Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study.

The present GUARD study was a prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin with or without metformin in adult patients with type 2 diabetes mellitus (T2DM) studied in routine clinical practice. Patients were enrolled from countries across four geographical regions. The primary endpoint was change in glycated haemoglobin (HbA1c) concentration from baseline after 24 weeks of treatment with vildagliptin with or without metformin. Of 19 331 patients analysed, 3511 received vildagliptin and 15 820 received vildagliptin plus metformin. At week 24, the mean HbA1c was reduced significantly from baseline by -1.27% (vildagliptin: -1.17%; vildagliptin plus metformin: -1.29%; p < 0.0001). Significant reductions in HbA1c from baseline were consistently reported regardless of patient age, body mass index (BMI) or baseline HbA1c. Weight and BMI were also significantly reduced from baseline. Vildagliptin treatment with or without metformin was generally well tolerated. It provided clinically relevant glycaemic and weight control, and was well tolerated in a large multi-ethnic population of patients with T2DM studied in routine clinical practice.

Cardiovascular disease risk factors in the South Asian population living in Kuwait: a cross-sectional study.

BACKGROUND: High rates of diabetes and cardiovascular disease have been reported in South Asian immigrants in many countries. However, the prevalence and characteristics of cardiovascular disease risk factors among a South Asian population living in Kuwait have not yet been investigated. This study was therefore designed to estimate the prevalence of cardiovascular disease risk factors and determine whether they are independently associated with diabetes in such a population. METHODS: A population-based cross-sectional study was conducted on 1094 South Asians (781 men and 313 women), mainly Indian and Pakistani (≥ 18 years of age), of whom 75.1% were Indians. Interviews were carried out, during which socio-demographic and anthropometric data were collected, followed by a physical examination and collection of fasting blood samples for laboratory investigations. Diabetes was defined by fasting plasma glucose ≥ 7 mmol/l, or being on treatment, and/or self-reported previously diagnosed Type 2 diabetes. RESULTS: The prevalence of diabetes was 21.1%, with 3.4% of that percentage of people being newly diagnosed. Using BMI measurements, 24.0% of those who participated in the study were obese and 46.1% were overweight. Dyslipidaemia was found in 77.6% and hypertension in 44.8%. Advancing age (≥ 40 years), male gender, high LDL, high total cholesterol, hypertension and positive family history of diabetes were significantly associated with increased risk of diabetes. CONCLUSION: Our study shows that the prevalence of cardiovascular disease risk factors in South Asian expatriates in Kuwait exceeds prevalence rates reported in their homeland and other countries. This may suggest the added stress of environmental factors on the development of cardiovascular disease risk factors in such populations. Specialized prevention programmes targeting such high-risk ethnic populations are paramount and need to be implemented.

Barriers to the delivery of optimal antidiabetic therapy in the Middle East and Africa.

BACKGROUND: The prevalence of type 2 diabetes is increasing worldwide, but developing nations will bear a disproportionate share of this burden. Countries in the Middle East and Africa are in a state of transition, where marked disparities of income and access to education and healthcare exist, and where the relatively young populations are being exposed increasingly to processes of urbanisation and adverse changes in diet that are fuelling the diabetes epidemic. Optimising diabetes care in these nations is crucial, to minimise the future burden of complications of diabetes. METHODS: We have reviewed the barriers to effective diabetes care with special relevance to countries in this region. RESULTS: The effects of antidiabetic treatments themselves are unlikely to differ importantly in the region compared with elsewhere, but economic inequalities within countries restrict access to newer treatments, in particular. Values relating to family life and religion are important modifiers of the physician-patient interaction. Also, a lack of understanding of diabetes and its treatments by both physicians and patients requires more and better diabetes education, delivered by suitably qualified health educators. Finally, sub-optimal processes for delivery of care have contributed to a lack of proper provision of testing and follow-up of patients in many countries. CONCLUSION: Important barriers to the delivery of optimal diabetes care exist in the Middle East and Africa.

The effect of vildagliptin relative to sulphonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: the VIRTUE study.

