Glucobay scientific update |
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Rev Diabet Stud. 2004 Summer;1(2):89-94.
Yajima K, Shimada A, Hirose H, Kasuga A, Saruta T.
Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
"Low dose" metformin improves hyperglycemia better than acarbose in type 2 diabetics.
OBJECTIVES: "High dose" metformin therapy (2,550 mg/day) is reported to improve glycemic control in type 2 diabetic patients with obesity (body mass index
(BMI) >/= 30). Some have reported that metformin therapy, even in low doses (500-750 mg/day), improves glycemic control in non-obese type 2 diabetic patients
(BMI approximately 25). However, it is unclear whether "low dose" metformin improves glycemic control better than acarbose in non-obese type 2 diabetic
patients, which has been shown to improve glycemic control in type 2 diabetes with obesity. METHODS: We randomly divided 22 non-obese type 2 diabetic
patients (mean BMI approximately 25) into two groups (A = 11, B = 11). Group A was treated with "low dose" metformin (500-750 mg/day) for 3 months, and
switched to acarbose (150-300 mg/day) for another 3 months. Group B was treated with acarbose first, and then switched to "low dose" metformin. RESULTS: "Low
dose" metformin significantly decreased the fasting plasma glucose (FPG) and HbA1c level in both groups A and B, whereas acarbose decreased HbA1c levels in
group B but not in group A. Overall, "low dose" metformin significantly decreased HbA1c (p=0.0165) levels as compared to acarbose. CONCLUSION: In conclusion,
"low dose" metformin therapy improved glycemic control better than acarbose in non-obese diabetics.
Clin Drug Investig. 2006;26(9):529-39.
Derosa G, Cicero AF, D'Angelo A, Ragonesi PD, Ciccarelli L, Fogari E, Salvadeo SA, Ferrari I, Gravina A, Fassi R, Fogari R.
Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.
Synergistic effect of doxazosin and acarbose in improving metabolic control in patients with impaired glucose tolerance.
BJECTIVE: The aim of this study was to evaluate if the expected improvement in glucose and lipid metabolism obtainable with doxazosin is or is not
synergistic with standard antihyperglycaemic treatment using the alpha-glucosidase inhibitor acarbose. METHODS: Patients in this randomised, controlled,
double-blind clinical trial were enrolled, evaluated and followed up at three Italian centres. We evaluated 107 patients (53 males and 54 females) with
impaired glucose tolerance (IGT) as determined by oral glucose tolerance tests (OGTTs). All patients took a fixed dose of acarbose 150 mg/day for 3 months,
after which they were titrated up to 300 mg/day for the next 3 months. In addition, patients were randomised to either placebo (53 patients: 27 males and 26
females, aged 50 +/- 4 [mean +/- SD] years) or doxazosin 4 mg/day (54 patients: 26 males and 28 females, aged 51 +/- 5 years) for the entire 6-month
treatment period. Parameters evaluated during the 6-month treatment period included body mass index (BMI), glycaemic control (glycosylated haemoglobin
[HbA(1c)], fasting plasma [FPG] and post-prandial plasma [PPG] glucose, fasting plasma [FPI] and post-prandial plasma [PPI] insulin levels, homeostasis model
assessment [HOMA]-index [insulin resistance]), lipid profile (total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein
cholesterol [HDL-C], and triglycerides [TG]), and systolic (SBP) and diastolic (DBP) blood pressure. RESULTS: Significant reductions in BMI, HbA(1c), FPG and
PPG compared with baseline were observed after 6 months in both groups (p < 0.05). A significant decrease in FPI was obtained after 6 months (p < 0.05) in
the doxazosin group compared with baseline, and this difference was also significant (p < 0.05) compared with the placebo group. Similarly, a significant
decrease in HOMA-index was observed at 6 months (p < 0.05) compared with baseline in the doxazosin group, and this difference was also significant (p < 0.05)
compared with the placebo group. Significant decreases in TC, LDL-C, HDL-C and TG (p < 0.05) were observed in the doxazosin group after 6 months compared
with baseline values. Significant decreases in SBP and DBP were also observed at 3 months in the doxazosin group compared with baseline (p < 0.05), and these
differences were significant (p < 0.05) compared with placebo. Furthermore, significant decreases in SBP and DBP were observed at 6 months (p < 0.01) in the
doxazosin group compared with baseline, and these differences were also significant (p < 0.01) compared with placebo. All patients who completed an OGTT at 6
months (96 patients) were restored to normal glucose tolerance status. CONCLUSION: In patients with IGT, doxazosin given in combination with acarbose seemed
to improve glycaemic and lipid control compared with placebo, with the benefits observed appearing to extend beyond those expected from improvements in blood
pressure. Patients in this study also benefited from acarbose therapy, which restored all patients from IGT to normal glucose tolerance status.
