Optimizing Diabetes Management Using a Low-Calorie Diet in Saudi Arabia: A Cost-Benefit Analysis.

BACKGROUND: Low-calorie diets, high in protein and low in carbohydrates, are commonly recommended for patients with pre-diabetes and type 2 diabetes. The objective of this study was to carry out a cost-benefit analysis (CBA) of a low-calorie versus a standard diet from the perspective of the Saudi Arabian health system. METHODS: The CBA compares costs and benefits of the two diet strategies over a 1-year time horizon. Costs included diet and diabetes treatment-related resources while benefits were measured in terms of the costs of diabetes complications avoided. Data on costs and benefits were collected from published literature and subject matter experts. Incremental costs were estimated as the cost difference between low-calorie and standard diet. Incremental benefits were estimated as cost difference from medical complications when following a low-calorie or standard diet. The incremental absolute cost-benefit ratio was calculated to show the difference between the costs and benefits of the low-calorie diet. Incremental relative cost-benefit ratio was calculated to show the cost per dollar of benefit obtained. Monte Carlo simulation modeled variability in outcomes due to variation in costs and uncertainty of diabetes complications. RESULTS: The 1 year cost of standard diet was US$2515 ± 156 compared to US$2469 ± 107 per patient for a low-calorie diet. Incremental benefit is estimated at US$21,438 ± 7367 per patient. The estimated incremental absolute cost-benefit ratio was US$ - 21,360 establishing that benefits are greater than costs, while the estimated incremental relative cost-benefit ratio is 0.0037, establishing that benefits are 270 times greater than costs. CONCLUSION: The low-calorie diet was the dominant strategy compared to the standard diet in modeled scenarios. These findings highlight the importance of a low-calorie diet as part of diabetes management programs for outpatients with type 2 diabetes.

Roadmap for the Management of Type 2 Diabetes and Hypertension in the Middle East: Review of the 2022 EVIDENT Summit.

Type 2 diabetes mellitus (T2DM) and hypertension are leading risk factors for death and disability in the Middle East. Both conditions are highly prevalent, underdiagnosed and poorly controlled, highlighting an urgent need for a roadmap to overcome the barriers to optimal glycaemic and blood pressure management in this region. This review provides a summary of the Evidence in Diabetes and Hypertension Summit (EVIDENT) held in September 2022, which discussed current treatment guidelines, unmet clinical needs and strategies to improve treatment outcomes for patients with T2DM and hypertension in the Middle East. Current clinical guidelines recommend strict glycaemic and blood pressure targets, presenting several treatment options to achieve and maintain these targets and prevent complications. However, treatment targets are infrequently met in the Middle East, largely due to high clinical inertia among physicians and low medication adherence among patients. To address these challenges, clinical guidelines now provide individualised therapy recommendations based on drug profiles, patient preferences and management priorities. Efforts to improve the early detection of prediabetes, T2DM screening and intensive, early glucose control will minimise long-term complications. Physicians can use the T2DM Oral Agents Fact Checking programme to help navigate the wide range of treatment options and guide clinical decision-making. Sulfonylurea agents have been used successfully to manage T2DM; a newer agent, gliclazide MR (modified release formulation), has the advantages of a lower incidence of hypoglycaemia with no risk of cardiovascular events, weight neutrality and proven renal benefits. For patients with hypertension, single-pill combinations have been developed to improve efficacy and reduce treatment burden. In conjunction with pragmatic treatment algorithms and personalised therapies, greater investments in disease prevention, public awareness, training of healthcare providers, patient education, government policies and research are needed to improve the quality of care of patients with T2DM and/or hypertension in the Middle East.

The prevalence of cardiovascular disease in adults with type 2 diabetes mellitus in Saudi Arabia - CAPTURE study.

