Evaluating the use of paracetamol to prevent fasting headache during the first week of Ramadan: A randomized, open-label, clinical trial.

BACKGROUND: Fasting headaches frequently occur during the first few days of Ramadan, and treatment is challenging because of fasting. OBJECTIVE: This study aimed to evaluate the effect of extended-release paracetamol on preventing fasting headaches. METHODS: A randomized, open-label clinical trial investigated the efficacy of extended-release paracetamol at a daily dose of 1330 mg in preventing fasting headache. Adults aged 18 years and older were recruited through the Clinical Trial Unit at the King Saud University Medical City. The eligible participants in the study fasted 13.5 h daily during the first week of Ramadan. Participants in the treatment and control arms were followed up to investigate the occurrence, severity, and timing of headache symptoms via self-reporting using a standardized headache diary scale with a daily online link or phone call. The primary outcome was the frequency of headache episodes while fasting during the first week of Ramadan. RESULTS: A total of 238 participants were enrolled and randomized. Of these, 173 followed the protocol (80 treated, 93 control) for at least the first day and were included in the analysis. Most participants were young and healthy, with a mean age of 32.2 ± 10.2 years. More men were included in the study (102/173; 59.0%), a small proportion of participants were smokers (31/173; 17.9%), and almost all participants reported being coffee drinkers (165/173; 95.4%); nonetheless, these characteristics were evenly distributed between the two groups in the study. The overall incidence of headache episodes was 33.0% (57/173) on day 1 and decreased to 11.3% (18/159) on day 7. On average over the 7 days, no significant effect was observed for the treatment on the incidence of headache, as the findings from the generalized estimating equation model indicated (ß = -0.398, p = 0.084; odds ratio = 0.67, 95% confidence interval [CI] 0.42-1.06). Moreover, there was initially no significant difference in the incidence of headache episodes between the treatment and control groups. However, the treatment group had significantly fewer headache episodes during fasting than the control group on day 3 (4/72 [5.6%] vs. 15/91 [16.5%], p = 0.031; relative risk [RR] = 0.34, 95% CI 0.12-0.97) and day 6 (5/69 [7.2%] vs. 20/90 [22.2%], p = 0.010; RR = 0.33, 95% CI 0.13-0.82). No adverse effects were observed during the study period. CONCLUSION: No significant differences were observed in the occurrence of fasting headaches between the two groups on most days during the study period. Additional studies are required to address fasting headaches during the first week of Ramadan.

Liraglutide's Effect on Weight Management in Subjects With Pre-diabetes: A Systematic Review & Meta-Analysis.

BACKGROUND: Despite the growing literature, the effectiveness of liraglutide in weight management among individuals with prediabetes and in preventing the disease remains controversial. This study aims to critically evaluate the extent of liraglutide's impact on weight management in this population and assess the heterogeneity among extant studies. METHODS: A systematic literature search was conducted across MEDLINE, Embase, ClinicalTrials.gov, and the reference list of retrieved studies to identify eligible English language randomized controlled trials evaluating liraglutide's effect on weight in individuals with pre-diabetes. Non-randomized studies, studies not reporting relevant outcomes, and those conducted on patients with type 2 diabetes were excluded from this review. Outcomes included a change from baseline in absolute body weight in kg, body mass index (BMI), waist circumference, glycosylated hemoglobin (HbA1c), and low-density lipoprotein cholesterol levels. Additional safety outcomes were also reported. Data were analyzed using R statistical software version 4.3.1. A fixed-effect model was used when pooling crude numbers for study outcomes. Moreover, a sensitivity analysis using random-effect model was performed and heterogeneity was assessed using I2 statistics. RESULTS: Five eligible studies were included, with a total of 1604 subjects in the liraglutide arm and 859 subjects in the control arm. Participants exposed to liraglutide showed a decrease in body weight (mean difference [MD] = -4.95 kg; 95% CI -5.16, -4.73; I2 = 93%), BMI (MD = -2.06 kg/m2; 95%CI -2.22, -1.89; I2 = 97%), waist circumference (MD = -4.61 cm; 95% CI -4.79, -4.43; I2 = 82%), HbA1c (MD = -0.33%; 95%CI -0.34, -0.31; I2 = 100%), and low-density lipoprotein cholesterol levels (MD = -0.36 mmol/L; 95% CI -0.39, -0.33; I2 = 99%). The overall effect size remained similar when using a random-effects model for all outcomes. In addition, the rate of adverse events was higher with liraglutide when compared to the control; however, the dropout rates were relatively lower in the former arm. CONCLUSION: While our meta-analysis suggests that liraglutide can reduce body weight, BMI, waist circumference, and HbA1c levels in individuals with pre-diabetes, the findings should be interpreted cautiously due to limitations such as the small number of trials and their short duration, and variability in dosages. Further randomized controlled trials examining long-term outcomes are essential to validate these findings and address the high heterogeneity among the studies included in this analysis.

