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Comparative Effectiveness of Antidiabetic Agents in Patients with Type 2 Diabetes Mellitus: A Multicenter Randomized Trial

Why this research?

The efficacy of new antidiabetic agents in patients with type 2 diabetes mellitus has mainly been studied in non-randomized or placebo-controlled trials. Such studies only establish the effectiveness of one treatment. Comparative effectiveness research is lacking to date.

Research question

What are the effects of different antidiabetic agents, in addition to metformin treatment, on the incidence of microvascular complications and cardiovascular disease in patients with type 2 diabetes mellitus?

How was this investigated?

The researchers conducted a multicenter randomized trial of the effectiveness of four commonly used antidiabetic agents (insulin glargine, glimepiride, liraglutide and sitagliptin) that were approved by the US Food and Drug Administration (FDA) for use in combination with metformin in patients with diabetes mellitus. 2. Patients diagnosed within the past 10 years and who were 30 years or older at that time were eligible for participation if they were treated with at least 500 mg metformin per day and an HbA1c level at the time of randomization. had a value of 50.8-69.4 mmol/mol. In this article, only the pre-specified secondary outcome measures are reported with regard to microvascular complications and cardiovascular diseases, namely: hypertension, dyslipidemia, a moderately or strongly increased albumin concentration, renal insufficiency (eGFR < 60 ml/min per 1.73 m2), diabetic peripheral neuropathy, major adverse cardiovascular events (MACE), hospitalization for heart failure and cardiovascular disease), and mortality.

Main results

During a mean follow-up period of 5.0 years in 5047 participants (mean age: 57.2 years; 36.4% female), no substantive differences were found in the cumulative incidence of hypertension and dyslipidemia between the four treatment groups. This also applied to the cumulative incidence of a moderately elevated albumin concentration (average: 2.57 events per 100 person-years), a highly elevated albumin concentration (1.08), renal insufficiency (2.91), diabetic peripheral neuropathy (16.66), MACE (1.0), hospitalization for heart failure (0.4), cardiovascular death (0.3) and overall mortality (0.6). There were small differences in the cumulative incidence of cardiovascular disease, with 1.87, 1.92, 1.36 and 2.00 events per 100 person-years in the insulin glargine, glimepiride, liraglutide and sitagliptin groups, respectively. When the effect of one treatment was compared with the combined effect of the other three treatments, the hazard ratios for cardiovascular disease were 1.07 (95% CI: 0.87-1.33) in the insulin glargine group, 1, 12 (95% CI: 0.90-1.39) in the glimepiride group, 0.71 (95% CI: 0.56-0.90) in the liraglutide group and 1.18 (95% CI: 0 .96-1.46) in the sitagliptin group.

2023-11-02 05:00:00
#Comparative #effectiveness #study #type #diabetes

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