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Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30 + metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis.

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  • معلومة اضافية
    • المصدر:
      Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: London : Nature Publishing Group, copyright 2011-
    • الموضوع:
      Biphasic Insulins/*adverse effects ; Cardiovascular Diseases/*chemically induced ; Hypoglycemic Agents/*adverse effects ; Insulin Aspart/*adverse effects ; Insulin, Isophane/*adverse effects ; Metformin/*adverse effects; Adolescent ; Adult ; Aged ; Biphasic Insulins/therapeutic use ; Blood Glucose/drug effects ; Body Mass Index ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/metabolism ; Female ; Glycated Hemoglobin/metabolism ; Heart Disease Risk Factors ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemia/metabolism ; Insulin/pharmacology ; Insulin Aspart/therapeutic use ; Insulin, Isophane/therapeutic use ; Male ; Middle Aged ; Risk Factors ; Weight Gain/drug effects ; Young Adult
    • نبذة مختصرة :
      We assessed whether comparative efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) plus metformin versus BIAsp 30 monotherapy differed for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI) by performing a post hoc analysis of the randomized controlled MERIT study. In the MERIT study, eligible patients were randomized 1:1 to receive BIAsp 30 plus metformin or BIAsp 30 for 16 weeks. Patients in the 2 treatment groups were classified into "low" and "high" risk subgroups based on their GloboRisk scores and into "BMI ≤ 26 kg/m 2 "and "BMI > 26 kg/m 2 " subgroups. Primary efficacy endpoint was between-treatments comparison of HbA1c changes from baseline for these 2 sets of subgroups. Between-treatments comparisons of secondary efficacy and safety endpoints were also performed. We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients. Meanwhile, for patients with BMI ≤ 26 kg/m 2 , compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m 2 , BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.
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    • الرقم المعرف:
      0 (Biphasic Insulins)
      0 (Blood Glucose)
      0 (Glycated Hemoglobin A)
      0 (Hypoglycemic Agents)
      0 (Insulin)
      0 (insulin aspart, insulin aspart protamine drug combination 30:70)
      53027-39-7 (Insulin, Isophane)
      9100L32L2N (Metformin)
      D933668QVX (Insulin Aspart)
    • الموضوع:
      Date Created: 20210219 Date Completed: 20211208 Latest Revision: 20240806
    • الموضوع:
      20240806
    • الرقم المعرف:
      PMC7893025
    • الرقم المعرف:
      10.1038/s41598-021-83410-x
    • الرقم المعرف:
      33602996