Effect of fasting-induced headache on calcitonin gene related peptide (CGRP) and other clinical biomarkers on the first day of Ramadan: Sub-analysis from a randomized open label clinical trial.

BACKGROUND: Fasting-induced headaches (FIHs) have been shown to occur on the first day of Ramadan and clearly decline thereafter. Despite the wealth of knowledge about different types of headaches (e.g., migraine-, cluster-, and tension-type headaches), research on the mechanism underlying FIHs, as well as their treatment, remains scarce. Our study aimed to investigate any association between FIHs during the first day of Ramadan and potential headache-related biomarkers, including fasting blood glucose (FBG), C-reactive protein (CRP), magnesium, vitamin B9, vitamin B12, homocysteine, and calcitonin gene related peptide (CGRP), and to assess whether a prophylactic use of paracetamol may influence these biomarkers. METHODS: As part of a randomized, open-label clinical trial that evaluated the effect of paracetamol as a prophylactic therapy for FIH, blood samples from stratified subjects in the prophylaxis and control groups were withdrawn while fasting after the 1st dose of paracetamol (in the prophylaxis group) and prior to reporting headache occurrence. RESULTS: Plasma and serum were separated for 61 subjects; 31 and 30 subjects from the prophylaxis and control groups, respectively. Overall, no significant differences were found in the levels of FBG, CRP, magnesium, vitamin B9, and vitamin B12 in headache-suffering subjects compared to those without headache despite the use of paracetamol for prophylaxis. Homocysteine, however, was significantly reduced in all subjects who experienced FIH compared to those without headache (median 6.9 [1.6] vs. 7.7 [2.7] umol/L; p = 0.041). On the contrary, when the CGRP was measured using immunoassay, it was found to be significantly elevated in all headache-suffering subjects compared to those without headache (median 126.1 [17.7] vs. 105.8 [19.6] pg/mL; p ≤ 0.0001). This difference was maintained upon comparing the headache to non-headache subjects in both the prophylaxis (median 121.5 [15.4] vs. 105.8 [9.4] pg/mL; p < 0.01) and control groups (median 128.5 [28.3] vs. 105.8 [23.8] pg/mL; p < 0.01). Additionally, an elevated CGRP level was found to increase the odds of having a FIH [OR = 1.32; 95%CI 1.06-1.22]. CONCLUSIONS: Our findings revealed the role of CGRP in FIHs for the first time and suggest further investigation in signaling pathways downstream CGRP receptors. Furthermore, the modulation CGRP or CGRP receptors could have a clinical application in the prevention of FIHs. TRIAL REGISTRATION: This study was registered with the Saudi Food and Drug Authority in the Saudi Clinical Trials Registry (SCTR; No. 22122102).

Clinical pharmacists' knowledge, attitude, perception, and beliefs about the role of pharmacogenetic testing for genes polymorphisms when prescribing mercaptopurine.

Background: Single nucleotide polymorphisms in the gene encoding proteins involved in mercaptopurine metabolism can influence drug efficacy and safety. This study aims to assess clinical pharmacists' knowledge about mercaptopurine-related genes and their polymorphisms and investigate their attitudes, perceptions, and beliefs about the need for and importance of pharmacogenetic testing for mercaptopurine. Methods: A cross-sectional descriptive study was conducted among oncology/hematology clinical pharmacists in Saudi Arabia using an online-questionnaire developed by experts in the field. The questionnaire consists of four-sections exploring clinical pharmacists' knowledge, attitudes, perceptions, and beliefs about the importance of gene testing and genes polymorphism when prescribing mercaptopurine. Descriptive statistics were used to analyze the data in the study. Results: A total of 41 oncology/hematology clinical pharmacists responded to the survey invitation. Almost half of them had more than 10 years of work experience, but only 17 % of them received formal training in pharmacogenetics. The overall level of knowledge about pharmacogenetics among participants was low, with a mean score of 2.8 points (1.7) out of 8 items. However, around 76 % agreed that it is important to perform pharmacogenetic screening prior to prescribing mercaptopurine, and almost 93 % state that it will influence their dosage recommendation. Most of the participants had a good perception (95.1 %) of their role in genetic testing for medication selection, dosing, and monitoring; however, about 10 % of surveyed pharmacists reported not being completely responsible about recommending pharmacogenetic testing. The surveyed pharmacists had a good belief in the importance of pharmacogenetic testing and their overall attitude was positive toward the use of pharmacogenetic testing, with emphasis on the importance of training on the proper assessment and interpretation of pharmacogenetic tests. Conclusions: Pharmacists demonstrated good perception and positive attitude toward pharmacogenetic testing, despite the low level of knowledge and limited formal training. Thus, more attention to developing national guidelines on pharmacogenetic testing is warranted to ensure successful pharmacogenetic testing implementation.

