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  1. What actually is Caffeine?

    May 10, 2012 by poster

    Caffeine is a chemical produced by several plants in order to kill or harm animals, particularly insects, which try to feed on them. The effect of the molecule in humans is to stimulate the central nervous system, heart rate and respiration. It is believed to function by reducing the ability of adenosine, which naturally slows down cell activity, to bind to receptors in the brain.

    Another effect of caffeine consumption is that it causes epinephrine (adrenaline) to be released. This causes several changes in the body including causing the heart to beat faster; the blood pressure to rise; and the liver to release sugar into the bloodstream for extra energy. because caffeine is a similar shape to adenosine and therefore it can bind to the adenosine receptors.

    Chocolate, coffee and cola are perhaps three of your favourite consumables; however, they are also three caffeine-rich substances which all contribute to your daily caffeine consumption. According to the BBC, people should not exceed 400mg caffeine a day, and this limit halves for pregnant women, for which only 200mg/day is recommended.

    Product Amount of caffeine (Estimated)
    One mug of filter coffee 140mg
    One mug of instant coffee 100mg
    One can of energy drink 80mg
    One mug of tea 75mg
    One 50g bar of dark chocolate 50mg
    One can of cola 40mg
    One 50g bar of milk chocolate 25mg

    Why is too much caffeine bad for us?

    There are several consequences of consuming too much caffeine. These include:-

    In the short-term:-

    • Shaking
    • Headaches
    • Increased urination
    • Nervousness
    • Increased blood pressure

    In the long-term:-

    • Addiction
    • Trouble sleeping
    • Stained teeth

    Potential risks in pregnant women:-

    • Higher risk of miscarriage
    • Low birth weight of baby

    If you are considering stopping or reducing your caffeine intake then, like all addictive drugs, you may experience some withdrawal symptoms. These may include headaches, muscle aches, irritability and an inability to concentrate. The symptoms will normally begin between 12 and 24 hours after your last caffeine consumption and climb to their worst point around 24 and 48 hours. Thankfully, the symptoms will normally stop within a week.

    Whilst a caffeine overdose can make us humans feel rather unwell, it can be lethal in some animals, such as small dogs and cats. So beware of leaving ground coffee or teabags lying around in places where small animals can get at them

     


  2. Fentanyl Patch Can Be Deadly to Children

    April 28, 2012 by poster

    Young children have died or become seriously ill from accidental exposure to a skin patch containing a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a safety alert to warn patients, caregivers and health care professionals about the dangers of accidental exposure to and improper storage and disposal of the fentanyl patch.

    The fentanyl transdermal system—the patch marketed under the brand name Duragesic and available as a generic product—contains fentanyl, a potent opioid pain reliever, and treats patients in constant pain by releasing the medicine over the course of three days. (Opioids are synthetic versions of opium that are used to treat moderate and severe pain.) An overdose of fentanyl—caused when the child either swallows the patch or applies it to his or her own skin—can cause death by slowing breathing and increasing the levels of carbon dioxide in the blood.

    Children are particularly vulnerable to a fentanyl overdose because, unlike adults, they have not been exposed to this type of potent medicine before and are more vulnerable to its effects. And a greater amount of the medicine is released if the patch is chewed and swallowed. Even after the patch is worn for three days, it may still retain more than 50 percent of the fentanyl.

    Early signs of fentanyl exposure could be hard to identify in young children. Lethargy has been among the reported symptoms, but that could be misinterpreted as fatigue. If there is reason to suspect that a child has been exposed to a fentanyl patch, Throckmorton says that emergency medical help should be sought immediately.

    • Keep fentanyl patches and other drugs in a secure location that is out of children’s sight and reach. Toddlers may think the patch is a sticker, tattoo or bandage.
    • Consider covering the fentanyl patch with an adhesive film to make sure the patch doesn’t come off your body.
    • FDA recommends disposing of used patches by folding them in half so that the sticky sides meet, and then flushing them down a toilet. They should not be placed in the household trash where children or pets can find them.FDA recognizes that there are environmental concerns about flushing medicines down the toilet. However, FDA believes that the risk associated with accidental exposure to this strong narcotic medicine outweighs any potential risk associated with disposal by flushing. When the patches are no longer needed, disposing by flushing completely eliminates the risk of harm to people in the home.FDA has included fentanyl patches on a list of medicines that should be flushed down a toilet because they could be especially harmful, and possibly fatal, in a single dose if used by someone other than the person for whom the medicine was prescribed.

      Throughout the day, make sure—either by touching it or looking at it—that the patch is still in place.

     


  3. Anxiety…..

    April 14, 2012 by poster

    Scientists have finally discovered the biological link between stress, anxiety, and depression. They have identified the interconnecting mechanism in the brain which has enabled them to show how stress and anxiety often lead to depression. This breakthrough discovery has opened more than one way to treat anxiety and depression.

