louise Wain (University of Leicester) said: “Our study shows the importance of looking at different measures of blood pressure in order to identify new genetic variants that affect levels of blood pressure in the population.”

Paul Elliott (Imperial College London) said: “Pulse pressure is a marker of the stiffness of the arteries that carry blood from the heart round the body. Our results could help understanding about the genetic mechanisms underlying relationships of pulse pressure with risk of heart disease and stroke.”

These important findings published in Nature and Nature Genetics were made possible by funding from the Wellcome Trust, the Medical Research Council, the British Heart Foundation, and the National Institute for Health Research, and provide greater understanding of the genetic architecture of blood pressure, a key determinant of cardiovascular health.

Contact: Alex Fernandes
press@qmul.ac.uk
44-207-882-7910
Queen Mary, University of London

US investment in health research remains stagnant

Aggressive medical therapy could help prevent stroke

To prevent a common type of stroke, intensive medical therapy could be better by itself than in combination with surgery that props open affected arteries. But it remains to be seen whether the apparent advantage will prove true over the long term.

The findings, from a national clinical trial conducted by University of Florida researchers and colleagues, will be published online in The New England Journal of Medicine online on Wednesday, Sept. 7.

Against expectations, the short-term risk of stroke and related death was twice as high in some cases for patients whose diseased arteries were widened via balloon angioplasty and stent insertion, compared with patients who received medical therapy alone. Although the 30-day risk of stroke for the stenting patients is concerning, long-term results could be more favorable, the researchers said.

“Five years from now, who will be doing better – the patients who are being medically managed, or those who received a stent?” said study co-author Michael F. Waters, M.D., Ph.D., director of the Shands at UF Stroke Program, who along with Brian L. Hoh, M.D., the William Merz associate professor of neurological surgery in the College of Medicine, led the UF portion of the trial.

The study will have a substantial impact on clinical practice and research, the researchers said, because it is the first randomized stroke trial to pit stenting against nonsurgical treatment for symptomatic intracranial atherosclerosis, a type of stroke caused by artery blockage in the brain. Early results clearly show that intensive medical management is key to improving health, the researchers said.

“This study provides an answer to a longstanding question by physicians – what to do to prevent a devastating second stroke in a high-risk population. Although technological advances have brought intracranial stenting into practice, we have now learned that when tested in a large group this particular device did not lead to a better health outcome,” said Walter Koroshetz, M.D., deputy director of the NIH National Institute of Neurological Disorders and Stroke, which funded the clinical trial.

Every 40 seconds, someone in the U.S. has a stroke. Stroke is the fourth leading cause of death and a leading cause of disability in the U.S. Almost 800,000 people a year have a new or recurring stroke, according to the American Heart Association. With higher than average rates of stroke and related deaths, parts of the southeastern U.S. are together termed the “Stroke Belt.”

Patients with the type of stroke known as symptomatic intracranial atherosclerosis do not respond well to existing treatments. One-quarter of those patients have another stroke within 12 months, and the risk of additional strokes continues in subsequent years. Doctors are unsure what the best course of treatment is.

To find out, the UF researchers and colleagues launched a clinical trial, nicknamed SAMMPRIS, at 50 sites around the country, including at the Medical University of South Carolina, the lead site. The study recruited 451 participants age 30 to 80 who had at least 70 percent narrowing in the arteries in the brain, and had experienced symptoms within the previous 30 days. UF recruited the second-highest number of patients among all sites, through its stroke program, which has been designated a Comprehensive Stroke Center by the Agency for Health Care Administration.

Patients in one group were randomly assigned to receive intensive management involving smoking cessation and medications for blood pressure, cholesterol, diabetes and blood-clot prevention. A second group of patients had that same medical treatment but also had balloon angioplasty and stent implantation into the affected brain artery to improve blood flow.

Almost 15 percent of patients who received stents had a stroke or died within 30 days of enrolling in the study, compared with just under 6 percent of patients in the medical therapy group. The stark difference between the groups persisted almost a year, by which time about 21 percent of patients who had received stents had had negative effects, compared with 12 percent in the medical group.

The researchers initially thought that patients who received stents would have fared better, given the successful use of similar procedures in clinical practice at the Shands at UF Stroke Program and other medical centers.

