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Archive - 12 - 2010
December 28, 2010 (Newswise) - Patients with diabetes, kidney disease and anemia who dont respond to treatment with an anti-anemia drug have a higher risk of cardiovascular disease or death, researchers at UT Southwestern Medical Center have found.The results suggest that testing such patients responsiveness to the drug and keeping blood iron levels a little low might reduce their risk, said Dr. Robert Toto, professor of internal medicine and clinical sciences and a senior author of the study, which appeared in the New England Journal of Medicine.These patients required higher doses and ended up having lower hemoglobin anyway, Dr. Toto said. The results of this study might lead us in directions that can help.The results were an unexpected finding of a study on darbepoetin alpha, which stimulates the production of red blood cells to counteract anemia. The drug, manufactured by Amgen, is sold under the name Aranesp.The study, called the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) showed that darbepoetin alpha works no better than a placebo for improving cardiovascular and kidney outcomes, but it did lower the risk for blood transfusion and resulted in modest improvement in patient-reported outcomes among people with diabetes, kidney disease and anemia. However, people receiving darbepoetin alpha had nearly a twofold higher risk for stroke. Cancer deaths were also higher among people receiving the drug.Darbepoetin alpha is one of a class of anti-anemia drugs that mimics erythropoietin, the bodys natural hormone that stimulates production of red blood cells.The combination of type 2 diabetes, chronic kidney disease and anemia affect about 1 million people in the U.S.TREAT was a double-blinded experiment with a control group that received a placebo. It included 4,038 participants, all of whom had type 2 diabetes, anemia and kidney damage, although not enough to require dialysis. Of these, 1,872 received injections of the drug, and 1,889 received placebo injections.Participants receiving darbepoetin alpha also received periodic subcutaneous injections of the drug with the aim of increasing their levels of hemoglobin a protein in red blood cells that carries oxygen to a level of 13 grams per deciliter. If someone in the control group dropped to a dangerous hemoglobin level below 9 g/dl, he or she received rescue therapy with darbepoetin until the hemoglobin level returned to a level above 9 g/dl.In analyzing the results, the researchers divided the participants into two groups: those whose hemoglobin levels promptly increased in response to early doses of darbepoetin alpha, and those whose bodies responded less strongly, with hemoglobin level staying low.The participants who had poor initial responses to the drug had a higher rate of death, heart attack, stroke or heart failure, the researchers found.The study cannot show whether those people had higher risk for those outcomes because they were in poorer health to begin with, or because of some action of the drug, the researchers stated.However, it does raise the question of whether treatment for anemia should be customized according to a patients response to the drug, Dr. Toto said. Our studies suggest that we might be able to use the initial dose response to identify high-risk groups in future studies, he said.For instance, if a persons hemoglobin level doesnt improve within one or two months of anti-anemia treatment, it may be better to stop the drug and seek alternative treatment. A state of mild anemia might pose less cardiovascular risk in such a case than continuing or escalating the dose in an attempt to reach a normal hemoglobin level, Dr. Toto said. Conversely, for patients who respond quickly to the drug, treating them until they reach the normal goal range recommended by the Food and Drug Administration appears safer, he said.Researchers from Brigham and Womens Hospital and Harvard Medical School; Tufts Medical Center; the University of Erlangen-Nuremburg, Germany; the Faculdade de Medicina de So Jos do Rio Prieto, Brazil; University Medical Center, Groningen, the Netherlands; Northwestern University Feinberg School of Medicine; Health Sciences Centre, St. Johns, Canada; Mario Negri Institute for Pharmacologic Research, Italy; Amgen; and the University of Glasgow also participated in the study.The study was funded by Amgen.
December 27, 2010 (Newswise) - New findings from the Monell Center reveal that weight gain of formula-fed infants is influenced by the type of formula the infant is consuming. The findings have implications related to the infants risk for the development of obesity, diabetes and other diseases later in life.Events early in life have long-term consequences on health and one of the most significant influences is early growth rate, said study lead author Julie Mennella, Ph.D., a developmental psychobiologist at Monell. We already know that formula-fed babies gain more weight than breast-fed babies. But we didnt know whether this was true for all types of formula.While most infant formulas are cows milk-based, other choices include soy-based and protein hydrolysate-based formulas. Protein hydrolysate formulas contain pre-digested proteins and typically are fed to infants who cannot tolerate the intact proteins in other formulas.In adults, pre-digested proteins are believed to act in the intestine to initiate the end of a meal, thus leading to smaller meals and intake of fewer calories. Based on this, the authors hypothesized that infants who were feeding protein hydrolysate formulas would eat less and have an altered growth pattern relative to infants feeding cows milk-based formula.In the study, published online in the journal Pediatrics, infants whose parents had already decided to bottle-feed were randomly assigned at two weeks of age to feed either a cows milk-based formula (35 infants) or a protein hydrolysate formula (24 infants) for seven months.Both formulas contained the same amount of calories, but the hydrolysate formula had more protein, including greater amounts of small peptides and free amino acids.Infants were weighed once each month in the laboratory, where they also were videotaped consuming a meal of the assigned formula. The meal continued until the infant signaled that s/he was full.Over the seven months of the study, the protein hydrolysate infants gained weight at a slower rate than infants fed cow milk formula. Linear growth, or length, did not differ between the two groups, demonstrating that the differences in growth were specifically attributable to weight.All formulas are not alike, said Mennella. These two formulas have the same amount of calories, but differ considerably in terms of how they influence infant growth.When the data were compared to national norms for breast-fed infants, the rate of weight gain of protein hydrolysate infants was comparable to the breast milk standards; in contrast, infants fed cows milk formula gained weight at a greater rate than the same breast milk standards.Analysis of the laboratory meal revealed the infants fed the protein hydrolysate formula consumed less formula during the meal.One of the reasons the protein hydrolysate infants had similar growth patterns to breast-fed infants, who are the gold standard, is that they consumed less formula during a feed as compared to infants fed cows milk formula said Mennella. The next question to ask is: Why do infants on cows milk formula overfeed?The findings highlight the need to understand the long-term influences of infant formula composition on feeding behavior, growth, and metabolic health. Future studies will utilize measures of energy metabolism and expenditure to examine how the individual formulas influence growth, and how each differs from breastfeeding.Also contributing to the study, which was funded by the National Institute of Child Health and Human Development, were Monell scientists Gary Beauchamp and Alison Ventura.
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