    Stephen Ferguson, professor in the Department of Physiology & Pharmacology at Robarts Research Institute, University of Western Ontario, Canada, has discovered a small molecule inhibitor, which can help provide a new and better way to treat anxiety, depression, and other related disorders.The scientists led by Ferguson and Ana Magalhaes conducted a series of molecular experiments to expose the connect pathway and to test the new inhibitor. They used a behavioral mouse model.

    These findings might very well pave the way for the development of a whole new range of drugs to selectively target anxiety to help tackle anxiety attacks and treat it more efficaciously. According to the scientist involved in the research project, the next step is to develop this inhibitor into an effective pharmaceutical agent.

    The World Health Organization says that depression, anxiety, and other related mood disorders are the most prevalent causes of chronic illnesses in the modernized world.
    It has also been discovered that with  mindfulness-based stress reduction (MBSR), people with diabetes are able to relieve stress and anxiety. A pilot study conducted on diabetes patients found that patients who practiced MBSR showed lower blood pressure levels as well as reduced stress, anxiety, and depression.

    Scientists have recognized seven attitudes that are taught during mindfulness meditation to cure anxiety disorders. They include: Be non-judgmental, use a beginner’s mind, have patience, be non-striving (do not try to make something happen, concentrate on the present moment), trust (yourself and your environment), accept what you are given, and lastly, let go.

    Anxiety takes several forms: phobia, social anxiety, obsessive-compulsive, and post-traumatic stress.. The physical effects of anxiety may include heart palpitations, tachycardia, muscle weakness and tension, fatigue, nausea, chest pain, shortness of breath, headache, stomach aches, or headaches. As the body prepares to deal with a threat, blood pressure, heart rate, perspiration, blood flow to the major muscle groups are increased, while immune and digestive functions are inhibited (the fight or flight response). External signs of anxiety may include pallor, sweating, trembling, and pupillary dilation. Someone who has anxiety might also experience it subjectively as a sense of dread or panic


  4. FDA Approves QNASL for the Treatment of Allergic Rhinitis

    April 4, 2012 by poster

    Allergic rhinitis  is the most common allergic disease in the U.S., affecting between 10 to 30 percent of adults and adolescents.3 It affects more than one in five people, causing some to have symptoms year round  and others to experience symptoms during specific times of the year, such as spring or fall.

    While intranasal corticosteroids are recommended as first-line therapy for AR, the only available options on the market prior to the approval of QNASLTM (beclomethasone dipropionate) were aqueous formulations. Results from a 2010 survey entitled NASAL Allergy Survey Assessing Limitations (NASAL), showed that some nasal allergy patients reported dissatisfaction with their current allergy treatment. Healthcare providers and specialists also reported patient dissatisfaction with current nasal sprays.

    Allergic rhinitis (AR) is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. For many AR patients, nasal congestion or a stuffy nose may be the most frequent and bothersome symptom. According to a recent survey, patients suffer considerable discomfort during allergy attacks, such that nearly two out of five (38 percent) said their discomfort was not tolerable without relief. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR. Morbidity associated with AR can be significant. Effective treatment of AR may improve asthma control when both diseases coexist.

    In the U.S., the prevalence of AR has increased during the past three decades; it is recently estimated at 20 percent in the general adult and adolescent populations. Of those Americans affected with AR, approximately 20 percent have SAR, 40 percent have PAR, and 40 percent have a combination of the two (i.e., PAR with seasonal exacerbation) depending on the allergen sensitivity. Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimate of $11.2 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences and 3.5 million lost work days per year are attributed to AR. In addition, the presence of co-morbidities such as asthma and sinusitis further increase AR-related treatment costs.

    QNASL Nasal Aerosol is a prescription corticosteroid medication that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. It is administered as a nonaqueous or “dry” spray delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant. QNASL Nasal Aerosol contains beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When QNASL Nasal Aerosol is sprayed into the nose, it may help reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing. It is not known if QNASL Nasal Aerosol is safe and effective in children under 12 years of age.


  5. MS Treatment with TYSABRI and the Touch Program

    March 12, 2012 by poster

    Because of the risk of PML, TYSABRI is available only through the TOUCH Prescribing Program, which stands for TYSABRI Outreach: Unified Commitment to Health. TOUCH is a restricted distribution program focused on safety. The goal of the TOUCH Prescribing Program is to minimize the risk of PML.

    TOUCH was developed with the help of the Food and Drug Administration (FDA).

    • Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI
    • Only certain pharmacies and infusion sites authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI

    TOUCH requires more interaction with doctors and nurses. Your treatment is closely monitored to help make sure TYSABRI continues to be right for you:

    • Once every 4 weeks at each infusion visit
    • Plan to see your doctor 3 months after your first infusion, 6 months after your first infusion, and at least as often as every 6 months thereafter

    TOUCH assigns you your own specially trained Biogen Idec Case Manager to help:

    • Get you started on therapy and answer questions about your therapy
    • Find an authorized infusion site in your area
    • Provide information about insurance coverage and possible sources of financial assistance, if needed

    The process for a patient to receive TYSABRI begins with an appointment with the prescribing neurologist in order to fill out the TOUCH Patient/Prescriber Enrollment Form. By signing this enrollment form, you acknowledge that you understand the potential risks associated with TYSABRI and agree to the requirements of the TOUCH Prescribing Program. This document also serves as your prescription.

    At this appointment, the neurologist explains the potential benefits and risks of TYSABRI treatment and gives you time to ask any questions. You must read the Patient Medication Guide and sign the TOUCH Enrollment Form.

    Biogen Idec then assigns a patient identification number to you, ensures that all paperwork is properly filled out, and that you have insurance coverage. They help you find an infusion center and notify the infusion center that you have been approved for an infusion.

    Before each infusion, the TOUCH Prescribing Program requires you to review the Patient Medication Guide and complete the Pre-infusion Patient Checklist with the infusion site staff. This checklist includes ensuring that you are enrolled in the TOUCH Prescribing Program. Four questions are read aloud and answered verbally by you. Your answers will decide whether or not you can receive your TYSABRI infusion:

    1. Over the past month, have you had any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, strength, or other problems) that have persisted over several days?
    2. Do you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia or lymphoma, or an organ transplant, that may suggest that your body is not able to fight infections well?
    3. In the past month, have you taken medicines to treat cancer or MS or any other medicines that weaken your immune system?
    4. In the past month, other than for the treatment of a recent relapse, have you taken any of the following medicines*: Solu-Medrol®, methylprednisolone, Decadron®, dexamethasone, Depo-Medrol®, prednisone, or other steroid medicines?

    If you answer yes to any of these questions, the infusion site staff must contact your healthcare professional prior to starting the infusion to determine whether you can go ahead with the infusion or whether it needs to be rescheduled.

     


  6. Diet Drug Qnexa Promises 10% Weight Loss

    February 27, 2012 by poster

    Qnexa, the first new obesity drug to head for tentative FDA approval in 13 years. (The last, Xenical, hit the market in 1999.) Of course, there’s good reason for that; numerous weight loss drugs have been found to have dangerous side effects, causing the FDA to reject them. In fact, Qnexa itself was rejected by the FDA in 2010. So what’s up now?

    So far, the story’s mainly being reported as a business story. And that it certainly is; the stock of Vivus, Inc. the Mountain View-based pharmaceutical upstart that created Qnexa, jumped 98 percent today in its first day of trading after the FDA panel’s 20 to 2 vote. Given past sales figures for diet drugs, Vivus can expect to make a boatload of cash on Qnexa and shareholders will smile all the way to the bank. One analyst predicted the drug could be the “next Lipitor,” resulting in millions of prescriptions. In terms of weight loss, Qnexa will likely produce smiles. Clinical data (not yet published) showed participants lost an average of 10 percent of their body weight, according to Vivus’ claims.

    What’s the price to your overall health of taking Qnexa?

    Qnexa is actually a “cocktail,” meaning it’s a combination of two previously FDA-approved drugs, phentermine — an appetite suppressant — and topiramate, an anti-convulsant. If you feel like you’ve heard the name phentermine before, you have — it’s the “phen” from the notorious diet drug cocktail of the 1980s, Fen-Phen, withdrawn from the market for damaging heart valves. Technically a contraction of the chemical name phenyl-tertiary-butylmine, phentermine has a similar pharmacology to amphetamine and works by suppressing appetite.

    Because it works by triggering the release of catecholamines, phentermine is known to have two heart-related side effects: tachycardia (increased heart rate) and elevated blood pressure. These side effects don’t happen with the frequency and severity that they do with amphetamines, but patient complaint boards are full of people posting messages about worrisome spikes in heart rate and blood pressure and resulting heart palpitations.

    It’s important to understand that phentermine is a very old drug, available for more than 40 years. And topiramate has been around for ages, too. What that means in terms of the FDA approval process is that both drugs are considered to be already approved, so less new testing is required than would be for a brand new formulation. However, when phentermine came under fire as part of Phen-Fen, some studies were undertaken to try to understand which drug might have caused the heart damage. While the studies seemed to indicate that phentermine wasn’t the primary culprit, they didn’t exonerate the drug either because it was extremely difficult for researchers to tease out the data. The FDA is concerned enough about heart problems from Qnexa that they are considering requiring studies – but the studies might come after the drug hits the market and people begin taking it.