But the striking difference between the two patient groups prompted the study’s independent safety monitoring body to call off new recruitment. The researchers will, however, continue to monitor previously enrolled patients for the next two years.

It’s not unusual for surgical patients to have more complications at first, the researchers said. That’s because the invasiveness of surgery poses an inherent risk regardless of the illness being treated.

“The real question is, is there a benefit to patients over the long term,” said study co-author and co-principal investigator Hoh, who is an associate professor of radiology and neuroscience in the UF College of Medicine. “If you think about it, when people are concerned about stroke, it’s not just their first month that matters, so we’re waiting to see what the longer-term results will be.”

Over time, improvement of stent design and honing of surgical techniques could help improve outcomes for patients.

“This is certainly not the final say on managing this disease,” Waters said. “This is another piece of the puzzle that helps to guide our hand.”

Contact: Czerne M. Reid
czerne@ufl.edu
352-273-5814
University of Florida

New half-match bone marrow transplant procedure yields promising outcomes for cancer patients

Half-matched bone marrow or stem cell transplants for blood cancer patients have typically been associated with disappointing clinical outcomes. However, a clinical trial conducted at the Kimmel Cancer Center at Jefferson testing its unique, two-step half-match procedure has produced some promising results: the probability of overall survival was 45 percent in all patients after three years and 75 percent in patients who were in remission at the time of the transplant.

Reporting in the journal Blood in a published-ahead-of-print article dated August 25, Neal Flomenberg, M.D., Chair of the Department of Medical Oncology at Thomas Jefferson University Hospital, Dolores Grosso, DNP, Co-Principal Investigator and lead author of the article, and colleagues discuss the results of 27 patients treated on this phase I/II trial who had diagnoses that included leukemia, lymphoma and myelodysplasia.

The patients received their transplant in two steps. First, after receiving radiation therapy to further treat their disease, the patients were given a specified dose of T cells (a type of immune cell that fights infection) from their half-matched family donor. The donors were parents, siblings or children of the patient. The patients next received the drug cyclophosphamide to help the newly infused donor T cells to be more tolerant to the patient’s body. The second step of the transplant occurred when the patients received a dose of their donors’ stem cells to help their blood counts return to normal and further strengthen their new immune system.

Dr. Flomenberg and his team found that after a follow-up of 28-56 months, overall survival for the patients after one year was 54 percent and 48 percent at three years. Patients in remission at the time of the transplant fared better with an overall survival of 75 percent. Seventeen of the 27 patients—with a median age of 52 years old—were alive six months after their transplant, which was the official end point of the trial.

While more recent studies have shown promising increases in overall survival for patients undergoing half-match transplants, historically, clinical outcomes for these types of transplants have been poor, which has limited the use of this type of procedure.

The results of the Jefferson trial represent a very promising improvement in this area.

Bone marrow or stem cell transplants are performed in order to replace a patient’s diseased immune system with that of a healthy donor. Traditionally, the use of a genetically fully matched donor has been associated with the best results in bone marrow transplant, but many patients lack a fully-matched related or unrelated donor. Almost every patient will have a half-matched donor (also known as a haploidentical donor) in their family, however.

The successful use of haploidentical donors would greatly expand the number of donors available to a patient, extending this therapy to almost everyone who would benefit from receiving a transplant. This would include minority patients, including patients with sickle cell anemia, who do not have as many fully-matched unrelated donors available to them.

“Our half-match bone marrow transplant results open up many doors for different types of patients who can’t find an exact match,” said Dr. Flomenberg. “It also justifies recommending that patients at high risk for relapse should consider having a half-match transplant early in the treatment of their disease.”

“Jefferson’s two-step procedure provides promising results that could serve as the basis for further exploration and optimization of the technique,” he added.

Jefferson medical oncologists’ approach is unique in that the dosage, timing and treatment of donor T cells was carefully controlled and optimized. No other transplant regimen controls the exact amount of donor T cells given. The investigators believe that dosing the T cells in this way helped avoid many of the life-threatening side effects of this type of transplant.

“We believe the dosage and timing of T cells from the donor into the patient is essential for success. In fact, it’s equally as important as prescribing specific doses of radiation and chemotherapy to initially treat the disease,” said Dr. Grosso. “The goal of this two-step regimen was to develop a better technique for half-matched patients with relapsed blood cancers initially, but we also showed that it can be appropriate for high risk patients earlier in their disease who lacked fully matched donor options.”