AIMS: To assess, in a real-world setting, the effect of vildagliptin compared with sulphonylurea (SU) treatment on hypoglycaemia in Muslim patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. METHODS: This multinational, non-interventional study, conducted in Asia and the Middle East, included Muslim adult patients with T2DM who received treatment with vildagliptin or SU as add-on to metformin or monotherapy. During a ~16-week observation period, data were collected up to 6 weeks before and 6 weeks after Ramadan fasting. The primary study objective was to compare the proportion of patients with ≥ 1 hypoglycaemic event (HE) during fasting. RESULTS: Of > 1300 patients enrolled in the study, 684 were treated with vildagliptin and 631 with SUs. Significantly fewer patients experienced ≥ 1 HE with vildagliptin compared with those receiving SUs (5.4% vs. 19.8%, respectively; p < 0.001); no vildagliptin-treated patients reported a grade 2 HE, vs. 4 SU-treated patients (p = 0.053). Mean HbA1c changes from baseline were vildagliptin: -0.24%, SUs: +0.02% (p < 0.001). Mean body weight reductions from baseline were vildagliptin: -0.76 kg, SUs: -0.13 kg (p < 0.001). A higher proportion of SU-treated patients experienced adverse events (AEs) compared with vildagliptin (22.8% vs. 10.2%). This difference was driven by hypoglycaemia as the most common AE. CONCLUSIONS: In this real-world study of fasting Muslim patients with T2DM, vildagliptin was associated with significantly fewer hypoglycaemic episodes compared with SU therapy. This outcome is particularly meaningful when viewed in the context of good glycaemic and weight control observed in vildagliptin-treated patients. Vildagliptin was well tolerated in this patient population.

Barriers to the delivery of diabetes care in the Middle East and South Africa: a survey of 1,082 practising physicians in five countries.

AIMS: Developing countries face a high and growing burden of type 2 diabetes. We surveyed physicians in a diverse range of countries in the Middle East and Africa (Egypt, Kingdom of Saudi Arabia, United Arab Emirates, South Africa and Lebanon) with regard to their perceptions of barriers to type 2 diabetes care identified as potentially important in the literature and by the authors. METHODS: One thousand and eighty-two physicians completed a questionnaire developed by the authors. RESULTS: Most physicians enrolled in the study employed guideline-driven care; 80-100% of physicians prescribed metformin (with lifestyle intervention, where there are no contraindications) for newly diagnosed type 2 diabetes, with lifestyle intervention alone used where metformin was not prescribed. Sulfonylureas were prescribed widely, consistent with the poor economic status of many patients. About one quarter of physicians were not undertaking any form of continuing medical education, and relatively low proportions of practices had their own diabetes educators, dieticians or diabetic foot specialists. Physicians identified the deficiencies of their patients (unhealthy lifestyles, lack of education and poor diet) as the most important barriers to optimal diabetes care. Low-treatment compliance was not ranked highly. Access to physicians did not appear to be a problem, as most patients were seen multiple times per year. CONCLUSIONS: Physicians in the Middle East and South Africa identified limitations relating to their patients as the main barrier to delivering care for diabetes, without giving high priority to issues relating to processes of care delivery. Further study would be needed to ascertain whether these findings reflect an unduly physician-centred view of their practice. More effective provision of services relating to the prevention of complications and improved lifestyles may be needed.

Optimising the medical management of hyperglycaemia in type 2 diabetes in the Middle East: pivotal role of metformin.

AIMS: Increases in the prevalence of type 2 diabetes will likely be greater in the Middle East and other developing countries than in most other regions during the coming two decades, placing a heavy burden on regional healthcare resources. METHODOLOGY: Medline search, examination of data from major epidemiological studies in the Middle Eastern countries. RESULTS: The aetiology and pathophysiology of diabetes appears comparable in Middle Eastern and other populations. Lifestyle intervention is key to the management of diabetes in all type 2 diabetes patients, who should be encouraged strongly to diet and exercise. The options for pharmacologic therapy in the management of diabetes have increased recently, particularly the number of potential antidiabetic combinations. Metformin appears to be used less frequently to initiate antidiabetic therapy in the Middle East than in other countries. Available clinical evidence, supported by current guidelines, strongly favours the initiation of antidiabetic therapy with metformin in Middle Eastern type 2 diabetes patients, where no contraindications exist. This is due to its equivalent or greater efficacy relative to other oral antidiabetic treatments, its proven tolerability and safety profiles, its weight neutrality, the lack of clinically significant hypoglycaemia, the demonstration of cardiovascular protection for metformin relative to diet in the UK Prospective Diabetes Study and in observational studies, and its low cost. Additional treatments should be added to metformin and lifestyle intervention as diabetes progresses, until patients are receiving an intensive insulin regimen with or without additional oral agents. CONCLUSIONS: The current evidence base strongly favours the initiation of antidiabetic therapy with metformin, where no contraindications exist. However, metformin may be under-prescribed in the Middle East.

