Metabolic control and incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy: an analysis of the Saudi Arabia data from the DISCOVER Observational Study programme.

OBJECTIVES: The aim of the global DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings (DISCOVER) Study was to provide a comprehensive real world assessment of the treatment pattern changes for patients with type 2 diabetes. The aim of this analysis was to assess the metabolic control and the annual incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy. DESIGN: This study is part of the observational, longitudinal, prospective multinational DISCOVER Study. SETTING: Governmental and private health sectors from different regions within Saudi Arabia. PARTICIPANTS: The study recruited 519 patients with type 2 diabetes aged ≥18 years who were switching to second-line therapy. Patients who were already using insulin/injectable agents, patients with type 1 diabetes, pregnant women, and patients undergoing dialysis or with a history of renal transplantation were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: Metabolic control among patients with type 2 diabetes mellitus; fear of hypoglycaemia; quality of life; and the incidence of complications, hypoglycaemic events and/or hospitalisations. Data were analysed using descriptive statistics. RESULTS: A total of 519 patients were recruited with a mean age of 52.4±11 years. Of these participants, 54.7% were male and 45.3% were female. The incidence of hypoglycaemia was 56.72/1000 patient-years. The Hypoglycemia Fear Survey II showed a significant increase in patient worry related to hypoglycaemia from 6.4±11.9 at baseline to (p=0.0446) at the 36-month follow-up. The incidence of hospitalisation was 30.81/1000 patient-years. There was a moderate improvement in glycaemic control, represented as an HbA1c reduction from 8.8% at baseline to 8.2% at the 36-month follow-up. The incidence of macroangiopathy was 24.51/1000 patient-years and the incidence of microvascular complications such as retinopathy and albuminuria was 47.00/1000 patient-years and 221.71/1000 patient-years, respectively. The mean score of fear of hypoglycaemia showed an increase with 13.0±21.5 at baseline to 16.1±22.2 at the 36-month follow-up. When assessing the patients' quality of life, there was an improvement in the mental component score from 47.4±9.1 at baseline to 53.0±6.7 at the 36-month follow-up. CONCLUSIONS: Treatment intensification decisions should be made individually, weighing the benefit of good glycaemic control against the risk of hypoglycaemia. TRIAL REGISTRATION NUMBER: NCT02322762 and NCT02226822.

Longitudinal assessment of the quality of life and patterns of antidiabetic medication use in patients with type 2 diabetes, Saudi Arabia perspective, DISCOVER study.

OBJECTIVES: Patients with type 2 diabetes nowadays have a wide range of new antidiabetic medications with better efficacy and safety. Physicians' attitude toward selecting antidiabetic medications to reach targeted glycemic control and better quality of life (QOL) has not been studied prospectively. The global DISCOVER study aims to comprehensively provide a real-world assessment of the treatment pattern changes for patients with type 2 diabetes, in addition to QOL assessment. The Kingdom of Saudi Arabia was one of the countries participating in the DISCOVER study program. METHODS: This study is a part of the prospective, longitudinal multinational DISCOVER study conducted in 38 countries including Saudi Arabia, a country facing an epidemic of type 2 diabetes, recruited 519 adult patients with type 2 diabetes with a mean age of 52.4 ± 11 years, where, they were followed up for three years period, where 477 patients completed the follow-up period. The clinical, biochemical, and patient lifestyle data were assessed periodically during the study period. DISCOVER study is registered with ClinicalTrials.gov identifiers: NCT02322762. RESULTS: The most frequently used antidiabetic medications (ADMs) initially and during the follow-up were biguanides (metformin) and sulfonylureas (gliclazide, glibenclamide, glimepiride, glipizide, and glyclopyramide). Insulin (premix Insulin, basal insulin, and basal/bolus insulin) and dipeptidyl peptidase-4 (DPP-4) inhibitors (sitagliptin, vildagliptin, saxagliptin, and linagliptin) were the most frequent second and alternative of therapy. Other medications namely thiazolidinediones (TZds) (pioglitazone and rosiglitazone), incretins (exenatide and liraglutide), and Sodium-glucose co-transporter-2 (SGLT-2) inhibitors (canagliflozin) were used at a lesser rate. Drug availability, efficacy, and safety were the main determinants for choosing antidiabetic medications. The physical component score of the QOL had shown a significant decrease, while the mental component score has demonstrated an increase in QOL using SF36v2 Survey. CONCLUSIONS: There is an increasing trend of using of newly available ADMs, mainly DPP-4 inhibitors. The major limitation of ADMs use is related to efficacy, availability, and safety. This warrant taking all the measures to overcome these limitations through adopting a multidisciplinary team approach for close monitoring of the patients and any unfavorable side effects. Additionally, global insurance coverage for all patients with type 2 diabetes could be a solution for the drug availability factor.

Depression and Associated Risk Factors Among Type 2 Diabetic Patients: A Cross Sectional Study on a Convenience Sample from the Diabetic Center, Khamis Mushait; Saudi Arabia.

