Evaluating the Clinical Effectiveness and Safety of Semaglutide in Individuals with Uncontrolled Type 2 Diabetes. Real-World Evidence from Saudi Arabia: The Observational, Multicenter, 15-Month EVOLUTION Study.

INTRODUCTION: This study aimed to assess the safety and effectiveness of semaglutide, administered either by weekly subcutaneous (SC) injection or orally, in real-life practice in Saudi Arabia in individuals with type 2 diabetes mellitus (T2DM). METHODS: A retrospective chart review study was conducted at 18 Saudi Arabia centers. An accredited centralized institutional review board approved the study. Medical records were included for individuals of any age ≥ 18 years with uncontrolled T2DM. The primary outcome measure was the laboratory glycated hemoglobin (HbA1c) level. Secondary measures included fasting blood glucose (FBG), weight, and hypoglycemia. All variables were checked after 6 and 12 months of semaglutide initiation. RESULTS: The analysis of this study included 1223 patients with uncontrolled T2DM (HbA1c > 7%). The mean (SD) baseline HbA1c was 10.02% (1.17). HbA1c was reduced by an average of 3.02% (0.84) and 3.17% (0.84) at 6 and 12 months, respectively. Results of a repeated measure analysis of variance (ANOVA) indicated significant differences in HbA1c (p value < 0.001). HbA1c levels at 6 and 12 months were significantly lower, 7.00% (0.70) and 6.85% (0.69), than at baseline, 10.02% (1.17). About 193 patients (56.4%) of the 295 patients having HbA1c < 9% achieved HbA1c of 5.7% or less. The frequency of hypoglycemia events was 4.60 (1.10) in the 3 months before semaglutide was initiated. The frequency of hypoglycemia events in the last 3 months was 2.30 (0.80) events and 0.80 (0.50) events at 6-month and 12-month follow-up visits, respectively. The percent reduction in body mass index (BMI) was an average of 13.07% (1.53) and 19.89% (4.07) at 6 and 12 months, respectively. Lipid profile and blood pressure were improved at 6 and 12 months. CONCLUSION: Semaglutide, administered either by SC injection or orally, provided substantial glycemic and weight-loss benefits in adults with T2DM.

Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study-UPDATES Saudi Arabia.

INTRODUCTION: Insulin degludec (degludec) has proven benefits in type 2 diabetes (T2D), in terms of improved glycaemic control, low risk of hypoglycaemia, and flexibility in dosing time. This prospective non-interventional UPDATES study aimed to investigate whether results obtained from randomised clinical trials and other real-world studies with degludec are generalisable to patients with T2D in routine clinical practice in Saudi Arabia. METHODS: Eligible adults (n = 561) with T2D received degludec for 26-34 weeks, at physicians' discretion and in accordance with local routine clinical practice. The primary endpoint was mean change in HbA1c from baseline to end of study (EOS). Secondary endpoints included mean change from baseline to EOS in fasting plasma glucose (FPG), daily insulin dose and rate of hypoglycaemia. RESULTS: At baseline, mean age, HbA1c and FPG were 55.7 years, 9.4% and 185.6 mg/dL, respectively. Mean (standard error [SE]) changes from baseline to EOS (crude analysis) were statistically significant for HbA1c (- 1.1 [0.08] %-points, 95% CI - 1.29, - 0.98; P < 0.0001), FPG (- 39.1 [3.42] mg/dL, 95% CI - 45.9, - 32.4; P < 0.0001) and total daily insulin dose (+ 4.7 [1.6] units, 95% CI 1.63, 7.86; P = 0.003, insulin-experienced population). In exploratory analysis of patients switching from insulin glargine U100 or U300 to degludec, similar reductions were seen in HbA1c and FPG. The rate of hypoglycaemia was significantly reduced with degludec versus previous treatment, with no apparent or unexpected safety and tolerability issues. The number of insulin-experienced patients utilising resources associated with severe hypoglycaemia was also reduced. Most patients (95.5%) were willing to continue treatment at EOS, and expressed a preference for degludec over their previous regimen (93.0%). CONCLUSION: Patients with T2D treated with degludec in routine clinical practice in Saudi Arabia experienced clinically significant improvements in glycaemic control and a lower rate of hypoglycaemia compared with baseline, with no new safety concerns reported. CLINICAL TRIAL REGISTRATION: NCT03785522.

