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Post by Clement on Oct 5, 2018 12:10:45 GMT -5
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Post by sportsrancho on Oct 5, 2018 12:19:50 GMT -5
For the first time, the ADA-EASD Consensus Report includes specific pharmacologic recommendations based on a patient’s profile and health history (Figure 2), providing instructions in the context of ASCVD, heart failure, kidney disease, weight, risk for hypoglycemia, or a need for low-cost options. One thing that hasn’t changed is an emphasis on comprehensive lifestyle management and metformin, which remains the preferred first-line agent. There is a new guidance for glucagon-like peptide 1 (GLP-1) receptor agonists, which are now recommended as the first injectable medication prior to insulin for most adults with type 2 diabetes who need the greater blood glucose-lowering of an injectable medication. For patients with chronic kidney disease, the panel recommends consideration of a sodium-glucose cotransporter 2 (SGLT2) inhibitor with proven benefits. Individual medications in both the GLP-1 receptor agonist and SGLT2 inhibitor classes have been shown to have cardiovascular benefits.
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Post by sportsrancho on Oct 5, 2018 12:20:40 GMT -5
This is horrible correct?
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Post by peppy on Oct 5, 2018 12:22:44 GMT -5
metformin, which remains the preferred first-line agent. There is a new guidance for glucagon-like peptide 1 (GLP-1) receptor agonists, which are now recommended as the first injectable medication prior to insulin for most adults with type 2 diabetes who need the greater blood glucose-lowering of an injectable medication. For patients with chronic kidney disease, the panel recommends consideration of a sodium-glucose cotransporter 2 (SGLT2) inhibitor with proven benefits. Individual medications in both the GLP-1 receptor agonist and SGLT2 inhibitor classes have been shown to have cardiovascular benefits. The panel recommends the target HbA1c to increase microvascular benefits is 7 percent or less (53 mmol/mol) for most nonpregnant adults with sufficient life expectancy, with individualization based on patient preferences and goals; risk of adverse effects including hypoglycemia and weight gain; and patient characteristics including frailty and comorbid conditions. The cost, adherence and tolerability burdens have been added as factors to be considered for all medication therapy The panel also recommends metabolic surgery for adults with type 2 diabetes and either 1) BMI ≥40 (BMI ≥37 for people of Asian ancestry) or 2) BMI ≥35 Figure 1—a Decision Cycle for Patient-Centered Glycemic Management in Type 2 Diabetes—representing a continuum of care for adults with type 2 diabetes throughout their lifetime. The Goals of Care are at the core—prevent complications and optimize quality of life. The steps are 1) assess key patient characteristics; 2) consider specific factors that impact choice of treatment; 3) shared decision-making to create a management plan; 4) agree on a management plan; 5) implement management plan; 6) ongoing monitoring and support including mental health, medication tolerance and adherence, monitoring of blood glucose, weight, nutrition, physical fitness and exercise, and smoking cessation counseling; 7) review and agree on management plan;
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Post by peppy on Oct 5, 2018 12:26:19 GMT -5
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Post by Clement on Oct 5, 2018 12:31:10 GMT -5
John Buce of Mannkind SAB is one of the co-chairs producing this report. I do not see anything here directly opening a door for Afrezza. So, what's up?
However, the following might indirectly open some doors: "The panel recommends the target HbA1c to increase microvascular benefits is 7 percent or less (53 mmol/mol) for most nonpregnant adults with sufficient life expectancy, with individualization based on patient preferences and goals; risk of adverse effects including hypoglycemia and weight gain; and patient characteristics including frailty and comorbid conditions. The cost, adherence and tolerability burdens have been added as factors to be considered for all medication therapy. " --- as in A1c less than or equal 7 with fewer hypos.
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Post by boca1girl on Oct 5, 2018 12:43:38 GMT -5
This is horrible correct? It does not endorse Afrezza as the Standard of Care as we are all hoping for.
