Acarbose In Patients Research Articles

Habitual Dietary Intake Affects the Altered Pattern of Gut Microbiome by Acarbose in Patients with Type 2 Diabetes.

The aim of this research was to reveal the characteristics of gut microbiome altered by acarbose intervention in Japanese patients with type 2 diabetes (T2D) and its possible association with habitual dietary intake. Eighteen patients with T2D were administered acarbose for four weeks. The abundances of two major phyla, namely Actinobacteria and Bacteroidetes, were reciprocally changed accompanied by the acarbose intervention. There were also significant changes in the abundances of ten genera, including the greater abundance of Bifidobacterium, Eubacterium, and Lactobacillus and the lower abundance of Bacteroides in the group after the intervention than that before the intervention. Hierarchical clustering of habitual dietary intake was performed based on the pattern of changes in the gut microbiota and were classified into distinct three clusters. Cluster I consisted of sucrose, cluster II mainly included fat intake, and cluster III mainly included carbohydrate intake. Moreover, the amount of change in Faecalibacterium was positively correlated with the intake of rice, but negatively correlated with the intake of bread. The intake of potato was negatively correlated with the amount of change in Akkermansia and Subdoligranulum. Acarbose altered the composition of gut microbiome in Japanese patients with T2D, which might be linked to the habitual dietary intake.

Evaluation of the Effects of Acarbose on Weight and Metabolic, Inflammatory, and Cardiovascular Markers in Patients with Obesity and Overweight.

Background:Metabolic syndrome (MetS) refers to a cluster of risk factors for cardiovascular disease and type 2 diabetes. The aim of this study is to assess the effects of acarbose as an antihyperglycemic agent (drug) on late complications of MetS.Methods:This double-blind randomized clinical trial was done on patients with MetS admitted to Isfahan Endocrine and Metabolism Research Center. They were assigned randomly to two groups: A who received acarbose (n = 32) and group B who received a placebo (n = 42) for 6 months. Cardiovascular indexes including flow-mediated dilation (FMD), intima-media thickness (IMT), epicardial fat thickness (EFT), and C-reactive protein (CRP) were measured at baseline and 6 months after the treatment and compared between the two groups.Results:Post-intervention mean of weight (mean difference: −2.5 ± 0.89) and abdominal obesity (mean difference: −2.2 ± 0.64) in acarbose group were significantly decreased (P value < 0.001). High-density lipoprotein (HDL) level in acarbose group was significantly higher than control group (44.7 ± 7.6 vs 41.1 ± 6.4; P value = 0.043), while the other metabolic parameters were not significantly different between the two groups (P value > 0.05). In both groups, CRP and EFT decreased significantly after the intervention, and the levels of CRP, EFT, and IMT markers in the acarbose group were significantly lower than control group (P value < 0.05).Conclusions:The administration of acarbose in patients with MetS can decrease weight and abdominal obesity as well as the reduction of inflammatory and cardiovascular markers, including CRP, EFT, and IMT and also increases HDL.

Dementia Risk in Type 2 Diabetes Patients: Acarbose Use and Its Joint Effects with Metformin and Pioglitazone.

This population-based retrospective cohort study investigated dementia risk associated with acarbose in patients with type 2 diabetes mellitus by using Taiwan’s National Health Insurance database. A cohort of 15,524 matched pairs of ever and never users of acarbose based on propensity score matching was enrolled from new-onset type 2 diabetes patients from 1999 to 2006. Patients who were alive on January 1, 2007, were followed up for dementia until December 31, 2011. Adjusted hazard ratios were estimated using Cox proportional hazards models. The results revealed that the incident case numbers (incidence rates) of dementia were 264 (407.19 per 100,000 person-years) for never users and 231 (337.94 per 100,000 person-years) for ever users. The hazard ratio for ever users versus never users was 0.841 (95% confidence interval, 0.704-1.005) and 0.918 (0.845-0.998) for every 1-year increment of cumulative duration of acarbose therapy. Subgroup analyses showed that the reduced risk associated with acarbose was only observed in women (adjusted hazard ratio, 0.783; 95% confidence interval, 0.618-0.992) and in non-users of metformin (adjusted hazard ratio, 0.635; 95% confidence interval, 0.481-0.837). A model comparing different combinations of acarbose, metformin, and pioglitazone suggested that users of all three drugs had the lowest risk of dementia (hazard ratio, 0.406; 95% confidence interval, 0.178-0.925). In conclusion, reduced risk of dementia associated with acarbose is observed in the female sex and in non-users of metformin. Moreover, users of all three drugs (acarbose, metformin, and pioglitazone) have the lowest risk of dementia.