Prevalence of Polypharmacy and Factors Associated with it Among Saudi Older Adults - Results from the Saudi National Survey for Elderly Health (SNSEH).

Background and Objectives: The percentage of Saudi older adults (SOA) is increasing over time. With advanced age, the prevalence of chronic diseases and multiple disabilities are increasing. This leads to increase utilization of multiple medications. The objectives of this study were to describe medication utilization, determine the prevalence of polypharmacy (PP) and factors associated with it among SOA. Methods: This cross-sectional study was conducted among community-dwelling SOA aged ≥ 60 years old using the Saudi National Survey for Elderly Health (SNSEH). The survey was conducted between 2006 and 2007 by the Ministry of Health on a nationally representative sample of SOA. The data included demographics, socioeconomic and health information such as diseases and medications. Polypharmacy was defined as the concurrent use of medications from ≥ 5 therapeutic classes. A modified Poisson multivariable regression was used to study factors associated with PP controlling for confounders. All analyses were done using STATA 14. Results: The study included 2,946 SOA; 50.4% were males, 60.9% were 60-70 years old, and 69.6% were illiterate. The most common medications used among SOA were: Paracetamol (67%), joint pain medications and NSAIDs (50% each), anti-diabetic and multivitamins and minerals (47% each). PP was identified in (51.5%) of participants. The most medication associated with PP were: Paracetamol (79.9%), multivitamins and minerals (71.6%), steroid and DMARDs (70.1%), NSAIDs (66.4%), anti-diabetic and anti-hypertensive (61.3%). Higher risk of PP was associated with diabetes (RR: 1.863; 95% CI: 1.686-2.059), hypertension (RR: 1.829; 95% CI: 1.624-2.060), having pain (RR: 2.282; 95% CI: 1.918-2.713), urinary incontinence (RR: 1.389; 95% CI: 1.238-1.560; ref: no urinary incontinence) or suggestive depression (RR: 1.379; 95% CI: 1.259-1.512). Similarly, compared to low income (<2500 SAR), higher incomes were more likely to have PP. On the other hand, compared to the central region, southern and northern regions were less likely to have PP (RR = 0.741; 95% CI: 0.652-0.843 and RR: 0.736; 95% CI: 0.596-0.908, respectively). Severe cognitive impairment was associated with a lower risk of PP (RR: 0.708; 95% CI: 0.501-1.000). Conclusion: The prevalence of PP among a nationally representative SOA was very high, i.e., 51.5%. Higher risk of PP was associated with many factors such as region, income, diabetes, hypertension, musculoskeletal pain, urinary incontinence, and depression. PP leads to many negative implications such as drug interactions, combined side effects, hospitalization, and death. Therefore, raising the knowledge of health care providers on the consequences of PP and providing medication therapy management services may help decrease the negative consequences of PP and improve therapy outcomes.

The Validity of the American Diabetes Association's Diabetes Risk Test in a Saudi Arabian Population.

Introduction The prevalence of type 2 diabetes (T2D) is growing worldwide. This study aimed to assess the sensitivity and specificity of the American Diabetes Association (ADA) and the United States Centers for Disease Control and Prevention's diabetes risk test in identifying Saudi Arabian patients at risk of developing T2D. Methods We conducted a one-month cross-sectional study that included patients older than 18 years who visited primary care facilities for any health concern in Riyadh City, Saudi Arabia. We used the Arabic language version of the ADA Prediabetes Risk Test questionnaire, a validated and reliable tool, to collect data. For this study, we analyzed the data using IBM SPSS Statistics for Windows, version 24.0 (IBM Corp., Armonk, New York). Moreover, we calculated sensitivity and specificity, positive predictive values (PPV), negative predictive value (NPV), the area under the curve (AUC), and Youden's index. Results A total of 180 participants were included in the study (121 women and 59 men; mean age = 45 years). The ADA Prediabetes Risk Test sensitivity was 78.9, specificity was 82, PPV was 32, and NPV was 76. Youden's index was 60.9 and the AUC was 0.6. Conclusion The ADA prediabetes risk assessment tool is highly sensitive and specific for determining the disease. It is a reliable and valid tool that has not yet been implemented to a great extent in Saudi Arabia. Therefore, future work should study the tool's effectiveness in risk assessment in additional local Saudi Arabian communities.