OBJECTIVES: To investigate cardiovascular disease (CVD) prevalence in adult patients with type 2 diabetes mellitus (T2DM) in Saudi Arabia using data from the CAPTURE cross-sectional study. METHODS: CAPTURE was a non-interventional, multinational study carried out between December 2018 and September 2019. In Saudi Arabia, clinical (including medication) and demographic data were collected across 7 sites (Alhada Armed Forces Hospital, Taif; King Saud University Medical City, King Saud University, Riyadh; Specialized Medical Centre Hospital, Riyadh; King Abdulaziz University Hospital, Jeddah; King Abdulaziz Hospital for National Guard, Al Ahsa; Diabetes and Endocrinology Center, Buraidah; and Dallah Hospital, Riyadh, Saudi Arabia) from adults aged ≥18 years. The prevalence of CVD was estimated and weighted according to care setting, with data between groups not statistically compared. RESULTS: Among the 883 adults enrolled in this study (566 from primary care, 317 from secondary care), 158 had established CVD, making the weighted prevalence of 18% (95% CI: [15.5-20.5]). The weighted prevalence of atherosclerotic CVD was 15.1% (95% CI: [12.8-17.5]), accounting for 82.4% of the CVD cases. Coronary heart disease was the most common subtype of CVD (13.4%), followed by cerebrovascular disease (1.7%). A total of 23.6% of patients were treated with glucose-lowering agents with proven cardiovascular benefit. CONCLUSION: In Saudi Arabia, approximately one in 5 adults with T2DM had established CVD, lower than the global prevalence, possibly because of disparities in patient characteristics, potential genetic predispositions, or a lack of accurate documentation due to poor coordination between care settings.

Real-world safety and effectiveness of iGlarLixi in people with type 2 diabetes who fast during Ramadan: The SoliRam observational study.

BACKGROUND AND AIMS: To evaluate the safety and effectiveness of iGlarLixi in adults with type 2 diabetes (T2D) fasting during Ramadan. METHODS: SoliRam was a multinational, prospective, single-arm, real-world observational study conducted during Ramadan 2020 and 2021 in adults with T2D treated with iGlarLixi ≥3 months at study entry. The primary endpoint was the percentage of participants experiencing ≥1 episode of severe and/or symptomatic documented hypoglycemia (<70 mg/dL [<3.9 mmol/L]). RESULTS: Among the 409 eligible participants followed during Ramadan, 96.8% fasted for ≥25 days and 92.4% did not break fasting during Ramadan. Four participants broke their fast due to hypoglycemia. Minimal adjustments were seen in antihyperglycemic therapies from pre to during Ramadan. Documented symptomatic hypoglycemia was experienced by 1.0%, 2.3%, and 0.3% of participants, respectively, during the last month of pre-Ramadan, Ramadan, and first month post-Ramadan. Mean change in HbA1c from pre-to post-Ramadan periods was -0.75% (-8.2 mmol/mol), and participants with HbA1c <7% (<53 mmol/mol) increased from 7.9% pre-Ramadan to 28.6% post-Ramadan. CONCLUSIONS: iGlarLixi is an effective and well-tolerated therapy for people with T2D, including those who intend to fast during Ramadan, and is associated with a low risk of hypoglycemia; benefits were observed both during and after Ramadan.

The Transcultural Diabetes Nutrition Algorithm: A Middle Eastern Version.

Diabetes prevalence is on the rise in the Middle East. In countries of the Gulf region-Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates-prevalence rates are among the highest in the world. Further, Egypt now ranks as one of the top 10 countries in the world for high number of people with diabetes. Medical nutrition therapy is key to optimal management of diabetes. Patient adherence to nutritional guidance depends on advice that is tailored to regional foods and cultural practices. In 2012, international experts created a transcultural Diabetes Nutrition Algorithm (tDNA) for broad applicability. The objective of this current project was to adapt the algorithm and supportive materials to the Middle East region. A Task Force of regional and global experts in the fields of diabetes, obesity, and metabolic disorders met to achieve consensus on Middle East-specific adaptations to the tDNA. Recommendations, position statements, figures, and tables are presented here, representing conclusions of the tDNA-Middle Eastern (tDNA-ME) Task Force. Educational materials can be used to help healthcare professionals optimize nutritional care for patients with type 2 diabetes. The tDNA-ME version provides evidence-based guidance on how to meet patients' nutritional needs while following customs of people living in the Middle Eastern region.

Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Who Fast During Ramadan in The Gulf Region: A Subgroup Analysis of the Real-World ORION Study.

