Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Mellitus During the Period of Ramadan in Four Countries (Egypt, Jordan, Lebanon, and Turkey): A Prospective Observational Study.

AIM: This non-interventional observational study aimed to describe the clinical outcomes of patients with T2DM treated with Gla-300 during the period of Ramadan. BACKGROUND: Type 2 diabetes mellitus (T2DM) patients who decide to fast during the holy month of Ramadan face several challenges in achieving glycemic control without increasing the risk of hypoglycemia. Insulin glargine-300 (Gla-300) has well-established safety and efficacy in improving glycemic control in multiple randomized clinical trials (RCTs). However, limited evidence is available regarding its safety and effectiveness during fasting. OBJECTIVE: The objective of this study was to assess the safety and clinical outcomes of insulin glargine-300 (Gla-300) in T2DM patients before, during, and after Ramadan. METHODS: We conducted a prospective, observational, non-comparative, multicenter study on patients with T2DM currently treated with Gla-300 who planned to fast and continue on Gla-300 during Ramadan in four countries (Egypt, Jordan, Lebanon, and Turkey). The study outcomes included the change in glycemic parameters and incidence of hypoglycemia before, during, and after Ramadan. RESULTS: One hundred and forty T2DM patients were included. Nearly 61% of the included patients had a duration of diabetes of <10 years. The mean Gla-300 daily doses during the pre-Ramadan, Ramadan, and post-Ramadan periods were 22.2 ±7.4, 20.4 ±7.5, and 22.5 ±4.7 IU, respectively. The mean change values from pre-Ramadan to Ramadan and post-Ramadan were -1.7 ±6.9 IU and 0.5 ±4.7 IU, respectively, among the included patients. The mean HbA1c decreased during the study period initiating from 7.9 ±1.4% pre-Ramadan to 6.9 ±0.4% post-Ramadan. The overall HBA1c target value was 6.9 ±0.4%, while the HbA1c target was achieved by 29 patients (21.9%). The mean fasting blood glucose (FPG) showed a reduction from baseline value in the post-Ramadan period by -0.9 ±2.3mmol/L. Five patients (3.57%) had symptomatic documented hypoglycemia during Ramadan, and none was considered to have severe hypoglycemia. CONCLUSION: Our study showed that insulin Gla-300 maintained the glycemic control of T2DM patients who decided to fast during the holy month of Ramadan without increasing the risk of hypoglycemia. Regular self-monitoring of blood glucose levels during Ramadan is highly recommended to avoid possible complications.

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.

Characteristics and treatment patterns of patients with type 2 diabetes in Lebanon: the DISCOVER study.

BACKGROUND: Lebanon is part of the global DISCOVER study, a global, noninterventional, multicentre, prospective study with 3-years of follow-up. AIMS: The aim of this study is to describe real-world clinical practice in terms of type 2 diabetes mellitus (T2DM) disease management and treatment patterns within Lebanon. METHODS: Baseline demographic and clinical parameters were captured on a standardized case report form, according to routine clinical practice at each clinical site. RESULTS: We recruited 348 patients. At the initiation of second-line therapy, mean duration of diabetes was 6.7 [standard deviation (SD) 6.5] years; mean HbA1c and fasting plasma glucose levels were 8.5% (SD 1.6%) and 178.7 (SD 56.5) mg/dL respectively. Almost half the patients were hypertensive (45.1%) or had dyslipidaemia (48.6%). Metformin monotherapy was used as first-line therapy in 56.9% of the patients and upfront dual therapy in 25%. The primary reason for changing firstline therapy was poor glycaemic control. The main factors in choosing the second-line therapy were efficacy, tolerability and hypoglycaemia. CONCLUSION: Clinical inertia was evident in this cohort of patients as they had suboptimal glycaemic control at the time of enrolment and the initiation of second-line therapy. Treatment intensification is required to reduce diabetes-related adverse outcomes.

Unexpected Gastric Ectopic Pancreas During Sleeve Gastrectomy: A Case Report.

BACKGROUND Ectopic or heterotopic pancreas is relatively rare pathology described as pancreatic tissue lacking communication with the normal pancreas. Ectopic pancreatic tissue can be found along the gastrointestinal tract, with the most common location the stomach along the greater curvature. This congenital condition could be identified incidentally, or present with symptoms that range from pain and bleeding to obstruction and malignant transformation. CASE REPORT We report a case of a 30-year-old female, who underwent laparoscopic sleeve gastrectomy for morbid obesity of body mass index (BMI) of 46 kg/m², and who was found to have a 3 cm submucosal mass at the lesser curvature while dividing the stomach. The sleeved stomach tube's intraoperative gastroscopy showed a submucosal mass at the posterior stomach wall towards the lesser curvature, increasing the suspicion of gastrointestinal stromal tumor (GIST) tumor. The choice was to continue with a secure margin and conversion to roux-en-y gastric bypass with gastric tumor resection. It turned out that the final pathology was submucosal ectopic pancreas. Despite being a rare pathology, for any submucosal gastric mass, ectopic pancreas should be on the differential diagnosis list. During the sleeve surgery, the mass was found, and the approach was changed to intraoperatively subtotal gastrectomy and roux-en-y gastric bypass. CONCLUSIONS Before any bariatric operation, even in asymptomatic young patients, it is worth doing routine upper endoscopy to prevent surprising intraoperative pathology.

