Combination therapy of diabetes

Early therapy using metformin and vildagliptin shows good results in type 2 diabetes

Lina Medvedeva, XX2 century

While diabetes cannot be cured, but timely (that is, as early as possible) and proper intensification of treatment can lead to sustained high-quality glycemic control and significantly delay the manifestation of complications.

In a new study, the results of which are published in The Lancet, scientists compared early therapy for type 2 diabetes with metformin and combination therapy combining metformin (metformin) and vildagliptin (vildagliptin).

The study participants (2001 people) were randomly divided into groups to receive metformin treatment at a dosage of up to 1000 mg in combination with 50 mg of vildagliptin twice a day, metformin alone or placebo. All participants were diagnosed with diabetes within the last two years, and they all had glycohemoglobin levels of 48-58 mmol/mol (6.5–7.5%). This indicator certifies that they were in the relatively early stages of the disease. They had not previously received drug therapy or had used metformin for less than a month before the start of the study.

Therapeutic failure, that is, achieving a glycohemoglobin level of 53 mmol/mol or higher, with two consecutive visits of researchers (they were conducted every 3 months), was observed in 62.3% of cases in the group where patients took only metformin, compared with 43.6% in the group with combined use of drugs.

In the monotherapy group, the average time to achieve therapeutic failure was 36.1 months, and in the combined group – 61.9 months. This can be equated to a 49% reduction in the risk of combined treatment compared to monotherapy.

"You can win a therapeutic window lasting two years," David Matthews from the University of Oxford told reporters.

Patients who suffered a therapeutic failure continued treatment without placebo control with metformin and vildagliptin until the next point of therapeutic failure, which is the need to start taking insulin. If another drug was needed, not insulin, patients dropped out of the study.

It is important to note that patients undergoing combination therapy at the first stage of the study also showed better results at the second stage. Those who started metformin monotherapy experienced a faster transition to insulin dependence (secondary therapeutic failure), despite the addition of vildagliptin after passing the first stage of therapeutic failure.

Whether patients benefit in the long run from receiving more intensive care from the start is, according to Matthews, "a serious question for diabetics."

In those who took vildagliptin from the very beginning, there was a significant slowdown, by 26%, in the onset of the second stage of therapeutic failure.

Prior treatment with vildagliptin did not lead to weight gain compared with treatment exclusively with metformin, and hypoglycemia rates in both groups were the same.

Despite the fact that the study was not aimed at assessing the consequences for the cardiovascular system, the researchers found some evidence of a delay in the first detection of a macrovascular event in the group with preliminary combination therapy, which implies that more intensive glycemic control led to a decrease in the risk of cardiovascular complications. However, this conclusion was based on a very small number of cases – 2.4% in the group with combination therapy and 3.3% in the group taking metformin alone.

The co-author of the study, Stefano Del Prato from the University of Pisa (Università di Pisa), stressed that the analysis of the results of macrovascular results is purely probing in nature and requires special research to reproduce the data obtained. However, he called the noted results intriguing, given that the study participants with early-stage diabetes are very different from the high-risk population groups whose representatives demonstrated the cardioprotective benefits of diabetes medications.

Del Prato also noted that in addition to vildagliptin and metformin, there are many other combinations of first-line drugs. "We believe," he said, "that this study opens a new era of exploring the potential benefits of combining different drugs for people with type 2 diabetes."

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