Clinical Question:
Among combination antiadiabetic agents which is more effective in achieving
and maintaining target blood glucose, glimepiride plus metformin or
rosiglitazone plus metformin in patients affected by type 2 diabetes and
metabolic syndrome?
Bottom Line:
The rosiglitazone-metformin association significantly improve the long-term
control of all insulin-resistance-related parameters in comparison with the
glimepiride-metformin-treated group. On the other side, glimepiride
treatment is associated to a slight improvement in cholesterolaemia, not
observed in the rosiglitazone-treated patients.
Reference:
Differential effect of glimepiride and rosiglitazone on metabolic control of
type 2 diabetic patients treated with metformin: a randomized, double-blind,
clinical trial.
Derosa G, Gaddi AV, Piccinni MN, Salvadeo S, Ciccarelli L, Fogari E, Ghelfi
M, Ferrari I, Cicero AF.Diabetes Obes Metab. 2006 Mar;8(2):197-205.
Study Design:
Randomized, controlled, double-blind clinical study
Synopsis:
Accumulating evidence suggests that combination therapy using oral
antidiabetic agents with different mechanisms of action may be highly
effective in achieving and maintaining target blood glucose levels. The aim
of our study is to evaluate the differential effect on glucose and lipid
parameters of the association between glimepiride plus metformin and
rosiglitazone plus metformin in patients affected by type 2 diabetes and
metabolic syndrome. Patients were enroled, evaluated and followed at two
Italian centres. We evaluated 99 type 2 diabetic patients with metabolic
syndrome (48 males and 47 females; 23 males and 24 females, aged 52 +/- 5
with glimepiride; 25 males and 23 females, aged 54 +/- 4 with cglitazone).
All were required to have been diagnosed as being diabetic for at least 6
months and did not have glycaemic control with diet and oral hypoglycaemic
agents such as sulphonylureas or metformin, both to the maximum tolerated
dose. All patients took a fixed dose of metformin, 1500 mg/day. We
administered glimepiride (2 mg/day) or rosiglitazone (4 mg/day) in a
randomized, controlled, double-blind clinical study. We evaluated body mass
index (BMI), glycaemic control, lipid profile [total cholesterol (TC),
low-density lipoprotein-cholesterol (LDL-C), high-density
lipoprotein-cholesterol and triglycerides] and lipoprotein parameters [apolipoprotein
A-I and apolipoprotein B (Apo B)] during 12 months of this treatment. A
total of 95 patients completed the study. Significant BMI decrease was
observed at 12 months in glimepiride and rosiglitazone group (p < 0.05 and p
< 0.01 respectively) as well as of glycated haemoglobin decrease (p < 0.05
and p < 0.01 respectively), mean fasting plasma glucose and postprandial
plasma glucose levels (p < 0.05 and p < 0.01 respectively). A decrease in
fasting plasma insulin and postprandial plasma insulin at 12 months (p <
0.05 and p < 0.01 respectively) compared with the baseline value in
rosiglitazone group was observed. Furthermore, homeostasis model assessment
index improvement was obtained only at 9 and 12 months (p < 0.05 and p <
0.01 respectively) compared with the baseline value in rosiglitazone group.
Significant TC, LDL-C and Apo B improvement (p < 0.05 respectively) was
present in glimepiride group after 12 months compared with the baseline
values, and these variations were significant (p < 0.05) between groups. Of
the 95 patients who completed the study, 8.5% of patients in glimepiride
group and 12.5% of patients in rosiglitazone group had side-effects (p = not
significant). Four patients had transient side-effects in glimepiride group
and six patients in rosiglitazone group. Altogether, we did not have
statistically significant changes in transaminases. |