    Now on to topiramate. The active ingredient in Topamax, topiramate causes a fairly high incidence of confusion, memory loss, concentration problems, and “psychomotor slowing” resulting — among other things — in difficulty finding the correct words. Topiramate also carries warnings for depression and mood problems, fatigue and “somnolence” (sleepiness). And then there’s that pesky “suicidal ideation” – talk about a permanent side effect. While these side effects aren’t considered as serious as heart damage, they’re significant and the incidence is surprisingly high; 42 percent of those taking topiramate reported one or more cognitive or mental problems. trave and Arena, also in the pipeline for FDA approval,  the FDA plans to have advisers discuss the  possibility of requiring heart-risk studies for all weight-loss drugs.

    As to the combination of the two drugs together? It’s a bit of an unknown. While Vivus registered four Stage III clinical trials with the government registry, no study results from any of those trials have been published, though presumably preliminary data were submitted to the FDA panel. If you take Qnexa, you’re  essentially allowing yourself to be a bit of a guinea pig in the watch  for side effects, just as the early takers of Phen-Fen did.

     


  7. What is MRSA?

    February 19, 2012 by poster

    MRSA stands for methicillin-resistant Staphylococcus aureus. The term is used to describe a number of strains of the bacteria, Staphylococcus aureus, that are resistant to a number of antibiotics, including methicillin.

    Staphylococcus aureus is a group of bacteria that live on the surface of people’s skin and inside the nose. It is normally harmless: most people who are carrying it are totally unaware that they have it. In fact, it is thought that up to 30% of the general population carries these bacteria in their nose or on their skin. This group of bacteria can be spread quite easily from person to person through contact.

    Problems occur if Staphyloccocus aureus bacteria are able to enter the body through a cut or wound. Most healthy people have strong immune systems and are able to fight off a Staphylococcus aureus infection themselves and have only mild symptoms. However, people with weakened immune systems (for example due to other illnesses) or who have undergone sugery (for example heart surgery or hip replacement) can develop more serious problems.

    In more vulnerable people, Staphyloccocus aureus bacteria have been known to cause boils, abscesses, impetigo, septic wounds, heart-valve problems and toxic shock syndrome. In extreme cases, it can result in death.  People with weakened immune systems who have been infected with Staphylococcus aureus require treatment with antibiotics to help clear the infection. The concern with MRSA strains of bacteria is that they are resistant to a number of the antibiotics that are normally used to treat Staphylococcus aureus infections.

    Because MRSA is resistant to a number of different antibiotics, it is harder to treat than non-resistant bacteria. However, MRSA is not resistant to every antibiotic and most strains of MRSA can still be treated with vancomycin, teicoplanin and mupirocin. For people with weakened immune systems who have become infected with MRSA, the best treatments are with the antibiotics vancomycin or teicoplanin. These two antibiotics are given as injections or through an intravenous drip and so are only given to people in hospital.


  8. Collaboration to Develop Myelin Regenerative Compounds for MS Treatment

    February 12, 2012 by poster

     The Myelin Repair Foundation (MRF) and ENDECE Neural, LLC have formed a partnership to expedite the advancement of myelin regeneration drug candidates for Multiple Sclerosis (MS) patients through pre-clinical studies and into Phase I clinical studies.

    Through this unique collaboration, the newly launched MRF Translational Medicine Center will assess the myelinregenerating capabilities of proprietary small molecule compounds from ENDECE Neural in novel MRF Multiple Sclerosis models for their effectiveness in reversing myelin damage.

    These ENDECE Neural compounds will be evaluated at the MRF Translational Medicine Center, which is dedicated to the acceleration of the drug discovery and development process for new MS treatments. This laboratory facility offers a rigorous, industry-leading translational medicine platform, led by MRF personnel with over four decades of extensive biopharma experience moving therapeutic compounds into clinical trials. The goal of the MRF Translational Medicine Center is to advance potential myelin repair treatment targets toward commercialization to benefit MS patients.

    “By combining the innovative approach by ENDECE Neural to remyelination and the resources available at the MRF Translational Medicine Center, we can expedite progress towards developing new MS treatments for patients,” says Dr. Jay Tung, Ph.D., Vice President of Drug Discovery and Research Operations at MRF. “We are excited to work with ENDECE Neural since we both share a deep commitment to bringing novel therapeutics to MS patients who simply cannot wait for new cures.”

    “We approached the Myelin Repair Foundation about joining forces because of their expertise in myelin repair models, in addition to their new in-house capabilities at the MRF Translational Medicine Center,” says Dr. James Yarger, Ph.D., President of ENDECE Neural. “Unlike current MS therapies, which target immune response and inflammation to slow relapses, our drug compounds are promising candidates for remyelination, with the potential to restore muscle control and mobility. Without remyelination, there can be no cure for MS,” states Dr. Yarger.

