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DaVita Study Demonstrates Clinical Application Of Sysmex Reticulocyte Hemoglobin Equivalent (RET-He) Parameter
Sysmex America, Inc. announced that a study titled "Day-to-Day, Week-to-Week, and Day-of-the-Week Variations in Tests of Anemia and Iron Status in Hemodialysis Patients" has identified Sysmex"s Reticulocyte Hemoglobin Equivalent (RET-He) parameter result as key input used by physicians to assist in Anemia treatment decisions in ESRD patients on hemodialysis. David Van Wyck, M.D., Vice President of Clinical Affairs at DaVita Inc., and Emeritus Professor of Medicine and Surgery at the University of Arizona College of Medicine, in Tucson et. al followed five hematologic parameters in 30 patients undergoing hemodialysis three times a week. The patients were followed for 12 consecutive treatment days. The parameters studied were Hb, Hct, reticulocyte Hb (RET He or CHr), TSAT and ferritin levels.
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Studies Examine Morning Sickness Drug, Progesterone Use To Prevent Premature Birth
The following summarizes news coverage on two pregnancy-related studies. ~ Morning sickness: The commonly prescribed heartburn drug metoclopramide -- sold generically and under the brand-names Reglan, Octamide and Maxolon -- can be used to treat morning sickness without harming the health of the fetus, according to a study published on Thursday in the New England Journal of Medicine, Time reports. The drug, which also has anti-nausea properties, is not FDA-approved for use in pregnant women in the U.S., though it is commonly prescribed in European and other countries to treat morning sickness (Park, Time, 6/10). According to the Los Angeles Times, U.S. physicians occasionally prescribe metoclopramide to treat severe morning sickness cases. The new study found that there were no statistically significant differences between infants born to women who took metoclopramide and those who did not. Researchers said that the findings "provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy." The study involved 81,703 births among women enrolled in Israel"s largest health HMO, including 33,458 who used the drug (Maugh, Los Angeles Times, 6/11). Jennifer Niebyl, a professor of obstetrics and gynecology at the University of Iowa, said, "There are very few drugs approved for use in the first trimester of pregnancy. But this study could lead to metoclopramide getting approved to treat morning sickness because this is good data with big numbers" (Time, 6/10).~ Progesterone: The hormone progesterone was not effective at preventing premature births among women pregnant with twins, despite evidence suggesting its effectiveness at preventing premature births in single pregnancies, according to a University of Edinburgh study published in the journal Lancet, Reuters reports. Multiple pregnancies have a larger health risk for women and significantly increase the likelihood of miscarriage, premature birth and long-term health problems. The study involved 500 women who took either progesterone or a placebo daily for 10 weeks. Although previous studies have shown that progesterone might prevent premature birth in certain high-risk pregnancies, the new findings show the treatment did not reduce the likelihood of premature delivery or a fetus dying in utero in twin pregnancies. Twenty-five percent of women delivered or had a fetus die before 34 weeks in the progesterone group, compared with 20% in the placebo group (Kahn, Reuters, 6/10).
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Cholesterol-Regulating Genes Identified By Scientists
Scientists at the European Molecular Biology Laboratory (EMBL) and the University of Heidelberg, Germany, have come a step closer to understanding how cholesterol levels are regulated. In a study published in the journal Cell Metabolism, the researchers identified 20 genes that are involved in this process. Besides giving scientists a better idea of where to look to uncover the mechanisms that ensure cholesterol balance is maintained, the discovery could lead to new treatments for cholesterol-related diseases.
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Rolofylline Did Not Demonstrate Efficacy For Acute Heart Failure In Clinical Trial

Merck & Co., Inc. said that preliminary results for the pivotal Phase III study of rolofylline (MK-7418), the Company"s investigational medicine for the treatment of acute heart failure, show that rolofylline did not meet the primary or secondary efficacy endpoints. While Merck will continue to analyze the data with outside experts, the Company will not file applications for regulatory approval this year. The results from this study will be presented at a medical meeting later this year. "Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive," said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. "These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients. "Merck remains committed to discovering and developing novel treatments for heart failure and for cardiovascular disease, which claim more than 17 million lives worldwide each year and remain the leading cause of death and a leading cause of disability," Dr. Bloomfield said. The primary hypothesis of the 2,033-patient pivotal Phase III study, PROTECT, was that rolofylline 30 mg would improve symptoms of acute heart failure compared to placebo. The secondary endpoints were that rolofylline 30 mg would reduce the risk of death or cardiovascular or renal re-hospitalization 60 days after treatment, and that rolofylline 30 mg would reduce the incidence of persistent kidney impairment. Details on the design of PROTECT are available at http://www.clinicaltrials.gov, identifiers NCT00328692 and NCT00354458. Rolofylline was acquired by Merck through NovaCardia, which Merck purchased in 2007. Results from the PROTECT pilot study, presented at previous medical meetings and published in 2008, had showed an overall trend toward efficacy (more patients with improved shortness of breath, fewer patients with worsening renal function and/or worsening heart failure). Merck"s late-stage pipeline of investigational medicines for cardiovascular disease includes MK-524A (approved in some markets outside the U.S.), MK-524B, ezetimibe/atorvastatin, and anacetrapib (MK-0859) for atherosclerosis, and vernakalant for atrial fibrillation. Merck


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