Impact of magnesium supplementation on clinical outcome and disease progression of patients with diabetic nephropathy: a prospective randomized trial.

Background: Magnesium (Mg) deficiency is closely linked with proteinuria. Objectives: To assess the impact of oral Mg citrate supplementation on the clinical outcome of diabetic nephropathy (DN) patients. Design: This was a prospective, randomized, controlled, open-label study. Methods: Sixty DN patients were recruited from Nephrology and Endocrinology departments, Ain Shams University Hospitals, Cairo, Egypt. Patients were assigned by stratified randomization based on their Mg status, to either Mg citrate group, (n = 30), who received the standard regimen + oral Mg citrate 2.25 g/day or Control group, (n = 30), who received the standard regimen only. The primary endpoint was a change in urinary albumin to creatinine ratio (UACR) after 12 weeks. Secondary outcomes were insulin resistance, glycemic control, lipid profile, serum osteocalcin, quality of life (QoL) and Mg tolerability. Results: Out of a total of 60 patients enrolled, only 54 patients (26 in Mg citrate group and 28 in the control group) completed the study. Groups were comparable at baseline. The UACR median percent reduction was significantly higher in the Mg citrate group (-6.87%) versus (-0.9%) in the Control group, p = 0.001. After 12 weeks, the estimated glomerular filtration rate significantly improved in the Mg citrate group versus Control group (p = 0.001). Comparable change was observed in glycemic indices. Lipid profile significantly improved in the Mg citrate group versus Control group (p = 0.001). Serum osteocalcin levels significantly declined in the Mg citrate group (p = 0.001) versus control group. Regarding QoL, the total score and all domains significantly improved in the Mg citrate group compared to control. The Mg supplement was tolerable with only mild reported side effects that required no intervention. Conclusion: Oral Mg citrate supplementation improved microalbuminuria in DN patients. It also had favorable effects on serum osteocalcin, lipid profile and QoL with no reported major side effects. Trial registration: ClinicalTrials.gov identifier: NCT03824379.

COVID-19 vaccine hesitancy in Egypt: a cross-sectional study.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) vaccine hesitancy is a major problem. This study aimed to determine the factors associated with COVID-19 vaccine acceptance. METHODOLOGY: A cross-sectional survey-based study was conducted on a sample of the Egyptian population using an online survey distributed through social media platforms, including Facebook, WhatsApp, and LinkedIn. The questionnaire was composed of five parts: part I describing the research questionnaire and its aim, part II assessing the demographic data, part III assessing knowledge and attitude towards COVID-19 infection, and part IV and V evaluating knowledge regarding COVID-19 vaccines, factors affecting vaccine acceptance and participants' attitude toward vaccination. Regression models were used to assess factors associated with vaccine acceptability. RESULTS: A total of 24376 responses were included in the statistical analysis. Females represented more than two-thirds of the study sample (70.5%,) and 18-24 years was the most commonly reported age group. Around one-third of the sample were healthcare professionals (HCPs). Only 14.3% of the participants received or registered to receive the vaccine, while 47% refused to be vaccinated. Regression analysis revealed that male gender, secondary education, older age, married or divorced status, presence of comorbidities, and higher level of knowledge regarding the vaccine were significantly associated with high vaccine acceptance. The most important vaccine attributes influencing vaccine selection in the current work were efficacy and safety. CONCLUSIONS: Vaccine hesitancy is currently a major challenge. Governments should design educational campaigns that provide trusted data related to vaccine efficacy and safety to encourage vaccination and enhance awareness.

The impact of clinical pharmacist implemented education on the incidence of prescribing errors in COVID-19 patients.

Background: Clinical pharmacists have a vital role during COVID-19 pandemic in mitigating medication errors, particularly prescribing errors in hospitals. That is owing to the fact that prescribing errors during the COVID-19 pandemic has increased. Aim: This study aimed to evaluate the impact of the clinical pharmacist on the rate of prescribing errors on COVID-19 patients in a governmental hospital. Methods: The study was a pre-post study conducted from March 2020 till September 2020. It included the pre-education phase P0; a retrospective phase where all the prescriptions for COVID-19 patients were revised by the clinical pharmacy team and prescription errors were extracted. Followed by a one-month period; the clinical pharmacy team prepared educational materials in the form of posters and flyers covering all prescribing errors detected to be delivered to physicians. Then, the post-education phase P1; all prescriptions were monitored by the clinical pharmacy team to assess the rate and types of prescribing errors and the data extracted was compared to that from pre-education phase. Results: The number of prescribing errors in P0 phase was 1054 while it was only 148 in P1 Phase. The clinical pharmacy team implemented education phase helped to significantly reduce the prescribing errors from 14.7/1000 patient-days in the P0 phase to 2.56/1000 patient-days in the P1 phase (p-value <0.001). Conclusion: The clinical pharmacist significantly reduced the rate of prescribing errors in patients with COVID-19 which emphasizes the great role of clinical pharmacists' interventions in the optimization of prescribing in these stressful conditions.