The prevalence of cardiovascular diseases, chronic kidney disease, and obesity in patients with type 2 diabetes mellitus and the description of concurrent treatments: A two-center retrospective cross-sectional study in Saudi Arabia.

Background: Atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), chronic kidney disease (CKD), and obesity are associated with increased morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Nonetheless, their prevalence among patients with T2DM in Saudi Arabia (SA) remains unknown. As current guidelines recommend, these comorbidities require adding certain antidiabetic agents with cardiorenal benefits. However, the prescribers' adherence to these recommendations remains unclear. Methods: A two-center retrospective cross-sectional study was conducted including adult patients (≥18 years) with T2DM admitted to hospital or seen at outpatient clinics between January and December 2020. Patients were classified into two groups based on the presence or absence of ASCVD. Patients with no prior ASCVD history were further classified based on the 10-year ASCVD risk estimation. Endpoints of interest included the prevalence of ASCVD, HF, CKD, and obesity in patients with T2DM. We also evaluated the characteristics of the utilized antidiabetic agents, statin, and aspirin therapies.. Results: Of the 1,218 included patients with T2DM, the majority were female (57.0 %), and aged 45-64 years (53.0 %) with a mean age of 59.3 ± 13.1 years. Hypertension and dyslipidemia were the most prevalent comorbidities (67.7 % and 69.0 %, respectively). Among all patients, 18.6 % had an established ASCVD and the prevalence of HF, CKD, and obesity were 5.1 %, 8.7 %, and 58.3 %, respectively. The most common types of ASCVD witnessed were revascularization (42.3 %), myocardial infarction (36.6 %), and stroke (33.9 %); with an increased prevalence of ASCVD as the age increases (52.8 % at age ≥ 65 years). In the non-ASCVD group, the 10-year ASCVD risk was intermediate or high in 62.7 % of these patients. The rates of utilization of guidelines-recommended therapies were 83.6 % for metformin, 9.4 % for GLP-1 RA, 10.8 % for SGLT2i, 35.2 % for aspirin alone or in combination with clopidogrel, and 79.7 % for statin therapy. Conclusions: ASCVD, HF, CKD, and obesity are common complications in patients with T2DM in SA, with low overall utilization of the recommended guidelines-recommended medical therapies. Multimodal strategies should be utilized to assess T2DM and its complications, and to improve prescribers' adherence to guidelines-recommended therapies.

Exploring the opportunities and challenges to implementing interprofessional education in Saudi Arabia: a qualitative study among faculty.

Interprofessional education (IPE) has potential benefits for improving the quality of patient care, but its implementation is challenged with multiple barriers. The primary objectives of this study were to explore the challenges, benefits, and incentives to establishing IPE from the perspective of healthcare faculty at King Saud University. Forty-five faculty members attended six focus groups, each consisting of 6-8 faculty members representing the five colleges. The focus group interview guide included the benefits of and barriers to establishing IPE in this academic institution, curricular design, and the feasibility of support from the colleges and University administration. A SWOC (Strengths, Weaknesses, Opportunities, Challenges) frame work was utilized to guide the focus group discussions, and the data were analyzed inductively using thematic analysis. Three main themes emerged and were related to (i) barriers, (ii) benefits, (iii) opportunities to facilitate the introduction of IPE, and (iv) suggestions on how to implement IPE and overcome challenges to establish an IPE curriculum. Participants were generally supportive of IPE and aware of the constraints that might impede its implementation. Moreover, they identified potential barriers and incentives to promote IPE. Although participants appreciated the long-term benefits of IPE, creating a supportive environment will require the involvement of the academic community, including students, faculty members, and the University's top management.

Comprehensive evaluation of six interventions for hospitalized patients with COVID-19: A propensity score matching study.