Effects of Acarbose on the Gut Microbiota of Prediabetic Patients: A Randomized, Double-blind, Controlled Crossover Trial.

IntroductionThe α-glucosidase inhibitor acarbose is an efficacious medicine for the treatment and prevention of type 2 diabetes mellitus (T2DM). However, the response of gut microbiota to acarbose is important, as the microbiota may have a critical role in the development of metabolic diseases, and acarbose is metabolized exclusively within the gastrointestinal tract. We explored the changes in the proportion and diversity of gut microbiota before and after treatment with acarbose in patients with prediabetes.MethodsWe designed a randomized, double-blind, controlled crossover trial in which 52 Chinese patients with prediabetes by an oral glucose tolerance test (OGTT) with a BMI of 18–35 kg/m2 were randomly allocated to treatment with acarbose or placebo. Gut microbiota characterizations were determined with 16S rDNA-based high-throughput sequencing.ResultsOf the 52 participants who entered the study, 40 (76.9%) completed the protocol. On the basis of the operational taxonomic unit (OTU) profiles, a total of 107 OTUs were significantly altered after acarbose treatment, with 76 (71%) assigned to the order of Clostridiales. Ruminococcaceae (15 OTUs) and Lachnospiraceae (22 OTUs) decreased in response to acarbose, and 48 OTUs increased by 12.8-fold, including Lactobacillaceae (8 of 9 belonging to Lactobacillus), Ruminococcaceae (6 of 11 belonging to Faecalibacterium), and Veillonellaceae (8 of 15 belonging to Dialister). At genera level, five flourished after treatment with acarbose, including Lactobacillus and Dialister, while Butyricicoccus, Phascolarctobacterium, and Ruminococcus were inhibited.ConclusionThis study suggests that the benefits of acarbose for T2DM may correlate with the selective modulation of the gut microbiota.Trial RegistrationChinese Clinical Trial Register number, ChiCTR-TTRCC-13004112.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0226-y) contains supplementary material, which is available to authorized users.

Comparison of adjunctive therapy with metformin and acarbose in patients with Type-1 diabetes mellitus.

Objective:All the aforementioned data have stimulated interest in studying other potential therapies for T1DM including noninsulin pharmacological therapies. The present study attempts to investigate the effect of adjunctive therapy with metformin and acarbose in patients with Type-1 diabetes mellitus.Method:In a single-center, placebo-controlled study (IRCT201102165844N1) we compared the results of two clinical trials conducted in two different time periods on 40 patients with Type-1 diabetes mellitus. In the first section, metformin was given to the subjects. After six months, metformin was replaced with acarbose in the therapeutic regimen. In both studies, subjects were checked for their BMI, FBS, HbA1C, TGs, Cholesterol, LDL, HDL, 2hpp, unit of NPH and regular insulin variations.Results:Placebo-controlled evaluation of selected factors has showna significant decrease in FBS and TG levels in the metformin group during follow up but acarbose group has shown substantial influence on two hour post prandial (2hpp) and regular insulin intake decline. Moreover, Comparison differences after intervention between two test groups has shown that metformin has had superior impact on FBS and HbA1C decline in patients. Nonetheless, acarbose treatment had noteworthy influence on 2hpp, TGs, Cholesterol, LDL, and regular insulin intake control.Conclusion:The results of this experiment demonstrate that the addition of acarbose or metformin to patients with Type-1 diabetes mellitus who are controlled with insulin is commonly well tolerated and help to improve metabolic control in patients.

Glycemic excursions are positively associated with HbA1c reduction from baseline after treatment with acarbose in patients with type 2 diabetes on metformin monotherapy.