Contact: Steve Graff
stephen.graff@jefferson.edu
215-955-6300
Thomas Jefferson University

It’s official — chocolate linked to heart health

High levels of chocolate consumption might be associated with a one third reduction in the risk of developing heart disease, finds a study published on bmj.com today.

The findings confirm results of existing studies that generally agree on a potential beneficial link between chocolate consumption and heart health. However, the authors stress that further studies are now needed to test whether chocolate actually causes this reduction or if it can be explained by some other unmeasured (confounding) factor.

The findings will be presented at the European Society of Cardiology Congress in Paris at 10:10 hrs (Paris time) / 09:10 hrs (UK time) Monday 29 August 2011.

The World Health Organisation predicts that by 2030, nearly 23.6 million people will die from heart disease. However, lifestyle and diet are key factors in preventing heart disease, says the paper.

A number of recent studies have shown that eating chocolate has a positive influence on human health due to its antioxidant and anti-inflammatory properties. This includes reducing blood pressure and improving insulin sensitivity (a stage in the development of diabetes).

However, the evidence about how eating chocolate affects your heart still remains unclear. So, Dr Oscar Franco and colleagues from the University of Cambridge carried out a large scale review of the existing evidence to evaluate the effects of eating chocolate on cardiovascular events like heart attack and stroke.

They analysed the results of seven studies, involving over 100,000 participants with and without existing heart disease. For each study, they compared the group with the highest chocolate consumption against the group with the lowest consumption. Differences in study design and quality were also taken into account to minimise bias.

Five studies reported a beneficial link between higher levels of chocolate consumption and the risk of cardiovascular events and they found that the “highest levels of chocolate consumption were associated with a 37% reduction in cardiovascular disease and a 29% reduction in stroke compared with lowest levels.” No significant reduction was found in relation to heart failure.

The studies did not differentiate between dark or milk chocolate and included consumption of chocolate bars, drinks, biscuits and desserts.

The authors say the findings need to be interpreted with caution, in particular because commercially available chocolate is very calorific (around 500 calories for every 100 grams) and eating too much of it could in itself lead to weight gain, risk of diabetes and heart disease.

However, they conclude that, given the health benefits of eating chocolate, initiatives to reduce the current fat and sugar content in most chocolate products should be explored.

Contact: Jacqueline Partarrieu
press@escardio.org
33-633-473-335
European Society of Cardiology

Apixaban proves superior to warfarin for preventing stroke, reducing bleeding and saving lives

A large-scale trial finds that apixaban, a new anticoagulant drug, is superior to the standard drug warfarin for preventing stroke and systemic embolism in patients with atrial fibrillation. Moreover, apixaban results in substantially less bleeding and also results in lower mortality.

The results were presented by Duke University Medical Center researchers at the European Society of Cardiology in Paris, France, today, and published simultaneously online in the New England Journal of Medicine.

“These are important findings because they show that, when compared to warfarin, a very effective treatment to prevent stroke, apixaban resulted in an additional 21 percent relative reduction in stroke or systemic embolism,” says Christopher B. Granger, M.D., the study’s lead author and professor of medicine at Duke. “It also resulted in a 31 percent relative reduction in major bleeding, as well as an 11 percent relative reduction in overall mortality.”

The improvement in stroke prevention was statistically significant with P=0.011, the lower rate of major bleeding at P<0.001, and the lower mortality at P=0.047. Hemorrhagic stroke was reduced by about 50%.

The randomized, double-blind clinical trial known as ARISTOTLE randomized 18,201 patients at 1034 clinical sites in 39 countries, giving them either 5 mg twice daily of apixaban or warfarin for an average of 1.8 years.

Apixaban has several major practical advantages over warfarin in addition to the therapeutic benefits, says John Alexander, M.D., a study co-author and Duke cardiologist. “It does not require monitoring and has few interactions with other medications or food. Apixaban was better tolerated than warfarin, with fewer discontinuations.”

The benefits of reducing stroke and lower rates of bleeding were consistent across all major subgroups, and despite the heterogeneity that exists in the quality of warfarin use across the world, says Alexander.

