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    Home > Active Ingredient News > Endocrine System > Sub-Journal of The Lancet: Dapagliflozin reduces new-onset diabetes by 33%, and two key studies add evidence of benefit!

    Sub-Journal of The Lancet: Dapagliflozin reduces new-onset diabetes by 33%, and two key studies add evidence of benefit!

    • Last Update: 2022-01-10
    • Source: Internet
    • Author: User
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    ▎ WuXi content editing team, "An ounce of prevention is better than a pound of cure
    .
    "
    (IS AN Ounce of Prevention Worth A Pound of Cure.
    ) - Benjamin Franklin (Benjamin Franklin) Currently, there are 537 million adults aged 20-79 Suffer from diabetes, accounting for 10.
    5% of the world's population of this age
    .

    Among them, type 2 diabetes accounts for the vast majority (over 90%)
    .

    Moreover, as the population ages and sedentary habits become more common, the prevalence of diabetes is still rising
    .

    Preventing diabetes can help reduce the burden of disease and reduce complications of diabetes, such as diabetic retinopathy, nephropathy, and neuropathy
    .

    However, life>
    .

    Therefore, we also need effective and safe drug treatments to prevent diabetes and its complications
    .

    SGLT2 inhibitor drugs first appeared as hypoglycemic agents and were well tolerated
    .

    Since then, a large number of studies have confirmed that such drugs can also bring heart and kidney benefits to patients, and this heart and kidney benefit is independent of blood sugar improvement
    .

    Previously, data from the heart failure test of the SGLT2 inhibitor dapagliflozin also suggested that in patients with heart failure, dapagliflozin also "in turn" prevented new-onset diabetes
    .

    Recently, "The Lancet Diabetes & Endocrinology" (The Lancet Diabetes & Endocrinology) published a summary analysis of the data from two key trials of Gligliflozin to further evaluate the impact of dapagliflozin on new-onset type 2 diabetes
    .

    The results showed that dapagliflozin treatment significantly reduced the risk of developing type 2 diabetes in patients with chronic kidney disease and heart failure by 33%
    .

    In the concurrent review article of "The Lancet-Diabetes and Endocrinology", Professor Alice YY Cheng of the University of Toronto pointed out that, instead of discussing whether it is necessary to use dapagliflozin for diabetes prevention in clinical practice, More attention should be paid to the two messages that it is necessary to screen for abnormal blood glucose in patients with kidney or heart disease; at the same time, we now have enough convincing reasons to use SGLT2 inhibitors in patients with chronic kidney disease and heart failure to reduce heart disease.
    The risk of blood vessels and kidneys, and reducing the development of type 2 diabetes can be described as "icing on the cake
    .
    "
    Screenshot source: The Lancet Diabetes & Endocrinology This study is a summary analysis of data from the DAPA-CKD trial and DAPA-HF trial
    .

    Both trials are phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials, respectively confirming that dapagliflozin can prevent adverse chronic kidney disease outcomes and reduce the risk of cardiovascular death and heart failure
    .

    This analysis included 4003 participants with no history of diabetes and HbA1c <6.
    5% (diagnostic threshold for diabetes) at baseline: 1398 (34.
    9%) from the DADA-CKD trial and 2605 (65.
    1%) from DAPA-HF Trial; 1995 (49.
    8%) received dapagliflozin and 2008 (50.
    2%) received placebo
    .

    In the continuous determination of HbA1c in the trial, if there are two continuous values ​​≥6.
    5%, or the diagnosis of diabetes is clinically diagnosed in the interval between trial visits, it is judged as new-onset type 2 diabetes
    .

    After a median follow-up of 21.
    2 months, 6.
    3% of the placebo group (126/2008, the event rate was 3.
    9/100 patient-years) and the dapagliflozin group 4.
    3% (85/1995, the event rate was 2.
    6 /100 patient-years) patients developed type 2 diabetes, and the risk of new type 2 diabetes in the dapagliflozin group was significantly lower by 33% (HR 0.
    67 [95% CI 0.
    51 ~ 0.
    88]; p=0.
    0040)
    .

    The gap between the two groups began to appear at 4 months
    .

    ▲The risk of new-onset type 2 diabetes in the dapagliflozin group (blue line) was significantly reduced (picture source: reference [1]) there is no heterogeneity between studies
    .

    The effects of dapagliflozin are similar in the pre-designated key subgroups, which include different gender, age, blood glucose status, BMI, glomerular filtration rate, systolic blood pressure, and baseline cardiovascular drug use
    .

    Image source: In the 123RF study, more than 90% of patients with newly developed type 2 diabetes were already in the pre-diabetes stage at the beginning of the study (HbA1c 5.
    7% ~ 6.
    4%)
    .

    The same review article emphasized that this reflects two important messages: (1) Patients with prediabetes have a high direct risk of developing type 2 diabetes
    .

    (2) Abnormal blood glucose is common in patients with kidney disease or heart disease, and it is important to carry out metabolic screening for these patients
    .

    In addition, the study also found that during the follow-up period, the difference in average HbA1c between the two groups of patients hardly changed
    .

    At 12 months, the difference between the dapagliflozin group and the placebo group was -0.
    01% (95% CI -0.
    03 ~ 0.
    01)
    .

    Regardless of whether they were in the pre-diabetes stage at the beginning of the study, the average HbA1c of the two groups of patients was basically similar
    .

    ▲Regardless of whether the study was in the pre-diabetes stage or not, the average HbA1c of the two groups of patients was basically similar (picture source: reference [1]) The discussion part of the paper pointed out that this result suggests that the benefits of dapagliflozin in preventing diabetes are not only As a result of reduced blood glucose biochemical indicators, dapagliflozin has indirect benefits in the indispensable underlying pathophysiological process from prediabetes to the progression of diabetes, including improving insulin resistance and improving β-cell function by reducing blood sugar toxicity
    .

    The same review article also pointed out that only about 30% of the patients in this analysis had an estimated glomerular filtration rate of more than 45 mL/min/1.
    73 m² at baseline, and the renal function was below this threshold, and the blood glucose efficacy of SGLT2 inhibitors would be affected.
    Limit
    .

    This supports that the effect of dapagliflozin on new-onset diabetes is not only “masking” the disease progression, but actually plays a preventive role
    .

    Of course, this has yet to be proved by randomized controlled diabetes prevention trials
    .

    Image source: 123RF In patients without type 2 diabetes at the beginning of the study, dapagliflozin was generally well tolerated
    .

    Compared with the placebo group (32∙3% [648/2004]), fewer patients in the dapagliflozin group (30∙0% [598/1991]) reported serious adverse events
    .

    However, the dapagliflozin group discontinued the study drug more frequently (5∙2% vs 4∙4%), and the most common reason for discontinuation was heart or kidney disease or infection
    .

    In summary, the paper points out that in addition to the clinical benefits of reducing the progression of kidney disease and heart failure, dapagliflozin may significantly reduce new-onset diabetes in patients with chronic kidney disease and heart failure
    .

    This is especially important for patients at high risk of developing diabetes, including patients with pre-diabetes
    .

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