Purpose: The purpose of this study was to evaluate the effectiveness of either hydroxychloroquine, triple combination therapy (TCT), favipiravir, dexamethasone, remdesivir, or COVID-19 convalescent plasma (CCP) in comparison with standard-of-care for hospitalized patients with COVID-19 using real-world data from Saudi Arabia. Patients and methods: A secondary database analysis was conducted using the Saudi Ministry of Health database for patients with COVID-19. Adult (≥18 years) hospitalized patients with COVID-19 between March 2020 and January 2021 were included in the analysis. A propensity score matching technique was used to establish comparable groups for each therapeutic approach. Lastly, an independent t-test and chi-square test were used to compare the matching groups in the aspects of the duration of hospitalization, length of stay (LOS) in intensive care units (ICU), in-hospital mortality, and composite poor outcome. Multilevel logistic regression model was used to assess the association between the severity stage of COVID-19 and the outcomes while using the medication or intervention used as a grouping variable in the model. Results: The mean duration of hospitalization was significantly longer for patients who received TCT, favipiravir, dexamethasone, or CCP compared to patients who did not receive these therapies, with a mean difference ranging between 2.2 and 4.9 days for dexamethasone and CCP, respectively. Furthermore, the use of favipiravir or CCP was associated with a longer stay in ICU. Remdesivir was the only agent associated with in-hospital mortality benefit. A higher risk of mortality and poorer composite outcome were associated with the use of favipiravir or dexamethasone. However, the logistic regression model reveled that the difference between the two matched cohorts was due to the severity stage not the medication. Additionally, the use of hydroxychloroquine, TCT, or CCP had no impact on the incidence of in-hospital mortality or composite poor outcomes. Conclusion: Remdesivir was the only agent associated with in-hospital mortality benefit. The observed worsened treatment outcomes associated with the use of dexamethasone or FPV shall be attributed to the severity stage rather than the medication use. In light of these varied results, additional studies are needed to continue evaluating the actual benefits of these therapies.

Acute kidney injury associated with piperacillin-tazobactam versus other antibiotics combined with vancomycin in critically ill patients: A retrospective cohort study.

Introduction: Evidence of acute kidney injury (AKI) induced by piperacillin-tazobactam (Piptazo) versus other broad-spectrum antibiotics (BSA) combined with vancomycin has been established in the literature. However, there is limited evidence regarding these combinations among critically ill patients. This study assessed the risk of nephrotoxicity of Piptazo versus other BSA as an add-on to vancomycin among patients admitted to an intensive care unit (ICU). Methods: We have reviewed patients' charts retrospectively to investigate AKI incidence among ICU patients receiving Piptazo versus other BSA as an add-on to vancomycin. Furthermore, we have assessed the duration of AKI and ICU stay, as well as the association between patients' criteria and risk of AKI using logistic regression analyses. Results: A total of 79 patients were included, 50 patients received the Piptazo combination while 29 patients received other BSA combinations. Almost 52 % of the patients in the Piptazo group developed AKI while only 37.9 % of those in the BSA group did, yet the difference was not statistically significant (p = 0.22). On the other hand, the risk of AKI was highly associated with vancomycin trough concentration above 20 mcg/mL, nephrotoxic medications, and African descent (OR 7.1, 95 %CI 1.96-25.84, OR 3.94, 95 %CI 1.27-12.2, OR 3.53, 95 %CI 1.1-11.27, respectively). Conclusion: Although the difference in AKI risk was not statistically significant between Piptazo versus BSA groups, the elevated trough concentration of vancomycin and the concomitant use of nephrotoxic medications, were found to increase the risk of AKI, independently of the combined antibiotics used.

Public awareness of online pharmacies, consumers' motivating factors, experience and satisfaction with online pharmacy services, and current barriers and motivators for non-consumers: The case of Saudi Arabia.

