Authors: Spengler, M.; Schmitz, H.; Landen, H.

Source: Clinical Drug Investigation, Volume 25, Number 10, 2005 , pp. 651-659(9)

Publisher: Adis International

Abstract:

Objective: The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 27 803 patients with diabetes mellitus (26 044 were diagnosed as having type 2 diabetes) over a 12-week treatment period.

Patients and methods: Overall efficacy data were reported for type 1 and type 2 diabetes, and a detailed data analysis was conducted for patients with type 2 diabetes. Tolerability was described for the total group. Of the type 2 diabetes patients, 37.6% were treated with diet only; 44.2% were additionally treated with sulphonylureas; 6.3% with metformin or metformin plus sulphonylurea; and 11.6% with insulin alone or in combination with oral treatment. The frequency of two or more concomitant diseases was 45.8% for all type 2 diabetes patients, and 62.4% in elderly patients (age 70 years).

Results: In patients with type 2 diabetes, acarbose administration in addition to the existing treatment resulted in reductions in mean blood glucose levels (fasting 50 mg/dL, 1h post-prandial [pp] 60 mg/dL, 2h pp 56 mg/dL), glycosylated haemoglobin (HbA_1c 1.3%; HbA₁ 1.6%) and bodyweight (1.5 kg). Results for type 1 diabetes patients were similar. No clinically relevant influence of age, body mass index or number of concomitant diseases on the results could be observed. Tolerability was good: 83% of patients had no adverse events, 13.7% reported flatulence, and 2.2% had at least one occurrence of diarrhoea. Hypoglycaemia was found in 0.07% of patients, mainly in combination with metformin or insulin. Tolerability was independent of patients’ age. Laboratory investigations gave no indication of other adverse events.

Conclusion: This postmarketing surveillance study documents the therapeutic benefit and good tolerability and compliance of acarbose as mono- and combination therapy, even in elderly and multimorbid patients.

Keywords: Acarbose; Alpha glucosidase inhibitors; Antihyperglycaemics; Diabetes mellitus

Document Type: Research article

Affiliations: 1: Medical Department and Department of Biometry, Bayer Vital GmbH, Leverkusen, Germany

Publication date: 2005-01-01

Related content

• In this: publication
• By this: publisher
• In this Subject: Pharmacology
• By this author: Spengler, M. ;  Schmitz, H. ;  Landen, H.

Website © Publishing Technology. Article copyright remains with the publisher, society or author(s) as specified within the article.

• Terms and conditions
• Privacy policy
• Information for advertisers