The number of events prevented per 1,000 people, which indicate absolute risk reduction, was also impressive, says Alexander. Apixaban prevented 6 patients from having a stroke, 15 patients from having major bleeding, and 8 patients from dying. The major effect on stroke prevention was on hemorrhagic stroke. Apixaban prevented 4 patients from having hemorrhagic stroke and 2 patients from having an ischemic or uncertain type of stroke.

Atrial fibrillation is a common abnormal heart rhythm that affects more than 2.6 million Americans. It occurs when the heart’s electrical activity becomes disorganized, resulting in an irregular heartbeat with ineffective contraction of the upper chambers of the heart. The potential for blood clots to form, and one’s risk for stroke, increases as a result.

Warfarin is a vitamin K antagonist that is well documented for its ability to prevent blood clots. Previous studies indicate that long-term use of warfarin in patients with atrial fibrillation and other stroke risk factors can reduce stroke by up to 70 percent. But only about half of patients who could benefit from warfarin actually do. Patients on warfarin must have regular blood tests to monitor and adjust the dose and avoid certain foods and medications that interfere with warfarin’s effect. Warfarin also increases bleeding rusj including including intracranial hemorrhage.

“There is an enormous unmet need for treatment of patients at risk for stroke associated with atrial fibrillation,” says Granger. “Only about half of patients who should be treated are being treated. The disparity exists because warfarin treatment has several limitations.”

Doctors and patients have been eagerly awaiting alternative therapies to warfarin, one of which is currently available. Several others are currently under investigation in large clinical trials.

Apixaban is an oral direct factor Xa inhibitor that showed promise last year when trial findings presented at the European Society of Cardiology showed apixaban patients were 54 percent less likely to have a stroke or blood clot than those who took aspirin. Apixaban and aspirin showed similar risks of major bleeding.

“Our study indicates treatment with apixaban is more effective than warfarin in preventing stroke without the need for anticoagulation monitoring,” says Lars Wallentin, M.D., the study committee’s co-chair, professor of cardiology, and director of the Uppsala Clinical Research Center University Hospital in Sweden.

The study also shows apixaban is safer than warfarin, according to Wallentin. “Our findings show a single dose of apixaban accomplishes the same stroke prevention goal as adjusted-dose warfarin with a substantially lower risk of all types of bleeding across different ages, and with lower rates of discontinuation.”

The study was coordinated by Uppsala Clinical Research Institute, Sweden and the Duke Clinical Research Institute.

It was funded by Bristol-Myers Squibb, Co and Pfizer Inc.

Additional study authors include: John J. V. McMurray, M.D., Cardiovascular Research Centre, University of Glasgow; Renato Lopes, DCRI; Elaine Hylek, Boston University; Michael Hanna, BMS; Hussein Al-Khalidi, DCRI; Jack Ansell, Lenox Hill Hospital; Dan Atar, Oslo University Hospital; Alvaro Avezum, Dante Pazzanese Institute of Cardiology; M. Bahit, ECLA Estudios Cardiologicos Latinoamerica; Rafael Diaz, ECLA Estudios Cardiologicos Latinoamerica; J. Donald Easton, Brown University; Justin Ezekowitz, University of Alberta; Greg Flaker, University of Missouri Health Care; David Garcia, University of New Mexico; Margarida Geraldes, BMS; Bernard Gersh, Mayo Clinic; Sergey Golitsyn, Russian Cardiology Research Center; Shinya Goto, Tokai University School of Medicine; J. Antonio Gonzalez-Hermosillo; Instituo N de Cardiologia Ignacio Chavez; Stefan Hohnloser, J.W. Goethe University; John Horowitz, University of Adelaide; Puneet Mohan, BMS; Petr Jansky, Motol University Hospital; Basil Lewis, Lady Davis Carmel Medical Center; Jose Lopez-Sendon, La Paz University Hospital; Prem Pais, St. John’s Medical College; Alexander Parkhomenko, Institute of Cardiology; Freek Verheugt, Radboud University Nijmegen Medical Centre; Jun Zhu, Fuwai Hospital

Contact: Debbe Geiger
Debbe.Geiger@duke.edu
919-660-9461
Duke University Medical Center

New study finds no nutritional difference between free-range and cage-produced eggs

Eggs produced by free-range hens are often perceived by the public to be nutritionally superior to eggs obtained from layers kept in traditional battery cages. However, a recent scientific study has called this popular perception into question by finding essentially no differences in the nutritional quality of eggs produced by hens from both management systems, said the Poultry Science Association (PSA).The findings also showed that cholesterol levels in all eggs were lower than U.S. Department of Agriculture guidelines, prompting the USDA to review and revise downward its estimates for average cholesterol levels in eggs.

The study, “Comparison of Fatty Acid, Cholesterol, and Vitamin A and E Composition in Eggs from Hens Housed in Conventional Cage and Range Production Facilities,” appeared in the July issue of Poultry Science, a journal published by PSA. Its author, Dr. Kenneth E. Anderson, a Professor in the Department of Poultry Science at North Carolina State University, collected data for the study in 2008 and 2009. The study was conducted concurrently with the North Carolina Layer Performance and Management Test (NCLP&MT), which evaluates the major commercial layer lines used in the United States.

“The key take away from this research is that an egg, no matter where it’s produced, is a very nutritious product. Eggs from a range production environment did have higher levels of total fat than eggs produced by caged hens, but they did not have higher levels of cholesterol. Perhaps the most striking finding was that both cage- and range-produced eggs actually have lower cholesterol levels than previously believed, which has led the USDA to lower the cholesterol guidelines for eggs in the USDA Nutrient Database for shell eggs to 185 mg per egg, down from 213 mg,” said Dr. Anderson.

Research Framework

Dr. Anderson conducted his study in North Carolina using more than 400 Hy-Line Brown pullets. The pullets were raised in accordance with the laying environment (range or cage) in the 37th NCLP&MT. All of the pullets in the study were hatch mates. Identical rearing dietary programs were used for both the range and cage pullets, with the only difference being the access the latter group had to the range paddock, a common hay mixture for North Carolina comprising both warm- and cool-season forages.

Pullets designated for the range facilities were brooded on litter until 12 weeks of age and then moved to a range environment. At 17 weeks, they were then moved to one of three production range paddocks. A parallel pattern was followed for the cage hens, which were reared in a cage rearing facility, and then at 17 weeks assigned to one of three groups of laying cages. All other rearing parameters were maintained as similar as possible.

Research Findings

Egg samples were collected at 50, 62, and 74 weeks of age during the productive life of the flock and sent to four different laboratories commonly used for egg nutrient analysis. The results showed no influence of housing environment (range or cage) on egg levels of vitamin A or vitamin E. However, β-carotene levels were higher in the range eggs, which, according to Dr. Anderson, may have contributed to the darker colored yolks observed in these eggs during the study. The study also found no difference in cholesterol content between range- and cage-produced eggs. Based on these results, Dr. Anderson concluded that “a significant nutritional advantage of eggs produced by chickens housed on range versus in cages could not be established.”

About PSA

The Poultry Science Association (PSA) is a global scientific society dedicated to the discovery and dissemination of knowledge generated by poultry research – knowledge that enhances human and animal health and well-being and provides for the ethical, sustainable, and economical production of food. Founded in 1908, PSA has a global membership of about 2,000. For more information, go to www.poultryscience.org.

About the American Egg Board (AEB)

AEB is the U.S. egg producer’s link to the consumer in communicating the value of The incredible edible egg™ and is funded from a national legislative checkoff on all egg production from companies with greater than 75,000 layers, in the continental United States. The board consists of 18 members and 18 alternates from all regions of the country who are appointed by the Secretary of Agriculture. The AEB staff carries out the programs under the board direction. AEB is located in Park Ridge, Ill. Visit www.IncredibleEgg.org for more information.

About the Egg Nutrition Center (ENC) The Egg Nutrition Center (ENC) is the health education and research center of the American Egg Board. Established in 1979, ENC provides science-based information to health promotion agencies, physicians, dietitians, nutritional scientists, media and consumers on issues related to egg nutrition and the role of eggs in the American diet. ENC is located in Park Ridge, IL. Visit www.eggnutritioncenter.org or www.nutritionunscrambled.com for more information.

Contact:
Egg Nutrition Center
Egg Nutrition News Bureau
312-233-1211
info@incredible-egg.org

Results of medication studies in top medical journals may be misleading to readers

Studies about medications published in the most influential medical journals are frequently designed in a way that yields misleading or confusing results, new research suggests.

Investigators from the medical schools at UCLA and Harvard analyzed all the randomized medication trials published in the six highest-impact general medicine journals between June 1, 2008, and Sept. 30, 2010, to determine the prevalence of three types of outcome measures that make data interpretation difficult.

