A Multinational, Observational Study to Investigate the Efficacy, Safety and Tolerability of Acarbose as Add-On or Monotherapy in a Range of Patients: The GlucoVIP Study (original) (raw)
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Long-term efficacy and tolerability of acarbose treatment in patients with type 2 diabetes mellitus
Clinical drug …, 2005
long-term acarbose therapy in type 2 diabetic patients. Study design: In this double-blind, single-centre group comparison, patients were randomised to receive either acarbose or matching placebo, in addition to their regular antidiabetic therapy, over a period of 78 weeks. Eligibility for inclusion in the efficacy evaluation included a study duration of ≥510 days. Methods: The primary efficacy parameter was the change in glycosylated haemoglobin (HbA1) from baseline to end of study. Secondary variables included changes in blood glucose and lipid parameters, as well as signs of retinopathy and nephropathy. Patients: A total of 139 patients were assessed for safety and 88 patients (44 in each treatment group) were included in the efficacy analysis. Patients were generally overweight and the majority had previously been treated with sulphonylureas. Results: Acarbose significantly improved fasting and 1-hour postprandial blood glucose levels compared with placebo (p = 0.039 and 0.009), and improvements in HbA1 with acarbose versus placebo fell just short of significance (p = 0.057). There were no differences between treatments in changes in microvascular complications, but blood pressure improved with acarbose treatment. Two patients in the acarbose group experienced elevated liver enzyme levels. Generally, acarbose had a good safety profile and was well tolerated. Conclusion: Long-term treatment with acarbose was safe and efficacious in patients with type 2 diabetes mellitus that was insufficiently controlled by other oral antidiabetics. 18. Lam KSL, Tiu SC, Tsang MW, et al. Acarbose in NIDDM
Indian Journal of Endocrinology and Metabolism, 2013
S674 inTRoducTion Diabetes is among the most challenging health problems of 21 st century. According to prevalence estimation of the International Diabetes Federation, 366 million people had diabetes in 2011; by 2030 this may rise to 552 million. [1] It has been estimated that 20% of global burden resides in South Eastern Asia Region, which will be tripled to 228 million by the year 2025 from the current 84 million. [2] India along with China will account for nearly a third of the estimated 300 million adult diabetics by the year 2025. [3] Prospective randomized controlled studies such as the Diabetes Prevention Program (DPP) in the USA, [4] the Finnish Diabetes Prevention Study [5] (DPS), the Da Qing impaired glucose tolerance (IGT) and Diabetes Study in China [6] and the Malmo study in Sweden [7] have shown that lifestyle modification involving diet and enhanced physical
Acarbose: its role in the treatment of diabetes mellitus
The Annals of …, 1996
To review the role of acarbose in the pharmacotherapy of diabetes mellitus. Searching MEDLINE was searched for articles and reviews (no search strategy or restrictions provided), and Bayer Pharmaceuticals (drug manufacturer) was contacted. Study selection Study designs of evaluations included in the review Clinical trials adhering to the following criteria: (1) randomised, double-blind, placebo-controlled, parallel group study design; (2) minimum of 25 patients enrolled per treatment arm; (3) treatment duration of 90 days or more; and (4) adherence to Food and Drug Administration Good Clinical Practice guidelines. Specific interventions included in the review Acarbose (alpha-glucosidase inhibitor), tolbutamide, combined acarbose and tolbutamide, metformin, sulfonylurea, insulin and placebo. Participants included in the review Patients with non insulin-dependent diabetes mellitus (NIDDM) were included. Outcomes assessed in the review The outcomes assessed were haemoglobin A1c levels, fasting blood glucose levels, postprandial blood glucose (PPG) levels, postprandial triglyceride, and adverse effects (weight gain). How were decisions on the relevance of primary studies made? The authors do not state how the papers were selected for the review, or how many of the authors performed the selection. How were differences between studies investigated? Descriptions of characteristics of the studies, such as drug treatment, dosage regimen, duration of the phases of the study and patient characteristics, were provided. No measure of heterogeneity was presented.
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 2013
Background: The prevalence of type 2 diabetes is increasing dramatically in the Middle East and North Africa region. However, there are few trials that have determined the effect of antidiabetic treatment in an observational setting in these countries. Methods: This was a noninterventional study performed in Morocco in 2006-2007 and in the Middle East in 2005-2006 to observe the efficacy and safety of acarbose in patients with pretreated or untreated type 2 diabetes. Glycemic parameters (fasting blood glucose, one-hour postprandial blood glucose, and HbA 1c) were recorded within a 3-month period. The observation period included an initial visit at the start of acarbose therapy and up to three follow-ups. Results: Acarbose was effective in reducing glycemic parameters in patients from Morocco (n = 1082) and the Middle East (n = 1737). The mean one-hour postprandial blood glucose decreased by 35.5% to 165.4 ± 47.9 mg/dL in the Middle East and by 35.5% to 179.0 ± 49.9 mg/dL in Morocco. Mean fasting blood glucose decreased by 30.8% to 126.6 ± 34.2 mg/dL (Middle East) and by 34.5% to 150.6 ± 47.1 mg/dL (Morocco). The absolute reduction in HbA 1c was 1.3% in the Middle East (final value 7.4%) and 1.0% in Morocco (final value 7.5%). Overall, 107 patients (Middle East) and 26 patients (Morocco) experienced minor drug-related adverse events, which were mainly gastrointestinal. The tolerability of acarbose was rated as very good/ good by 80.8% in the Middle East and by 68.6% in Morocco. Conclusion: This study illustrates the efficacy and safety of acarbose in the treatment of type 2 diabetic patients in an observational setting.