Purpose: Online pharmacies (OPs) represent a growing field that plays a major role in providing pharmaceutical services in Saudi Arabia (SA). Thus, investigating public awareness of this option and assessing consumers' experiences and satisfaction, as well as opportunities and barriers for OPs, were the main aims of this study. Participants and methods: In this cross-sectional study, adult participants (≥18 years) in SA completed a three-part, custom-designed online questionnaire. The first section collected information on participants' demographic characteristics, their awareness of the existence of OPs, and history of OP purchases. The second section explores customer satisfaction levels and motivating factors. Finally, the third section investigated non-consumers' reasons for not purchasing from OPs and sought information about services that could motivate them to make future purchase decisions. Results: In total, 487 participants completed the questionnaire; they were mostly female (65.7%) and younger than 40 years (57.1%). Among all the respondents, 89.3% were aware of the existence of OPs, and 60.2% purchased from OPs in the past. Most were satisfied with the product quality (92.7%), completeness of order delivery (91.2%), and condition of the product and packaging (89.3%). Furthermore, 99.2% of respondents indicated that they would continue to purchase from OPs. Customers' main motivational factors included saving time (85.5%), offers and discounts (83.6%), and variety of products (82.1%). Among non-consumers, the main reasons for not purchasing from OPs included a personal preference to visit a community pharmacy (87.2%), the ability to talk to pharmacists directly (83.6%), and the vicinity of a pharmacy (80.0%). Conclusions: These findings confirm the increasing level of awareness regarding the existence of OPs in SA. Overall, OP customers expressed satisfaction with the services provided. Nevertheless, various areas of improvement have emerged, such as improved delivery time and providing medical consultation services. Increasing public awareness of OP services provided is essential considering their significant role in reforming the healthcare system in SA.

Clinical characteristics and dosing of apixaban and rivaroxaban for the management of venous thromboembolism: A multi-center retrospective observational study.

Background: Since the risk of recurrence of venous thromboembolism (VTE) increases with duration or inadequate anticoagulation dosage, a proper regimen of apixaban and rivaroxaban is essential in patients with VTE, especially during the acute phase. This study aims to describe the clinical characteristics and dosing of anticoagulants for patients who received apixaban or rivaroxaban for VTE treatment. Methods: The multi-center retrospective observational study included patients diagnosed with VTE who had received apixaban or rivaroxaban between January 1, 2016, and December 31, 2021. The study's description of real-world practices includes patients' characteristics, along with anticoagulant dose and duration used for lead-in or maintenance therapy to manage VTE. Results: The study involved 695 patients with VTE; 342 of whom were treated with apixaban (49.2%), while 353 were treated with rivaroxaban (50.8%). During the acute phase, 30.1% and 19.3% of patients did not receive lead-in therapy with apixaban and rivaroxaban, respectively, and 1.2% received reduced doses of either medication. Among the patients who received apixaban alone for lead-in, the majority (79.5%) received the recommended duration, while 17.1% received a shorter lead-in duration (≤5 days), with an overall mean duration of 6.5 days. Most patients who received rivaroxaban alone for lead-in (93.0%) received the drug for the recommended duration, with an overall mean duration of 20.2 days. Most of the patients who did not receive apixaban or rivaroxaban for lead-in used parenteral anticoagulants for varying durations; however, around 25.0% of these patients did not receive any lead-in anticoagulant and started on maintenance therapy. Overall, patients who did not receive apixaban or rivaroxaban lead-in therapy were commonly associated with a higher risk of bleeding according to their clinical characteristics. Conclusion: A notable proportion of patients with VTE who were mostly at low to intermediate risk of bleeding received non-recommended doses or durations of apixaban or rivaroxaban for lead-in therapy. Large studies are needed to establish evidence about the outcomes associated with these practices.

Local causes of essential medicines shortages from the perspective of supply chain professionals in Saudi Arabia.

Background: The global supply chains of essential medicines faced frequent disruptions over the past five years, particularly during the COVID-19 pandemic. Different causes of prescription drug supply interruptions have been identified in Saudi Arabia. However, studies have yet to explore the views of pharmaceutical supply chain personnel regarding the causes of these interruptions. Therefore, this study aimed to survey individuals working in the pharmaceutical supply chains about their views on the observed interruptions in the supply of some essential drugs. Methods: This was a questionnaire-based cross-sectional study. The 10-item questionnaire was created based on the findings of previously published research that investigated the root causes of essential drug shortages and the impact of COVID-19 pandemic on the supply chains of essential drugs in Saudi Arabia. Purposive sampling was used to identify individuals with at least one year of experience in the area of the pharmaceutical supply chain, and the data collection occurred between April 19th, 2022 and October 23rd, 2022. In addition, descriptive statistics (e.g., frequencies and percentages) were conducted to present the views of the respondents. Results: Seventy-nine pharmaceutical supply chain specialists accepted the invitation and completed the questionnaire. About two-thirds (69.62%) of the respondents reported that centralized pharmaceutical procurement negatively affected the supply chain of essential drugs. Procurement of unregistered medications by the Saudi Food and Drug Authority (SFDA), as well as generic drugs with a history of recalls, and failure to supply requested quantities were the three most commonly reported reasons behind the observed interruptions in the supply of some essential drugs according to those respondents with a negative view of the centralized procurement. Furthermore, failure of pharmaceutical companies to inform SFDA of potential drug shortages, manufacturing issues, poor demand forecasting, unpredictable increase in demand, and low prices of essential drugs were also believed to be behind the observed interruptions in the supply of some essential medicines. Conclusion: The majority of surveyed pharmaceutical supply chain professionals held negative views about the role of centralized pharmaceutical procurement in exacerbating the issues with essential medicines supply chain. Future research should examine different strategies to improve purchasing and procurement practices in Saudi Arabia.