Fertil Steril. 2007 Apr 5;
Penna IA, Canella PR, Vieira CS, Silva de Sa MF, Reis RM, Ferriani RA.
Department of Obstetrics and Gynecology, School of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil; Gynecology Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Cardiovascular risk factors are reduced with a low dose of acarbose in obese patients with polycystic ovary syndrome.
Polycystic ovary syndrome (PCOS) is defined by menstrual irregularity, hyperandrogenism, chronic anovulation, and enlarged ovaries with multiple follicles.
Polycystic ovary syndrome is highly prevalent in women, affecting up to 10% of all women of reproductive age and reducing the possibility of spontaneous
conception. In addition to altering reproductive function, PCOS has systemic implications, especially in the cardiovascular system. Cardiovascular risk (CVR)
in PCOS patient increases because of insulin resistance, elevated androgen levels, and association with obesity. Those alterations promote cardiovascular
risk factors, such as endothelial dysfunction, elevated homocysteine levels, left ventricular hypertrophy, and reduced high-density lipoprotein (HDL)
cholesterol (1).
Orv Hetil. 2006 Aug 6;147(31):1443-6.
Simon K, Dobo E, Nadasy T, Retih I, Racz I.
Varosi Korhaz-Rendelointezet, Belgyogyaszati Osztaly, Siofok.
[The most effective approach in reduction of cardiovascular risk in type 2 diabetes
It is well known that the target blood glucose values are not fulfilled in treatment of
patients with type 2 diabetes mellitus. (UKPDS) The high mortality rate in type 2 diabetes
mellitus is associated with the augmented cardiovascular risk. It is well documented, that the
beneficial influence of high blood pressure, dyslipidaemia, and hypercoagulation compared to
hyperglycaemia, is a more powerful approach in reduction of cardiovascular risk in type 2
diabetes mellitus. The effect of medical interventions on alteration of cardiovascular risk
and glucose homeostasis is not always concordant: betablockers mandatorily reduce
cardiovascular risk, but may result in deterioration of blood glucose values, sulfanylurea
drugs effectively reduce hyperglycaemia, but could paradoxically increase the cardiovascular
risk. The acarbose, methformin, thiazolidindione, fibric acid treatment improves the profile
of vascular risk factors, additionally could have a beneficial metabolic effect resulting in
reducing cardiovascular risk in patients with type 2 diabetes mellitus. In conclusion: the
cardiovascular risk in type 2 diabetes mellitus can be most effectively influenced by
reduction of high blood pressure, dyslipidaemia, and dysfunction of haemostasis. The
improvement of glucose homeostasis is, novel medical interventions seem to be important tools
in reducing cardiovascular risk in patients with type 2 diabetes mellitus.
Am J Physiol Regul Integr Comp Physiol. 2005 Feb 17;
Savastano DM, Carelle M, Covasa M.
Department of Nutritional Sciences, College of Health and Human Development, The Pennsylvania State University, University Park, PA, USA.
SEROTONIN-TYPE 3 RECEPTORS MEDIATE INTESTINAL POLYCOSE- AND GLUCOSE- INDUCED SUPPRESSION OF INTAKE.
Ondansetron, a selective serotonin-type 3 (5-HT3) receptor antagonist, was used to test the hypothesis that duodenal infusion of isosmotic solutions of Polycose or its hydrolytic product glucose, suppressed intake through 5-HT3 receptors. Polycose suppressed sucrose intake across both concentrations infused (132mM, 7.6 +/- 0.6 ml; 263mM, 2.3 +/- 0.5 ml), compared to intake under control conditions (12.6 +/- 0.3 ml, P <0.001). Pretreatment with 1.0 mg/kg ondansetron attenuated reduction of sucrose intake induced only by the highest concentration of Polycose (4.6 +/- 0.8 ml, P=0.004). Dose response testing revealed that suppression of food intake by 263mM Polycose was attenuated by ondansetron administered at 1.0, 2.0, and 5.0mg/kg equally, but not when given at 0.125, 0.25, and 0.5 mg/kg. Acarbose, an alpha-glucosidase inhibitor, attenuated Polycose-induced suppression of food intake and pretreatment with 1.0 mg/kg ondansetron had no further effect. Suppression of intake following 990mM glucose, but not mannitol infusion, was attenuated by pretreatment with 1.0 mg/kg ondansetron. The competitive SGLT1 inhibitor, phloridzin had no effect on 60 min 990mM glucose-induced suppression of intake or the ability of ondansetron to attenuate this suppression of intake. Conversely, glucose-induced suppression of intake was attenuated by phloridzin at earlier time points, and further attenuated when rats were pretreated with 1.0 mg/kg ondansetron. Ondansetron administration alone had no effect on intake at any dose tested. We conclude that 5-HT3 receptors participate in the inhibition of food intake by intraduodenal infusion of carbohydrate solutions through a post-hydrolytic, preabsorptive mechanism.
