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.

Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study).

BACKGROUND/AIMS: Corticosteroids (CSs) are frequently used in coronavirus disease 2019 (COVID-19); however, their utility remains controversial in mild to moderate cases. The timing of CSs initiation during the disease course remains unaddressed. The study aims to evaluate the impact of early CSs in non-severe COVID-19. METHODS: A randomized controlled, open-label study was conducted on 754 COVID-19 patients randomized into a study group (n = 377) in which patients received CSs with COVID-19 protocol and a control group (n = 377) in which patients received COVID-19 protocol only. RESULTS: Both groups were comparable regarding baseline characteristics, presenting symptoms, and inflammatory markers. The composite endpoint (need for O2, need for hospitalization or 28-day mortality) was significantly (p = 0.004) lower in the CS group 42 (11.14%) versus the control group 70 (18.67%) with odds ratio 0.55 (95% confidence interval [CI], 0.36 to 0.83), absolute risk reduction 7.53% (95% CI, 2.46% to 12.59%) and number needed to treat of 13.29 (95% CI, 7.94 to 40.61). Regarding severity at day 10, only (11.1%) of the study group patients were severe versus (18.7%) of the control group patients (p < 0.001). The median time-to-return to daily activity in the CS group was 8.0 days, while in the control group, it was 22.0 days (p < 0.001). CONCLUSION: In non-severe COVID-19, CS may decrease hospitalization, severity, and mortality.

Egyptian Atherosclerosis and Vascular Biology Association Consensus on the Use of Sodium Glucose Cotransporter-2 Inhibitors in Heart Failure with Reduced Ejection Fraction.

Heart failure (HF) is a common cause of cardiovascular mortality and morbidity. Despite advances in treatment, the prognosis remains poor. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors decrease HF events by 27-39% in high-risk patients with type 2 diabetes mellitus (T2DM). Moreover, the DAPA-HF and EMPEROR-Reduced studies randomized patients with HF with reduced ejection fraction (HFrEF) with or without diabetes mellitus to receive guideline-directed medical therapy versus guideline-directed medical therapy plus an SGLT-2 inhibitor. Both studies showed the benefits of SGLT-2 inhibitors. In addition, SGLT-2 inhibitors have shown improvement according to the EMPEROR-Preserved study of HF with preserved ejection fraction (HFpEF). Therefore, a panel of cardiology experts from the Egyptian Atherosclerosis and Vascular Biology Association (EAVA) revised the literature for SGLT-2 inhibitors in HF, along with the recommended indications and contraindications, and this article presents their consensus on the topic. The panel concluded that SGLT-2 inhibitors have significantly benefited patients with chronic HFrEF, as indicated through the DAPA-HF and EMPEROR-Reduced trials. The panel recommended early use of dapagliflozin 10 mg or empagliflozin 10 mg in patients with symptomatic chronic HFrEF, whether diabetic or non-diabetic, to ameliorate HF hospitalization rate, mortality, symptoms, and decline in renal function.

Efficacy of growth hormone supplementation with ultrashort GnRH antagonist in IVF/ICSI for poor responders; randomized controlled trial.

OBJECTIVES: To compare the ICSI-ET outcomes in poor responders who underwent ovarian stimulation by the ultrashort GnRH antagonist protocol with or without adjuvant GH injection. MATERIAL AND METHODS: This randomized controlled study was conducted at Al-Azhar University from December-2018 to June-2019 upon 156 participants. All patients received the same preparations. After randomization, in the study group, women have received GH 4 IU/day subcutaneous injection from the second day of the cycle stopped one day before ovum pickup. While in the control group, women have received subcutaneous saline in the same dosing as in the study group. After intervention, all procedures were the same in both groups. The main outcome measure was the clinical pregnancy rate. Statistical analysis was based on the intention-to-treat population. RESULTS: Both groups were comparable with regard their baseline characteristics (p-values > 0.05). Ovulation characteristics were comparable (p-values > 0.05). The level of E2 is significantly (p-value = 0.003) higher in the GH group. The oocyte retrieved number was significantly (p-value < 0.001) higher in the GH group 4.94 ± 1.77 than in the control group 3.74 ± 1.82. The mean number of MII oocytes was significantly (p-value < 0.001) higher in the GH group 3.3 ± 1.36 than in the control group 2.29 ± 1.24. Fertilization characteristics, implantation rate, pregnancy rate were comparable (p-values > 0.05). CONCLUSION: Despite the fact that this study showed no significant increase in the clinical and chemical pregnancy rates by the addition of GH to the ultrashort antagonist protocol in poor responders, the number of retrieved oocytes was significantly higher in the GH group. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759301.

