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    Home > Active Ingredient News > Endocrine System > The latest family standing drug list was announced. Why did the original metformin sustained-release tablets make the list again?

    The latest family standing drug list was announced. Why did the original metformin sustained-release tablets make the list again?

    • Last Update: 2022-01-09
    • Source: Internet
    • Author: User
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    *It is only for medical professionals to read for reference.
    Why did this "guanidine" fly into the homes of the people again? What is the reason behind it? As the cornerstone drug of the first-line treatment of type 2 diabetes (T2DM), metformin is currently one of the most widely used oral hypoglycemic drugs in the world and the core drug for the prevention and control of diabetes in the world [1]
    .

     On December 23, the 2020-2021 “China Family Standing Drug Listed Brand” co-sponsored by Family Doctor Online and the New Generation Market Monitoring Agency announced that Merck’s classic hypoglycemic drug Gwazhi XR (metformin hydrochloride sustained-release tablets) ) It stood out from the 109 common pharmaceutical products in 28 categories, and was selected into the list of Chinese family standing hypoglycemic drug brands (Figure 1)
    .

     Figure 1 Gehuazhi XR (Metformin Hydrochloride Sustained-Release Tablets) was selected as a brand list of Chinese family standing hypoglycemic drugs.
    It is worth noting that this is not the first time the drug has won this honor-in the "2019~2020 Chinese family standing drug list brand "In, this originally developed metformin hydrochloride sustained-release tablet is already on the list
    .

    There are three reasons why this medicine is so popular with diabetics, and see this article to reveal one by one
    .

     Reason 1: Metformin is the first-line hypoglycemic drug unanimously recommended by all major hypoglycemic guidelines.
    In the latest version of the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China", metformin is the only hypoglycemic drug recommended as the first-line parallel with life>
    .

    The reason is that metformin can achieve short-term and long-term hypoglycemic effects through multiple hypoglycemic mechanisms, while taking into account fasting blood glucose (FPG), postprandial blood glucose (PPG), and glycosylated hemoglobin (HbA1c) control.
    The recommended optimal dose for patients is 2000mg/day , Can reduce HbA1c2.
    0%, and is well tolerated and safe.
    Metformin can be used alone or in combination with other oral/injection hypoglycemic drugs [1].
    Studies have shown that compared with insulin monotherapy, metformin combined with insulin can be more effective Good control of blood sugar, reduce insulin consumption, reduce weight gain and reduce the risk of hypoglycemia
    .

    A large number of clinical studies have confirmed that metformin can directly improve the function of vascular endothelial cells and improve insulin resistance by reducing risk factors for cardiovascular disease, and has a clear cardiovascular protective effect [1]
    .

     Reason 2: The innovative sustained-release technology of the original metformin sustained-release tablets made up for the shortcomings of metformin.
    Metformin is a highly water-soluble compound that is quickly released in the stomach when it meets water after taking it, which may cause irritation to the local gastrointestinal mucosa[3,4 ]
    .

    In addition, the absorption window of metformin is very narrow, and the absorption point is only in the upper part of the small intestine.
    The drug will quickly pass through the upper part of the small intestine without being completely absorbed.
    Therefore, it needs to be taken 2-3 times or more a day to ensure a day's hypoglycemic effect
    .

     Govazhi XR (metformin hydrochloride sustained-release tablets) has a unique and innovative sustained-release technology, also known as GSD (GelShield) two-phase controlled release system, and has obtained patents in China, the United States and Europe (Figure 2, 3) [5, 6, 7 ]
    .

    Through the ingenious combination of internal and external phases, it slows down the dissolution rate of metformin in water and significantly reduces gastrointestinal irritation.
    At the same time, by extending the time that the drug stays in the stomach, the drug components are fully released and the upper part of the small intestine is fully released.
    It is fully absorbed and successfully reduced the number of daily medications.
    You only need to take the medication once a day after dinner
    .

    Figure 2 The basic composition of the GSD biphasic controlled release system Figure 3 The material composition of the GSD biphase controlled release system.
    The patient's medication compliance can further improve the effect of hypoglycemic effect
    .

     Reason 3: The original metformin sustained-release tablets have sufficient clinical evidence.
    The original metformin sustained-release tablets are the first to be marketed abroad.
    Therefore, there is sufficient clinical research evidence to prove that compared with ordinary metformin tablets, the sustained-release dosage form guarantees effective hypoglycemic reduction at the same time , It only needs once a day, has better gastrointestinal tolerance, and improves patient compliance with medication [1]
    .

    For example, in a study in the United States, the initial use of the original metformin extended-release tablets can reduce the incidence of gastrointestinal adverse events by 50%, and the incidence of diarrhea events by 75%.
    Patients who converted from ordinary metformin tablets to extended-release tablets, the stomach The incidence of intestinal events was reduced by 50% compared to before the transition (Figure 4) [8]
    .

     Figure 4 Starting metformin sustained-release tablets can reduce gastrointestinal adverse events.
    In China, there is also a prospective, open-label, randomized, multi-center study called CONSENT.
    532 newly diagnosed T2DM patients in China were randomly given to the original study metformin.
    Release tablets or ordinary metformin tablets were treated for 16 weeks, and the efficacy and safety of the two were compared [9]
    .

    Studies have shown that sustained-release tablets reduce HbA1c by 1.
    6% once a day, and the HbA1c<7% compliance rate is 70%.
    The hypoglycemic effect is equivalent to that of ordinary metformin tablets multiple times a day, and patient compliance reaches 97% [9]
    .

    Moreover, it significantly reduces the frequency of gastrointestinal adverse events and diarrhea (number of events/number of patients) [9]
    .

    It has also been observed in the study that the incidence of gastrointestinal adverse events is significantly reduced after the patients who are intolerant to ordinary tablets are converted to sustained-release tablets [9]
    .

    Summary The original research metformin sustained-release tablets, as the basic hypoglycemic drug for patients with T2DM, only need to be taken once a day.
    It has a good hypoglycemic effect, smaller gastrointestinal reactions, and better compliance.
    It is an ideal therapeutic formulation of metformin, and it is continuous It is well-deserved to be included in the list of family standing medicines for diabetic patients
    .

    References: [1].
    Mu Yiming, Ji Linong, Li Chunlin, et al.
    Chinese Journal of Diabetes, 2019, 027(003):161-173.
    [2].
    Chinese Journal of Diabetes, Chinese Journal of Diabetes, 2021, 13 (4):315-408.
    [3].
    McCreight LJ, et al.
    Diabetologia, 2016, 59(3):426-35.
    [4].
    Forslund K, et al.
    Nature, 2015, 528(7581): 262-6.
    [5].
    Biphasic controlled release delivery system for high solubility pharmaceuticals and method.
    US6475521 B1.
    [6].
    Biphasic controlled release delivery system for high solubility pharmaceuticals and method.
    EP1063973 B1.
    [7].
    "High solubility pharmaceuticals and method" Drug Biphasic Controlled Release Delivery System and Method" China, CN99804134 .
    3[P].
    2001-5-16.
    [8].
    Blonde L, Dailey GE, Jabbour SA, Reasner CA, Mills DJ.
    Curr Med Res Opin, 2004, 20(4):565-572.
    [9].
    Ji L, Liu J, Yang J, et al.
    Diabetes Obes Metab, 2018, 20(4):1006-1013.
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