INTRODUCTION: To evaluate the safety and effectiveness of insulin glargine 300 U/mL (Gla-300) in people with type 2 diabetes mellitus (T2DM) in the Gulf region who fast during Ramadan. METHODS: ORION was a real-world, prospective, observational study in people with T2DM treated with Gla-300 during pre-Ramadan, Ramadan, and post-Ramadan periods. This subgroup analysis included 222 participants from the Gulf region (Kuwait, Saudi Arabia, United Arab Emirates, and Qatar). The primary endpoint was the percentage of participants experiencing severe and/or symptomatic documented hypoglycemia (self-monitored plasma glucose [SMPG] ≤ 70 mg/dL) during Ramadan. Changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), SMPG, body weight, insulin dose, and adverse events (AEs) were also evaluated. RESULTS: The primary endpoint was reported in one (0.5%) participant during Ramadan. The incidence rate of symptomatic documented hypoglycemia (SMPG ≤ 70 mg/dL) decreased from the pre-Ramadan (3.2%) to Ramadan period (0.5%), and no severe hypoglycemia events were reported during the study. Reductions were observed in HbA1c (mean ± standard deviation: - 0.51 ± 0.95% [- 5.5 ± 10.4 mmol/mol]), FPG (- 13.9 ± 47.5 mg/dL), and SMPG (- 6.1 ± 27.1 mg/dL). No significant changes were observed in body weight or Gla-300 dose. AEs were reported in 11 (5.0%) participants. CONCLUSION: In a real-world setting in the Gulf region, Gla-300 treatment in people with T2DM during Ramadan was associated with a low incidence of hypoglycemia and improved glycemic control. TRIAL REGISTRATION: CTRI/2019/02/017636.

Advancing Therapy in Suboptimally Controlled Basal Insulin-Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial.

OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA1c ≥7.5% and ≤10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. RESULTS: Both primary efficacy end points were met: after 26 weeks, baseline HbA1c (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference -0.2% [97.5% CI -0.4, -0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference -1.9 kg [95% CI -2.3, -1.4]) and percentage of participants achieving HbA1c <7% without weight gain and HbA1c <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (P < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30. CONCLUSIONS: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy. VIDEO 1: diacare;dc21-0393v4/F1F1f1Infographic available at https://care.diabetesjournals.org/content/dc21-0393-infographic.

Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN.

INTRODUCTION: To analyse the safety and effectiveness of gliclazide modified release (MR) in adults with type 2 diabetes mellitus participating in Ramadan from three geographically and culturally different regions of the world included in the DIA-RAMADAN study. METHODS: DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6-8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4-6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events. RESULTS: Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA1c and fasting plasma glucose. CONCLUSION: These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.

Sulfonylureas in the Current Practice of Type 2 Diabetes Management: Are They All the Same? Consensus from the Gulf Cooperation Council (GCC) Countries Advisory Board on Sulfonylureas.

Since their inception in the commercial market in the mid-twentieth century, sulfonylureas (SUs) have remained a therapeutic option in the management of type 2 diabetes (T2D). Despite their established glucose-lowering effects, there is no consensus among global experts and modern guidelines regarding the priority of SUs in relation to other therapeutic options, given the lack of evidence that SUs are associated with a low risk of macrovascular events and excess mortality. However, findings from recent trials and real-time observations have resolved this contentious issue somewhat, albeit to varying degrees. The present consensus discusses the role of SUs in contemporary diabetes management in the Gulf Cooperation Council (GCC) countries. Regional experts from these countries gathered virtually to formulate a consensus following presentations of topics relevant to SU therapy with an emphasis on gliclazide, including long-term efficacy, cost, end-organ benefits, and side effects, based on up-to-date evidence. The present narrative review reflects the conclusions of this assembly and provides a platform upon which future guidelines for the use of SUs in the GCC can be tailored.

Advancing therapy with iGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomized controlled trial.

