Oral yeast infection

A drug approved to treat certain autoimmune diseases and cancers successfully alleviated symptoms of a rare genetic syndrome called autoimmune polyendocrine syndrome type 1 (APS-1). Researchers identified the treatment based on their discovery that the syndrome is linked to elevated levels of interferon-gamma (IFN-gamma), a protein involved in immune system responses, providing new insights into the role of IFN-gamma in autoimmunity. A drug approved to treat certain autoimmune diseases and cancers successfully alleviated symptoms of a rare genetic syndrome called autoimmune polyendocrine syndrome type 1 (APS-1). Researchers identified the treatment based on their discovery that the syndrome is linked to elevated levels of interferon-gamma (IFN-gamma), a protein involved in immune system responses, providing new insights into the role of IFN-gamma in autoimmunity. The study, led by researchers at the National Institutes of Health's National Institute of Allergy and Infectious Diseases, was published today in the New England Journal of Medicine. In a three-stage study, conducted in mice and people, the researchers examined how APS-1 causes autoimmune disease. The syndrome is marked by dysfunction of multiple organs, usually beginning in childhood, and is fatal in more than 30% of cases. This inherited syndrome is caused by a deficiency in a gene that keeps the immune system's T cells from attacking cells of the body, leading to autoimmunity; chronic yeast infections in the skin, nails, and mucous membranes; and insufficient production of hormones from endocrine organs, such as the adrenal glands. Symptoms include stomach irritation, liver inflammation, lung irritation, hair loss, loss of skin coloring, tissue damage, and organ failure. In the first stage of this study, researchers led by scientists in NIAID's Laboratory of Clinical Immunology and Microbiology examined the natural history of APS-1 in 110 adults and children. Blood and tissues were analyzed to compare gene and protein expression in people with and without APS-1. They found elevated IFN-gamma responses in the blood and tissues of people with APS-1, indicating that IFN-gamma may play an important role in the disease and providing a pathway to target for treatment. In the second stage of the study, the scientists examined mice with the same gene deficiency that causes APS-1 in people, finding that the animals also experienced autoimmune tissue damage and elevated IFN-gamma levels. Mice also deficient in the gene for IFN-gamma did not have autoimmune tissue damage, which showed a direct link between IFN-gamma and APS-1 symptoms. With this understanding, the researchers looked for a drug that could be used to lower IFN-gamma activity in people. They selected ruxolitinib, a Janus kinase inhibitor, because it acts by shutting down the pathway driven by IFN-gamma. When ruxolitinib was administered to the mice with the gene deficiency that causes APS-1, IFN-gamma responses were normalized and T cells were prevented from infiltrating tissues and damaging organs. These results showed that ruxolitinib could alleviate effects of the gene deficiency, suggesting that it could be effective for treatment of APS-1 in people. The researchers administered ruxolitinib, which was supplied by the NIH Clinical Center, to five people -- two adults and three children -- with APS-1 in the third stage of the study. The dosing and regimens were tailored to the individuals, and the treatments were continued for over a year. The drug was safe and tolerated well, and improvement in symptoms was seen in all study participants. Blood and tissue analyses revealed decreased production of IFN-gamma from T cells, as well as normalized levels of IFN-gamma in the blood. Many APS-1-related symptoms were reduced, including hair loss, oral yeast infections, stomach and bowel irritation, hives, and thyroid inflammation. The results revealed that normalizing IFN-gamma levels using ruxolitinib could reduce the damaging effects of APS-1 in people. The scientists note that a study with a larger and more diverse group of patients is needed to determine whether ruxolitinib and similar drugs are suitable treatments for individuals with APS-1. They write that understanding the role of IFN-gamma in autoimmunity may lead to the development of treatments for related diseases. This research highlights the importance of finding the causes of and treatments for rare diseases.

