Efficacy and safety of glimepiride as initial treatment in Russian patients with type 2 diabetes mellitus
https://doi.org/10.14341/DM2013495-100
Abstract
Aim.
To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients (T2DM).
Materials and Methods.
This is a multi-center, open-label prospective observational study. 245 treatment-naive T2DM patients, who had not achieved glycemic goals on lifestyle therapy during first 12 weeks after the diagnosis, were enrolled in this study. Anti-diabetes treatment was initiated with glimepiride and continued during the 6-month follow-up period. Prescription of the initial dose (1 mg per day) and further dose adjustments were carried out by the attending physician in accordance with the glimepiride data sheet. Dynamics of HbA1c, fasting plasma glucose (FPG), 2 h postprandial blood glucose (2hPPG), weight and waist circumference, as well as the incidence of hypoglycemia were the evaluated parameters.
Results.
The baseline HbA1c (mean: 7.9?0.5%; female: 7.8?0.4% ; male: 8.0?0.6%) was significantly reduced at week 12 (mean 7.2?0.6%, p<0.001; female: 7.1?0.5%; male: 7.2?0.6%), and at the final visit (6.6?0.7%, p<0.001; female: 6.6?0.7; male: 6.5?0.7). 71.7% of the subjects achieved the HbA1c target (<7%) at the end of the study. FPG and 2hPPG levels decreased by 2.3?1.3 mmol/L and 3.1?1.9 mmol/L, respectively (p<0.001). Of note, FPG and PPG at baseline were 8.2?1.2 mmol/L and 10.5?1.9 mmol/L, respectively. The incidence of hypoglycemia (as defined by BG <3.9 mmol/L in the presence of the relevant symptoms) was 10.2%. Nocturnal symptomatic hypoglycemia was observed in 1.6% of cases. No severe hypoglycemic events were reported.
Body weight and BMI reduced by 1.0 kg and 0.4 kg/m2, respectively, during the follow-up period. The mean glimepiride daily dose at the end of the follow-up was 2.8?1.3 mg. Observed reduction in weight and low incidence of hypoglycemia could be attributed to continued effects of the lifestyle therapy and relatively short history of T2DM (average duration of diabetes was 1.4?2.4 years (median 0.5 years).
Conclusion.
Glimepiride effectively improved glycemic control in treatment-naive T2DM patients over a 6-month period. The use of glimepiride in this population also showed a favorable safety profile. This data provides further rationale for the use of glimepiride for the initiation of pharmacological therapy in T2DM patients.
To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients (T2DM).
Materials and Methods.
This is a multi-center, open-label prospective observational study. 245 treatment-naive T2DM patients, who had not achieved glycemic goals on lifestyle therapy during first 12 weeks after the diagnosis, were enrolled in this study. Anti-diabetes treatment was initiated with glimepiride and continued during the 6-month follow-up period. Prescription of the initial dose (1 mg per day) and further dose adjustments were carried out by the attending physician in accordance with the glimepiride data sheet. Dynamics of HbA1c, fasting plasma glucose (FPG), 2 h postprandial blood glucose (2hPPG), weight and waist circumference, as well as the incidence of hypoglycemia were the evaluated parameters.
Results.
The baseline HbA1c (mean: 7.9?0.5%; female: 7.8?0.4% ; male: 8.0?0.6%) was significantly reduced at week 12 (mean 7.2?0.6%, p<0.001; female: 7.1?0.5%; male: 7.2?0.6%), and at the final visit (6.6?0.7%, p<0.001; female: 6.6?0.7; male: 6.5?0.7). 71.7% of the subjects achieved the HbA1c target (<7%) at the end of the study. FPG and 2hPPG levels decreased by 2.3?1.3 mmol/L and 3.1?1.9 mmol/L, respectively (p<0.001). Of note, FPG and PPG at baseline were 8.2?1.2 mmol/L and 10.5?1.9 mmol/L, respectively. The incidence of hypoglycemia (as defined by BG <3.9 mmol/L in the presence of the relevant symptoms) was 10.2%. Nocturnal symptomatic hypoglycemia was observed in 1.6% of cases. No severe hypoglycemic events were reported.
Body weight and BMI reduced by 1.0 kg and 0.4 kg/m2, respectively, during the follow-up period. The mean glimepiride daily dose at the end of the follow-up was 2.8?1.3 mg. Observed reduction in weight and low incidence of hypoglycemia could be attributed to continued effects of the lifestyle therapy and relatively short history of T2DM (average duration of diabetes was 1.4?2.4 years (median 0.5 years).
Conclusion.
Glimepiride effectively improved glycemic control in treatment-naive T2DM patients over a 6-month period. The use of glimepiride in this population also showed a favorable safety profile. This data provides further rationale for the use of glimepiride for the initiation of pharmacological therapy in T2DM patients.