    About the Myelin Repair Foundation

    The Myelin Repair Foundation is a Silicon Valley-based, non-profit research organization focused on accelerating the discovery and development of myelin repair therapeutics for Multiple Sclerosis. Its Accelerated Research Collaboration(TM) (ARC(TM)) model is designed to optimize the process of medical research, drug development and the delivery of new patient treatments.

    About ENDECE Neural, LLC

    ENDECE Neural, LLC is the privately held neurological drug development subsidiary of ENDECE, a biopharmaceutical company located in Wisconsin. As a small molecule drug discovery business, ENDECE was founded on the premise that the ability to control multiple genes within signaling pathways would create opportunities for treating diseases with largely unmet medical needs, including neurodegenerative diseases, cancer, and pain. ENDECE has several late pre-clinical stage programs, including therapeutics for Multiple Sclerosis (ENDECE Neural, LLC) and Cancer (ENDECE Oncology, LLC). The Intellectual Property (IP) surrounding the portfolio of small molecule compounds owned and developed by ENDECE is protected by six composition of matter and use patents; the first has been issued. The management team of ENDECE has previously taken multiple drug candidates from laboratory discovery, through clinical studies, and the FDA approval process to commercial launch.

     


  9. Worried of Getting Old and having Wrinkled skin?

    February 5, 2012 by poster

    Ever since Alpha Hydroxy Acids (AHA) have been found to reduce tiny facial lines and fade age spots on the skin, beauty products worldwide are including them in skin creams in the highest concentration the FDA will allow. AHA is made from the juices of citric acid fruits. Higher and more effective dosages are used by Dermatologists and other medical professionals for out-patient skin treatments. AHA reverses sun damage and imparts a more youthful glow to the skin but it cannot get rid of deep lines or sags. So, what fruits contains citric acid? As the name implies, citric acid is present in citrus fruits including lemons, limes, oranges, and grapefruits. It is also present in pineapple.

    For an anti aging skin treatment, it is the best to use facial masks that contain a high level of antioxidants such as vitamin C that is contained in a guava (the vitamin C winner!), grapefruit and kiwi. Adding this vitamin in fruits and vegetables to your daily nutrition will also benefit your skin. Anther antioxidant that is crucial to the anti ageing effect is vitamin A (retinol). It is mainly found in  butternut squash, carrot, guava, mango, and in  tomato.

     All the anti aging products contain retinol – that is the reason to use the ingredients above in your diet and your facial masks. Retinol in a diet is proven to smoothen the skin, remove it’s UV pigmentation, and improve its elasticity and firmness. The yogurt and milk that many mask recipes contain  include the anti aging  amino acids, which stimulate the production of collagen. For a dry and wrinkled or mixed type of skin – avoid using too much of the oily ingredients in your homemade mask recipe. Use the recipes with the oil ingredient in them only once or twice a week, because it may clog up the pores when you go overboard.

    You should advise your dermatologist before applying any homemade remedies,  in case you have a sensitivity to any of the ingredients of the face mask recipes. Although these recipes are traditionally proven to be effective, it is not a substitute for a professional clinical treatment.

    Grape Juice Anti Aging Skin Care Mask

    Ingredients: 1/5 cup of a grape juice 1 tbsp of orange juice 3 tbsp. of yogurt, 3% fat or higher
    How To Use: Apply the mixture on your face for 2 minutes, then wash. You can use this mask daily.
    The Benefits:The grapes make your skin look younger (they contain large amounts of Retinol) and the proteins in the milk – much stronger. The vitamin C in the orange juice is also your skin’s best friend.

    Daily Anti Aging Skincare Recipe:

    The How To: Mix a 3% organic milk with grape juice, then apply for 15 minutes.Rinse the mask with a room temperature water. You can replace the milk with an organic yogurt.
    The benefits: It will give your skin essential proteins and the grapes have an excellent smoothing effect. The milk is an excellent anti aging skincare ingredient, because it contains amino acids for our skin maintenance.

    Honey Mask for Anti Aging Skin Care

    Ingredients: 1 tbsp of honey 2 tbsps of grape juice or mashed grapes 1 small mashed kiwi
    How to use: Mix honey with grape juice and mashed kiwi fruit, then apply for 15 minutes. Wash it with warm water, and then with a cold one. For oily or combined skin add green apple mash or juice. To archieve best results apply this mask once a week.
    The Benefits: The honey contains minerals, that are well known in the traditional home remedies for the wrinkles treatment. It contains group A vitamins and many other essential vitamins and minerals.