FRIDAY, May 12, 2023 -- Receiving a diagnosis of asthma may be frightening, but learning what the treatment options are can help alleviate the anxiety that comes with diagnosis. Depending on the severity, certain asthma medications may help you manage your symptoms. Here, experts break down the most common long-term and quick-acting medications for asthma, how they work and potential side effects. Long-term medications These drugs are ones the patient takes daily as a means of controlling asthma and preventing asthma attacks. These can be in pill form or used as inhalers. Bronchodilators: Long-acting beta-2 agonists (LABA) relax the muscle bands around your airway (bronchi), making it easier to get air in and mucus out. These medications for asthma are taken twice a day through an inhaler and last up to 12 hours, according to the Cleveland Clinic . LABA medications should be given with a corticosteroid. (See combination medications below.) The main side effects of LABA medications are nervous or shaky feelings, hyperactivity, overexcitement, increased heart rate, upset stomach and trouble sleeping. Salmeterol (Serevent) Formoterol (Foradil) Long-acting muscarinic antagonists (LAMA) also relax the muscle bands around your airway, the National Heart, Lung, and Blood Institute (NHLBI) says. This asthma medication is used if the steroid/LABA combination doesn’t give enough relief. Do not use this medication if you have glaucoma or are at risk of urinary retention. Tiotropium bromide (Respimat) Theophylline. While not used often, theophylline can be useful in relaxing the airways and preventing reactions to irritants. It is taken as a pill and used for mild asthma symptoms. You may need to have blood tests drawn on a regular basis to make sure the level of medication is correct, the Mayo Clinic says. Side effects are the same as the other bronchodilators, but may also include chest pain or discomfort, dizziness, fainting, increase in urine volume or seizures. Theophylline (Theo-24, Theo-Dur, Slo-Bid, and others) Corticosteroids: Corticosteroids are steroids that reduce inflammation in the airways, according to the NHLBI. They may be taken as a pill, although very few patients are on the pill for long term. It is frequently used in an inhaler, often combined with a LABA. Side effects from the inhaled form are thrush (a mouth infection) and a hoarse voice. Inhaled corticosteroids include: Fluticasone (Flovent HFA, Arnuity Ellipta, others) Budesonide (Pulmicort Flexhaler) Mometasone (Asmanex Twisthaler) Beclomethasone (Qvar RediHaler) Ciclesonide (Alvesco) Combination asthma medications (Corticosteroid and LABA): Fluticasone and salmeterol (Advair) Budesonide and formoterol (Symbicort) Fluticasone and Vilanterol (Breo) Leukotriene modifiers reduce swelling and help keep your airways open for up to 24 hours. According to Mayo Clinic, these medications block the effects of leukotrienes, immune system chemicals that cause asthma symptoms. Side effects are uncommon, but may include nausea, headache, tiredness or diarrhea. Montelukast (Singulair) Zafirlukast (Accolate) Zileuton (Zyflo) Quick-acting asthma medications These are a group of medications that are used when a patient has a flare-up or an asthma attack. Inhaled short-acting beta2-agonists (SABAs) open the airways so air can flow through them during an asthma attack. They start working within 15 to 20 minutes and continue to work for 4 to 6 hours, according to the Cleveland Clinic. Side effects can include tremors, rapid heartbeat, allergic reactions, muscle pain, worsening breathing, dry mouth, headache, sore throat or trouble sleeping. Inhaled forms of SABA medications include: Albuterol (Ventolin) Levalbuterol (Xopenex) Albuterol and ipratropium bromide combination (DuoNeb) Corticosteroids. Oral corticosteroids are usually prescribed for short-term use to help a patient overcome a flare-up. This type of medication quickly reduces swelling and inflammation in the airways. Side effects include: Cataracts, osteoporosis, weight gain, high blood sugar, increased risk of infections, thinning bones and fractures, thin skin, bruising and slower wound healing, mood swings, depression and aggressive behavior. Prednisone (Deltasone, Prednicot, and others ) Methylprednisolone (Medrol, Solu-Medrol, Depo-Medrol) Short-acting anticholinergic bronchodilators help open the airways quickly. This medicine may be less effective than SABAs, but it is an option for people who experience side effects with other medications, the Cleveland Clinic says. Side effects you may experience with these inhalers are dry throat, eyes and nose; unusual taste; nausea and vomiting; or temporary blurred vision if the medicine gets in your eyes. Ipratropium bromide (Atrovent) Tiotropium bromide (Spiriva Respimat) Corticosteroid reliever. In January 2023, the FDA approved Airsupra, which can be used as needed to prevent bronchoconstriction and asthma attacks. In a study conducted before the approval, the risk of severe asthma exacerbation was significantly lower with a fixed-dose combination of albuterol and budesonide than with as-needed use of albuterol alone. Most common side effects are headache, oral yeast infection, cough, and difficulty speaking. Airsupra (albuterol-budesonide) Posted May 2023

(PRNewsfoto/Boehringer Ingelheim) (PRNewsfoto/Eli Lilly and Company) Jardiance® (empagliflozin) is the first SGLT2 inhibitor to demonstrate a statistically significant reduction in the primary outcome of HbA1c (a marker of average blood sugar) in participants aged 10-17 living with type 2 diabetes compared to placebo Safety data in this vulnerable population was similar to that in adults with type 2 diabetes, confirming the well-established safety profile of Jardiance INGELHEIM, Germany and RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 7, 2022 /PRNewswire/ -- The DINAMO phase III clinical trial met its primary endpoint by demonstrating a statistically significant reduction in HbA1c (a marker of average blood sugar) with Jardiance® (empagliflozin) compared with placebo for children and adolescents aged 10-17 years living with type 2 diabetes. When Jardiance was added to other baseline treatments (diet, exercise, metformin and/or insulin) HbA1c was reduced by 0.84% compared with placebo at week 26 (95% CI –1.50 to –0.19; P=0.012). The results were presented today at the International Diabetes Federation (IDF) World Diabetes congress 2022, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. The DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents) trial included youth aged 10-17 years with type 2 diabetes and HbA1c ≥6.5% and ≤10.5%. Participants were randomly assigned treatment with Jardiance (10 or 25 mg) (n=52), Tradjenta® (linagliptin) (5 mg) (n=53) or placebo (n=53) once daily. All participants were treated with diet and exercise plus, when appropriate, metformin and/or insulin. The overall safety data was generally consistent with previous findings in adults with type 2 diabetes, confirming the well-established safety profile of