Prevalence of childhood obesity in the state of Kuwait.

BACKGROUND: Overweight and obesity have reached an epidemic in Kuwait, with the highest rate of adult obesity in the region. National estimates of childhood obesity in Kuwait are scarce. The purpose of this study is to evaluate the prevalence of overweight and obesity among school children in Kuwait. METHODS: This is a cross-sectional study of a representative sample of 6-18 years old school children, randomly selected from 244 schools in Kuwait. Anthropometric data was measured from 6574 students in September 2012-June 2013. Overweight and obesity have been defined in accordance with the Centres for Disease Control and Prevention (CDC), International Obesity Task Force (IOTF) and World Health Organization (WHO) 2007 criteria. RESULTS: The prevalence estimate overweight was based on the three different systems (CDC = 17.7%, IOTF = 23.3%, WHO = 21.6%). The prevalence of obesity was (CDC = 33.9%, IOTF = 28.2%, WHO = 30.5%). Boys had a higher percentage of obesity regardless of the classification system used. CONCLUSIONS: The prevalence of childhood obesity is alarmingly high in the State of Kuwait and exceeds the prevalence rates reported from neighbouring countries and from North America.

High incidence of childhood-onset IDDM in Kuwait. Kuwait Study Group of Diabetes in Childhood.

OBJECTIVE: To determine the incidence of insulin-dependent diabetes mellitus (IDDM) in children aged 0-14 years in Kuwait, as part of the World Health Organization Multinational Collaborative Study (DIAMOND), and to determine if the incidence rates have increased. RESEARCH DESIGN AND METHODS: All cases of IDDM diagnosed before the child's 15th birthday between 1 January 1992 and 31 December 1993 were recorded. Prospective notification of all children with newly diagnosed diabetes who were admitted to hospitals and periodic review of hospital medical records provided the primary source; notification by physicians working in diabetic clinics, in which registry of all new cases is mandatory, provided the secondary source of ascertainment. RESULTS: The degree of ascertainment was 92.2%. The annual incidence of IDDM for children aged 0-14 years over the 2-year period was 15.4/100,000 (95% confidence interval, 12.4-19), with a male:female ratio of 1.2:1. The age-specific annual incidence rates for the age-groups 0-4, 5-9, and 10-14 years were 12.8, 15.1, and 18.3/100,000, respectively, with a male:female ratio of 1.45:1 in the 0- to 4-year-old age-group and an equal sex ratio in the 5- to 9- and 10- to 14-year-old age-groups. No significant difference was detected between incidence rates of IDDM in boys and girls in the three age-groups. There was no significant linear trend toward an increase in IDDM incidence rates as age advanced. Compared with a previous study by Taha et al. (Taha T, Moussa M, Rashed A, Fenech F: Diabetes mellitus in Kuwait: incidence in the first 29 years of life. Diabetologia 25:306-308, 1983), there was a nearly fourfold increase of IDDM in the age-group 0-14 years, mainly in those children < 5 years old, suggesting a rapid increase in a short period of time. CONCLUSIONS: Kuwait has the highest incidence of IDDM in children in the region, and an apparently increasing incidence has been demonstrated over the last decade.

Treatment of type 1 diabetes with insulin lispro during Ramadan.

