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    Home > Active Ingredient News > Endocrine System > The only new basal insulin analog on the list!

    The only new basal insulin analog on the list!

    • Last Update: 2022-04-28
    • Source: Internet
    • Author: User
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    *Read only for medical professionals to choose the ideal basal insulin - for efficacy, safety and cost-effectiveness
    .

    The latest diabetes map released by the International Diabetes Federation (IDF) shows that in the ten years from 2011 to 2021, the number of adult diabetic patients in China has increased from 90 million to 140 million [1], an astonishing increase
    .

    But at the same time, the current situation of diabetes management in China is not optimistic, and the awareness rate, treatment rate, and compliance rate of patients are less than half [2]
    .

    In this context, timely selection of powerful hypoglycemic measures is particularly important
    .

     The Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)[3] pointed out that when oral hypoglycemic drugs are ineffective or contraindicated, insulin should be used to control hyperglycemia and reduce the risk of diabetes complications
    .

    Insulin therapy may be the primary, or even necessary, measure of glycemic control at certain times, especially when the disease is prolonged
    .

    In fact, the choice of insulin, not only the blood sugar can be effectively controlled, but also has certain advantages from the perspective of pharmacoeconomics
    .

    Recently, long-acting insulin analogs were included in the 2021 World Health Organization (WHO) Essential Medicines List (EML) [4], which also confirms this
    .

     Among them, insulin degludec U100 is the only new basal insulin analog included [4], so why is insulin degludec favored by WHO? Hypoglycemic efficacy, safety and cost-effectiveness are indispensable! Looking at the inclusion criteria of the Essential Drug List, the three major criteria are indispensable.
    Looking at the EML in 2021, it is not difficult to find that effectiveness, safety, and cost-effectiveness are important criteria for whether a drug is included in the EML
    .

    For example, some drugs with enormous clinically relevant benefits and good safety profiles, but prohibitively expensive and unaffordable even in high-income countries, were not recommended for inclusion in the list by the Committee
    .

     The affordability issue is not limited to newer drugs, as some "old" high-potency drugs, such as insulin, are also often a major barrier to access for patients requiring chronic, sometimes lifelong treatment, due to their pricing [4]
    .

     The committee underlines the continuing challenge of making these medicines more affordable to those who need them and to communities [4]
    .

    This is critical for low- and middle-income countries given the steadily increasing number of patients who may need these drugs [4]
    .

     Diabetes is a chronic disease that is prevalent in the world and requires long-term or even life-long treatment, which brings a huge economic burden to patients and countries
    .

    According to statistics, the healthcare expenditure related to diabetes (20-79 years old) in China will be as high as 165.
    3 billion US dollars in 2021 [1], an increase of more than 50 billion US dollars compared with the data in 2017 [3]
    .

    Therefore, it is undoubtedly urgent for clinicians and patients in China to seek hypoglycemic drugs that take into account the effectiveness, safety and cost-effectiveness
    .

     Looking at the status quo of diabetes from the list of essential medicines, a powerful weapon under the pandemic In the context of the diabetes pandemic, EML in 2021 has added two categories of long-acting insulin analogs and sodium-glucose co-transporter-2 (SGLT-2) inhibitors hypoglycemic drugs
    .

    For the former, this application is the fourth time the Expert Committee has considered it for inclusion in the EML
    .

     The committee recommended that the EML core list include long-acting insulin analogs (insulin detemir, insulin degludec, insulin glargine, and their quality-assured biosimilars as therapeutic alternatives) (Figure 1) [4]
    .

    The committee once again acknowledged that insulin is a life-saving essential medicine with an urgent public health need
    .

    Achieving reliable, equitable and affordable access to insulin remains a major public health challenge in many countries
    .

    The committee believes that insulin analogs are clinically significant in reducing the incidence of symptomatic and nocturnal hypoglycemia compared to human insulin, especially in patients at high risk for hypoglycemia, justifying the recommendation to include long-acting insulin The decision for analogs is reasonable [4]
    .

     Figure 1 2021 EML newly added long-acting insulin analogs that take into account effectiveness, safety, and cost-effectiveness.
    Among the long-acting insulin analogs included in EML this time, insulin degludec is currently the longest-acting basal insulin, with a long half-life Up to 25 hours [4], stable without peaks, a daily injection of 1 injection can help patients better control their blood sugar and help their blood sugar reach the target
    .

    Through evidence-based evidence, it can be found that in terms of efficacy, safety, and cost-effectiveness, insulin degludec is in line with the principles of WHO's adjustment of EML
    .

     In terms of efficacy and safety, the ReFLeCT study showed that glycated hemoglobin (HbA1c) and fasting blood glucose (FPG) were significantly improved (P<0.
    001) after 12 months of switching from other basal insulins to insulin degludec therapy (P<0.
    001).
    The risk of hypoglycemia was significantly reduced (RR: 0.
    46; 95% CI: 0.
    38-0.
    56) [6]
    .

    The CONFIRM study also showed (Fig.
    2) that in insulin-naïve patients with type 2 diabetes, HbA1c improved with insulin degludec compared to insulin glargine U300 after 180 days of initiation of insulin degludec or insulin glargine U300 treatment It was significantly better (treatment difference: 0.
    27%, P=0.
    03), and the risk of hypoglycemia was reduced by 30% (RR: 0.
    70; 95% CI: 0.
    49-0.
    99) [7]
    .

     Figure 2 CONFIRM study results Poor blood sugar control will bring long-term complications and increased risk of death, which will further increase the health and economic burden of patients [8]
    .

    Effective blood sugar control can help patients save additional medical expenses in the future
    .

    Hypoglycemia is associated with an increased risk of cardiovascular disease and death [9].
    Reducing the risk of hypoglycemia can help reduce future related medical costs and save emergency and hospitalization costs related to hypoglycemia
    .

     Summary Taking efficacy, safety, and cost-effectiveness as the consideration criteria, WHO will include long-acting insulin analogs in EML in 2021
    .

    Among them, the new basal insulin analog, insulin degludec, has a half-life of 25 hours, and is currently the longest-acting long-acting insulin analog.
    There is sufficient evidence-based evidence that the use of insulin degludec can effectively control glucose without increasing the patient’s hypoglycemia.
    Blood sugar risk, while improving long-term health outcomes for patients and saving direct medical costs, are ideal for cost savings
    .

    The selection of EML this time is in line with the criteria of taking into account the effectiveness, safety and cost-effectiveness, and also lays the foundation for its wider clinical application
    .

    Reference: [1].
    IDF Diabetes Map 2021.
    https://diabetesatlas.
    org/data/en/country/42/cn.
    html.
    [2].
    Li Y, et al.
    BMJ.
    2020 Apr 28;369: m997.
    [3].
    Diabetes Branch of Chinese Medical Association.
    Chinese Journal of Diabetes.
    2021;13(4): 315-409.
    [4].
    Executive summary.
    The Selection and Use of Essential Medicines 2021.
    [5].
    Medical Center, et al.
    Chinese Journal of Diabetes.
    2021;13(1):14-46.
    [6].
    Fadini GP, et al.
    J Clin Endocrinol Metab.
    2019;104(12):5977-5990.
    [7].
    Tibaldi J, et al.
    Diabetes Obes Metab.
    2019 Apr;21(4):1001-1009.
    [8].
    Xu Zhangrong.
    Chinese Journal of Diabetes, 2010;18(5):398-400.
    [9].
    International Hypoglycaemia Study Group.
    Lancet Diabetes Endocrinol.
    2019 May;7(5):385-396.
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