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Medical Defence Union Encourages Doctors To Say Sorry If Things Go Wrong, UK
The Medical Defence Union (MDU) the UK"s largest medical defence organisation has reassured doctors that they are not admitting liability if they apologise when something has gone wrong with their treatment of a patient.
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Predicting Fatal Fungal Infections
In a study published in The Journal of Infectious Diseases, researchers from Albert Einstein College of Medicine of Yeshiva University have identified cells in blood that predict which HIV-positive individuals are most likely to develop deadly fungal meningitis, a major cause of HIV-related death. This form of meningitis affects more than 900,000 HIV-infected people globally most of them in sub-Saharan Africa and other areas of the world where antiretroviral therapy for HIV is not available.
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Women Who Quit Smoking Early In Pregnancy Reduce Risks Of Preterm Birth, Stunted Fetal Growth
Pregnant women who quit smoking during the first trimester and women who never smoked during pregnancy have a similar risk of delivering preterm or very small infants, according to a study published in the journal Obstetrics and Gynecology, Reuters reports. Premature delivery and stunted infant growth are the most well-documented side effects of smoking during pregnancy, and the risks increase for older women, according to study author Laura Polakowski of the Centers for Disease Control and Prevention and colleagues. For the study, the researchers analyzed 915,441 birth certificates for infants born in 2005 in 11 states that include information on whether the woman smoked during pregnancy.The study found that 10% of women who smoked for the entire pregnancy gave birth to "preterm but not too small for gestational age" infants, compared with 8% of women who quit during the first trimester. Fifteen percent of women who smoked the entire pregnancy gave birth to full-term infants who were small for their gestational age, while 2% gave birth to premature infants who were small for gestational age. Among women who quit smoking during the first trimester, these outcomes occurred 9% and 1% of the time, respectively.After adjusting for the women"s age, previous preterm births and other factors, the researchers found that women who quit smoking in the first trimester reduced their risk of giving birth to a preterm, normal-size infant by 31%. The risk of delivering a full-term, unusually small infant was cut by 55% and the risk for delivering a preterm, unusually small infant was reduced by 53%. The risks were also reduced for women who quit smoking during their second trimester, although less significantly. The researchers found that the risk reduction was particularly high for older women -- especially those older than age 40 -- who quit smoking during the first trimester. According to the study, the results indicate that the risk of delivering a preterm or small-for-gestational-age infant for pregnant women who quit smoking during the first trimester is "comparable to those who never smoke during pregnancy" (Reuters, 7/21).
Public Health

Salix's Once-Daily APRISO Demonstrates Long-Term Safety In Patients For Maintenance Of Remission From Ulcerative Colitis

Data was announced today that demonstrated Salix Pharmaceuticals" (NASDAQ:SLXP) APRISO™ (mesalamine) 0.375g extended-release capsules had a favorable safety profile in patients in remission from ulcerative colitis (UC) for up to 24 months. APRISO is approved for use up to six months. The majority of treatment-emergent adverse events were mild or moderate in intensity, and were similar to what was seen during the 6-month phase 3 trials. The study, which is the first to examine the long-term safety profile of APRISO, was presented at the Digestive Disease Week (DDW) annual meeting in Chicago, Illinois. "It is important to provide UC patients with a new treatment option that can be safely used over the long-term," said Dr. Glenn L. Gordon, Medical Director and President of the Center for Digestive and Liver Diseases, Inc. in Mexico, Missouri. "The favorable long-term safety profile of APRISO, combined with once-daily dosing, may support its use as first-line therapy for long-term* maintenance of UC remission." Patients with UC may experience periods of remission (times when the symptoms go away) that can last for months or years. Maintenance therapy refers to treatment given to patients to enable them to stay in remission, and to maintain their health in a disease-free, or limited-disease, state. UC is a lifelong disease; therefore, maintenance medications must usually be taken for a prolonged period of time. The Long-Term Safety Analysis Safety data for this analysis included 557 patients in remission from UC who were treated with APRISO in a long-term, open-label extension trial, with 250 patients exposed to APRISO for greater than one year, of which 137 patients were exposed for over 18 months. Patients included in this long-term safety analysis were either new, or had rolled over from two randomized, double-blind, placebo-controlled, phase 3 trials. The majority of treatment-emergent adverse events were mild or moderate in intensity, and were similar to what was seen during the 6-month phase 3 trials. Overall, long-term compliance with APRISO was high, with an average compliance of 90 percent in the safety analysis population. Additional Abstracts Presented at DDW Further Support the Safety and Efficacy of APRISO for the Maintenance of Remission of UC. Poster #T1202 Two phase 3 studies (n=562) showed that a significantly greater proportion of patients receiving once-daily APRISO (1.5 g) remained relapse-free after six months of treatment, compared to placebo (79 percent vs. 62 percent [PPoster #T1204 A post hoc analysis of two clinical trials (n=562) revealed that the majority of a sub-population of patients (n=158) who had previously received corticosteroid therapy to treat UC flares or to maintain UC remission, remained in remission after treatment with APRISO (1.5 g). Of the patients who had previously received corticosteroids, 77 percent of patients treated with APRISO did not experience a relapse, compared to 55 percent of patients receiving placebo (P=0.006). Further, according to the Kaplan-Meier log-rank statistics, the probability of patients remaining relapse-free without further corticosteroid treatment was significantly higher in those treated with APRISO, versus placebo. The probability of remaining relapse-free for the corticosteroid subpopulation was comparable to the entire study population (Poster #T1202). Limiting exposure to steroids is important for these patients who may require long-term treatment. About APRISO APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates, amniosalicylates, or to any of the components of APRISO capsules. The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in greater than 3% of adult patients taking 1.5 g/day of APRISO (versus placebo) were headache (11% vs. 8%), diarrhea (8% vs. 7%), upper abdominal pain (5% vs 3%), nausea (4% vs 3%), nasopharyngitis (4% vs 3%), influenza and influenza-like illness (4% vs 4%) and sinusitis (3% vs 3%). Salix acquired rights to market APRISO in the U.S. from Dr. Falk Pharma GmbH of Freiburg, Germany. Mesalamine granules have been approved in Germany since 2001 for the treatment of symptoms related to inflammatory bowel disease. In addition, consistent with the FDA-approved labeling, once-daily dosing of mesalamine granules is currently approved via the mutual recognition procedure in Austria, Belgium, Denmark, Finland, Greece, Ireland, Luxemburg, Netherlands, Norway, Portugal, Sweden, Spain and the UK. About Salix Pharmaceuticals Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix"s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete with any required development and regulatory submission of these products, and market them through the Company"s gastroenterology specialty sales and marketing team. About Dr. Falk Pharma Dr. Falk Pharma GmbH one of the most recognized companies worldwide in gastroenterology. Dr. Falk Pharma products are sold in more than 60 countries. The Falk Foundation, which is associated with the Company, provides medical information via international symposia, forums and postgraduate courses. Over the past 40 years the Falk Foundation has sponsored more than 200 symposia in which over 100,000 physicians from 110 countries have come together to advance knowledge in gastroenterology and hepatology. Salix Pharmaceuticals


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