Is it possible to achieve a safe glycated hemoglobin level during intensive hypoglycemic therapy? (results of ADVANCE study)
https://doi.org/10.14341/2072-0351-5646
Abstract
Aim.
To study efficacy of glycemic control in terms of reduced HbA1c level using glyclazide modified release (MR) in patients with DM2 and differentclinical characteristics at the initial stage of therapy in the framework of ADVANCE study (Action in Diabetes and Vascular Disease: Preterax andDiamicron Modified Release (MR) Controlled Evaluation).
Materials and methods.
A total of 11140 patients aged 55 years or older with DM2 and one or several cardiovascular risk factors were randomized forthe study. They were randomly distributed between 2 groups, one to receive intensive hypoglycemic therapy with glyclazide MR the other to be treatedin a standard mode as recommended by local, regional or national guidelines after a 6 week introductory phase. The efficacy of therapy was assessedbased on the following criteria: absolute change in HbA1c level (difference between the last and the first values obtained during the randomizationperiod), real HbA1c level achieved, percent of patients with target HbA1c level (<7.0, <6.5 or <6.0%) in the end of the follow-up (median 5 yr).Also, the efficacy was evaluated in subgroups formed based on the patients age and sex, DM duration, BMI, starting HbA1c level, and the use ofhypoglycemic agents.
Results.
Mean HbA1c level decreased by the end of the 5 year follow-up period from 7.5 to 6.5 and 7.3% in patients given intensive and standardhypoglycemic therapy respectively. Intensive therapy allowed to achieve the target HbAc1 level (<7.0, <6.5 or <6.0%) in a greater number of patientsof all subgroups (p<0.0001). The key independent predictors of HbA1c reduction were its initial level, duration of DM, and BMI in the early phaseof the study. Patients given intensive therapy did not increase mean body mass and had only rare episodes of severe hypoglycemia even if somewhatmore frequent than in the control group.
Conclusion.
Intense hypoglycemic therapy with glyclazide MR is well tolerated and equally efficient in DM2 patients with a wide range of clinicalcharacteristics.
To study efficacy of glycemic control in terms of reduced HbA1c level using glyclazide modified release (MR) in patients with DM2 and differentclinical characteristics at the initial stage of therapy in the framework of ADVANCE study (Action in Diabetes and Vascular Disease: Preterax andDiamicron Modified Release (MR) Controlled Evaluation).
Materials and methods.
A total of 11140 patients aged 55 years or older with DM2 and one or several cardiovascular risk factors were randomized forthe study. They were randomly distributed between 2 groups, one to receive intensive hypoglycemic therapy with glyclazide MR the other to be treatedin a standard mode as recommended by local, regional or national guidelines after a 6 week introductory phase. The efficacy of therapy was assessedbased on the following criteria: absolute change in HbA1c level (difference between the last and the first values obtained during the randomizationperiod), real HbA1c level achieved, percent of patients with target HbA1c level (<7.0, <6.5 or <6.0%) in the end of the follow-up (median 5 yr).Also, the efficacy was evaluated in subgroups formed based on the patients age and sex, DM duration, BMI, starting HbA1c level, and the use ofhypoglycemic agents.
Results.
Mean HbA1c level decreased by the end of the 5 year follow-up period from 7.5 to 6.5 and 7.3% in patients given intensive and standardhypoglycemic therapy respectively. Intensive therapy allowed to achieve the target HbAc1 level (<7.0, <6.5 or <6.0%) in a greater number of patientsof all subgroups (p<0.0001). The key independent predictors of HbA1c reduction were its initial level, duration of DM, and BMI in the early phaseof the study. Patients given intensive therapy did not increase mean body mass and had only rare episodes of severe hypoglycemia even if somewhatmore frequent than in the control group.
Conclusion.
Intense hypoglycemic therapy with glyclazide MR is well tolerated and equally efficient in DM2 patients with a wide range of clinicalcharacteristics.
About the Authors
Marina Vladimirovna Shestakova
Endocrinological Research Centre, Moscow
Minara Shamkhalovna Shamkhalova
Endocrinological Research Centre, Moscow
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Review
For citations:
Shestakova M.V., Shamkhalova M.Sh. Is it possible to achieve a safe glycated hemoglobin level during intensive hypoglycemic therapy? (results of ADVANCE study). Diabetes mellitus. 2011;14(2):110-115. (In Russ.) https://doi.org/10.14341/2072-0351-5646
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