In addition, they reviewed each study’s abstract to determine the percentage that reported results using relative rather than absolute numbers, which can also be a misleading.

The findings are published online in the Journal of General Internal Medicine.

The six journals examined by the investigators— the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, the Annals of Internal Medicine, the British Medical Journal and the Archives of Internal Medicine — included studies that used the following types of outcome measures, which have received increasing criticism from scientific experts:

Surrogate outcomes (37 percent of studies), which refer to intermediate markers, such as a heart medication’s ability to lower blood pressure, but which may not be a good indicator of the medication’s impact on more important clinical outcomes, like heart attacks.

Composite outcomes (34 percent), which consist of multiple individual outcomes of unequal importance lumped together — such as hospitalizations and mortality — making it difficult to understand the effects on each outcome individually.

Disease-specific mortality (27 percent), which measures deaths from a specific cause rather than from any cause; this may be a misleading measure because, even if a given treatment reduces one type of death, it could increase the risk of dying from another cause, to an equal or greater extent.

“Patients and doctors care less about whether a medication lowers blood pressure than they do about whether it prevents heart attacks and strokes or decreases the risk of premature death,” said the study’s lead author, Dr. Michael Hochman, a fellow in the Robert Wood Johnson Foundation Clinical Scholars Program at the David Geffen School of Medicine at UCLA’s division of general internal medicine and health services research, and at the U.S. Department of Veterans Affairs’ Los Angeles Medical Center.

“Knowing the effects of a medication on blood pressure does not always tell you what the effect will be on the things that are really important, like heart attacks or strokes,” Hochman said. “Similarly, patients don’t care if a medication prevents deaths from heart disease if it leads to an equivalent increase in deaths from cancer.”

Dr. Danny McCormick, the study’s senior author and a physician at the Cambridge Health Alliance and Harvard Medical School, added: “Patients also want to know, in as much detail as possible, what the effects of a treatment are, and this can be difficult when multiple outcomes of unequal importance are lumped together.”

The authors also found that trials that used surrogate outcomes and disease-specific mortality were more likely to be exclusively commercially funded — for instance, by a pharmaceutical company.

While 45 percent of exclusively commercially funded trials used surrogate endpoints, only 29 percent of trials receiving non-commercial funding did. And while 39 percent of exclusively commercially funded trials used disease-specific mortality, only 16 percent of trials receiving non-commercial funding did.

The researchers suggest that commercial sponsors of research may promote the use of outcomes that are most likely to indicate favorable results for their products, Hochman said.

“For example, it may be easier to show that a commercial product has a beneficial effect on a surrogate marker like blood pressure than on a hard outcome like heart attacks,” he said. “In fact, studies in our analysis using surrogate outcomes were more likely to report positive results than those using hard outcomes like heart attacks.”

The new study also shows that 44 percent of study abstracts reported study results exclusively in relative — rather than absolute — numbers, which can be misleading.

“The way in which study results are presented is critical,” McCormick said. “It’s one thing to say a medication lowers your risk of heart attacks from two-in-a-million to one-in-a-million, and something completely different to say a medication lowers your risk of heart attacks by 50 percent. Both ways of presenting the data are technically correct, but the second way, using relative numbers, could be misleading.”

Still, the authors acknowledge that the use of surrogate and composite outcomes and disease-specific mortality is appropriate in some cases. For example, these outcomes may be preferable in early-phase studies in which researchers hope to quickly determine whether a new treatment has the potential to help patients.

To remedy the problems identified by their analysis, Hochman and McCormick believe that studies should report results in absolute numbers, either instead of or in addition to relative numbers, and that committees overseeing research studies should closely scrutinize study outcomes to ensure that lower-quality outcomes, like surrogate makers, are only used in appropriate circumstances.

“Finally, medical journals should ensure that authors clearly indicate the limitations of lower-quality endpoints when they are used — something that does not always occur,” McCormick said.

The authors did not receive any internal or external funding for this research.

The Robert Wood Johnson Foundation focuses on the pressing health and health care issues facing our country. As the nation’s largest philanthropy devoted exclusively to improving the health and health care of all Americans, the Foundation works with a diverse group of organizations and individuals to identify solutions and achieve comprehensive, meaningful and timely change. For more than 35 years, the Foundation has brought experience, commitment, and a rigorous, balanced approach to the problems that affect the health and health care of those it serves. When it comes to helping Americans lead healthier lives and get the care they need, the Foundation expects to make a difference in your lifetime.

