Skip to main content
Erschienen in: Clinical Drug Investigation 10/2003

01.10.2003 | Original Research Article

Effect of Add-On Acarbose to Insulin Therapy in Routine Clinical Practice

verfasst von: K. R. Klocke, K. Stauch, Dr H. Landen

Erschienen in: Clinical Drug Investigation | Ausgabe 10/2003

Einloggen, um Zugang zu erhalten

Abstract

Objective and design

This post-marketing surveillance study collected data on the efficacy and tolerability of acarbose in patients with insulin-treated type 2 diabetes mellitus and, in particular, on its effect on postprandial blood glucose under normal daily practice conditions.

Patients and methods

A total of 1142 patients were included in this observational study in which the treating physicians had sole responsibility for determining acarbose doses and other therapeutic measures. Efficacy parameters consisted of fasting and postprandial blood glucose and glycosylated haemoglobin (HbA1c). Additionally, cholesterol, triglycerides and weight were analysed. All patient data had to be recorded by the attending physician on a case report form. Patients were asked to self-monitor blood glucose daily after breakfast (1h) and to keep a diary.

Results

Mean HbA1c improved by 0.9%, fasting blood glucose by 32.4 mg/dL, and postprandial hyperglycaemia by 49.7 mg/dL during the observation period compared with baseline. Comparable results were obtained in combination with conventional, functional or intensive insulin therapy. Mean weight was reduced by 0.7kg. The incidence of acarbose-related side effects was low (6.9%) and consisted mostly of gastrointestinal complaints. The majority of patients assessed acarbose treatment positively.

