Περίληψη:
Background and objective: Multiple oral therapies are required long term
for the majority of patients with type 2 diabetes mellitus to achieve
acceptable glycaemic levels; alternatively, insulin therapy has to be
initiated. This study investigated the addition of acarbose to maximum
doses of sulfonylurea in very poorly controlled type 2 diabetes patients
and assessed its effect in delaying further glycaemic deterioration.
Study design: In this 78-week, double-blind, placebo-controlled European
study, patients were randomised to receive acarbose, titrated to a
maximum dose of 100mg three times daily, or matching placebo.
Concomitant sulfonylurea treatment (glibenclamide/gliclazide) was to
remain unchanged throughout the study. A sample size of 171 patients per
treatment arm was calculated. The primary efficacy analysis was
intention to treat.
Methods: The change in glycosylated haemoglobin (HbA(1c)) levels from
baseline to the end of the study was regarded as the primary efficacy
variable. Patients whose HbA(1c) levels increased above 10.5% on two
consecutive visits terminated the study prematurely because of insulin
administration. Secondary efficacy variables included the changes in
blood glucose and C-peptide, both at fasting and at the 1h-postprandial
level.
Patients: A total of 330 patients (acarbose 164, placebo 166) were valid
for the efficacy analysis. Patients were generally overweight (body mass
index 29.0 kg/ m(2)) and showed very poor metabolic control (HbA(1c) >
9%, fasting blood glucose > 200 mg/dL, and 1h-postprandial blood
glucose > 300 mg/dL).
Results: Acarbose significantly improved HbA(1c) levels compared with
placebo (least square mean [LS-mean] difference -0.54%, 95% CI -0.86
to -0.22; p = 0.001). A number of patients had to discontinue the study
prematurely because of insulin administration (24.5% in the placebo and
14.2% in the acarbose group).
Συγγραφείς:
Bachmann, W
Petzinna, D
Raptis, SA
Wascher, T and
Westermeier, T
European Acarbose Study Grp