The Impact of Clinical Pharmacist Implemented Protocol on Albumin Utilization and Cost in an Intensive Care Unit in Egypt.

Introduction: Albumin is an expensive non-blood plasma substitutes with limited availability that has been reported to be inappropriately used in healthcare settings. Hence, interventions are recommended to control its misuse. Objective: To evaluate the impact of clinical pharmacist implemented dispensing protocol on optimization of albumin use in an intensive care unit (ICU). Design: A retrospective prospective 3-phase interventional study was conducted in an ICU in a tertiary Egyptian hospital over a period of 2 years. Methods: The study included three phases; a preparation phase where a local albumin dispensing protocol and a restriction dispensing form were prepared by clinical pharmacists and was approved by the local Drugs and Therapeutics Committee, a retrospective pre-implementation phase in which the medical records of all ICU patients receiving albumin were evaluated for appropriateness of albumin use according to the developed protocol, and a prospective implementation phase where the dispensing protocol and restriction dispensing form were applied. The pattern of albumin consumption and cost were recorded and compared between the retrospective and prospective phases. Results: In the retrospective phase, 190 ICU patients received albumin of whom 83.6% was considered inappropriate indications for albumin compared to only 44 patients in the prospective phase of whom 16% was considered inappropriate (p-value <0.001). Clinical pharmacists' interventions significantly decreased the inappropriate albumin consumption from 4.7 vials/patient in the retrospective phase to 2.7 vials/patient in the prospective phase (p-value <0.001) with a total cost savings of 313,900 Egyptian Pounds (19,930 US Dollars). Conclusion: The current study showed that clinical pharmacists' interventions led to a significant control on albumin use and consequently reduced the cost associated with its consumption.

Efficacy and Safety of Metformin Use in Rheumatoid Arthritis: A Randomized Controlled Study.

Objective: To evaluate the efficacy and safety of metformin use in rheumatoid arthritis (RA) patients receiving conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). Methods: A prospective, randomized, controlled, single blinded, study was carried on 66 RA patients with moderate and high disease activity state, receiving csDMARDs. Patients were simply randomized to receive either metformin 850 mg twice daily (Metformin group, n = 33), or placebo twice daily (Control group, n = 33) in addition to their stable anti-rheumatic regimen and followed up for 6 months. Serum C-reactive protein (CRP), disease activity of 28 joints based on CRP (DAS-28-CRP), and quality of life (QOL) were evaluated at baseline and then every 3 months. Moreover, serum adiponectin was assessed at baseline and after 6 months. Results: Sixty patients completed the study. Drop out was due to intolerance to metformin side effects (n = 3) and non-compliance (n = 3). Metformin significantly decreased CRP levels and DAS-28-CRP after 6 months compared to the control group (p-value <0.001). A significant improvement in QOL of metformin group was observed as early as after 3 months (p-value = 0.006) with a continued improvement observed at 6 months (p-value <0.001) compared to the control group. Despite the significantly higher serum adiponectin in the metformin group at baseline, it was significantly reduced after 6 months in the metformin group with median percent change of -63.49% compared to the significant increase in the control group with median percent change of 92.40%. Conclusion: Metformin significantly improved inflammation, disease severity, and QOL in RA patients with high safety profile. Clinical Trial Registration: Clinical-Trials.gov, identifier [NCT08363405].

Pharmacovigilance education to healthcare professionals: Will it affect their performance in reporting adverse drug reactions?

AIM: To assess impact of pharmacovigilance (PV) educational program on knowledge, attitude and practice (KAP) of healthcare professionals (HCPs). METHODS: a prospective study was conducted on HCPs at an Egyptian hospital. The study included: pre-education phase; where KAP questionnaire was administered by HCPs to obtain baseline data, intervention phase; where educational sessions were held by clinical pharmacists and Egyptian PV centre, and post-education phase; where the questionnaire was re-administered by participants 9 months post-receiving educational sessions. The questionnaire comprised five sections: participants' demographics, knowledge, attitude and practice sections and two multiple choice questions asking about the importance of establishment of ADRs monitoring centre, and factors hindering ADRs reporting. Pre-education and post-education data were compared. RESULTS: From 221 HCPs invited to participate, only 153 filled the pre-education and post-education questionnaires. At baseline, the median (range) of the total KAP score were 1 (0-7), 1 (0-4) and 4 (0-14) for physicians, nurses and pharmacists, respectively. All KAP scores were low for all HCPs at baseline with the pharmacists having significantly higher knowledge and attitude scores compared with physicians, and nurses (P < .001). After education, all scores significantly increased and 13 ADRs were reported by HCPs compared with only 2 at baseline. CONCLUSION: It was concluded that educational program had a significant impact on enhancing KAP of HCPs towards PV and ADRs reporting.