     

     

     


  10. FDA Approves Bydureon – The First and Only Once-Weekly Treatment for Type 2 Diabetes

    January 29, 2012 by poster

    SAN DIEGO and DUBLIN, Jan. 27, 2012 /PRNewswire/ — Amylin Pharmaceuticals, Inc. and Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes. Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. Bydureon will be available in pharmacies nationwide in February.

    “With Bydureon, U.S. physiciansand patients can now choose a therapy that offers continuous blood sugar control in just one dose per week,” said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. “New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control.”

    The approval of Bydureon (pronounced by-DUR-ee-on) was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with Bydureon resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with Byetta (exenatide) injection, a twice-daily form of exenatide that has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. Bydureon uses Alkermes’ proprietary technology for long-acting medications to provide a controlled release of exenatide. “As the first and only once-weekly diabetes treatment, Bydureon represents an important milestone in Amylin’s promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes,” said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. “Bydureon builds upon the proven benefits of Byetta, offering significant improvements in glycemic control in a single weekly dose.”

    In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, patients taking once-weekly Bydureon experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking Byetta. A1C is a measure of average blood sugar over three months.  Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking Bydureon and 3.0 pounds for patients taking Byetta (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by Bydureon users (14 percent) than by Byetta users (35 percent). Other common treatment-emergent adverse events in the Bydureon group included diarrhea, upper respiratory tract infection and injection site nodules. There were no major hypoglycemic events.

    Bydureon has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of Bydureon outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of Bydureon on medullary thyroid cancer and cardiovascular disease. More information will be available at www.bydureon.com.

    Bydureon is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. In the DURATION clinical studies, the delivery system was well accepted by patients and physicians.


  11. What’s New in Diet and Nutrition Trends

    January 21, 2012 by poster

    Our fascination with self-improvement shows no signs of waning, and there’s no shortage of new diet trends aimed at helping us meet our health goals. Watchers of food and nutrition trends say the road to better health is paved with new possibilities — along with some old ones that are poised to make a comeback. While the trend for low-carb diets appears to be past its prime, according to experts, trends that are on the way up include:

    • Whole-health diets.
    • Back-to-basics eating plans.
    • Exotic dietary influences.

    Just the Basics

    “The biggest trend I see is a back-to-the-basics approach — getting away from highly processed foods and back to whole foods,” says nutritionist Cynthia Sass, MPH, RD, a national spokeswoman for the American Dietetic Association. Similarly, trend forecaster Gerald Celente predicts a turn away from the “strictly weight loss diet book” and a move toward what he calls “whole health” eating — diets that not only help us lose weight, but live a healthier lifestyle.

    “We will focus our attention on those plans that provide us with receipes for staying healthy in mind, body and spirit,” says Celente, publisher of The Trends Journaland director of TrendsResearch.com. “Functional foods” will be another trend, adds Sass, co-author of Your Diet Is Driving Me Crazy: When Food Conflicts Get In the Way of Your Love Life. “Food as medicine or functional foods will continue to grow — foods that heal, foods for prevention, anti-aging foods, foods for specific health issues, foods as nutrition therapy,” she says. “Foods will be increasingly marketed this way to consumers.”

    More Diet and Food Trends to Watch:

     Exotic Tastes

    Some food experts say we’ll be looking to exotic spices and side dishes to perk up our diets. ”Americans have become more open-minded about different tastes and flavors from the world,” says Greg Drescher, senior director of strategic initiatives at The Culinary Institute of America in Hyde Park, N.Y. This will not only mean tastier meals at home, but healthier restaurant eating, too, Drescher predicts. “When restaurants first rolled out health initiatives, sales collapsed for items marked ‘heart healthy,’” says Drescher, who coordinates the institute’s annual Worlds of Healthy Flavors conference held in conjunction with the Harvard School of Public Health. “But thanks to the convergence of America’s growing immigrant population, interest in culinary adventure, changing palates, and the availability of diverse ingredients, the food industry can meet health challenges with full-flavored cuisines.” Drescher says he expects to see both home and restaurant cooks using more ingredients like:

    • Pomegranates, pistachios, and peaches.
    • Exotic grains such as quinoa, millet, and bulgur.
    • Bread alternatives like rice paper, tortillas, and pita bread.
    • Spices with a Middle Eastern twist, like cardamom and zatar.

  12. Do Extra Doses of Vitamin C Really Ward Off a Cold?

    January 16, 2012 by poster

    Loading up on megadoses of vitamin C—say, between 1,000 and 5,000 milligrams (mg)—doesn’t do anything to prevent illness, says Adriane Fugh-Berman, M.D., an associate professor in the Department of Physiology and Biophysics at Georgetown University. An infusion of vitamin C also isn’t likely to make the duration of a cold any shorter, according to Gigi El-Bayoumi, M.D., associate professor of medicine at the George Washington School of Medicine and Health Sciences. During trials, only one in 10 people taking vitamin C found their colds cleared up faster. Vitamin C consumption often has a psychological effect, El-Bayoumi adds: People feel better because they are doing something about their illness.