About the Authors
Alexander Sergeevich Ametov
Russian Medical Academy of Postgraduate Education, Moscow
Russian Federation
MD, PhD, Professor, Head of Endocrinology and diabetology department
Russian Federation
MD, PhD, Professor, Head of Endocrinology and diabetology department
Fatima Totrazovna Abaeva
Russian Medical Academy of Postgraduate Education, Moscow
Russian Federation
Postgraduate student
Russian Federation
Postgraduate student
References
1. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33. The Lancet 1998;352(9131):837–853.
2. DOI: 10.1016/S0140-6736(98)07019-6.
3. Аметов АС. Уровень гликированного гемоглобина как значимый маркер полноценного гликемического контроля и предиктор поздних сосудистых осложнений сахарного диабета 2 типа. Русский Медицинский Журнал. 2011; 19(13): 832–837. [Ametov AS. Uroven' glikirovannogo gemoglobina kak znachimyy marker polnotsennogo glikemicheskogo kontrolya i prediktor pozdnikh sosudistykh oslozhneniy sakharnogo diabeta 2 tipa. Russkiy Meditsinskiy Zhurnal. 2011; 19(13):832–837.]
4. Standards of Medical Care for Patients With Diabetes Mellitus. Diabetes Care. 2003;26(suppl 1):s33–s50.
5. DOI: 10.2337/diacare.26.2007.S33
6. Effects of Intensive Glucose Lowering in Type 2 Diabetes. New England Journal of Medicine. 2008;358(24):2545–2559.
7. DOI: 10.1056/NEJMoa0802743
8. Дедов ИИ, Шестакова МВ, Аметов АС, Анциферов МБ, Галстян ГР, Майоров АЮ, Петунина НА, Сухарева ОЮ. Проект «Консенсус совета экспертов Российской ассоциации эндокринологов (РАЭ) по инициации и интенсификации сахароснижающей терапии сахарного диабета 2 типа». Сахарный диабет. 2011; (1):95–108. [Dedov I, Shestakova M, Ametov A, Antsiferov M, Galstyan G, Mayorov A, et al. Consensus statement by a panel of experts of the Russian Association of Endocrinologists (RAE) on initiation and intensificationof hypoglycemic therapy for type 2 diabetes mellitus. Diabetes mellitus. 2011;(1):95-105.
9. DOI: 10.14341/2072-0351-6256 ]
10. Дедов ИИ, Шестакова МВ. Сахарный диабет. Москва: «Универсум Паблишинг»; 2003. [Dedov II, Shestakova MV. Diabetes mellitus. Moscow: «Universum Pablishing»; 2003]
11. Аметов АС, Иванова ЕВ. Гипогликемия. Сахарный диабет 2 типа: проблемы и решения. 2011. С. 115–143. [Ametov AS, Ivanova EV. Gipoglikemiya. Sakharnyy diabet 2 tipa: problemy i resheniya. 2011. P. 115–143.]
12. Аметов АС. Уровень гликированного гемоглобина как значимый маркер полноценного гликемического контроля и предиктор поздних сосудистых осложнений сахарного диабета 2 типа. Русский Медицинский Журнал. 2011; 19(13): 832–837. [Ametov AS. Uroven' glikirovannogo gemoglobina kak znachimyy marker polnotsennogo glikemicheskogo kontrolya i prediktor pozdnikh sosudistykh oslozhneniy sakharnogo diabeta 2 tipa. Russkiy Meditsinskiy Zhurnal. 2011; 19(13): 832–837.]
13. Müller G, Hartz D, Pünter J, Ökonomopulos R, Kramer W. Differential interaction of glimepiride and glibenclamide with the β-cell sulfonylurea receptor I. Binding characteristics. Biochimica et Biophysica Acta (BBA) – Biomembranes 1994;1191(2):267–277.
14. DOI: 10.1016/0005-2736(94)90177-5
15. Campbell RK. Glimepiride Role of а new sulfonylurea in the treatment of tуре 2 diabetes mellitus. Ann Pharmacother 1998;32(10):1044–1052.
16. DOI: 10.1345/aph.17360
17. Schade DS, Jovanovic L, Schneider J. A Placebo-Controlled, Randomized Study of Glimepiride in Patients with Type 2 Diabetes Mellitus for Whom Diet Therapy is Unsuccessful. The Journal of Clinical Pharmacology. 1998;38(7):636–641.
18. DOI: 10.1002/j.1552-4604.1998.tb04471.x
19. Guo X-h, Lv X-f, Han P, Zhang X-z, Yang H-z, Duan W-r, et al. Efficacy and safety of glimepiride as initial treatment in Chinese patients with Type 2 diabetes mellitus. Current Medical Research and Opinion. 2013;29(3):169–174.
20. DOI: 10.1185/03007995.2013.765396
Review
For citations:
Ametov A.S., Abaeva F.T. Efficacy and safety of glimepiride as initial treatment in Russian patients with type 2 diabetes mellitus. Diabetes mellitus. 2013;16(4):95-100. https://doi.org/10.14341/DM2013495-100
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