The impact of ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia on the incidence and severity of post-thoracotomy pain syndrome: A randomized, controlled study.

OBJECTIVE: The aim of this randomized controlled trial was to evaluate U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA) on the emergence of post-thoracotomy pain syndrome (PTPS) after thoracotomies for thoracic tumours. METHODS: This trial included 89 patients with chest malignancies, scheduled for thoracotomy were randomly allocated into two groups: Group A "PCA-group N=44" receiving patient-controlled analgesia and group B "SAPB group N=45" where analgesia was provided by SAPB. The primary outcome measure was the assessment for the possible emergence of PTPS at 12 weeks. The secondary outcome measures were pain relief measured using visual analog scale (VAS) score, Quality of life was assessed using Flanagan Quality of Life Scale (QOLS) and Activity level was assessed using Barthel Activity of daily living (ADL) score. RESULTS: At week 8, PTPS incidence was significantly (p = .037) higher in the PCA group (45%) than in the SAPB group (24%) with a relative risk of 1.38 and 95% CI (1.01-1.9) while the incidence of PTPS at week 12 was significantly (p = .035) higher in the PCA group (43%) than in the SAPB group (22%) with a relative risk of 2.38 and 95% CI (1.23-4.57). The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than the PCA group (38.6%) (p = .028) at week 12. Pain intensity: VAS-R and VAS-D (pain scores at rest and with activity, respectively) was comparable (p > .05) between both groups at 6, 12, 18 and 24 hr, however VAS was significantly higher in the PCA group at week 8 (p = .046) and week 12 (p = .032) . Both groups were comparable regarding ADL and QOL scores (p > .05). CONCLUSION: Serratus anterior plane block is assumed to be a good alternative for post-thoracotomy analgesia following thoracotomies. The current work hypothesized that SAPB for a week postoperatively, may reduce the emergence of PTPS and may reduce the demand for pain therapy in those patients. SIGNIFICANCE STATEMENT: The current work hypothesized that SAPB for a week postoperatively, is a good loco-regional alternative for post-thoracotomy analgesia following thoracotomies for chest malignancies, it may reduce the emergence of PTPS and the demand for pain therapy in these patients.

Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage.

OBJECTIVE: To assess the impact of a cervical traction maneuver (Amr's maneuver) used in conjunction with active management of the third stage of labor (AMTSL) on the incidence of postpartum hemorrhage (PPH). METHOD: The present multicenter randomized controlled trial was conducted in Cairo between March 1, 2016, and June 30, 2017. Women aged at least 18 years who had singleton pregnancies and were candidates for vaginal delivery were enrolled. After block randomization, AMTSL was performed for all participants. Following placental delivery, Amr's maneuver using cervical traction for 90 seconds was carried out in the study group. The primary outcome, incidence of PPH (>500 mL blood loss) within 6 hours of delivery, was compared between the study and control groups in an intention-to-treat analysis. RESULTS: There were 852 patients randomized to the study (n=426) and control (n=426) groups. The incidence of PPH was significantly lower in the study group compared with the control group (6 [1.4%] vs 19 [4.5%]; P=0.015). Absolute risk reduction of 3.1% (95% CI 0.8-5.6), relative risk reduction of 0.32 (95% CI 0.13-0.78), and number needed to treat of 33 (95% CI 129-18) were observed in the study group. CONCLUSION: Amr's maneuver was effective in decreasing the incidence of PPH. ClinicalTrials.gov Identifier: NCT02660567.