Chain Drug Review, March 16th, 2020

Prediabetes Prevalence Needs Public Health Response ATLANTA Nearly one in need for effective public health five adolescents and one in four strategies that promote healthy young adults have prediabetes eating habits physical activity according to a study from the and stress management Centers for Disease Control and said CDC director Dr Robert Prevention CDC Redfield These lifestyle behaviors Those with the condition can begin early in a have blood sugar levels that childs life and should continue are above normal but not yet high enough to be type 2 diabetes DIABETES CARE REPORT through adolescence and adulthood to reduce onset of type 2 diabetes Eighteen percent of adolescents ages 12 to 18 and 24 of adults 19 to 34 had prediabetes The percentage was higher in males and Hispanic young adults had higher rates of prediabetes than white young adults Adolescents and young adults with prediabetes had significantly Positive Opinion on Lilly Insulin INDIANAPOLIS The European global development leader for insulins at Lilly Maximizing the amount of time spent in the target blood glucose range is a constant balancing act and daily challenge Many people with diabetes struggle to keep their blood glucose in the target range following meals and may benefit from a mealtime insulin with a fast onset of action Mirroring what works in people without diabetes The positive opinion was based on clinical pharmacological studies in type 1 and type 2 diabetes and studies from the PRONTO clinical program PRONTO T1D and PRONTOT2D were designed as phase 3 treat to target trials in which each arm is treated to achieve the same level of glycemic control allowing comparisons in other important treatment effects such as rates of hypoglycemia post meal glucose control and glucose time in range Both studies met the primary endpoint of non inferior A1c Besides being at risk for full blown diabetes they have an increased risk of chronic kidney disease heart disease and stroke Monitoring the percentage of adolescents and young adults with prediabetes can help determine the future risk of type 2 diabetes To do this CDC researchers used data from the National Health and Nutrition Examination Survey covering the years 2005 to 2016 The prevalence of prediabetes in adolescents and young adults reinforces the critical higher cholesterol levels systolic blood pressure abdominal fat and lower insulin sensitivity than those with normal glucose tolerance which increased their risk of type 2 diabetes and other cardiovascular diseases Were already seeing increased rates of type 2 diabetes and diabetes related complications in youth and young adults and these new findings are evidence of a growing epidemic and a tremendously worrisome threat to the future of our nations health said Ann Albright director of CDCs Division of Diabetes Translation Additional research is needed to support the development of interventions for youth and increasing access to programs that we know work for young adults like the CDC led National Diabetes Prevention Program Research shows that adults with prediabetes who take part in a structured lifestyle change program including weight management and exercise can cut their risk of developing type 2 diabetes by 58 71 for people over 60 Participation in the program can help prevent or delay type 2 diabetes in those at high risk The program available to those 18 and older is taught by trained lifestyle coaches and encourages healthy whole life changes to help participants address barriers to improved nutrition increased physical activity and coping mechanisms for stress reduction Parents can also help turn the tide on prediabetes by encouraging healthy eating and increased physical activity They can aim for their children to get 60 minutes of physical activity a day There are several ways state and local organizations can create a supportive environment to promote healthy weight and help prevent diabetes related to obesity CDC noted States and communities can support mothers who choose to breast feed and work with early care and education centers and schools to improve healthy food and beverage offerings and opportunities for physical activity for children They can also increase access to healthy and affordable food and make it easier and safer to walk and bike where families live learn work and play CDC also reported that Hispanics and Asians had a higher incidence of diagnosed and undiagnosed diabetes than whites although the rate varied among subgroups Broadly the age sex adjusted percentage of adults living with diagnosed or undiagnosed diabetes was 22 in Hispanics 19 for non Hispanic Asians and 12 for non Hispanic whites Among Hispanics the agesex adjusted percentage of adults living with both diagnosed and undiagnosed diabetes was 25 for Mexicans 22 for Puerto Ricans 21 for Cubans Dominicans 19 for Central Americans Continued on page 57 Fresenius Launches Kit for Hypoglycemia LAKE ZURICH Ill Fresenius Kabi has rolled out the Glucagon Emergency Kit a Food and Drug Administration approved and cost effective alternative to treat severe hypoglycemic episodes in people with diabetes in the U S The kit includes glucagon for injection 1 mg and a prefilled glass syringe with 1 ml of sterile water for injection USP For people with diabetes a severe hypoglycemic episode can occur anywhere and at any time said John Ducker president and chief executive officer of Fresenius Kabi USA Our new Glucagon Emergency Kit allows clinicians flexibility and choice for treating patients experiencing severe hypoglycemia This is another example of Fresenius Kabis commitment to providing cost effective products that deliver life saving care The kit is designed to be convenient and easy to use Patients can carry it with them so it is available should they experience severe hypoglycemia The bright orange case makes it easy for a patient or caregiver to find it and act quickly To help make the kit more affordable there is a co pay assistance program for patients who qualify Fresenius Kabi is also making injection training kits available to health care providers to help educate patients Glucagon for injection is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes It is contraindicated in patients with pheochromocytoma insulinoma or a known hypersensitivity to glucagon or any of the excipients Medicines Agencys EMAs Committee for Medicinal Products for Human Use CHMP has issued a positive opinion for Eli Lilly and Co s new mealtime insulin for the treatment of adults with diabetes as part of a multiple daily injection regimen or delivered by an insulin pump This novel fast acting formulation of insulin lispro is being evaluated for use in adults with type 1 and type 2 diabetes to reduce blood glucose This is the first regulatory step toward approval for this new insulin in Europe The CHMP opinion is referred for final action to the European Commission which grants approval in the European Union Lilly plans to market the medicine under the trade name Liumjev in the EU and the medicine has been referenced to date as URLi or LY900014 in scientific disclosures The CHMP opinion brings us another step closer to providing adults with diabetes in Europe with a new treatment option to help manage their blood glucose levels especially their blood glucose levels following meals said Deirdre Ibsen reduction from baseline compared to Humalog at 26 weeks when URLi and Humalog were dosed at mealtime Further URLi demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog Overall URLi showed no significant difference in severe nocturnal or overall hypoglycemia rates in study participants compared to Humalog and the two insulins had similar safety and tolerability profiles across Phase 3 studies Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also showed that URLi was absorbed significantly faster into the blood stream compared to Humalog insulin aspart and fast acting insulin aspart The early blood glucose profile with the investigational insulin closely matched that of participants without diabetes We developed URLi to provide a mealtime insulin option that more closely mirrors the way insulin works in people without diabetes Ibsen said Lilly has submitted URLi for approval with regulatory authorities in the U S and Japan Chain Drug Review March 16 2020 53