OBJECTIVE: To compare insulin lispro with regular human insulin with respect to blood glucose control and frequency of hypoglycaemia in patients with type 1 diabetes who wished to fast during the month of Ramadan. RESEARCH DESIGN AND METHODS: Insulin lispro or regular human insulin was given together with NPH insulin, twice daily before the morning and evening meals, for two weeks each in an open-label, randomised, cross-over design, and 64 patients completed the protocol. Blood glucose was self-monitored at fasting morning and evening, and 1-h and 2-h after the post-sunset meal on three consecutive days at the end of each treatment period. RESULTS: The 2-h blood glucose excursion after the post-sunset meal was significantly (p=0.026) lower with insulin lispro (2.50 +/- 0.46 mmol/l) than with regular human insulin (3.47 +/- 0.49 mmol/l). Daily insulin doses did not differ between treatments but compliance with recommended time of injection was better with insulin lispro. Hypoglycaemia incidence (insulin lispro, 15 (23.4%) patients; regular human insulin 31 (48.4%) patients; p=0.004) and frequency (insulin lispro, 0.70 +/- 0.19; regular human insulin 2.25 +/- 0.36 episodes/patient/30 days; p<0.001) were lower with insulin lispro. Five (22.7%) of the episodes during insulin lispro occurred during the nocturnal period compared with 27 (36.5%) of the episodes while on regular human insulin. CONCLUSIONS: Glycaemic control, measured by postprandial glycemic excursions, was improved and hypoglycaemia was significantly reduced with insulin lispro compared with regular human insulin. Patients with type 1 diabetes who insist on fasting during Ramadan may be better managed with insulin lispro.

Non-insulin-dependent diabetes in Kuwait: prevalence rates and associated risk factors.

Non-insulin-dependent diabetes mellitus (NIDDM) is a major clinical and public health problem in Kuwait. The objective of the study was to determine prevalence rates of NIDDM among a representative sample of the Kuwaiti adult population aged 20 and older in two out of five governorates and identify the associated risk factors for the disease. A total of 3003 subjects (1105 men and 1898 women) were interviewed and examined by the research team during the period September 1995 to June 1996. A specially designed questionnaire was completed and the physical examination included height, weight and blood pressure measurements. Fasting blood samples were withdrawn, centrifuged immediately and refrigerated. Interpretation of oral glucose tolerance tests were based on the World Health Organisation diagnostic criteria for diabetes mellitus (1985). The denominator used for computing the prevalence was obtained from the 1995 Kuwait census. The overall prevalence of NIDDM in this study was found to be 14.8% (14.7% in men, 14.8% in women). Diabetic subjects presented at a relatively young age, prevalence rate in the age group 20-39 was 5.7% (95% confidence interval, 4.4-7.0) and in the age group 40-59 was 18.3% (95% confidence interval, 16.1-20.6). Obesity was found to be a significant risk factor, P < 0.001. The strong association of family history of NIDDM (adjusted odds ratio = 1.80, P < 0.001) suggests a genetic component. Hypertension was markedly associated with NIDDM and IGT (P < 0.001). With the demographic transition which already started among the Kuwaiti population and if the prevalence of NIDDM remains the same, aging of the population will contribute to even more upward trends in prevalence of abnormal glucose tolerance with its serious impact on morbidity and mortality among the Kuwaiti population. The strong association between hypertension and NIDDM may suggest a common approach to the prevention and control of these two conditions.

Impact of the 1997 American Diabetes Association criteria on classification of glucose intolerance among Kuwaitis below 50 years of age.

Type 2 (non-insulin-dependent) diabetes is emerging as a leading chronic non-communicable disease among the adult Kuwaiti population. Based on the World Health Organization and similar reports the projected estimates for subjects suffering from type 2 diabetes by the years 2000 and 2010 show a striking tendency to high rates of the disease in our area. We report the prevalence rates of glucose intolerance among a relatively young adult Kuwaiti population below 50 years of age and the effect of implementing the recent 1997 American Diabetes Association diagnostic criteria on the frequency of type 2 diabetes, impaired glucose tolerance and impaired fasting glucose among this group. The overall prevalence rate for the three categories of glucose intolerance reached as high as 15.8% (95% CI, 14.2 to 17.4). Age, though all subjects were below 50 years, parental history of type 2 diabetes, diastolic blood pressure and serum triglycerides were found to be significant associated risk factors for the development of type 2 diabetes. Obesity was an apparent significant factor associated with the three forms of glucose intolerance (p < 0.001). Obesity and physical inactivity were documented in both non-diabetic and more so in diabetic Kuwaiti adults, which should form the basis of any immediate intervention programme. An integrated approach to the prevention of the described critical risk factors associated with type 2 diabetes is highly recommended in Kuwait. Research, focused on genetics of type 2 diabetes in the highly susceptible Kuwaiti population, should be planned.

Adiponectin, insulin resistance and clinical expression of the metabolic syndrome in patients with Type 2 diabetes.

