Postmarketing surveillance of acarbose treatment in Taiwanese patients with type 2 diabetes mellitus.
OBJECTIVE
This postmarketing surveillance (PMS) study was conducted to assess the efficacy, safety and acceptance of acarbose treatment in patients with type 2 diabetes mellitus.


METHODS
Patients were recruited in this open, prospective, uncontrolled, non-randomised multicentre study by 159 physicians throughout Taiwan, following the guidelines of the Bureau of National Health Insurance (BNHI) of Taiwan. Primary efficacy parameters were changes in fasting blood glucose, postprandial blood glucose and glycosylated haemoglobin (HbA(1c)) values during treatment with acarbose.


RESULTS
The majority of the 1558 enrolled patients received acarbose 50 mg three times daily, had previously been treated with a sulphonylurea and/or biguanide, and were observed for a mean period of 13.9 weeks. Most patients (91.8%) received concomitant oral antihyperglycaemic agents. Acarbose reduced fasting blood glucose concentrations by 32.0 mg/dL and 2-hour postprandial blood glucose levels by 52.2 mg/dL. HbA(1c) was reduced by 1.0% from 9.9% to 8.9%, and bodyweight remained stable. The attending physicians assessed that acarbose was associated with 'very good' or 'good' general efficacy in 46.0% of patients, 'very good' or 'good' tolerability in 60.6% and 'very good' or 'good' patient acceptance in 63.4%. These ratings were higher for patients receiving acarbose monotherapy compared with those taking other antihyperglycaemic therapies in addition to acarbose. Only 2.0% of all patients experienced drug-related adverse events.


CONCLUSIONS
Acarbose treatment provides an efficacious, safe and well accepted alternative for metabolic improvement in Taiwanese patients with type 2 diabetes under daily-life treatment conditions.
Hung
Yi-Jen
YJ
Tri-Service General Hospital, Taiwan, Taipei, Taiwan, ROC.
Kuo
Shi-Wen
SW
Wang
Chao-Hung
CH
Chang
Hung-Yu
HY
Hsieh
Sheng-Hwu
SH
Landen
Harald
H
D020909:Acarbose / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies
D020909:Acarbose; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents