ประสิทธิผลของยา Voglibose ในการลดระดับ HbA1c ในผู้ป่วยเบาหวานชนิดที่ 2 ที่มีระดับน้ำตาล FPG น้อยกว่า 126 มก./ดก. และมีระดับ HbA1c มากว่า 6.5%

บทคัดย่อ

Objective : To study the efficacy and safety of voglibose in type 2 diabetes patients with fasting plasma glucose (FPG) < 126 mg/dl and hemoglobin A_1c (HbA_1c) > 6.5%

Method : The study population consisted of type 2 diabetes patients with FPG < 126 mg/dl and HbA_1c > 6.5%. Patients with the following conditions were excluded: smoking, chronic gastrointestinal disease, hepatic disease, renal disease and hypoglycemia. The study consisted of a 6 month life style modifications period followed by a 12 month Voglibose treatment period, patients were receive Voglibose 0.3 mg twice daily for 6 months and followed by thrice daily for 6 months. Additional HbA_1c and FPG levels were also measured at 6 months, 12 month and 18 months after starting study. Blood chemistry including cholesterol, triglyceride, HDL, LDL, BUN and creatinine were measured at 6 months and 18 months after starting study. Data were expressed as mean ± S.D. Statistical analyses were done by Student’s t-test and chi-square test where appropriate differences were considered statistically significant at P ≤ 0.05.

Results : HbA_1c levels were significantly decreased from 7.70  ±  0.74% to 7.06  ±  0.73% (P < 0.001) and 6.81 ± 0.71% (P < 0.001) after Voglibose treatment at 6 and 12 months. There was no significant re- duction of FPG levels. Serious adverse drug events, severe abdominal symptoms and hypoglycemia, were reported in 10.71% of patients who took Voglibose. Abdominal distention was reported in 22.09%, while increased flatulenoe was noted in 8.14%.

Conclusion : This study demonstrated that Voglibose, at a dose of 0.3 mg in 2 or 3 times daily, could significantly lower HbA_1c levels in the type 2 diabetes patients with FPG <126 mg/dl and HbA_1c >6.5%. The effects were seen both at 6 and 12 months after Voglibose treatment but at a dose of 3 times daily significantly decreased HbA_1c levels than a dose of 2 times daily. Adverse drug events were commonly associated with mild gastrointestinal symptoms. Slight hypoglycemia was occurred with patients who needed insulin injection.