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Post by peppy on Oct 5, 2018 13:27:47 GMT -5
This is horrible correct? It does not endorse Afrezza as the Standard of Care as we are all hoping for. no insulin on their standard of care for type two. ============================================================== Are there GLP-1 manufactures in Europe? -BYDUREON Manufactured by Amylin Pharmaceuticals, Inc., San Diego, CA 92121 -liraglutide (Rx) Brand and Other Names:Victoza, Saxenda. Novo Nordisk Canada Inc. ADLYXIN (lixisenatide) Sanofi Tanzeum. sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY Trulicity- eli lilly OZEMPIC® (semaglutide) injection, Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd Denmark
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Post by joeypotsandpans on Oct 5, 2018 13:29:39 GMT -5
This is horrible correct? It does not endorse Afrezza as the Standard of Care as we are all hoping for. It does state the following that is key when a patient is not in compliance and inquires about Afrezza: The report suggests that a patient’s medication-taking and self-management behavior (adherence) be specifically considered as part of the decision cycle, ensuring a good match between patient and care plan. Inconsistent medication-taking behavior affects almost half of people with diabetes, which leads to suboptimal blood glucose control and increased CVD risk.This is key in the insurance part of the equation...the changes/updates are opening doors regarding taking the patient's compliance into consideration. In essence it is instructing physicians to be more receptive of the individual patients when it comes to listening to wants and needs with life style and compliance.
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Post by agedhippie on Oct 5, 2018 14:23:59 GMT -5
John Buce of Mannkind SAB is one of the co-chairs producing this report. I do not see anything here directly opening a door for Afrezza. So, what's up? The role of people on an advisory board is not to promote a company's product, it is to provide their expertise to the company to help the company make better decisions. In the case of the SAB it's to make better scientific decisions.
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Post by bill on Oct 5, 2018 14:25:52 GMT -5
John Buce of Mannkind SAB is one of the co-chairs producing this report. I do not see anything here directly opening a door for Afrezza. So, what's up? However, the following might indirectly open some doors: "The panel recommends the target HbA1c to increase microvascular benefits is 7 percent or less (53 mmol/mol) for most nonpregnant adults with sufficient life expectancy, with individualization based on patient preferences and goals; risk of adverse effects including hypoglycemia and weight gain; and patient characteristics including frailty and comorbid conditions. The cost, adherence and tolerability burdens have been added as factors to be considered for all medication therapy. " --- as in A1c less than or equal 7 with fewer hypos. Perhaps one of our "connected" members might raise the above points to Mike C--an absence of Afrezza in the report and the report being co-chaired by one of MNKD's SAB members... The quotation about putting the fox amongst the chickens in the henhouse comes to mind .
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Post by stevil on Oct 5, 2018 15:44:58 GMT -5
This is horrible correct? It's either really good or horrible. Really good because MNKD now has a target to beat and knows who the enemy is. If they can prove safety, adherence, and efficacy over GLP-1s, it's going to be an easy road. Really bad because it'll take a lot of work. GLP-1s are known to help with weight loss and cardiac benefits. They're backed by heavy pockets who can afford to design advantageous trials and have greater resources to reach doctors. MNKD has its work cut out for it. Once you have a concept instilled in your mind, it takes a lot of convincing to change perceptions. MNKD may have to prove weight neutrality and cardiac benefit over time and across many different ethnic groups. They may have to prove adherence is higher and leads to better outcomes. They may have to prove the absolute risk ratio is lower with Afrezza vs GLP-1s etc. If you notice, GLP-1s have been on the market for a long time. Afrezza is different enough from other insulins that it may have to pay its dues and wait until the evidence shakes out to prove superiority. Fortunately, this shouldn't take longer than a year or so to flesh out. Adherence will be there only unknown variable at that point, mostly because GLP-1s can be injected every 1-2 weeks. It's a lot easier to adhere to that simplistic of a regimen.
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Post by uvula on Oct 5, 2018 16:36:47 GMT -5
Shouldn't the report mention that an a1c of 7 was chosen not because it is good but it is a tradeoff between good control and severe hypos? An a1c of 7 should not be considered the gold standard without an asterisk explaining why it was picked.
Once that is in writing the next step would be to show that an a1c of 6 is better than 7 and it can be a achieved with afrezza w/o more hypos.
This is all wishful thinking.
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Post by cedafuntennis on Oct 5, 2018 16:36:55 GMT -5
Yes, but lets keep in mind that we only need a few % points of this market to be profitable and prove what Afrezza does in the real world.
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Post by mango on Oct 5, 2018 17:14:38 GMT -5
This is horrible correct? Indeed. For patients with chronic kidney disease, the panel recommends consideration of a sodium-glucose cotransporter 2 (SGLT2) inhibitor with proven benefits. Individual medications in both the GLP-1 receptor agonist and SGLT2 inhibitor classes have been shown to have cardiovascular benefits.FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetesThe U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.www.fda.gov/Drugs/DrugSafety/ucm617360.htm
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