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Long-Term Glycaemic Durability of Early Combination Therapy Strategy versus Metformin Monotherapy in Korean Patients with Newly Diagnosed Type 2 Diabetes Mellitus.

ABSTRACT: We assessed the glycaemic durability with early combination (EC; vildagliptin+metformin [MET], n=22) versus MET monotherapy (n=17), among newly-diagnosed type 2 diabetes mellitus (T2DM) enrolled (between 2012 and 2014) in the VERIFY study from Korea (n=39). Primary endpoint was time to initial treatment failure (TF) (glycosylated hemoglobin [HbA1c] ≥7.0% at two consecutive scheduled visits after randomization [end of period 1]). Time to second TF was assessed when both groups were receiving and failing on the combination (end of period 2). With EC the risk of initial TF significantly reduced by 78% compared to MET (n=3 [15%] vs. n=10 [58.7%], P=0.0228). No secondary TF occurred in EC group versus five patients (29.4%) in MET. Patients receiving EC treatment achieved consistently lower HbA1c levels. Both treatment approaches were well tolerated with no hypoglycaemic events. In Korean patients with newly diagnosed T2DM, EC treatment significantly and consistently improved the long-term glycaemic durability as compared with MET.

SUBMITTER: Yoo SJ

PROVIDER: S-EPMC8640145 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Long-Term Glycaemic Durability of Early Combination Therapy Strategy versus Metformin Monotherapy in Korean Patients with Newly Diagnosed Type 2 Diabetes Mellitus.

Yoo Soon-Jib SJ Chang Sang-Ah SA Sohn Tae Seo TS Kwon Hyuk-Sang HS Lee Jong Min JM Moon Sungdae S Proot Pieter P Paldánius Päivi M PM Yoon Kun Ho KH

Diabetes & metabolism journal 20201112 6

We assessed the glycaemic durability with early combination (EC; vildagliptin+metformin [MET], n=22) versus MET monotherapy (n=17), among newly-diagnosed type 2 diabetes mellitus (T2DM) enrolled (between 2012 and 2014) in the VERIFY study from Korea (n=39). Primary endpoint was time to initial treatment failure (TF) (glycosylated hemoglobin [HbA1c] ≥7.0% at two consecutive scheduled visits after randomization [end of period 1]). Time to second TF was assessed when both groups were receiving and ...[more]

PMID: 33176094

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Project description:BackgroundCardiovascular disease is a major cause of mortality and morbidity in people with type 2 diabetes mellitus (T2DM). Studies have consistently identified dyslipidemia as an important risk factor for the development of macrovascular disease. The landmark United Kingdom Prospective Diabetes Study has shown that metformin therapy reduces cardiovascular events in overweight people with T2DM. This study investigates the effect of metformin monotherapy on serum lipid profile in statin-naïve individuals with newly diagnosed T2DM, and whether the effect, if any, is dosage-related.MethodsThis cohort study enrolled individuals exceeding 20 years of age, with recent onset T2DM, who received at least 12 months of metformin monotherapy and blood tests for serum lipid at 6-month intervals. Exclusion criteria involved people receiving any additional antidiabetic medication or lipid-lowering drug therapy. Lipid-modifying effect of metformin was recorded as levels of serum triglycerides (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) measured at six month intervals.ResultsThe study enrolled 155 participants with a mean age of 58.6 years and average glycosylated hemoglobin A1c of 8%. After initiating metformin therapy, LDL-C was significantly reduced from 111 mg/dl to 102 mg/dL at 6 months (P < 0.001), TG was reduced from 132 mg/dl to 122 mg/dL at 12 months (P = 0.046), and HDL-C increased from 45.1 mg/dL to 46.9 mg/dL at 12 months (P = 0.02). However, increasing the dosage of metformin yielded no significant effect on its lipid-lowering efficacy.DiscussionMetformin monotherapy appreciably improves dyslipidemia in statin-naive people with T2DM. Its lipid-modifying effect may be attributable to insulin sensitization, reduction of irreversibly glycated LDL-C, and weight loss. In practice, people with dyslipidemia who are ineligible for lipid-lowering agents may benefit from metformin therapy. Moreover, previous studies report a synergistic effect between metformin and statin, which may further reduce cardiovascular events in at-risk individuals. Overall, metformin is a safe and efficacious approach to alleviate dyslipidemia in people with newly diagnosed T2DM.

Project description:BackgroundDiabetes mellitus (DM) is a well-known risk factor for tuberculosis (TB). Metformin, which is an essential anti-diabetic drug, has been shown to exhibit anti-TB effects in patients with DM. Its effect on preventing the development of TB among patients who are newly diagnosed with DM remains unclear.MethodsThis was a retrospective cohort study using the claims database of the Korean Health Insurance Review and Assessment Service. The study population included patients who were newly diagnosed with type 2 DM and who were treated with anti-diabetic drugs between 1 January 2003 and 31 March 2011. A patient was defined as a metformin user if he/she had taken metformin for more than 28 days within 6 months since cohort entry, and as a metformin non-user if he/she had never been treated with metformin. The development of TB within 2 years after the index date was compared by Cox proportional hazard regression models between metformin users and 1:1 propensity score (PS)-matched non-users.ResultsAmong 76,973 patients who were newly diagnosed with type 2 DM, 13,396 were classified as metformin users, 52,736 were classified as metformin non-users, and 10,841 were excluded from the final analysis. PS-matched Cox proportional hazard regression models revealed that metformin use was not associated overall with the prevention of TB development (HR 1.17; 95% CI 0.75-1.83; P = 0.482). There was a trend, however, towards a reduction in the development of TB among patients taking a higher cumulative dose of metformin. Patients who were in the highest quartile (Q4) of cumulative metformin dose had only a 10% risk of developing TB compared to metformin non-users. In contrast, during the early phases of metformin treatment, patients in the second quartile (Q2) of cumulative metformin use had a higher risk of developing TB than patients in the first quartile (Q1).ConclusionsOnly the highest cumulative doses of metformin were protective against the development of TB among patients who were newly diagnosed with type 2 DM; lower cumulative doses of metformin did not appear to reduce the incidence of active TB infection.

Dataset Information

Long-Term Glycaemic Durability of Early Combination Therapy Strategy versus Metformin Monotherapy in Korean Patients with Newly Diagnosed Type 2 Diabetes Mellitus.

Publications

Long-Term Glycaemic Durability of Early Combination Therapy Strategy versus Metformin Monotherapy in Korean Patients with Newly Diagnosed Type 2 Diabetes Mellitus.

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