Skip to main content
Top
Published in: Clinical Drug Investigation 10/2006

01-10-2006 | Original Research Article

Postmarketing Surveillance of Acarbose Treatment in Taiwanese Patients with Type 2 Diabetes Mellitus

Authors: Yi-Jen Hung, Dr Shi-Wen Kuo, Chao-Hung Wang, Hung-Yu Chang, Sheng-Hwu Hsieh, Harald Landen

Published in: Clinical Drug Investigation | Issue 10/2006

Login to get access

Abstract

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 (HbA1c) values during treatment with acarbose.
Results: The majority of the 1558 enrolled patients received acarbose 50mg 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. HbA1c 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.
Conclusion: 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.
Literature
1.
go back to reference King H, Aubert RE, Herman WH. Global burden of diabetes, 1995–2025: prevalence, numerical estimates, and projections, Diabetes Care 1998; 21: 1414–31PubMedCrossRef King H, Aubert RE, Herman WH. Global burden of diabetes, 1995–2025: prevalence, numerical estimates, and projections, Diabetes Care 1998; 21: 1414–31PubMedCrossRef
2.
go back to reference Chang CJ, Lu FH, Yang YC, et al. Epidemiologic study of type 2 diabetes in Taiwan. Diabetes Res Clin Pract 2000; 50Suppl. 2: S49–59PubMedCrossRef Chang CJ, Lu FH, Yang YC, et al. Epidemiologic study of type 2 diabetes in Taiwan. Diabetes Res Clin Pract 2000; 50Suppl. 2: S49–59PubMedCrossRef
3.
go back to reference Heine RJ, Nijpels G, Mooy JM. New data on the rate of progression of impaired glucose tolerance to NIDDM and predicting factors. Diabet Med 1996; 13(3 Suppl. 2): S12–4PubMed Heine RJ, Nijpels G, Mooy JM. New data on the rate of progression of impaired glucose tolerance to NIDDM and predicting factors. Diabet Med 1996; 13(3 Suppl. 2): S12–4PubMed
4.
go back to reference Alberti KGMM. The clinical implications of impaired glucose tolerance. Diabet Med 1996; 13: 927–37PubMedCrossRef Alberti KGMM. The clinical implications of impaired glucose tolerance. Diabet Med 1996; 13: 927–37PubMedCrossRef
5.
go back to reference Harris MI, Flegal KM, Cowie CC, et al. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in US adults: the Third National Health and Nutrition Examination Survey, 1988–1994. Diabetes Care 1998; 21: 518–24PubMedCrossRef Harris MI, Flegal KM, Cowie CC, et al. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in US adults: the Third National Health and Nutrition Examination Survey, 1988–1994. Diabetes Care 1998; 21: 518–24PubMedCrossRef
6.
go back to reference The DECODE Study Group. Will new diagnostic criteria for diabetes mellitus change the phenotype of patients with diabetes? Reanalysis of European epidemiological data. BMJ 1998; 317: 371–5CrossRef The DECODE Study Group. Will new diagnostic criteria for diabetes mellitus change the phenotype of patients with diabetes? Reanalysis of European epidemiological data. BMJ 1998; 317: 371–5CrossRef
7.
go back to reference Haffner SM. The importance of hyperglycemia in the nonfasting state to the development of cardiovascular disease. Endocr Rev 1998; 19: 583–92PubMedCrossRef Haffner SM. The importance of hyperglycemia in the nonfasting state to the development of cardiovascular disease. Endocr Rev 1998; 19: 583–92PubMedCrossRef
8.
9.
go back to reference The DECODE Study Group. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med 2001; 161: 397–404CrossRef The DECODE Study Group. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med 2001; 161: 397–404CrossRef
10.
go back to reference Laube H. Acarbose: an update of its therapeutic use in diabetes treatment. Clin Drug Invest 2002; 22: 141–56CrossRef Laube H. Acarbose: an update of its therapeutic use in diabetes treatment. Clin Drug Invest 2002; 22: 141–56CrossRef
11.
go back to reference Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359: 2072–7PubMedCrossRef Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359: 2072–7PubMedCrossRef
12.
go back to reference Yang W, Lin L, Qi J, et al. The preventive effect of acarbose and metformin on the progression to diabetes mellitus in the IGT population: a 3-year multicenter prospective study. Clin J Endocrinol Metab 2001; 17: 131–6 Yang W, Lin L, Qi J, et al. The preventive effect of acarbose and metformin on the progression to diabetes mellitus in the IGT population: a 3-year multicenter prospective study. Clin J Endocrinol Metab 2001; 17: 131–6
13.
go back to reference Pan CY, Gao Y, Chen JW, et al. Efficacy of acarbose in Chinese subjects with impaired glucose tolerance. Diabetes Res Clin Pract 2003; 61: 183–90PubMedCrossRef Pan CY, Gao Y, Chen JW, et al. Efficacy of acarbose in Chinese subjects with impaired glucose tolerance. Diabetes Res Clin Pract 2003; 61: 183–90PubMedCrossRef
14.
go back to reference Chiasson JL, Josse RG, Gomis R, et al. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM Trial. JAMA 2003; 290: 486–94PubMedCrossRef Chiasson JL, Josse RG, Gomis R, et al. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM Trial. JAMA 2003; 290: 486–94PubMedCrossRef