    Vitamin C is water-soluble and not considered harmful if you take more than the daily recommended dose of 100 mg, as long as you don’t exceed 2000 mg, says Larry Walker, Ph.D., director of the National Center for Natural Products Research at the University of Mississippi. If you take more vitamins than the body requires, they will simply be excreted in urine.

    Still looking for the magic cure for a cold? The jury is still out about the effectiveness of the herbal supplement echinacea and zinc nasal sprays. And just because a substance is natural, that doesn’t mean it doesn’t have side effects, cautions El-Bayoumi. “When taken every two hours, zinc actually causes insomnia.” That is the dosage that should be used to make a very mild difference in a cold’s duration, she adds.

    No drugs yet treat the viral infection that causes the common cold, says Walker. Over-the-counter drugs treat only the cold’s symptoms.

    The best way to prevent illness is just what Mama told you: Eat a healthy diet of fruits and vegetables, get at least eight hours of sleep per night, avoid smoking and excess alcohol consumption, stay well hydrated, and wash your hands regularly, says El-Bayoumi. However, she adds that a hand sanitizer that contains at least 60 percent alcohol can cut down on colds and the flu by 50 percent.


  13. FDA Approves Intermezzo for Wake / Sleep Problems

    January 9, 2012 by poster

    The U.S. Food and Drug Administration today approved Intermezzo(zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

    This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

    Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause excessive daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.

    Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien.  Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

    “For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” said Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research. “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”

    Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

    Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking—without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.

    Intermezzo is a federally controlled substance because it can be abused or lead to dependence.

    Intermezzo is made by Transcept Pharmaceuticals Inc. of Port Richmond, Calif.


  14. What is Medical Nutrition Therapy? Part 2

    January 3, 2012 by poster

    This is the second of 2 posts :What is Medical Nutrition Therapy?

    Dietary modification:

    Dietary modification may include implementation of specialized diets for chronic conditions and diseases. Specialized diets in medical nutrition therapy may include:

    • supplemental nutrition for patients who cannot obtain adequate nutrients through food intake alone
    • enteral nutrition delivered via tube feeding into the gastrointestinal tract for those unable to eat normally or digest food
    • parenteral nutrition delivered via intravenous infusion (IV) for those who cannot absorb nutrients

     Patient education

    Patient education is a critical dimension of medical nutrition therapy, in that patient compliance is essential to the success of any preventive or therapeutic nutritional program. Patient education in MNT may include task, guideline, and meal planning exercises. These exercises help to educate patients regarding proper food choices in the treatment or control of their specific illness or condition. Tasks are usually simple and objective responsibilities agreed upon by the dietitian, nutritionist, or doctor and the patient. An example of a task might include the patient’s reviewing an itemized grocery receipt with the dietitian to determine if the foods that were purchased were appropriate to the nutrition plan.

    A guideline approach provides the patient with nutrition information related to their specific illness, to be applied to their current eating habits. The patient can learn to plan and prepare appropriate meals with the dietitian’s help, and eventually become able to manage their nutritional regimen on their own.

    Preventive care at all points along the spectrum of illness—primary (preventing disease), secondary (early diagnosis), and tertiary (preventing or slowing deterioration)—requires active patient participation as well as guidance from the dietitian and physician or nurse. Education, motivation, and counseling contribute to effective patient participation.

    Preparation:  There are many nonmedical issues that must be factored into planning appropriate dietary counseling and MNT. Due attention must be given to the patient’s usual food choices, food likes and dislikes, cultural values, and the patient’s ability to implement the dietary changes. In particular, the attitudes of other family members often influence the patient’s compliance. Family members who are embarrassed by a patient’s eating disorder, for example, may make her or his eating patterns and weight fluctuations the focus of most of the family’s interactions. This focus will tend to reinforce the eating disorder rather than the medical nutrition therapy

    Aftercare: 

    Nutrition therapy will be effective only if the patient is willing to implement the suggested recommmendations. If a patient does not follow the recommended dietary guidance, then they will not receive a health benefit from MNT. Patients who require continued MNT (parenteral or enteral nutrition) after leaving a hospital should receive frequent follow-up and monitoring by a registered dietitian.

    Results:

    The large-scale results of MNT have been impressive enough in terms of cost-effectiveness to capture the attention of many large companies. A number of registered dietitians are now conducting on-site nutrition classes in corporate workplaces, participating in health and wellness fairs, and working with corporation food services to design more healthful menus, in addition to offering MNT to the firm’s employees.