AIM: Premix insulin is commonly used in some regions of the world, despite the higher risk of hypoglycaemia and weight gain compared with basal insulin, based on the premise that it offers a simplified insulin regimen. iGlarLixi is a once-daily titratable fixed-ratio formulation that combines basal insulin glargine 100 units/mL (iGlar) and the GLP-1 RA, lixisenatide, which offers a single-injection option for treatment intensification, with improved HbA1c reductions, similar hypoglycaemia risk and more favourable bodyweight profiles over iGlar alone. This randomized controlled study directly compares, for the first time, treatment intensification with iGlarLixi versus premix insulin analogue biphasic insulin aspart 30 (BIAsp 30) in adults with T2D inadequately controlled on basal insulin in combination with one or two oral antihyperglycaemic drugs. MATERIALS AND METHODS: This was an open-label, active-controlled, comparative, parallel-group, multicentre, phase 3b study. In total, 887 adults with T2D uncontrolled on basal insulin were randomized to switch to either iGlarLixi once daily, or BIAsp 30 twice daily, for 26 weeks. RESULTS: Overall, 887 participants were enrolled (mean age 59.8 years, 50.2% female) from 89 centres in 17 countries. At baseline, 65.6% had a duration of T2D of 10 years or longer, and the mean HbA1c at baseline was 8.6%. CONCLUSIONS: The study directly compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with T2D uncontrolled on basal insulin and one or more oral antihyperglycaemic agents. These results provide robust clinical data that may inform clinicians in their therapeutic management of people with T2D uncontrolled on basal insulin requiring additional therapy.

A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN.

AIMS: To explore the real-world safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. METHODS: DIA-RAMADAN (NCT04132934) was a prospective, international, observational study conducted in nine countries. Patients >18 years of age with T2DM (N = 1244) were examined at an inclusion visit (V0) occurring 6-8 weeks before the start of Ramadan. Patients received a diary to report treatment changes, hypoglycaemic events (HEs), and other adverse events. Gliclazide MR was taken once daily for 14-18 weeks. A second visit (V1) was conducted 4-6 weeks after the end of Ramadan. The primary endpoint was the proportion of patients reporting ≥1 symptomatic HE. Changes in HbA1c, fasting plasma glucose (FPG), and body weight were secondary endpoints. RESULTS: The proportion of patients reporting ≥1 symptomatic HE during Ramadan was low (2.2%) with no reported severe HEs. There was a significant reduction in HbA1c (-0.3%), FPG (-9.7 mg/dL), body weight (-0.5 kg) and body mass index (-0.2 kg/m2) between V0 and V1 (p < 0.001). CONCLUSIONS: Patients with T2DM treated with gliclazide MR during Ramadan have a low risk of hypoglycaemia and maintain glycaemic control and weight while fasting.

Prevalence of lipid abnormalities and cholesterol target value attainment in patients with stable coronary heart disease or an acute coronary syndrome in Saudi Arabia.

OBJECTIVES: To provide an overview of the extent of hyperlipidemia in very high-risk patients, and how lipid-lowering therapy (LLT) is used in a real-world setting. Methods: In this multicenter observational study, data were collected from LLT-treated patients with stable CHD or an ACS in Saudi Arabia between 2013 and 2014. Individuals were included if they were greater than 18 years and had a full lipid profile available, recorded either prior to the baseline physician visit (CHD patients) or within 24-hours of admission to hospital (ACS patients).  Results: A total of 737 patients were included in the study, 597 with stable CHD and 140 with ACS. Few patients in either group had an LDL-C level of greater than 70 mg/dl, which is advocated for very high-risk patients (24.3% and 11.4%, respectively). The median distances to this value were 19.0 mg/dl (CHD) and 25.0 mg/dl (ACS). Low doses of statins were being utilized (31 and 24 mg/day for CHD and ACS, respectively), with only minimal intensification for the ACS patients after hospital admission (41 mg/day at follow-up). Conclusions: Achievement of recommended LDL-C levels was poor for patients with stable CHD or an ACS. Statin intensity was low, indicating huge scope for intensifying the treatment of these very high-risk patients.

Direct and indirect health economic impact of hypoglycaemia in a global population of patients with insulin-treated diabetes.

