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 M ethods: 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%; HbA(1) 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.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Spengler M,Schmitz H,Landen Hdoi
10.2165/00044011-200525100-00004subject
Has Abstractpub_date
2005-01-01 00:00:00pages
651-9issue
10eissn
1173-2563issn
1179-1918pii
25104journal_volume
25pub_type
杂志文章abstract::Early initiation of rational and effective combination therapy consisting of antihypertensive drugs with two different and complementary mechanisms of actions is increasingly becoming accepted in clinical practice and by guidelines as a first-line approach to control blood pressure (BP) and prevent cardiovascular outc...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/11538440-000000000-00000
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journal_title:Clinical drug investigation
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更新日期:2018-09-01 00:00:00
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更新日期:2013-11-01 00:00:00
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更新日期:2013-02-01 00:00:00
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pub_type: 杂志文章
doi:10.2165/00044011-199816020-00005
更新日期:1998-01-01 00:00:00
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更新日期:2016-12-01 00:00:00