Diabetes Care. 2005 Mar;28(3):736-44.
Padwal R, Majumdar SR, Johnson JA, Varney J, McAlister FA.
Department of Medicine, 2E3.22 Walter C. Mackenzie HSC, University of Alberta Hospital, 8440-112th St., Edmonton, AB, Canada, T6G 2B7.
A systematic review of drug therapy to delay or prevent type 2 diabetes.
OBJECTIVE: To systematically review the evidence for the prevention of type 2 diabetes by pharmacological therapies. RESEARCH DESIGN AND METHODS: Randomized controlled trials and cohort studies examining the effect of oral hypoglycemic agents, antiobesity agents, antihypertensive agents, statins, fibrates, and estrogen on the incidence of type 2 diabetes were identified from MEDLINE, EMBASE, the Cochrane Controlled Trials Registry, and searches of reference lists. Two reviewers independently assessed studies for inclusion and performed data extraction. RESULTS: Ten studies of oral hypoglycemic agents and 15 studies of nonoral hypoglycemic agents were found. Oral hypoglycemic agents and orlistat are the only drugs that have been studied in randomized controlled trials with diabetes incidence as the primary end point. In the largest studies of 2.5-4.0 years' duration, metformin (relative risk [RR] 0.69, 95% CI 0.57-0.83), acarbose (0.75, 0.63-0.90), troglitazone (0.45, 0.25-0.83), and orlistat (hazard ratio [HR] 0.63, 95% CI 0.46-0.86) have all been shown to decrease diabetes incidence compared with placebo; however, follow-up rates varied from 43 to 96%. Current evidence for statins, fibrates, antihypertensive agents, and estrogen is inconclusive. In addition, the critical question of whether drugs are preventing, or simply delaying, onset of diabetes remains unresolved. CONCLUSIONS: Currently, no single agent can be definitively recommended for diabetes prevention. Future studies should be designed with diabetes incidence as the primary outcome and should be of sufficient duration to differentiate between genuine diabetes prevention as opposed to simple delay or masking of this condition.
Metabolism. 2005 Mar;54(3):387-90.
Fujisawa T, Ikegami H, Inoue K, Kawabata Y, Ogihara T.
Effect of two alpha-glucosidase inhibitors, voglibose and acarbose, on postprandial hyperglycemia correlates with subjective abdominal symptoms.
Abstract To assess the possible difference in effectiveness of 2 alpha-glucosidase inhibitors, voglibose and acarbose, the relationship between postprandial hyperglycemia and subjective abdominal symptoms was investigated. A total of 21 inpatients with type 2 diabetes were recruited to a single-center, 2-period, crossover trial. The subjects were given acarbose (150 mg/d) or voglibose (0.9 mg/d) under an isocaloric diet, and the postprandial (2 hours) increment in blood glucose level, M value which is a marker for fluctuation of blood glucose levels, and subjective abdominal symptom score were monitored. There was no significant difference between the 2 agents in postprandial increment in blood glucose level, M value, and subjective symptom score. When patients were divided according to subjective symptoms, however, the sum postprandial glucose increments were significantly different according to the agent ( P = .03), with favorable efficacy in patients in whom the alpha-glucosidase inhibitor caused abdominal symptoms, demonstrating a significant interaction ( P = .04) between treatment and symptomatic grouping. The results demonstrated that 50 mg acarbose and 0.3 mg voglibose had similar overall effects on postprandial hyperglycemia as well as subjective symptoms, but marked interindividual variation existed. Subjective symptoms may be a predictor of the divergent clinical response to each agent.
Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003639.
Van de Laar F, Lucassen P, Akkermans R, Van de Lisdonk E, Rutten G, Van Weel C.
Department of General Practice and Family Medicine, 229 HAG, University Medical Centre Nijmegen, P.O. Box 9101, Nijmegen, NETHERLANDS, 6500 HB.
