G. Mertes, Safety and efficacy of acarbose in the treatment of Type 2 diabetes: data from a 5-year surveillance study, DIABET RE C, 52(3), 2001, pp. 193-204
This 5-year surveillance study assessed the tolerability and safety of acar
bose in patients with diabetes. A total of 2035 patients were enrolled of w
hom 1954 were classified as having Type 2 diabetes. The study was open with
no control group. Physicians had sole control of the acarbose doses prescr
ibed. Fasting blood glucose levels, 2-h postprandial glucose levels, HbA(1)
or HbA(1C) and other clinical parameters, such as lipids and liver enzyme
levels, were also assessed as measures of efficacy and safety. One-third of
the patients received acarbose as monotherapy and two-thirds in combinatio
n with other glucose-lowering treatment. The concomitant diseases were also
assessed. Doses of acarbose were low in the majority of the patients and w
ell tolerated. The incidence of acarbose-associated side effects was 4.7%.
No sustained adverse changes in laboratory measures occurred. Over the 5 ye
ars, HbA(1) and glycated haemoglobin (HbA(1C)) decreased by 2.4 and 1.8% po
ints, respectively, and the mean fasting glucose and 2-h postprandial gluco
se decreased by 2.7 and 3.3 mmol/l. Mean body weight was reduced by 0.9 kg.
The results suggest that when used in long-term day-to-day management of d
iabetes, acarbose is well tolerated and can improve glycaemic control as mo
notherapy, as well as in combination therapy. In a high-risk patient group
acarbose proved to be a safe drug. (C) 2001 Elsevier Science Ireland Ltd. A
ll rights reserved.