Validation of diabetes medication adherence scale in the Lebanese population.

AIM: To validate the Diabetes Medication Adherence Scale (DMAS-7), determine its concordance with another validated scales and to assess factors affecting medication adherence. METHODS: A cross-sectional study was conducted on a sample of Lebanese patients with diabetes using a questionnaire. The level of adherence was measured using the DMAS-7 and the Lebanese Medication Adherence Scale (LMAS-14). Bivariate and multivariate analyses were conducted, and the scale was validated in terms of reliability, predictive ability, and construct validity using SPSS version 19. RESULTS: Out of 300 eligible patients, the rate of adherence was 33.7%. Measures of validity showed good reliability (Cronbach alpha = 0.627), and good construct validity with LMAS-14 (Spearman's rho = 0.846; Cohen's kappa = 0.711). DMAS-7 was found to be both correlated with LMAS-14 (ICC average measure = 0.675; p-value <0.001) in addition to possessing a better predictive value. Thus, DMAS-7 showed to have good concordance and increased validity compared to LMAS-14. Having an optimal glycated hemoglobin (HbA1C) (OR = 0.779; p = 0.001) and performing regular physical activity (OR 2.328; p = 0.002) increased medication adherence. CONCLUSION: The DMAS-7 showed to be reliable and valid instrument superior to LMAS-14 in predicting adherence levels to oral anti-diabetic medications, and thus can be used to achieve better glycemic outcomes.

Efficacy and safety of a generic rosuvastatin in a real-world setting: prospective, observational clinical study in Lebanese patients.

BACKGROUND: No published studies have assessed the efficacy and safety of rosuvastatin generics. OBJECTIVES: Primary objective to assess the safety and efficacy of a generic rosuvastatin in reducing plasma low-density-lipoprotein cholesterol (LDL-C) in Lebanese dyslipidemic patients. Changes in high-density lipoprotein cholesterol, triglycerides and adverse effects were secondary objectives. DESIGN: Prospective, observational, non-comparative. SETTING: Multiple outpatient clinics in Lebanon. PATIENTS AND METHODS: Dyslipidemic patients requiring statin therapy were followed for 2 months after prescription of a generic rosuvastatin at the physician's discretion. Efficacy and safety measurements were collected from medical records. MAIN OUTCOME MEASURES: Efficacy was assessed based on the evaluation of mean and percent change in LDL-C between baseline and week 8 as well as the proportion of patients reaching target LDL-C levels. Safety was assessed based on the evaluation of the incidence of adverse events (AEs) during the study period. RESULTS: Two months after initiation of generic rosuvastatin, LDL-C levels in the 313 eligible patients who completed the study significantly decreased from 4.3 (0.8) mmol/L (168.2 [31.3] mg/dL) at baseline to 2.7 (0.7) mmol/L (105.9 [25.5] mg/dL) (P < .001). The mean percent change in LDL-C level was highest in subjects receiving generic rosuvastatin at a dose of 40 mg/day (-47.4%), followed by 20 mg/day (-36.8%), and 10 mg/ day (-31.4%); 82.5% of patients reached the target LDL-C level as set by their physician at baseline. Thirteen patients (4%) reported six AEs during treatment: abdominal pain, headache, stomach ache, insomnia, musculoskeletal pain/myalgia and nausea. No clinically significant changes in serum creatinine, serum creatine kinase, or liver function tests were reported. One patient withdrew because of an adverse event. CONCLUSIONS: Generic rosuvastatin was efficacious and safe in reducing LDL-C levels and helping the majority of patients achieve LDL-C targets after a short treatment period. LIMITATIONS: The observational nature, and a control group, and the relatively short duration of follow-up limit the generalizability of results. The authors received fees for study activities at patient visits from an independent clinical research organization subcontracted by the sponsor.

Densitometer type and impact on risk assessment for osteoporosis.

Studies have shown a high correlation between measurements of bone mineral density (BMD) obtained on differentdual-energy X-ray absorptiometry machines. Challenger osteodensitometers (Diagnostic Medical System [DMS],Montpellier, France) are becoming widely used but little is known about their clinical performance. The aim of this study was to compare BMD measurements and the resulting patient classification based on T-scores obtained on a DMS Challenger device to those obtained on Hologic 4500A (Bedford, MA) device. Fifty-three volunteers were studied. The BMD of the spine and of the hip were simultaneously measured on both densitometers. BMD values obtained on the Challenger were significantly higher than those obtained with the Hologic QDR4500 (p<0.001). The correlations coefficients between the Hologic QDR4500 and the DMS Challenger measured BMDs were r=0.70 at the femoral neck, r=0.70 at the trochanter, and r=0.83 at the spine (p<0.001). Among the 35 postmenopausal women, there was discordance in the WHO T-score-based classification in 28 subjects (80%) at the spine, 18 subjects (52%) at the femoral neck, and 14 subjects (42%) at the trochanter. The intermachine agreement was low: The kappa score was -0.10 at the spine, 0.2 at the femoral neck, and 0.3 at the trochanter. In conclusion, this study cautions against the use of non established densitometers that leads to underdiagnosis of patients and, subsequently, to inappropriate treatment strategies.