Fixed-Dose Combination Therapy of Rosiglitazone and Metformin for Drug-Naïve Type 2 Diabetes Mellitus

Shih-Ting Tseng ； Yi-Sun Yang ； Chien-Ning Huang

《Formosan Journal of Endocrinology and Metabolism》 6卷2期 (2015/12) Pp. 70-80

https://doi.org/10.6856/FJEM.201512_6(2).0003

摘要

Background. This six-month, open label phase IV study aimed to evaluate the efficacy of rosiglitazone/ metformin (RSG/MET) fixed-dose combination (Avandamet) in newly-diagnosed, drug naïve patients with type 2 diabetes mellitus (T2DM). Methods. Low-dose Avandamet (4mg rosiglitazone/1000mg metformin per day) were given to patients with moderate hyperglycemia (HbA_(1c) 6.5 - 9%), while high-dose Avandamet (6mg rosiglitazone/1500mg metformin per day) were given to those with severe hyperglycemia (HbA_(1c) 9 - 11%). Medications were up-titrated on the 3^(rd) month if there was no reduction of HbA_(1c) ＞ 0.7% or fasting plasma glucose (FPG) ＞ 30 mg/dl. The primary efficacy endpoint was change from baseline in HbA_(1c) and FPG by week 24. Results. 68 newly-diagnosed and drug naïve T2DM patients were recruited. 35 (51%) patients were initially given low dose but 14 eventually had dose up-titrated, while 33 patients were initially given high dose with later dose up-titrated. After six months of treatment, HbA_(1c) levels were reduced from 7.9% to 6.7% (delta = -1.24%; P ＜ 0.05) in the low dose group, and from 10.0% to 6.9% in the high dose group (delta = -3.10%, P ＜ 0.05). FPG and high sensitivity C-reactive protein levels decreased and adiponectin increased. Body mass index increased only in the high dose group. Both initial treatment doses were generally well-tolerated. Conclusion. Fixed-dose combination therapy of rosiglitazone/metformin was effective in reducing HbA_(1c) in six months for both moderate and severe hyperglycemia in drug-naïve T2DM patients. Improved measurements of inflammatory biomarkers suggest possible cardio-protective effects in longterm therapy.

關鍵字

rosiglitazone ； metformin ； type 2 diabetes