AIMS: The Hypoglycaemia Assessment Tool (HAT) study investigated the health economic impact of hypoglycaemic events in 24 countries, including countries without previously published data on hypoglycaemia. METHODS: Self-assessment questionnaires and patient diaries (4-week prospective period) were completed by adults with type 1 (T1D) or type 2 diabetes (T2D) treated with insulin for more than 12 months (N = 27,585). RESULTS: Direct economic impacts of hypoglycaemia during the 4-week prospective period, included increased blood glucose monitoring (reported by 69.7% [T1D] and 60.9% [T2D] of patients), hospitalisation (T1D 2.1%; T2D 3.4% of patients) and medical contact (clinic or telephone; T1D 3.8%; T2D 6.8% of patients). Regional variation in medical contact and hospitalisation was found, with the highest usage in Russia (T1D 17.1%; T2D 17.3%), and Latin America (T1D 5.2%; T2D 6.8%) respectively. Indirect economic impacts following hypoglycaemia included loss of productivity due to absence from work or study; 3.9% (T1D) and 6.2% (T2D) of patients. Regional differences in work productivity were noted among patients with T2D, with a low prevalence in Northern Europe and Canada (0.9%) and high in Southeast Asia (14.6%). CONCLUSIONS: This study shows that hypoglycaemia has a significant but variable impact on the economics of diabetes healthcare globally.

Filling the Knowledge Gap in Diabetes Management During Ramadan: the Evolving Role of Trial Evidence.

UNLABELLED: Muslim patients with type 2 diabetes (T2D) who fast during Ramadan face challenges in diabetes management due to substantial alterations in lifestyle and treatment that frequently accompany the decision to fast. International guidelines for treating T2D do not fully address the clinical issues unique to fasting, and other guidance documents lack the large and high-quality evidence base available for non-fasting conditions. We reviewed 10 randomized controlled trials and 20 observational studies in T2D during Ramadan to assess the quality of evidence and identify issues in trial design that should be addressed in future studies. Results indicated that heterogeneity in key aspects of trial design precluded meaningful comparisons across studies. These included patients' baseline treatment at entry; use of a cutoff for glycemic control [glycated hemoglobin (HbA1c)] for eligibility; exclusion of patients with a history of recurrent hypoglycemia or hypoglycemia unawareness, or with other serious systemic diseases; duration of treatment and follow-up, selection of safety versus efficacy as primary end point; and definition and measurement of those end points. Fructosamine was rarely used as an efficacy end point, despite the advantage of reflecting glycemic control over a period more closely aligned with the duration of Ramadan fasting than HbA1c. Adherence to treatment, definition and adherence to fasting, and changes in diet and exercise were reported inconsistently, and when reported, not in a fashion that would allow adequate control of confounding due to these variables. Despite a large body of evidence demonstrating their safety and efficacy in non-fasting populations, only two trials reported data for glucagon-like peptide-1 analogs, and neither involved a head-to-head comparison against dipeptidyl peptidase-4 inhibitors. More rigorous studies using trial designs suited to the unique conditions of a fasting population and capturing both standardized efficacy and safety end points are needed to provide better guidance to optimal treatment of T2D during Ramadan fasting. FUNDING: Novo Nordisk AG.

Incidence of hypoglycemia in patients with type 2 diabetes treated with gliclazide versus DPP-4 inhibitors during Ramadan: A meta-analytical approach.

AIM: Hypoglycemia can be a concern for patients with type 2 diabetes when fasting during Ramadan. In this analysis, we assessed the incidence of symptomatic hypoglycemic events in fasting patients treated with gliclazide or dipeptidyl peptidase-4 (DPP-4) inhibitors. METHODS: A systematic literature review was performed to identify randomized clinical trials comparing the efficacy and safety of gliclazide with DPP-4 inhibitors when treating adults with type 2 diabetes fasting during Ramadan. The primary endpoint of all included studies was the incidence of symptomatic hypoglycemic events. RESULTS: The pooled analysis included three randomized trials. There was no evidence of heterogeneity between the studies (I(2)=0%). There was no significant difference in the incidence of symptomatic hypoglycemic events in patients fasting during Ramadan treated with either a DPP-4 inhibitor or gliclazide (5.6% versus 7.2%, risk ratio 1.12, 95% CI 0.73-1.73, p=0.61). CONCLUSION: Patients treated with either gliclazide or DPP-4 inhibitors while fasting during Ramadan have similarly low risks of experiencing symptomatic hypoglycemia. Gliclazide is an effective oral antidiabetic that may be suitable for the management of patients with type 2 diabetes during Ramadan. Individualized Ramadan-focused advice and evening intake of treatment may improve the management of patients with diabetes during Ramadan.