Background: Studies had confirmed that diabetic patients have a greater risk for developing depression. Our objectives were to estimate the prevalence and predictors of depression among type 2 diabetic patients. Methods: A cross-sectional study at the Diabetic Center, Armed Forces Hospital-Southern Region (AFHSR), Khamis Mushait was conducted in the period from March to June 2017. The study includes a convenience sample of type 2 diabetic patients. Self-administered questionnaires were utilized. It consists of personal characteristics, diabetes-related information's, and the Arabic version of the Patient Health Questionnaire (PHQ-9). Proper statistical analyses were done to assess the significance of the correlates with p ≤ 0.05 considered significant. Results: The study included 350 diabetic patients out of 410 with a response rate of 85.4%. Their age ranged between 28 and 100 years with a mean ±SD of 61.4±13 years. The prevalence of depression among them was 36.6%. Logistic regression revealed that patients older than 50 years were at lower risk for developing depression as compared to those aged between 28 and 40 years OR and 95% CI were 0.21 (0.08-0.57), 0.30 (0.12-0.78) and 0.33 (0.12-0.91) for patients in the age groups 51-60, 61-70 and > 70 years, respectively. Diabetic patients with thyroid dysfunction, neuropathy, those treated with insulin, and noncompliant patients were at double risk for developing depression compared to their counterparts (OR = 2.26, 95% CI = 1.20-4.27, p = 0.012); (OR = 2.35, 95% CI = 1.22-4.53, p = 0.011); (OR = 1.92, 95% CI = 1.08-3.40, p = 0.026); (AOR = 2.14, 95% CI = 1.01-4.53, p = 0.047) respectively. Conclusion: Almost one third of type 2 diabetic patients were depressed. Younger patients, having comorbid thyroid disorders or neuropathy, those treated with insulin and noncompliant patients were at higher risk for developing depression. Proper screening and treatment of depression is a crucial part of the health care management of diabetic people.

Self-Monitoring of Blood Glucose and Hypoglycemia Association During Fasting in Ramadan Among Patients with Diabetes.

PURPOSE: The study aims to assess current practices of patients with diabetes to control blood glucose levels during Ramadan. PATIENTS AND METHODS: A cross-sectional approach has been used for collecting data through a structured and interview-based questionnaire to assess the association between self-monitoring of blood glucose (SMBG) and hypoglycemia. The questionnaire has recorded information about demographics, duration of diabetes, and treatment of diabetes, and hypoglycemia complications faced during Ramadan. The primary outcomes of this study include frequency of SMBG during fasting in Ramadan and association of SMBG and hypoglycemia and break of fasting. However, the secondary outcomes include medications, glycemic control, and other influencing factors. The data was analyzed using Statistical Package of Social Sciences (SPSS) version 20. RESULTS: The findings have shown that the majority of the patients used a combination of metformin+sulphonylurea (23.02%) following metformin+insulin (20.86%), insulin (12.94%), and metformin (8.63%). Whereas diet control, high or low blood sugar, insulin dose adjustment in fasting conditions were the most influential factors during Ramadan when the blood sugar levels were tested. Majority of the patients monitored their blood glucose level during pre-iftar (56.8%) following to hypoglycemia (30.2%), post-iftar (29.4%), and rarely monitored in afternoon (3.5%) despite that only 10.1% monitored their blood glucose on a daily basis. Patients who had symptoms of hypoglycemia and had to break their fasting at least once were 41% and 27.2%, respectively. There is a significant association between age and gender with symptoms of low blood sugar level. Additionally, a significant association between blood sugar monitoring and high blood sugar level has been shown (p=0.041), indicating that lack in daily blood sugar monitoring can increase the blood sugar level of a patient during Ramadan. CONCLUSION: The present study has helped in providing better understanding about the self-monitoring of blood glucose level and hypoglycemia. Furthermore, it also emphasizes the pre-Ramadan education about when to break their fasting along with frequency and timing of SMBG.

Serum biomarkers for acute hepatotoxicity of Echis pyramidum snake venom in rats.

Echis pyramidum is a venomous viper responsible for most cases of envenomation in Arabian Peninsula. We determined the acute phase (3-6 h) changes in serum markers of liver function including alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) and bilirubin in adult male Sprague Dawley rats injected with Echis pyramidum venom (EPV) in the doses of 0.00 (control), 0.25, 0.50 and 1.00 mg/kg bodyweight. We also analyzed markers of oxidative stress including superoxide dismutase (SOD), catalase (CAT), total thiols (T-SH) and thiobarbituric acids reactive substances (TBARS) in liver. The results showed significant and dose- and time-dependent increases in serum ALT, ALP and GGT activities after a single injection of EPV. Serum bilirubin was significantly increased by medium and high doses of EVP after 3 h post-injection and then decreased at 6 h. The low dose of EPV neither affected the activity of SOD nor altered the levels of liver T-SH and TBARS, however, it significantly decreased the activity of CAT at 6 h post-injection of EPV. The medium dose of EPV significantly reduced liver SOD activity after 6 h whereas the high dose significantly reduced the SOD activity at 3 h and 6 h post-dosing. Both medium and high doses of EPV caused significant as well as dose- and time-dependent reductions in liver CAT activities. The high dose significantly reduced T-SH and increased TBARS in rat liver. Further studies are warranted to test the pharmacological potential of early phase antioxidant therapy for neutralizing the toxic effects of EPV.