15.
go back to reference Hanefeld M, Cagatay M, Petrowitsch T, et al. Acarbose reduces the risk for myocardial infarction in type 2 diabetic patients: meta-analysis of seven long-term studies. Eur Heart J 2004; 25: 10–6PubMedCrossRef Hanefeld M, Cagatay M, Petrowitsch T, et al. Acarbose reduces the risk for myocardial infarction in type 2 diabetic patients: meta-analysis of seven long-term studies. Eur Heart J 2004; 25: 10–6PubMedCrossRef
16.
go back to reference Mertes G. Safety and efficacy of acarbose in the treatment of type 2 diabetes: data from a 5-year surveillance study. Diabetes Res Clin Pract 2001; 52: 193–204PubMedCrossRef Mertes G. Safety and efficacy of acarbose in the treatment of type 2 diabetes: data from a 5-year surveillance study. Diabetes Res Clin Pract 2001; 52: 193–204PubMedCrossRef
17.
go back to reference Chan JCN, Chan KWA, Ho LLT, et al. An Asian multicenter clinical trial to assess the efficacy and tolerability of acarbose compared with placebo in type 2 diabetic patients previously treated with diet. Diabetes Care 1998; 21: 1058–61PubMedCrossRef Chan JCN, Chan KWA, Ho LLT, et al. An Asian multicenter clinical trial to assess the efficacy and tolerability of acarbose compared with placebo in type 2 diabetic patients previously treated with diet. Diabetes Care 1998; 21: 1058–61PubMedCrossRef
18.
go back to reference Kado S, Murakami T, Aoki A, et al. Effect of acarbose on postprandial lipid metabolism in type 2 diabetes mellitus. Diabetes Res Clin Pract 1998; 41: 49–55PubMedCrossRef Kado S, Murakami T, Aoki A, et al. Effect of acarbose on postprandial lipid metabolism in type 2 diabetes mellitus. Diabetes Res Clin Pract 1998; 41: 49–55PubMedCrossRef
19.
go back to reference Lam KSL, Tiu SC, Tsang MW, et al. Acarbose in NIDDM patients with poor control on conventional oral agents: a 24-week placebo-controlled study. Diabetes Care 1998; 21: 1154–8PubMedCrossRef Lam KSL, Tiu SC, Tsang MW, et al. Acarbose in NIDDM patients with poor control on conventional oral agents: a 24-week placebo-controlled study. Diabetes Care 1998; 21: 1154–8PubMedCrossRef
20.
go back to reference Lin BJ, Wu HP, Huang HS, et al. Efficacy and tolerability of acarbose in Asian patients with type 2 diabetes inadequately controlled with diet and sulphonylureas. J Diabetes Complications 2003; 17: 179–85PubMedCrossRef Lin BJ, Wu HP, Huang HS, et al. Efficacy and tolerability of acarbose in Asian patients with type 2 diabetes inadequately controlled with diet and sulphonylureas. J Diabetes Complications 2003; 17: 179–85PubMedCrossRef
21.
go back to reference Hwu CM, Ho LT, Fuh MMT, et al. Acarbose improves glycemic control in insulin-treated Asian type 2 diabetic patients: results from a multinational, placebo-controlled study. Diabetes Res Clin Pract 2003; 60: 111–8 Hwu CM, Ho LT, Fuh MMT, et al. Acarbose improves glycemic control in insulin-treated Asian type 2 diabetic patients: results from a multinational, placebo-controlled study. Diabetes Res Clin Pract 2003; 60: 111–8
22.
go back to reference Sumual AR, Pandelaki K, Rotty LAW. Acarbose/metformin combination versus metformin alone in Indonesian patients with type 2 diabetes. J ASEAN Fed Endocrine Soc 2003; 21: 24–31 Sumual AR, Pandelaki K, Rotty LAW. Acarbose/metformin combination versus metformin alone in Indonesian patients with type 2 diabetes. J ASEAN Fed Endocrine Soc 2003; 21: 24–31
23.
go back to reference Vijan S, Kent DM, Hayward RA. Are randomized controlled trials sufficient evidence to guide clinical practice in type II (non-insulin-dependent) diabetes mellitus? Diabetologia 2000; 43: 125–30PubMedCrossRef Vijan S, Kent DM, Hayward RA. Are randomized controlled trials sufficient evidence to guide clinical practice in type II (non-insulin-dependent) diabetes mellitus? Diabetologia 2000; 43: 125–30PubMedCrossRef
25.
go back to reference Neuser D, Benson A, Bruckner A, et al. Safety and tolerability of acarbose in the treatment of type 1 and type 2 diabetes mellitus. Clin Drug Invest 2005; 25: 579–87CrossRef Neuser D, Benson A, Bruckner A, et al. Safety and tolerability of acarbose in the treatment of type 1 and type 2 diabetes mellitus. Clin Drug Invest 2005; 25: 579–87CrossRef
27.
go back to reference Qiao Q, Tuomilehto J. Diagnostic criteria of glucose intolerance and mortality. Minerva Med 2001; 92: 113–9PubMed Qiao Q, Tuomilehto J. Diagnostic criteria of glucose intolerance and mortality. Minerva Med 2001; 92: 113–9PubMed
Metadata
Title
Postmarketing Surveillance of Acarbose Treatment in Taiwanese Patients with Type 2 Diabetes Mellitus
Authors
Yi-Jen Hung
Dr Shi-Wen Kuo
Chao-Hung Wang
Hung-Yu Chang
Sheng-Hwu Hsieh
Harald Landen
Publication date
01-10-2006
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 10/2006
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.2165/00044011-200626100-00002

Other articles of this Issue 10/2006

Clinical Drug Investigation 10/2006 Go to the issue