Endocrine Practice, 2006
This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The study investigated the use of acarbose on the rate of progression of impaired glucose tolerance (IGT) to Type2 diabetes. Placebo was used as a comparator. Acarbose was administered at a dose of 100 mg three times a day. Type of intervention Secondary prevention. Economic study type Cost-effectiveness analysis Study population The study population comprised patients with IGT. Further inclusion or exclusion criteria were not reported. However, the analysis was based on a separate parent clinical trial, the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM). Details of the study have been published elsewhere (Chiasson et al. 1998 and 2002, see 'Other Publications of Related Interest' below for bibliographic details). Setting The setting was not explicitly stated, but it appears to have been primary care. The economic study was carried out in Sweden.
The Lancet Diabetes & Endocrinology
Background The impact of acarbose on cardiovascular outcomes in patients with coronary heart disease and impaired glucose tolerance is unknown. Methods Chinese patients with coronary heart disease and impaired glucose tolerance were randomised to double-blind acarbose 50 mg three times daily or placebo, added to standardised cardiovascular secondary prevention therapy. Acarbose was hypothesised to be superior to placebo for a composite outcome of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalisation for unstable angina or hospitalisation for heart failure. The completed study is registered with ClinicalTrials.gov NCT00829660 and ISRCTN 91899513. Findings Of 6526 patients randomised, 6522 were followed for median 5•0 years. The primary composite outcome occurred in 470 acarbose group participants (14•4%; 3•33 per 100 person-years) and in 479 placebo group participants (14•7%; 3•41 per 100 person-years). Acarbose was not superior to placebo for the primary outcome (hazard ratio 0•98; 95% Confidence Interval [CI] 0•86 to 1•11; P=0•73), with no significant subgroup interactions. No significant differences were seen between treatment groups for the secondary composite outcome (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke), death from any cause, cardiovascular death, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalisation for unstable angina, or hospitalisation for heart failure. Diabetes developed less frequently in the acarbose group (N=436, 13•3%; 3•17 per 100 person-years) compared with the placebo group (N=513, 15•8%; 3•84 per 100 personyears) (rate ratio 0•82; 95% CI 0•71 to 0•94; P=0•005). Gastrointestinal disorders were numerically more frequent with acarbose but adverse event rates did not differ significantly between groups. Interpretation In Chinese patients with coronary heart disease and impaired glucose tolerance, acarbose did not reduce the risk of major adverse cardiovascular events but did reduce the incidence of diabetes.
Efficacy and Safety of Acarbose in Metformin-Treated Patients With Type 2 Diabetes
Diabetes Care, 1998
OBJECTIVE To demonstrate the efficacy, tolerability, and safety of acarbosecompared with placebo in patients with type 2 diabetes inadequatelycontrolled with diet and metformin (2,000 or 2,500 mg/day in divideddoses). RESEARCH DESIGN AND METHODS This study had a multicenter randomized double-blind placebo-controlled parallel-group comparison design. The trial lasted 31 weeks and consisted of a 1-week screening period, a 6-week placebo pretreatment period, and a 24-week period of acarbose or placebo, with a forced titration from 25–50 mg t.i.d. and a titration of 50–100 mg tid that was based on glucose control. The primary efficacy variable wasthe mean change from baseline in HbAlc. Secondary efficacy variables included mean changes from baseline in fasting and postprandial plasma glucose, serum insulin, and triglyceride levels. RESULTS The addition of acarbose to patients on background metformin and diet therapy showed a statistically significant reduction in mean HbAlc of 0.65%. Th...
Journal of diabetes research, 2014
To investigate the potential benefits of acarbose treatment on cardiovascular disease (CVD) in patients with type 2 diabetes by using nationwide insurance claim dataset. Among 644,792 newly diagnosed type 2 diabetic patients without preexisting CVD in a nationwide cohort study, 109,139 (16.9%) who had received acarbose treatment were analyzed for CVD risk. Those with CVD followed by acarbose therapy were also subjected to analysis. During 7 years of follow-up, 5,081 patients (4.7%) developed CVD. The crude hazard ratio (HR) and adjusted HR were 0.66 and 0.99, respectively. The adjusted HR of CVD was 1.19, 0.70, and 0.38 when the duration of acarbose use was <12 months, 12-24 months, and >24 months, respectively. Adjusted HR was 1.14, 0.64, and 0.41 with acarbose cumulative doses <54,750 mg, 54,751 to 109,500 mg, and >109,500 mg, respectively. In patients with type 2 diabetes without preexisting CVD, treatment with acarbose showed a transient increase in incidence of CVD ...