Promising drug repurposing approach targeted for cytokine storm implicated in SARS-CoV-2 complications.

A global threat has emerged in 2019 due to the rapid spread of Coronavirus disease (COVID-19). As of January 2021, the number of cases worldwide reached 103 million cases and 2.22 million deaths which were confirmed as the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This global pandemic galvanized the scientific community to study the causative virus (SARS-CoV2) pathogenesis, transmission, and clinical symptoms. Remarkably, the most common complication associated with this disease is the cytokine storm which is responsible for COVID-19 mortality. Thus, targeting the cytokine storm with new medications is needed to hamper COVID-19 complications where the most prominent strategy for the treatment is drug repurposing. Through this strategy, several steps are skipped especially those required for testing drug safety and thus may help in reducing the dissemination of this pandemic. Accordingly, the aim of this review is to outline the pathogenesis, clinical features, and immune complications of SARS-CoV2 in addition to suggesting several repurposed drugs with their plausible mechanism of action for possible management of severe COVID-19 cases.

The effect of itraconazole on the clinical outcomes of patients with advanced non-small cell lung cancer receiving platinum-based chemotherapy: a randomized controlled study.

Itraconazole is an oral antifungal that has a been reported to have anticancer effect in non-small cell lung cancer (NSCLC) through inhibition of angiogenesis. The aim is to evaluate the effect of using itraconazole on the clinical outcome of metastatic NSCLC. This was a prospective randomized controlled open-label study conducted on 60 chemotherapy-naive metastatic NSCLC. Patients were simply randomized to either Control group who received platinum-based chemotherapy for a maximum of six cycles or Itraconazole group who received the same chemotherapy regimen in addition to itraconazole 200 mg daily for 21 days starting from day 1 in each cycle. Primary outcome was 1-year progression-free survival (PFS) while secondary outcomes included overall response rate (ORR), 1-year overall survival (OS) and tolerability. The two groups were comparable at baseline with no significant difference between groups regarding demographics and clinical characteristics. The ORR in Control group was 66.7% versus 90% in Itraconazole group (p value 0.028). There was a significant difference between groups regarding PFS where the mean 1-year PFS was 5.415 months in Control group versus 6.556 months in Itraconazole group (p value = 0.002). However, there was no significant difference between groups with respect to 1-year OS. All adverse effects reported were tolerable except for one patient who developed grade 2 cardiotoxicity in Itraconazole group requiring itraconazole discontinuation. Itraconazole use was beneficial in NSCLC in terms of 1-year PFS and ORR which was not reflected by improvement in 1-year OS.Clinical trial.gov registration number: NCT03664115, date of registration: September 10, 2018.

A prospective randomized controlled study of cisplatin versus carboplatin-based regimen in advanced squamous nonsmall cell lung cancer.

BACKGROUND: The use of cisplatin (Cis) versus carboplatin (Carb) in the treatment of advanced nonsmall cell lung cancer (NSCLC) is controversial. The aim of the study was to compare the safety and efficacy of Cis versus Carb in squamous NSCLC. PATIENTS AND METHODS: A prospective, randomized, controlled, open-label study was conducted on advanced squamous NSCLC patients who were randomly assigned to receive Cis (40 mg/m 2 [day 1 and day 8]) or Carb (area under the curve = 5 [day 1]) combined with gemcitabine [Gem] (1000 mg/m 2 [day 1 and day 8]) of a 3-week schedule for six cycles. Study objectives were a radiological response after three cycles and six cycles, 1-year progression-free survival (PFS), 1-year overall survival (OS), and quality of life (QOL) assessment using functional assessment of cancer therapy-lung at baseline, after three cycles, and after six cycles. STATISTICAL ANALYSIS: Statistical analysis was done using Statistical Package for Social Science version 15. A P < 0.05 was considered statistically significant. RESULTS: Seventy-one patients were enrolled (Gem/Cis group [n = 36], Gem/Carb group [n = 35]). Response rates were comparable in both arms. Nonsignificant differences were found regarding 1-year PFS (P = 0.308) and 1-year OS (P = 0.929) between the two groups. Neutropenia was significantly higher in Gem/Carb group, while vomiting and ototoxicity were significantly higher in Gem/Cis group. The effect on QOL was similar in both groups. CONCLUSION: Cis and Carb have similar efficacy, tolerability, and effect on QOL and both can be used as a first-line treatment of squamous NSCLC.