    On the individual level, the effectiveness of MNT depends on the commitment of all members of the health-care team—but especially on the patient who has the nutrition-related illness. Prioritized goals are critical when developing the nutrition treatment plan, together with ongoing assessment by the patient and health care team members. Physicians must understand the patient’s dietary plan and reinforce the nutrition therapy when interacting with the patient.

    The American Dietetic Association maintains as its official position that MNT is an essential and cost-effective part of comprehensive health care services. Medical nutrition therapy is also effective in treating disease and preventing disease complications.

    Health care team roles:

    In general, only registered dietitians (R.D.) have sufficient training and knowledge to accurately assess the nutritional adequacy of a patient’s diet. Nutrition support teams, however, include registered dietitians as team members, often as team leaders. Because food and nutrition services span both medical and social contexts, medical nutrition therapy should be an interdisciplinary task in patient care. Physicians should learn the indications for special diets in order to facilitate referrals to dietitians and to reinforce patient compliance. Dietitians are needed to monitor patient populations receiving enteral, parenteral, and specialized oral therapies in conjunction with other health care team members (physicians, nurses/aids, home care workers, etc).

    Some insurance plans cover fees for nutritional counseling by physicians and nurse practitioners as well as by registered dietitians directly supervised by physicians or employed by a participating institution. This inclusiveness reflects the growing significance of MNT in health care as well as the importance of coordinating the work of different health professionals in the area of nutrition.

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  15. What is Medical Nutrition Therapy? Part 1

    December 31, 2011 by poster

    Medical nutrition therapy (MNT) refers to the assessment of the nutritional status of patients with an illness, diet-related condition, or injury, in order to benefit the patient’s own health and reduce health-care costs. MNT includes setting goals for the patient’s treatment and developing a specialized nutrition prescription that includes patient education and self-management training. MNT, which is also called therapeutic nutrition, has become an increasingly important component of integrated health-care systems.

    Purpose:  The purpose of MNT is to identify patients at risk for major nutrition-related health problems and recommend dietary adjustments leading to better health outcomes and improved quality of life. Eight of the 10 leading causes of death in the American population—including coronary heart disease, stroke, diabetes mellitus, and some cancers—are related to food and alcohol consumption patterns. Other important patient populations who benefit from MNT include the obese, the elderly, and infants of low birth weight. Obesity increases the risk of gout, osteoarthritis, sleep apnea, and hypertension as well as stroke and cardiovascular disease; while many of the elderly suffer from malnutrition. Low birth rate is the greatest single health risk in newborns.

    MNT is also used to treat such disorders as anorexia and bulimia nervosa, cystic fibrosis, irritable bowel syndrome, hyperlipidemia, difficulty with lactose digestion, gastric ulcers, sprue (a malabsorption syndrome), and (in children) failure to thrive. Adequate nutrition is essential to reduce morbidity and mortality from these and other acute or chronic conditions. MNT helps to contain health-care costs while benefiting patients directly by offering alternatives to more expensive drug treatments and minimizing the need for surgery or lengthy hospital stays.

    Description:  Medical nutritional therapy is used in a variety of treatment settings, including home care and outpatient care as well as acute or long-term care facilities. In most of these settings, medical nutrition therapy includes a comprehensive review of the patient’s medical history and a dietary assessment with laboratory values and anthropometric measurements.

    Intake Assessment:

    A key part of MNT includes an assessment of the patient’s current and past diet history. A dietary assessment is often conducted to determine the macronutrient (energy or caloric, protein, and fat) content and the micronutrient (vitamin and mineral) content of the patient’s food intake. Some of the most common dietary assessment tools include food records, dietary recalls, food frequency questionnaires, diet histories, and several other methods of data collection, including biochemical indices. A scientific assessment of nutritional status may be compiled from the information collected from clinical evaluations, biochemical tests, and dietary information. The clinical evaluation includes measurements of the patient’s height, weight, and percentage of body fat (determined by skinfolds or hydrostatic weighing). In addition, a clinical evaluation may also include observation for signs of nutrient deficiencies in the mouth, skin, eyes, and nails. The information collected from a clinical evaluation is added to the results of the dietary assessment and biochemical tests to provide a comprehensive picture of the patient’s current nutritional status and relative risk factors for diet-related illnesses. MNT can then be designed to treat the patient’s specific illness or diet-related condition.

    In addition to the patient’s overall medical history and specific evaluation of any diet-related illnesses or conditions, an intitial evaluation may include an assessment of his or her:

    • psychosocial data, including food-related attitudes and behaviors
    • sociological data, including cultural practices, housing, cooking facilities, financial resources, and support of family and friends.
    • general understanding of nutrition, including the relationship of diet to his or her disease or condition.
    • learning style, together with his or her readiness to modify or change behavior.
    • current exercise and activity level

    (continued in Part 2)