General Internal Medicine and Health Services Research is a division within the Department of Medicine at the David Geffen School of Medicine at UCLA. It provides a unique interactive environment for collaborative efforts between health services researchers and clinical experts with experience in evidence-based work. The division’s 100-plus clinicians and researchers are engaged in a wide variety of projects that examine issues related to access to care, quality of care, health measurement, physician education, clinical ethics and doctor/patient communication. The division’s researchers have close working relationships with economists, statisticians, social scientists and other specialists throughout UCLA and frequently collaborate with their counterparts at the RAND Corp and Charles Drew University.

Cambridge Health Alliance is an innovative, award-winning health system that provides high quality care in Cambridge, Somerville, and Boston’s metro-north communities. It includes three hospital campuses, a network of primary care and specialty practices, the Cambridge Public Health Dept., and the Network Health plan. CHA is a Harvard Medical School teaching affiliate and is also affiliated with Harvard School of Public Health, Harvard School of Dental Medicine, and Tufts University School of Medicine.

For more news, visit UCLA Newsroom and UCLA News|Week and follow us on Twitter.

Contact: Enrique Rivero
erivero@mednet.ucla.edu
310-794-2273
University of California – Los Angeles Health Sciences

HIV infection rates are on the rise

Since HIV infection rates began to rise again around 2000, researchers have been grasping for answers on what could be causing this change, especially in the homosexual community. The rising numbers are a stark contrast to the 1990′s, when infection rates dropped due to increased awareness of the virus. A new study in Israel reveals that the number of new HIV cases diagnosed each year in the last decade saw a startling increase of almost 500% compared to the previous decade, and similar trends have been reported in a number of other developed nations, including the U.S.

According to Prof. Zehava Grossman of Tel Aviv University’s School of Public Health at the Sackler Faculty of Medicine and the Central Virology Laboratory of the Ministry of Health, a new approach to studying HIV transmission within a community has yielded a disturbing result. By cross-referencing several databases and performing a molecular analysis of the virus found in patients, an astonishingly high number of newly-diagnosed men with male sexual partners were found to have contracted the virus from infected, medicated partners who are already aware of their HIV-positive status.

Reported in the journal Clinical Infectious Diseases, these findings indicate that the public health approach towards HIV counselling and education needs to be reconsidered, Prof. Grossman says.

Bypassing the questionnaires

Researchers had begun to suspect that the rise in infection rates was due to a change in social behavior, but hard evidence was lacking. The answers, Prof. Grossman says, were not easy to find by asking the patients themselves. Questionnaires and similar methods to gather information are hard to interpret because, in addition to the difficulty of recruiting an accurate cross-section of the population, people are often unwilling to be frank about risky sexual behavior.

To unravel the mystery, Prof. Grossman and her colleagues at the Central Virology Laboratory directed by Prof. Ella Mendelson and Israel’s leading AIDS clinicians turned to the virus itself. Working with senior epidemiologists of the Public Health Services of Israel’s Ministry of Health, they conducted a comprehensive analysis of laboratory, clinical, and epidemiological data, including information about patients’ diagnosis and treatment, sexually transmitted diseases contracted along with HIV, and the molecular characteristics of the virus in different patients.

Prof. Grossman and her colleagues found that an overwhelming number of new cases were infected with HIV strains that had already developed resistance to existing HIV drug therapies. Because the virus can only become resistant if previously exposed to medication, this result indicates that new patients are often infected by an HIV-positive partner already receiving the therapies. More often than in the past, HIV found in different patients could be traced back to a common source.

Changing the educational approach

While people are now more knowledgeable about the virus and aware of the risks of unprotected sex, it appears that an increasing number of homosexual men, including those who are infected and treated for HIV, are likely to engage in risky sexual behaviour. Public health authorities, educators, and activists should be encouraged to find new ways of changing this attitude and of better imprinting the message about the risk and consequences of HIV transmission, particularly within the gay community.

Clearly, Prof. Grossman warns, the need to establish the values of safe sex within at-risk populations is as imperative as it has ever been.