Alpha-glucosidase inhibitors for type 2 diabetes mellitus.
BACKGROUND: Alpha-glucosidase inhibitors such as acarbose or miglitol, have the potential to improve glycemic control in type 2 diabetes mellitus. The true value of these agents, especially in relation to diabetes related mortality and morbidity, has never been investigated in a systematic literature review and meta-analysis. OBJECTIVES: To assess the effects of alpha-glucosidase inhibitors s in patients with type 2 diabetes mellitus. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE, Current Contents, LILACS, databases of ongoing trials, reference lists of reviews on the topic of alpha-glucosidase inhibitors and we contacted experts and manufacturers for additional trials. Date of most recent search: December 2003 (Current Contents) and April 2003 (other databases). SELECTION CRITERIA: Randomised controlled trials of at least 12 weeks duration comparing alpha-glucosidase inhibitor monotherapy in patients with type 2 diabetes with any other intervention and that included at least one of the following outcomes: mortality, morbidity, quality of life, glycemic control, lipids, insulin levels, body weight, adverse events. DATA COLLECTION AND ANALYSIS: Two reviewers read all abstracts, assessed quality and extracted data independently. Discrepancies were resolved by consensus or by the judgement of a third reviewer. A statistician checked all extracted data entrance in the database. We attempted to contact all authors for data clarification. MAIN RESULTS: We included 41 trials (8130 participants), 30 investigated acarbose, seven miglitol, one trial voglibose and three trials compared different alpha-glucosidase inhibitors. Study duration was 24 weeks in most cases and only two studies lasted amply longer than one year. We found only few data on mortality, morbidity and quality of life. Acarbose had a clear effect on glycemic control compared to placebo: glycated haemoglobin -0.8% (95% confidence interval -0.9 to -0.7), fasting blood glucose -1.1 mmol/L (95% confidence interval -1.4 to -0.9), post-load blood glucose -2.3 mmol/L (95% confidence interval -2.7 to -1.9). The effect on glycated haemoglobin by acarbose was not dose-dependent. We found a decreasing effect on post-load insulin and no clinically relevant effects on lipids or body weight. Adverse effects were mostly of gastro-intestinal origin and dose dependent. Compared to sulphonylurea, acarbose decreased fasting and post-load insulin levels by -24.8 pmol/L (95% confidence interval -43.3 to -6.3) and -133.2 pmol/L (95% confidence interval -184.5 to -81.8) respectively and acarbose caused more adverse effects. AUTHORS' CONCLUSIONS: It remains unclear whether alpha-glucosidase inhibitors influence mortality or morbidity in patients with type 2 diabetes. Conversely, they have a significant effect on glycemic control and insulin levels, but no statistically significant effect on lipids and body weight. These effects are less sure when alpha-glucosidase inhibitors are used for a longer duration. Acarbose dosages higher than 50 mg TID offer no additional effect on glycated hemoglobin but more adverse effects instead. Compared to sulphonylurea, alpha-glucosidase inhibitors lower fasting and post-load insulin levels and have an inferior profile regarding glycemic control and adverse effects.
Curr Opin Pharmacol. 2005 Apr;5(2):184-9.
Delorme S, Chiasson JL.
Division of Endocrinology-Metabolism and Nutrition, Centre hospitalier de l'Universite de Montreal, Quebec, Canada.
Acarbose in the prevention of cardiovascular disease in subjects with impaired glucose tolerance and type 2 diabetes mellitus.
The prevalence of glucose intolerance is increasing dramatically worldwide. Both impaired glucose tolerance (IGT) and type 2 diabetes are associated with excess mortality from cardiovascular disease. It is now generally accepted that these cardiovascular complications are related to prevailing hyperglycemia, particularly postprandial hyperglycemia. Acarbose specifically decreases the postprandial glycemic surge in IGT and diabetic subjects. The Study To Prevent Non-insulin-dependent Diabetes Mellitus (STOP-NIDDM) trial has shown that acarbose treatment in IGT subjects decreased the risk of progression to diabetes by 36%. Furthermore, it was associated with a 49% risk reduction of cardiovascular events. In a subgroup of subjects, acarbose treatment was accompanied by a 50% decrease in the progression of intima-media thickness of the carotids. Finally, a meta-analysis of seven major studies on the use of acarbose in the treatment of diabetes indicated that acarbose treatment was associated with a 35% risk reduction of cardiovascular disease. It is proposed that the mechanism by which acarbose can lower the risk of cardiovascular events is through diminution of oxidative stress induced by postprandial glycemic excursion.
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