Results of the Dyslipidemia International Study (DYSIS)-Middle East: clinical perspective on the prevalence and characteristics of lipid abnormalities in the setting of chronic statin treatment.

BACKGROUND: Therapeutic intervention with low-density lipoprotein cholesterol-lowering agents known as statins has been demonstrated to reduce cardiovascular risk. However, many patients on statin treatment have persistent dyslipidemia and remain at a high risk of cardiovascular disease. Therefore, the objective of this study was to assess the frequency of lipid abnormalities in patients receiving chronic statin treatment. METHODS: As part of an international, cross-sectional, observational study, DYSIS-Middle East enrolled 2,182 patients in the United Arab Emirates (UAE), Saudi Arabia, Lebanon and Jordan. All patients were over 45 years of age and had been on statin treatment for at least three months. Data on demographics, lipid parameters and cardiovascular risk profile were recorded. Cardiovascular risk was defined according the guidelines of the European Society of Cardiology. RESULTS: The majority of patients (82.6%) were classified as being at very high risk of cardiovascular events, and 61.8% of all patients did not attain LDL-C target levels. Low high-density lipoprotein cholesterol levels and elevated triglyceride levels were noted in 55.5% and 48.5% of patients, respectively. Multivariate logistical regression modeling indicated that factors independently associated with LDL-C levels not being at goal were lifestyle choices, diabetes mellitus, ischemic heart disease, and blood pressure ≥ 140/90 mmHg. CONCLUSIONS: Almost two-thirds of statin-treated patients in the United Arab Emirates, Saudi Arabia, Lebanon and Jordan had inadequately controlled lipid levels. More comprehensive surveillance, awareness and treatment regimens, as well as modification of lifestyle choices, is necessary to halt the rise in cardiovascular disease-related mortality.

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Taif, Saudi Arabia cohort of the A1chieve study.

BACKGROUND: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. MATERIALS AND METHODS: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for participants enrolled from Taif, Saudi Arabia. RESULTS: A total of 791 subjects were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients were started on or were switched to biphasic insulin aspart (n = 238), insulin detemir (n = 325), insulin aspart (n = 9), basal insulin plus insulin aspart (n = 85) and other insulin combinations (n = 127). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.7%) and insulin user (mean HbA1c: 9.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -2.3%, insulin users: -2.6%). SADRs including major hypoglycaemic events did not occur in the study patients. CONCLUSION: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

Diagnostic accuracy of high-resolution neck ultrasonography in the follow-up of differentiated thyroid cancer: a prospective study.

OBJECTIVE: To conduct a prospective study of the diagnostic value of features of cervical lymph nodes (large size, central location, abnormal shape, cystic changes, calcifications, and loss of echogenic hilum), assessed by neck ultrasonography (US), in patients scheduled for surgical treatment of persistent or recurrent differentiated thyroid cancer. METHODS: We studied 152 US abnormalities in 42 patients (median age, 38.5 years) who had undergone one or more neck operations, with or without radioiodine therapy, but continued to have persistent or recurrent disease, which was confirmed by fine-needle aspiration. Another surgical procedure was planned for these patients. On the day of operation, patients underwent a detailed US neck examination by an experienced radiologist. US abnormalities were plotted on a standard diagram of the neck and given specific numbers to help track them during surgical intervention and histopathologic examinations. The US features were compared with the final histopathologic diagnosis. RESULTS: Of 152 US abnormalities, 127 involved cervical lymph nodes and 25 involved other types of tissue. In univariate analysis, size, absent echogenic hilum, cystic changes, calcifications, and central location (medial to the sternomastoid muscle) of cervical lymph nodes were significantly associated with the presence of metastatic involvement. In multivariate analysis, only central location (odds ratio, 4.07; 95% confidence interval [CI], 1.64 to 10.10) and size (odds ratio, 5.14; 95% CI, 1.64 to 16.06) remained significant. The receiver operating characteristic curve for the size of lymph nodes showed a large area under the curve of 0.77 (95% CI, 0.68 to 0.85), and a size of 7.5 mm showed the highest sensitivity and specificity. CONCLUSION: Size and central location of cervical lymph nodes assessed by US during follow-up of patients with differentiated thyroid cancer were the most important predictors of presence of metastatic disease.