Conclusion

The addition of acarbose to different insulin regimens provided an efficacious and safe treatment for better glycaemic and weight control.
Literatur
1.
Zurück zum Zitat Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 1999; 281: 2005–12PubMedCrossRef Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 1999; 281: 2005–12PubMedCrossRef
2.
Zurück zum Zitat Buse JB. The use of insulin alone and in combination with oral agents in type 2 diabetes. Prim Care 1999; 26: 931–50PubMedCrossRef Buse JB. The use of insulin alone and in combination with oral agents in type 2 diabetes. Prim Care 1999; 26: 931–50PubMedCrossRef
3.
Zurück zum Zitat Yki-Järvinen H. Combination therapies with insulin in type 2 diabetes. Diabetes Care 2001; 24: 758–67PubMedCrossRef Yki-Järvinen H. Combination therapies with insulin in type 2 diabetes. Diabetes Care 2001; 24: 758–67PubMedCrossRef
4.
Zurück zum Zitat Hanefeld M, Fischer S, Julius U, et al. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia 1996; 39: 1577–83PubMedCrossRef Hanefeld M, Fischer S, Julius U, et al. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia 1996; 39: 1577–83PubMedCrossRef
5.
Zurück zum Zitat 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
6.
Zurück zum Zitat Temelkova-Kurktschiev TS, Koehler C, Henkel E, et al. Post-challenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level. Diabetes Care 2000; 23: 1830–4PubMedCrossRef Temelkova-Kurktschiev TS, Koehler C, Henkel E, et al. Post-challenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level. Diabetes Care 2000; 23: 1830–4PubMedCrossRef
7.
Zurück zum Zitat Haller H. The clinical importance of postprandial glucose. Diabetes Res Clin Pract 1998; 40 Suppl. : S43–9PubMedCrossRef Haller H. The clinical importance of postprandial glucose. Diabetes Res Clin Pract 1998; 40 Suppl. : S43–9PubMedCrossRef
8.
Zurück zum Zitat Ceriello A. The post-prandial state and cardiovascular disease: relevance to diabetes mellitus. Diabetes Metab Res Rev 2000; 16: 125–32PubMedCrossRef Ceriello A. The post-prandial state and cardiovascular disease: relevance to diabetes mellitus. Diabetes Metab Res Rev 2000; 16: 125–32PubMedCrossRef
9.
Zurück zum Zitat Del Prato S. Post-prandial hyperglycaemia: the necessity for better control. Int J Clin Pract Suppl 2000; 112: 3–8PubMed Del Prato S. Post-prandial hyperglycaemia: the necessity for better control. Int J Clin Pract Suppl 2000; 112: 3–8PubMed
10.
Zurück zum Zitat Hanefeld M. Post-prandial hyperglycaemia and vascular disease. Int J Clin Pract Suppl 2000; 112: 13–8PubMed Hanefeld M. Post-prandial hyperglycaemia and vascular disease. Int J Clin Pract Suppl 2000; 112: 13–8PubMed
11.
Zurück zum Zitat Tuomilehto J, Del Prato S. Mealtime glucose regulation in type 2 diabetes. Int J Clin Pract 2001; 55: 380–3PubMed Tuomilehto J, Del Prato S. Mealtime glucose regulation in type 2 diabetes. Int J Clin Pract 2001; 55: 380–3PubMed
12.
Zurück zum Zitat Duckworth WC. Hyperglycemia and cardiovascular disease. Curr Atheroscler Rep 2001; 3: 383–91PubMedCrossRef Duckworth WC. Hyperglycemia and cardiovascular disease. Curr Atheroscler Rep 2001; 3: 383–91PubMedCrossRef
13.
Zurück zum Zitat Hanefeld M. The role of acarbose in the treatment of non-insulin-dependent diabetes mellitus. J Diabetes Complications 1998; 12: 228–37PubMedCrossRef Hanefeld M. The role of acarbose in the treatment of non-insulin-dependent diabetes mellitus. J Diabetes Complications 1998; 12: 228–37PubMedCrossRef
14.
Zurück zum Zitat 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
15.
Zurück zum Zitat 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(4): 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(4): 486–94PubMedCrossRef
16.
Zurück zum Zitat Chiasson JL, Josse RG, Hunt JA, et al. The efficacy of acarbose in the treatment of patients with non-insulin-dependent diabetes mellitus: a multicenter controlled clinical trial. Ann Intern Med 1994; 121: 928–35PubMed Chiasson JL, Josse RG, Hunt JA, et al. The efficacy of acarbose in the treatment of patients with non-insulin-dependent diabetes mellitus: a multicenter controlled clinical trial. Ann Intern Med 1994; 121: 928–35PubMed
17.
Zurück zum Zitat Coniff RF, Shapiro JA, Seaton TB, et al. A double-blind placebo-controlled trial evaluating the safety and efficacy of acarbose for the treatment of patients with insulin-requiring type II diabetes. Diabetes Care 1995; 18: 928–32PubMedCrossRef Coniff RF, Shapiro JA, Seaton TB, et al. A double-blind placebo-controlled trial evaluating the safety and efficacy of acarbose for the treatment of patients with insulin-requiring type II diabetes. Diabetes Care 1995; 18: 928–32PubMedCrossRef
18.
Zurück zum Zitat Kelley DE, Bidot P, Freedman Z, et al. Efficacy and safety of acarbose in insulin-treated patients with type 2 diabetes. Diabetes Care 1998; 21: 2056–61PubMedCrossRef Kelley DE, Bidot P, Freedman Z, et al. Efficacy and safety of acarbose in insulin-treated patients with type 2 diabetes. Diabetes Care 1998; 21: 2056–61PubMedCrossRef
19.
Zurück zum Zitat Spengler M, Cagatay M. The use of acarbose in the primary-care setting: evaluation of efficacy and tolerability of acarbose by postmarketing surveillance study. Clin Invest Med 1995; 18: 325–31PubMed Spengler M, Cagatay M. The use of acarbose in the primary-care setting: evaluation of efficacy and tolerability of acarbose by postmarketing surveillance study. Clin Invest Med 1995; 18: 325–31PubMed
20.
Zurück zum Zitat 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
21.
Zurück zum Zitat 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
22.
Zurück zum Zitat Lebovitz HE. α-Glucosidase inhibitors as agents in the treatment of diabetes. Diabetes Rev 1998; 6: 132–45 Lebovitz HE. α-Glucosidase inhibitors as agents in the treatment of diabetes. Diabetes Rev 1998; 6: 132–45
Metadaten
Titel
Effect of Add-On Acarbose to Insulin Therapy in Routine Clinical Practice
verfasst von
K. R. Klocke
K. Stauch
Dr H. Landen
Publikationsdatum
01.10.2003
Verlag
Springer International Publishing
Erschienen in
Clinical Drug Investigation / Ausgabe 10/2003
Print ISSN: 1173-2563
Elektronische ISSN: 1179-1918
DOI
https://doi.org/10.2165/00044011-200323100-00001

Weitere Artikel der Ausgabe 10/2003

Clinical Drug Investigation 10/2003 Zur Ausgabe