The aim of the present study was to examine the association between glycemic excursions before treatment and HbA1c reduction after treatment intensification with acarbose or glibenclamide in patients with type 2 diabetes (T2D). Patients receiving single or dual oral antidiabetic drug treatment with an HbA1c of 7.0-11.0% (53-97 mmol/mol) were switched to metformin monotherapy (500 mg, t.i.d.) for 8 weeks, followed by randomization to either acarbose (100 mg, t.i.d.) or glibenclamide (5 mg, t.i.d.) as add-on treatment for 16 weeks. Glycemic excursions were assessed as mean amplitude of glycemic excursions (MAGE) with 72-h ambulatory continuous glucose monitoring. Treatment efficacy was evaluated as relative HbA1c reduction (%), calculated as (baseline HbA1c - post-treatment HbA1c)/baseline HbA1c × 100. Fifty patients (mean [±SD] age 53.5 ± 8.2 years, 48% men, mean baseline HbA1c 8.4 ± 1.2%) were analyzed. Baseline MAGE was positively correlated with relative HbA1c reduction from baseline in patients treated with acarbose (r = 0.421, P = 0.029) but not glibenclamide (r = 0.052, P = 0.813). Linear regression analysis revealed that the association between baseline MAGE and relative HbA1c reduction from baseline (β = 0.125, P = 0.029) in patients treated with acarbose remained significant after adjustment for several confounders (P <0.05 for all models). In patients with T2D on metformin monotherapy, baseline MAGE was positively correlated with relative HbA1c reduction from baseline after treatment with acarbose, but not glibenclamide. These findings highlight the importance of glycemic excursions in individualized treatment for patients with T2D.

Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus.

Aims. To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A) tablet compared with acarbose in patients with type 2 diabetes. Methods. This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15) and were treated for 24 weeks. Patients and clinical trial staffs were masked to treatment assignment throughout the study. The primary outcome measures were glycated hemoglobin (HbA1c) and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment. Analysis included all patients who completed this study. Results. By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P < 0.001). No significant difference was found when compared with acarbose group (P = 0.652). Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P < 0.05), without any significant differences compared with acarbose group (P = 0.748 and 0.558, resp.). The fasting plasma glucose levels were not significantly changed in both groups. One of 23 patients in SZ-A group (4.76%) and 5 of 15 patients in acarbose group (33.33%) suffered from gastrointestinal adverse events. Conclusions. Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes.

Combined use of basal insulin analog and acarbose reduces postprandial glucose in patients with uncontrolled type 2 diabetes.

Aims/IntroductionEarly initiation of basal insulin therapy is recommended for normalizing fasting blood glucose in type 2 diabetes mellitus. However, basal insulin treatment might not adequately control postprandial glucose levels. The present study evaluated whether the combination of the α-glucosidase inhibitor, acarbose, and basal insulin improved blood glucose control under daily-life treatment conditions in a large sample of Korean patients.Materials and MethodsThe present study was a multicenter, prospective, observational study under daily-life treatment conditions. A total of 539 patients with type 2 diabetes who were treated with basal insulin and additional acarbose were enrolled and followed up for 20 weeks. Changes in hemoglobin A1c, fasting and postprandial blood glucose were evaluated at baseline and at the end of the observation period. The physician and patient satisfaction of the combination treatment and safety were assessed.ResultsHemoglobin A1c decreased by 0.55 ± 1.05% from baseline (P < 0.0001). Fasting and postprandial blood glucose levels were reduced by 0.89 ± 3.79 and 2.59 ± 4.77 mmol/L (both P < 0.0001). The most frequently reported adverse drug reactions were flatulence (0.37%) and abnormal gastrointestinal sounds (0.37%), and all were mild in intensity and transient. In the satisfaction evaluation, 79.0% of physicians and 77.3% of patients were ‘very satisfied’ or ‘satisfied’ with the combined basal insulin and acarbose therapy.ConclusionsCombination therapy of basal insulin and acarbose in patients with type 2 diabetes improved glucose control, and had no drug-specific safety concerns, suggesting that the treatment might benefit individuals who cannot control blood glucose with basal insulin alone.

An observational study of acarbose treatment in patients with type 2 diabetes from the Middle East and Morocco

BackgroundThe 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.MethodsThis 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 HbA1c) 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.ResultsAcarbose 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 HbA1c 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.ConclusionThis study illustrates the efficacy and safety of acarbose in the treatment of type 2 diabetic patients in an observational setting.

Use of the Alpha-Glucosidase Inhibitor Acarbose in Patients with ‘Middleton Syndrome’: Normal Gastric Anatomy But with Accelerated Gastric Emptying Causing Postprandial Reactive Hypoglycemia and Diarrhea

Postprandial reactive hypoglycemia, early satiety and diarrhea are well-recognized side effects following full or partial gastrectomy or gastric bypass. It has only recently been realized, however, that patients with normal gastric anatomy may experience similar symptoms and signs due to primary accelerated gastric emptying (Middleton syndrome). In previous case studies, patients responded well to the use of dietary modification (frequent small-volume meals) alone. The authors describe two patients with this syndrome who continued to experience symptoms of reactive postprandial hypoglycemia despite dietary intervention but became asymptomatic following the addition of the alpha-glucosidase inhibitor acarbose.

Early Improvement in Carotid Plaque Echogenicity by Acarbose in Patients With Acute Coronary Syndromes

The resolution of hyperglycemia is associated with suppression of in-hospital cardiac complications in patients with acute coronary syndromes (ACS). This study evaluated carotid artery plaque echolucency using ultrasound in patients with ACS and type 2 diabetes mellitus (DM) to determine whether acarbose, an α-glucosidase inhibitor, may rapidly stabilize unstable atherosclerotic plaques. ACS patients with type 2 DM and carotid plaques (n=44) were randomly assigned to treatment with acarbose (150 or 300 mg/day, n=22) or a control group (no acarbose, n=22). Acarbose treatment was initiated within 5 days after the onset of ACS. Unstable carotid plaques were assessed by measuring plaque echolucency using carotid ultrasound with integrated backscatter (IBS) before, and at 2 weeks, 1 and 6 months after the initiation of treatment. An increase in the IBS value reflected an increase in carotid plaque echogenicity. As results, the IBS value of echolucent carotid plaques showed a significant increase at 1 month and a further increase at 6 months after treatment in the acarbose group, but there was minimal change in the control group. The increase in IBS values was significantly correlated with a decrease in C-reactive protein levels. Acarbose rapidly improved carotid plaque echolucency within 1 month of therapy in patients with ACS and type 2 DM.

The effect of combination therapy of sulfonylurea, metformin, and acarbose in type 2 diabetes mellitus patients

Diabetes mellitus is a complex disorder that involves multiple pathophysiological defects. As the disease progresses, further functional decline in β-cell is apparent. In most cases, patients on oral antidiabetic therapy will require not only an increase in dose, but also the addition of a second or third oral agent. The aim of this study was to evaluate the effectiveness and safety of triple therapy with sulfonylurea, metformin, and acarbose in patients with poorly controlled glycemia. The study design was a prospective observational study in 49 type 2 diabetic patients followed in Department of Endocrinology RSUP Dr Sardjito Indonesia from May 2007 to September 2008. Patients with hypertension were included if their blood pressure was well controlled with antihypertensive medication. All patients with documented gastrointestinal disease were excluded. At baseline and at 3-month intervals, levels of HbA1C, fasting and postprandial plasma glucose, hypoglycemic episodes, and edverse event were evaluated. Fourty nine patients, 22 men and 27 women, aged 62.84 + 7.85 years, diabetes duration of 11.92 + 6.09 years were studied. The initial HbA1C level was 8.08 + 1.89 % which significantly increased to 8.73 + 2.37 % (p<0.05). Only 32.98 % of subjects achieved target value of HbA1C (≤ 7 %). Fasting and post-prandrial plasma glucose values were increased from 160.39 + 60.25 mg/dL to 170.71 + 56.60 mg/dL and 210.31 + 75.88 mg/dL to 218.67 + 75.03 mg/dL respectively, but not significantly different. Acarbose was more frequently associated with flatulence (46 %) and abdominal bloating (12 %), metformin with flatulence (12 %), nausea (14 %), diarrhea (2 %) and abdominal discomfort (6 %). In conclusion, combination therapy of sulfonylurea, metformin, and acarbose in type 2 diabetic patients with poorly controlled glycemia can cause the additive risk of adverse events. Key words : triple therapy, glycemic control, type 2 diabetes mellitus

Comparison of vildagliptin and acarbose monotherapy in patients with type 2 diabetes: a 24-week, multi-center, double-blind, double-dummy, active-controlled, randomized trial

Objective To compare the efficacy and tolerability of monotherapy with vildagliptin and acarbose in patients with type 2 diabetes (T2DM). Methods Drug-naive T2DM patients were treated by vildagliptin(100 mg daily, given as two equally-divided doses, n=399)or acarbose (up to 300 mg daily, given as three equally-divided doses, n=202) for 24 weeks in this multi-center, randomized, double-blind, double-dummy, parallel-arm and active-controlled study. Results Vildagliptin and acarbose decreased HbA1Cto a similar extent during 24-week treatment. The adjusted mean change from baseline to endpoint in HbA1C was-1.44% in patients receiving vildagliptin and-1.36%in those receiving acarbose, meeting the statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference ≤0.4%). There was no significant difference in responder rates between groups(P>0.05). Fasting plasma glucose(FPG) tended to decrease more with acarbose (-1.52 mmol/L)than with vildagliptin(-1. 25 mmol/L), not meeting the statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference >0.6 mmol/L). Body weight did not change in vildagliptin-treated patients(-0.5 kg)but decreased in acarbose-treated patients (-1. 8 kg, P<0.01). The proportion of patients experiencing any adverse event was 33. 6% vs 50. 0% in patients receiving vildagliptin or aearbose, respeetively. Adverse gastrointestinal events were significantly more frequent with acarbose(24. 8%)than with vildagliptin (11.3%, P<0.01). No hypoglycemia was reported in either treatment group. Conclusion Vildagliptin is effective and well tolerated in patients with T2DM, demonstrating similar HbA1C reduction as aearbose, but with less adverse gastrointestinal event. Key words: Dipeptidyl peptidase-Ⅳ ; HbA1C ; Glucagon-like peptide-1 ; Incretin hormones

