Safety of Empagliflozin in Patients with Type 2 Diabetes Mellitus in Saudi Arabia: A Post-Authorisation Safety Study

Background: Empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor is used as a monotherapy or in combination for lowering the elevated blood glucose level in patients with type 2 diabetes mellitus (T2DM). It is often associated with certain adverse reactions (urinary tract infection (UTI), diabetes ketoacidosis (DKA), and genital infections). Thus, the Saudi Food and Drug Administration requested a post-authorisation safety study to monitor the safety of empagliflozin during the defined observation period. Methodology: The local, comparator, non-interventional, regulatory post-marketing study using “new user” design was conducted in patients with T2DM, treated with empagliflozin (10 or 25 mg) and dipeptidyl peptidase-4 (DPP-4) inhibitors (NCT03764631). Study was conducted from 2018 to 2020, wherein each patient was followed up for 12 months after the index period. Incidence and occurrence of DKA, severe UTIs, volume depletion and dehydration were observed along with metformin, insulin and treatment complexity status and adverse events in the index and Ramadan period. All data collected were analysed using descriptive statistics. Results: Among the 1502 patients enrolled (empagliflozin [n = 751] and DPP-4 inhibitors [n = 751]), 0.1% patients (n = 1) in each group and Conclusion: Empagliflozin was well tolerated over a period of 12 months, with no safety concerns and a favourable benefit/risk ratio.

Is peri-transplant blood transfusion associated with worse transplant outcomes?A retrospective study

BACKGROUND Blood transfusion is common during the peri-transplantation period.The incidence of immunological reactions to blood transfusion after kidney transplantation and their consequences on graft outcomes have not been extensively studied.AIM To examine the risk of graft rejection and loss in patients who received blood transfusion in the immediate peri-transplantation period.METHODS We conducted a single-center retrospective cohort study of 105 kidney recipients,among them 54 patients received leukodepleted blood transfusion at our center between January 2017 and March 2020.RESULTS This study included 105 kidney recipients,of which 80%kidneys were from living-related donors,14%from living-unrelated donors,and 6%from deceased donors.Living-related donors were mostly first-degree relatives(74.5%),while the rest were second-degree relatives.The patients were divided into transfusion(n=54)and non-transfusion(n=51)groups.The average hemoglobin level at which blood transfusion was commenced was 7.4±0.9 mg/dL.There were no differences between the groups in terms of rejection rates,graft loss,or death.During the study period,there was no significant difference in creatinine level progression between the two groups.Delayed graft function was higher in the transfusion group;however,this finding was not statistically significant.A high number of transfused packed red blood cells was significantly associated with increased creatinine levels at the end of the study.CONCLUSION Leukodepleted blood transfusion was not associated with a higher risk of rejection,graft loss,or death in kidney transplant recipients.

Saudi Consensus on the Usage of Sodium-Glucose Cotransporter-2 Inhibitors on the Management of Chronic Kidney Diseases

According to recent epidemiological data, chronic kidney diseases (CKDs) affect approximately 10% of the global population. Like many countries, CKD is a significant public health issue in Saudi Arabia. The prevalence of CKD in Saudi Arabia is estimated to be around 4.5% of the adult population, with a higher prevalence in older age groups. Sodium-glucose cotransporter-2 inhibitors (SGLT2is) are a class of oral medications used to treat type 2 diabetes mellitus (T2DM). In addition to their glucose-lowering effects, SGLT2i have been shown to have beneficial effects on kidney function in patients with or without T2DM. Therefore, a Saudi task force gathered to develop an explicit, evidence-based consensus on SGLT2i use in CKD Saudi patients. A panel of 14 experts made up a task force. An initial concept proposal was obtained. The proposal was divided into several topics discussed on 24 May 2023. A literature review was carried out. The literature search was completed on 3rd June 2023. A drafted report was distributed to the entire panel. Approval of the recommendations required consensus, defined as a majority approval (i.e. above 75%). The recommendations were revised to accommodate any differences of opinion until a consensus was reached. Recommendations were finally formulated on 21st June 2023. Subsequently, the panel reviewed and discussed the supporting rationale of the revised recommendations. This article presents these practical recommendations.