both Jardiance and Tradjenta. "Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it's important to recognize and treat diabetes early in its course," said Lori Laffel, M.D., principal investigator of the DINAMO study and chief of the Pediatric, Adolescent, and Young Adult Section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School. "Today's results from the DINAMO global clinical trial demonstrated that the SGLT2 inhibitor Jardiance compared with placebo significantly improved overall blood sugar control in children and adolescents with type 2 diabetes. These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin is the only globally available oral treatment for youth." A secondary endpoint from the trial showed that at week 26, Jardiance reduced fasting plasma glucose (–35.2 mg/dL; P=0.0035). "With more than 41,000 new cases worldwide annually, type 2 diabetes in today's young people is a global public health issue, especially in light of the rise of risk factors such as obesity," said Lykke Hinsch Gylvin, M.D., chief medical officer at Boehringer Ingelheim. "The clinically meaningful benefit and consistent safety profile demonstrated with Jardiance in the DINAMO trial is an encouraging outcome for the vulnerable population of children and adolescents." "The rise in the prevalence of type 2 diabetes in the pediatric population highlights a clear unmet need," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Eli Lilly & Company. "Having overcome the challenges in recruitment and design that pediatric trials tend to face, the outcomes of DINAMO represent another positive step forward in Boehringer Ingelheim and Lilly's commitment to improve the lives of people living with cardio-renal and metabolic conditions such as type 2 diabetes." Reduction in HbA1c in participants treated with Tradjenta was not statistically significant when compared with placebo. A numerical reduction of 0.34% (P=0.2935) was observed. The findings have been submitted for publication in a peer-reviewed journal. About DINAMO: DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents DINAMO (NCT03429543) enrolled children and adolescents aged 10-17 years with type 2 diabetes (HbA1c ≥6.5% and ≤10.5%). Of the 262 participants screened, 158 were randomly assigned to treatment with Jardiance (10 or 25 mg) (n=52), Tradjenta (5 mg) (n=53) or placebo (n=53) once daily. All participants were treated with diet and exercise plus metformin and/or insulin (or no background if metformin intolerant). The trial compared efficacy and safety of a Jardiance dosing regimen compared with placebo and Tradjenta compared with placebo on durable glycemic control in youth with type 2 diabetes. Wh a t is JARDIANCE? JARDIANCE is a prescription medicine used to: reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease lower blood sugar along with diet and exercise in adults with type 2 diabetes JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine). JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work. IMPORTANT SAFETY INFORMATION Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE. Do not take JARDIANCE if you are on dialysis. J A RDIANCE can cause serious side effects, including: Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms, and if possible, check for ketones in your urine: nausea vomiting stomach-area (abdominal) pain tiredness trouble breathing Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking JARDIANCE. You may be at a higher risk of dehydration if you: take medicines to lower your blood pressure, including water pills (diuretics) are on a low salt diet have kidney problems are 65 years of age or older Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long. Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your healthcare provider if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting. L o w blood sugar (hypoglycemia): If you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include: headache drowsiness weakness dizziness confusion irritability hunger fast heartbeat sweating shaking or feeling jittery Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have a fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema). Va ginal yeast infection. Talk to your healthcare provider if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching. Y east infection of the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your healthcare provider if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around the penis. Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away. Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE may include: swelling of your face, lips, throat, and other areas of your skin difficulty with swallowing or breathing raised, red areas on your skin (hives) If you have any of these symptoms, stop taking JARDIANCE and contact your healthcare provider or go to the nearest emergency room right away. T h e most common side effects of JARDIANCE include urinary tract infections and yeast infections in females. These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare provider or pharmacist. Before taking JARDIANCE, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems have liver problems have a history of infection of the vagina or penis have a history of urinary tract infections or problems with urination are going to have surgery. Your healthcare provider may stop JARDIANCE before you have surgery. Talk to your healthcare provider about when to stop taking JARDIANCE if you are having surgery and when to start it again are eating less or there is a change in your diet have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking) have type 1 diabetes. JARDIANCE should not be used to treat people with type 1 diabetes are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with JARDIANCE are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Y o u are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. For more information, please see Prescribing Information and Medication Guide.CL-JAR-100131 10.17.2022 Boehringer Ingelheim and Eli Lilly and Company In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at . About Eli Lilly and Company Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/newsroom or follow us on Facebook, Instagram and LinkedIn. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance® as a treatment for adults with type 2 diabetes, to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease, and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, and as a potential treatment for adults with cardio-kidney-metabolic conditions and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date or that Jardiance® will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. Jardiance®, EMPEROR-Reduced®, EMPEROR-Preserved®, EMPA-REG OUTCOME® and EMPACT-MI® are registered trademarks of Boehringer Ingelheim. P-LLY MPR-US-102413 CONTACTS: Jennifer Forsyth Boehringer Ingelheim Email: [email protected] Phone: (203) 791-5889 Kristiane Bello Eli Lilly and Company Email: [email protected] Phone: (317) 315-9052 SOURCE Eli Lilly and Company