Beneficial metabolic effects of nateglinide versus acarbose in patients with newly-diagnosed type 2 diabetes

To investigate the acute and chronic effects of nateglinide versus acarbose on plasma asymmetric dimethylarginine (ADMA) levels and lipid profiles in patients with newly-diagnosed type 2 diabetes. A crossover trial of nateglinide and acarbose was conducted on 16 drug-naïve patients with newly-diagnosed type 2 diabetes during a total period of 9 weeks. Plasma glucose, serum insulin, free fatty acids (FFA), lipids and lipoproteins, and plasma ADMA were measured. The efficiencies of a single dose of nateglinide (120 mg) and acarbose (50 mg) for lowering postprandial hyperglycemia were similar. Compared to acarbose, nateglinide significantly increased postprandial insulin release after a standard meal test in patients with type 2 diabetes. Nateglinide acutely decreased postprandial 120 min FFA concentrations and 240 min ADMA levels more significantly than acarbose. The fasting high-density lipoprotein cholesterol level increased and the low-density lipoprotein cholesterol level decreased significantly, but the fasting levels of triglycerides, total cholesterol, and ADMA were unchanged after 4 weeks of treatment with nateglinide. Acarbose did not affect fasting lipid profiles or the ADMA levels after 4 weeks of treatment. These results suggest that the reduction of postprandial FFA and ADMA concentrations induced by nateglinide may be associated with the partial restoration of early-phase insulin secretion and may impart a cardiovascular advantage in comparison with acarbose.

Acarbose and metabolic control in patients with type 2 diabetes with newly initiated insulin therapy

This study was designed to investigate the effect of acarbose in patients with type 2 diabetes with newly initiated insulin treatment who had previously been insufficiently controlled with oral antihyperglycaemic agents [haemoglobin A(1c) (HbA(1c)) >/= 8%]. In this 20-week double-blind, placebo-controlled study, 163 patients were randomized to receive acarbose up to 100 mg three times a day or matching placebo. Both the groups were newly initiated with insulin, which was adjusted according to blood glucose values. Primary efficacy parameter was the change in HbA(1c) from baseline; changes in daily insulin doses were also assessed. Mean HbA(1c) was significantly reduced by acarbose compared with placebo (2.31 vs. 1.81%, p = 0.033). Insulin doses were comparable at the end of the study. There was no difference in blood glucose and triglyceride levels between the treatment groups. Postprandial serum insulin levels increased in both treatment arms owing to insulin administration but less so under acarbose. In contrast to the placebo group, an increase in body mass index was prevented for acarbose-treated patients. As adjunct administration to newly initiated insulin therapy, acarbose enhances the optimization of blood glucose control in patients with type 2 diabetes.

Postprandial hyperglycaemia and vascular damage - the benefits of acarbose

Traditional risk factors do not fully explain the increased risk of cardiovascular disease (CVD) in diabetes. Epidemiology shows that hyperglycaemia is a continuous CVD risk factor and that two-hour postprandial glucose levels are more strongly associated with CVD than fasting glucose. Good glycaemic control is proven to reduce the risk of microvascular complications, but equivalent evidence for CVD risk reduction is lacking. However, in the Study to Prevent Non-Insulin Dependent Diabetes Mellitus (STOP-NIDDM), acarbose reduced the risk of diabetes in those with impaired glucose tolerance by 36% (p=0.0017) and the risk of any cardiovascular event by 49% (p=0.0326) versus placebo. Furthermore, a meta-analysis of trials of acarbose in patients with type 2 diabetes suggests a significant reduction of CVD events. This review examines evidence that postprandial hyperglycaemia plays a major role in vascular damage, particularly through non-traditional risk factors such as oxidative stress and subclinical inflammation, and how acarbose may prevent this damage.