Hamstring autograft utilization in reconstructing anterior cruciate ligament:Review of harvesting techniques,graft preparation,and different fixation methods

Rupture of the anterior cruciate ligament(ACL)is a common orthopedic injury.Various graft options are available for the reconstruction of ruptured ACL.Using the hamstring muscle as an autograft was first described in 1934,and it remains a commonly harvested graft for ACL reconstruction.Hamstring autografts can be harvested using the traditional anteromedial approach or the newer posteromedial technique.An isolated semitendinosus tendon can be used or combined with the gracilis tendon.There are numerous methods for graft fixation,such as intra-tunnel or extra-tunnel fixation.This comprehensive review discusses the different hamstring muscle harvesting techniques and graft preparation options and fixation methods.It provides a comprehensive overview for choosing the optimal surgical technique when treating patients.

The Impact of the FreeStyle LibreTM Flash Glucose Monitoring System on Glycemic Control in Patients with Diabetes;Observational Multicenter 15-Months Study

Objectives: The study was to determine the impact of using the FreeStyle LibreTM flash glucose monitoring system on glycemic control and the rate of events due to diabetes in people with diabetes from different types and age groups. Methods: a retrospective cohort chart review study was carried out at three centers in the Taif region in the Kingdom of Saudi Arabia: The study was approved by an accredited centralized institutional review board. Paper or electronic medical records were included for individuals of any age with diabetes (type 1, type 2, gestational diabetes) managed with diet, insulin therapy, or/and oral antihyperglycemic medication and/or non-insulin injection therapy. The primary outcome measure was the laboratory HbA1c level as well as reduction. Secondary outcome measures were frequency of severe hypoglycemia, admission to hospital or ER visit related to diabetes complications, and severe hyperglycemia (DKA or HHS). Results: Data was analyzed from 1695 patients. The average HbA1c before using the flash glucose monitoring system was 9.60% ± 1.44% and 3 months HbA1c after using the FreeStyle LibreTM flash glucose monitoring system was 8.70% + 1.45% for a difference of -0.90% ([95% CI -0.92: -0.88];p 65 years, (p-values Conclusion: The benefits of using the FreeStyle LibreTM flash glucose monitoring system are self-evident in reducing HbA1c and events due to hyperglycemia or hypoglycemia.

Clinical Practice Recommendations for Assessment and Management of Hypothyroidism

Hypothyroidism is a common disorder, potentially severe, often clinically ignored, easily diagnosed by laboratory tests, and highly treatable. It may cause chronic illnesses if left untreated. Saudi Society of Endocrinology and Metabolism (SSEM) assembled a panel of twelve endocrinologists with experience in thyroid diseases in adults and children and made up a task force. An initial concept proposal that included types of hypothyroidism, population, scope, and prevalence in Saudi Arabia was obtained. The proposal was divided into several topics discussed in February 2022. The panel approved that the consensus will include all types of hypothyroidism in Saudi Arabia, screening, diagnosis, management, and special population. A literature review was carried out. Most of the latest international guidelines were screened in Europe and USA. The literature search was completed in March 2022. They drafted a report that was distributed to the entire panel. Approval of the recommendations required consensus, defined as a majority approval. The recommendations were revised to accommodate any differences of opinion until a consensus was reached. Recommendations were finally formulated on April 2022. Subsequently, the panel reviewed and discussed the supporting rationale of the revised recommendations. This article presents these practical recommendations.

Acute lymphoblastic leukemia in a β-thalassemia intermedia child: A case report

BACKGROUNDβ-thalassemia intermedia(βTI)is one of the hemoglobinopathies.It constitutes 10%ofβ-thalassemia cases yet being associated with a better quality of life thanβ-thalassemia major(βTM).CASE SUMMARY We recently reported the first case of acute lymphoblastic leukemia(ALL)from Egypt in a child withβTM,and we herein report the first case of ALL from Egypt in a child withβTI.In this report,literature was reviewed for cases of malignancies associated withβTI and the possible factors underling the relationship between the two entities.CONCLUSION We stress that physicians should have a high index of suspicion of malignancies in thalassemia patients if they present with any suggestive symptoms or signs.