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Sepracor Pharmaceuticals Ltd Withdraws Its Marketing Authorisation Application For Lunivia (eszopiclone)
The European Medicines Agency has been formally notified by Sepracor Pharmaceuticals Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Lunivia (eszopiclone), 2 and 3 mg tablets.
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New Model Suggests Role Of Low Vitamin D In Cancer Development
In studying the preventive effects of vitamin D, researchers at the Moores Cancer Center at the University of California, San Diego, have proposed a new model of cancer development that hinges on a loss of cancer cells" ability to stick together. The model, dubbed DINOMIT, differs substantially from the current model of cancer development, which suggests genetic mutations as the earliest driving forces behind cancer.
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UAW To Accept Up To 20% Of GM Stock; Agrees To Concessions On Retiree Health Care Obligations, Labor Rules
United Auto Workers leaders on Tuesday agreed to accept up to 20% of General Motors stock, as well as concessions on labor rules and retiree health care obligations, as the automaker faces a June 1 deadline to restructure or seek bankruptcy protection, the Detroit News reports (Aguilar/Shepardson, Detroit News, 5/27). Under the deal, the voluntary employees" beneficiary association would receive 17.5% of common GM stock, $6.5 billion of preferred shares, a $2.5 billion note and warrants equal to 2.5% of GM"s stock (Reuters/USA Today, 5/27). In addition, the VEBA would receive $585 million annually in interest income on its preferred stock (Detroit News, 5/27). Another concession included in the tentative deal is the elimination of dental, vision and some prescription drug coverage for hourly retirees (Shepardson/Aguilar, Detroit News, 5/26). UAW also would hold a seat on the GM board of directors (Cho et al., Washington Post, 5/27).Because of a proposed deal announced earlier this month, the Treasury Department and UAW, together, are to own 89% of GM"s stock, meaning that if the UAW-GM deal is approved, the Treasury would own about a 70% share of GM"s stock (Detroit News, 5/26). Current bondholders would hold about a 10% stake in the company (Washington Post, 5/27). The remaining 1% would be held by existing shareholders (Detroit News, 5/26).The total 20% is about half of what was anticipated (Higgins, Detroit Free Press, 5/26). The "significant concessions" made by UAW, which was eligible to receive up to 39% of GM"s equity through the VEBA, "could mean that [GM] is attempting to appease unsecured bondholders, who charged that the UAW was getting a better deal," according to the News (Detroit News, 5/27). UAW said the revised agreement with GM was necessary for the automaker to survive, but the deal will leave hundreds of thousands of GM retirees paying higher out-of-pocket medical expenses, the Wall Street Journal reports (Stoll et al., Wall Street Journal, 5/27).UAW members are scheduled to vote on the agreement on Wednesday and Thursday (Detroit News, 5/26). However, "[e]ven with UAW approval, GM is still likely to file for bankruptcy, since bondholders are unlikely to swallow deep concessions," according to the News (Detroit News, 5/27).
Nutrition

New Data Confirm That Diovan(R) And Valsartan-Based Combinations Offer Patients Sustained, 24-hr BP-lowering Efficacy

Data presented at the 19th Scientific Meeting of the European Society of Hypertension (ESH) confirm that Diovan® (valsartan) and valsartan-based combinations deliver sustained, 24-hr blood pressure (BP)-lowering efficacy2-6. Studies have suggested that the relative risks of acute myocardial infarction, stroke and sudden cardiac death are 40%, 49% and 29% higher, respectively, when the period between 6 a.m. and noon is compared to the rest of the day1. Increases in heart rate and BP are known to occur as a person awakens from sleep; the renin-angiotensin system (RAS) is also activated, possibly contributing to the morning BP rise1. "Blood pressure evaluation over 24 hours, as measured by ambulatory blood pressure monitoring, is an accurate and important way to assess the effectiveness of an antihypertensive therapy," said Professor Rainer DÃÜsing, Department of Cardiovascular Medicine, University of Bonn, Germany. "If we can reduce and control blood pressure, and minimize the early-morning blood pressure surge in patients at high cardiovascular risk, we may have a better chance of improving patient outcomes." Results from five separate studies presented at ESH (EVALUATE2, VITAE3, EXPERT4, VALOROUS5 and "Study 2302"6) confirm that Diovan®, Co-Diovan® (valsartan/hydrochlorothiazide [HCT]), Exforge® (valsartan/amlodipine) and Exforge HCT® (valsartan/amlodipine/HCT) effectively reduce BP over the full 24-hour period. In addition, valsartan-based triple therapy was associated with greater reductions in ambulatory BP throughout the 24-hour period, when compared to respective dual combinations6. Exforge HCT was approved in the United States in April 2009 by the US Food and Drug Administration (FDA) for second-line treatment of hypertension7, and is currently undergoing regulatory review in the European Union. Study Highlights: - Results from the EVALUATE2 study, involving 482 patients with Stage 2 hypertension (JNC 7), demonstrated that Co-Diovan provided significantly greater reductions at the end of the study in both daytime and night-time mean ambulatory BP (ABP) than the combination of amlodipine/HCT (pð‰¤0.05). In addition, significantly more patients achieved ABP goal (125/80 mmHg over 30-hour ABPM reading), whether it was administered in the morning or in the evening (-11.5 ± 10 and -10.2 ± 9 mmHg, respectively; both pReferences 1. White WB. Importance of blood pressure control over a 24-hour period. J Manag Care Pharm 2007;13(8 Suppl B):34-9. 2. Black HR, et al. Comparison of 24-hour ambulatory blood pressure response with combination of valsartan/hydrochlorothiazide and amlodipine/hydrochlorothiazide in patients with stage 2 hypertension. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 1168. Updated information presented at meeting. 3. Raij L, et al. Combination of valsartan/hydrochlorothiazide provides improved 24-hour blood pressure response compared with amlodipine/hydrochlorothiazide in prediabetic, obese, hypertensive patients. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 1170. Updated information presented at meeting. 4. Asmar R, et al. Efficacy on blood pressure control, in essential hypertensive patients uncontrolled with amlodipine 5 mg of an amlodipine / valsartan combination: ExPERT Study. 19th Scientific Meeting of the European Society of Hypertension, June 13, 2009; Abstract No. 714. 5. Palatini P, et al. The 24 hour blood pressure lowering efficacy of morning versus evening administration of valsartan compared to lisinopril based therapy in patients with hypertension. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 907. Updated information presented at meeting. 6. Lacourciere Y, et al. Twenty-four hour ambulatory BP control of therapy with amlodipine/valsartan/HCTZ triple combination compared to dual therapy in patients with moderate to severe hypertension. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 1412. Updated information presented at meeting. 7. IMS MIDAS sales data, May 2009. Novartis


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