Evaluation of the Efficacy and Tolerability of Acarbose in Patients??with Diabetes Mellitus

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). 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. 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.

Análisis de la Relación Coste-efectividad de la Acarbosa en el Tratamiento de pacientes con Intolerancia a la Glucosa

ObjectiveTo perform a cost-effectiveness analysis of treatment with acarbose in patients with impaired glucose tolerance (IGT) in comparison with conventional treatment (based on medical counseling on diet and health and without drug treatment) from the perspective of the public payer. Material and methodA cost-effectiveness analysis was performed using data on efficacy, the incidence of diabetes mellitus type 2 (DM2) and cardiovascular events from the STOPNIDDM clinical trial of acarbose treatment vs. placebo. The study used a decision tree analysis to estimate the health and economic impact of the two alternative treatments in a population of 1,000 patients over a period of 40 months. Resource use and cost data refer to the Spanish health care system. ResultsIn the base case, acarbose treatment was slightly dominant over conventional treatment since it achieved improved outcomes at an even lower cost. Sensitivity analysis revealed that acarbose treatment lost dominance due to a moderately positive cost-effectiveness ratio for avoided progression to DM2 in some scenarios. The cost-effectiveness ratio was particularly sensitive to the cost of cardiovascular treatments, the risk of progression to DM2, the daily doses of acarbose, and the publicly funded share of the cost of this drug. ConclusionsAcarbose treatment in patients diagnosed with IGT appeared to be the dominant alternative compared with conventional treatment. The cost per avoided progression to DM2 and per additional individual free of a cardiovascular event was moderately low in some of the scenarios included in the sensitivity analysis. For a more comprehensive evaluation of the possible treatment of patients with IGT, the alternatives under comparison and the time horizon of the study would need to be increased and more refined health outcome measures, comprising all the treatment's health effects, would need to be introduced.

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

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. 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 (HbA(1c)). 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. Mean HbA(1c) 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. The addition of acarbose to different insulin regimens provided an efficacious and safe treatment for better glycaemic and weight control.

Improved Glycemic Control and Lipid Profile in a Randomized Study of Pioglitazone Compared with Acarbose in Patients with Type 2 Diabetes Mellitus

To assess the efficacy of pioglitazone treatment in comparison with that of acarbose treatment in patients with type 2 diabetes mellitus. In this randomized, parallel-group, open-label study patients were assigned to treatment with either pioglitazone (n = 129) or acarbose (n = 136). During a 1-week run-in patients commenced an individualized dietary regimen which was maintained throughout the study. Patients received the assigned study medication for 26 weeks. Serum glycosylated hemoglobin (HbA1c) levels, insulin resistance and lipid profiles were determined at baseline and at endpoint. Mean HbA1c was reduced from 8.98+/-1.20% to 7.82+/-1.95% with pioglitazone treatment and from 9.03+/-1.32% to 8.55+/-1.96% with acarbose treatment during the 26-week study. The change from baseline to endpoint was significantly greater for pioglitazone compared with acarbose when analyzed for all patients (p < 0.001) and for those who had (p = 0.009) or had not (p < 0.001) received previous medication for diabetes mellitus. Compared with acarbose, pioglitazone produced a significantly greater decrease in fasting glucose, insulin and insulin resistance (p < 0.001 for each). Triglycerides were decreased by 71.1+/-184.1 mg/dl with pioglitazone compared with 38.1+/-171.3 mg/dl with acarbose (p = 0.001 for difference between groups). High density lipoprotein (HDL)-cholesterol level was increased by 7.8+/-10.2 mg/dl with pioglitazone compared with a decrease of 0.8+/-24.1 mg/dl with acarbose (p < 0.001). While serum low density lipoprotein (LDL)-cholesterol levels remained unchanged with both treatment regimens, the decrease from baseline in very low density lipoprotein (VLDL)-cholesterol was significantly greater with pioglitazone than with acarbose (p < 0.04). Pioglitazone decreased systolic blood pressure by 5.6+/-17.7mm Hg compared with a 0.4+/-18.4mm Hg increase during acarbose treatment (p < 0.001). Pioglitazone caused a significantly greater decrease compared with acarbose in serum levels of gamma-glutamyl aminotransferase (p < 0.001) and alanine aminotransferase (p = 0.004). Six months of pioglitazone treatment decreased insulin resistance and improved glycemic control to a significantly greater extent than acarbose treatment. Pioglitazone was also associated with a significantly improved lipid profile, suggesting a reduction in risk of coronary heart disease.