American Friends of Tel Aviv University (www.aftau.org) supports Israel’s leading, most comprehensive and most sought-after center of higher learning. Independently ranked 94th among the world’s top universities for the impact of its research, TAU’s innovations and discoveries are cited more often by the global scientific community than all but 10 other universities.

Internationally recognized for the scope and groundbreaking nature of its research and scholarship, Tel Aviv University consistently produces work with profound implications for the future.

Contact: George Hunka
ghunka@aftau.org
212-742-9070
American Friends of Tel Aviv University

Is marriage good for the heart?

Giving your heart to a supportive spouse turns out to be an excellent way to stay alive, according to new research from the University of Rochester. Happily wedded people who undergo coronary bypass surgery are more than three times as likely to be alive 15 years later as their unmarried counterparts, reports a study published online August 22 in Health Psychology, a publication of the American Psychological Association.

“There is something in a good relationship that helps people stay on track” says Kathleen King, professor emerita from the School of Nursing at the University of Rochester and lead author on the paper.

In fact, the effect of marital satisfaction is “every bit as important to survival after bypass surgery as more traditional risk factors like tobacco use, obesity, and high blood pressure,” says coauthor Harry Reis, professor of psychology at the University of Rochester.

But the marriage advantage plays out differently for men and women. For men, marriage in general is linked to higher survival rates and the more satisfying the marriage, the higher the rate of survival. For women, the quality of the relationship is even more important. While unhappy marriages provide virtually no survival bonus for women, satisfying unions increase a wife’s survival rate almost fourfold, the study found.

“Wives need to feel satisfied in their relationships to reap a health dividend,” explains Reis. “But the payoff for marital bliss is even greater for women than for men.” Some studies have suggested that marriage is not beneficial for women, Reis explains. But by factoring in the level of satisfaction, this research provides a more nuanced picture. “A good marriage gets under your skin whether you are male or female,” he says.

The researchers tracked 225 people who had bypass surgery between 1987 and 1990. They asked married participants to rate their relationship satisfaction one year after surgery. The study adjusted for age, sex, education, depressed mood, tobacco use, and other factors known to affect survival rates for cardiovascular disease.

Fifteen years after surgery, 83 percent of happily wedded wives were still alive, versus 28 percent of women in unhappy marriages and 27 percent of unmarried women. The survival rate for contented husbands was also 83 percent, but even the not-so-happily married fared well. Men in less-than-satisfying unions enjoyed a survival rate of 60 percent, significantly better than the 36 percent rate for unmarried men.

“Other research has shown that women are more physiologically sensitive to relationship distress than men, so an unhappy marriage can take a greater toll on their health,” explains Reis.

“Coronary bypass surgery was once seen as a miracle cure for heart disease,” says King. “But now we know that for most patients, graphs are a temporary patch, even more susceptible to clogging and disease than native arteries. So, it’s important to look at the conditions that allow some patients to beat the odds.”

King is skeptical of the widespread belief that a major health scare like going through bypass surgery leads to life-changing behavior. “The data show that many people go back to the lifestyle that they had before,” she says.

King says that this study points to the importance of ongoing relationships for both men and women. Supportive spouses most likely help by encouraging healthy behavior, like increased exercise or smoking cessation, which are critical to long-term survival from heart disease. She also suggests that a nurturing marriage provides patients with sustained motivation to care for oneself and a powerful reason to “stick around so they can stay in the relationship that they like.” These are qualities of the relationship that likely existed before bypass surgery, and continued afterward, says King.

The study cites earlier research showing that people with lower hostility in their marriages have less of the kind of inflammation that is linked to heart disease, which may help explain why people in this study benefited from satisfying marriages.

About the University of Rochester

The University of Rochester (www.rochester.edu) is one of the nation’s leading private universities. Located in Rochester, N.Y., the University gives students exceptional opportunities for interdisciplinary study and close collaboration with faculty through its unique cluster-based curriculum. Its College, School of Arts and Sciences, and Hajim School of Engineering and Applied Sciences are complemented by its Eastman School of Music, Simon School of Business, Warner School of Education, Laboratory for Laser Energetics, School of Medicine and Dentistry, School of Nursing, Eastman Institute for Oral Health, and the Memorial Art Gallery.

Contact: Melissa Greco Lopes
mgrecolo@admin.rochester.edu
585-276-3693
University of Rochester

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