BACKGROUND: Obesity and the metabolic syndrome have emerged as clinical and public health crises in many populations, but not all obese patients have the syndrome. As adipocytes produce several adipokines that modulate insulin action as well as glucose and lipid metabolism, we postulate that estimation of adipokines may be useful addition to the criteria used to identify obese individuals with the metabolic syndrome. OBJECTIVE: To evaluate the determinants and associations of plasma adiponectin in relation to the metabolic syndrome in patients with Type 2 diabetes. DESIGN: Cross-sectional study. SETTING: General Teaching Hospital. PATIENTS: One hundred and thirty five (57 M, 78 F) patients with Type 2 diabetes mellitus. MEASUREMENTS: Adiponectin, leptin, high-sensitivity C-reactive protein (hs-CRP), fasting plasma insulin, glucose, glycated hemoglobin and full lipid profile. Patients were classified on the basis of the degree of adiposity, insulin resistance (IR) (homeostasis model assessment of insulin resistance (HOMA-IR)) and the number of the American Heart Association and the National Heart, Lung and Blood Institute criteria of the metabolic syndrome. RESULTS: Adiponectin levels were inversely correlated with age, indices of obesity, IR and hs-CRP. Overweight/obese and non-obese insulin-sensitive patients had significantly higher (P<0.05) adiponectin levels than those with IR despite similar body mass index and waist circumference. Therefore, within each category of obesity stratification, lower adiponectin levels were associated with IR. Adiponectin showed stepwise decrease with increasing number of the criteria for diagnosis of the metabolic syndrome. Using multiple logistic regression, the odds ratio of the metabolic syndrome as predicted by adiponectin was 0.73 (95% confidence interval 0.53-0.96; P=0.04). At cutoff point of 18 ng/ml, the diagnostic sensitivity and specificity of adiponectin for the metabolic syndrome were 83 and 65%, respectively, in male patients and 92 and 41%, respectively, in female patients. Receiver operating characteristic analysis showed that adiponectin had significantly higher area under the curve compared with leptin, leptin:adiponectin ratio and triglycerides for the detection of the metabolic syndrome. CONCLUSIONS: In patients with Type 2 diabetes, adiponectin concentrations are closely related to IR and the components of the metabolic syndrome. Adiponectin concentration may be a useful addition to the criteria used for identifying obese subjects with the metabolic syndrome.

Foot infections in diabetics: the antibiotic choice.

The authors studied 59 diabetics with foot infections to determine the organisms responsible and the sensitivity to antibiotics. All infections were polymicrobial (aerobic and anaerobic). On average 3.2 isolates per culture were obtained from the depth of the infection. The commonest organisms in order of frequency were: Staphylococcus aureus, beta-hemolytic streptococci, Proteus sp., Bacteroides sp., enterococci, Klebsiella sp. and Pseudomonas aeruginosa. A combination of piperacillin and cloxacillin is recommended as initial therapy for foot infections in diabetic patients because it was found to be effective for 73% of the causative microorganisms.

Further evidence for the rising incidence of childhood Type 1 diabetes in Kuwait.

AIMS: To provide age-gender standardized incidence rate, temporal trend and seasonal variation of Type 1 diabetes in Kuwaiti children aged < or = 14 years. METHODS: Data were prospectively collected over a period of 6 years (1992-1997) according to the DiaMond Project protocol using the capture-recapture method of ascertainment. RESULTS: Data ascertainment varied between 90% and 96%. The incidence rate of Type 1 diabetes was 20.1 per 100,000 children 0-14 years (95% confidence interval (CI) 18.0-22.1); age-standardized incidence rate 20.9 (95% CI 18.8-23.0). The incidence rate among boys, 21.1 per 100,000 (95% CI 18.1-24.1) was slightly higher than that among girls, 19.0 per 100,000 (95% CI 16.1-21.8). The age-standardized incidence rate was 21.9 (95% CI 18.9-24.8) in boys, and 19.9 (95 CI 17.1-22.8) in girls. Incidence rates increased with age in both sexes (boys chi(2) for linear trend = 13.5, P < 0.001; and for girls chi(2) = 27.8, P < 0.0001). There was a significant trend towards increase in overall incidence during the 6-year period (chi(2) = 6.210, P = 0.013), and in age group 5-9 (chi(2) = 10.8, P = 0.001). Seasonality was demonstrated overall, in boys and girls (P < 0.001). CONCLUSION: The incidence of Type 1 diabetes in Kuwait is high compared with the neighbouring Arab countries, and it appears to be increasing as in many European populations.