Fasting during Ramadan and acute kidney injury (AKI): a retrospective, propensity matched cohort study.

BACKGROUND: During the month of Ramadan, Muslims abstain from daytime consumption of fluids and foods, although some high-risk individuals are exempt. Because fasting's effects on the risk of acute kidney injury (AKI) have not been established, this study assesses the relationship between fasting and risk of AKI and identifies patients at high risk. METHODS: A single-center, retrospective, propensity-score matched, cohort study was conducted with data collected from adult patients admitted to the emergency room during Ramadan and the following month over two consecutive years (2016 and 2017). AKI was diagnosed based on the 2012 definition from the Kidney Disease: Improving Global Outcomes clinical practice guideline. Multivariable logistic regression analyses were used to examine the correlation and measure the effect of fasting on the incidence of AKI, and assess the effect of different variables on the incidence of AKI between the matching cohorts. RESULTS: A total of 1199 patients were included; after matching, each cohort had 499 patients. In the fasting cohort, the incidence of AKI and the risk of developing AKI were significantly lower (adjusted odds ratio (AOR) 0.65;95% confidence interval (CI) 0.44-0.98). The most indicative risk factors for AKI were hypertension (AOR 2.17; 95% CI 1.48-3.18), history of AKI (AOR 5.05; 95% CI 3.46-7.39), and liver cirrhosis (AOR 3.01; 95% CI 1.04-8.70). Patients with these factors or most other comorbidities in the fasting cohort had a lower risk of AKI as compared with their nonfasting counterparts. CONCLUSION: The data show a strong reduction in the risk of developing AKI as a benefit of fasting, particularly in patients with comorbid conditions. Therefore, most patients with comorbid conditions are not harmed from fasting during Ramadan. However, larger prospective studies are needed to investigate the benefit of fasting in reducing the risk of developing AKI.

The impact of using pictorial aids in caregivers' understanding of patient information leaflets of pediatric pain medications: A quasi-experimental study.

Introduction: Patient information leaflets (PILs) are one of the main sources of information for over-the-counter medications (OTCs). This study aimed to assess caregivers' understanding of instructions in PILs provided with paracetamol medications and the impact of pictograms use. Methods: A quasi-experimental study was conducted among caregivers of children aged < 13 years recruited in pediatric outpatient clinics at University Medical City in Riyadh. The calculated sample size was 128; at least 64 participants were needed in each group (the text-only group and the text-plus pictograms group). Caregivers' health literacy was assessed using a validated Arabic version of the Newest Vital Sign scale. Participants' understanding of PILs instructions was assessed using eight questions on the route of administration, minimal hours between doses, max daily dose, shake medication before use, storage, and reporting adverse events; and was rated based on the number of questions correctly understood. Characteristics of participants were compared by Pearson X2 and t-test was used to assess the significance of mean score differences between groups. Results: A total of 130 caregivers participated in the study; almost half of them were mothers (47%, [n = 61]) and 43% (n = 56) have "a possibility of limited health literacy". The mean number of correct answers to questions assessing the understanding of PILs instructions was significantly higher among the text-plus pictograms group compared to the text-only group (5.25 ± 1.85 vs. 4.38 ± 1.27; p < 0.001). When results were controlled for age and gender, better health literacy was found to be associated with a better understanding of instructions (B = 0.39, 95 %CI 0.23-0.54). Conclusion: Limited comprehension of medications instructions was observed; adding pictorial aids to PILs might enhance the comprehension. Differences in health literacy levels of caregivers should be considered when designing PILs.

Economic analysis of glucagon like peptide-1 receptor agonists from the Saudi Arabia payer perspective.

Objectives: To perform a cost of control analysis of glucagon like peptide-1 receptor agonists (GLP1RA) in Saudi Arabia (SA) and determine the economic impact of adopting GLP1RAs. Methods: A budget impact model that captures the cost of control model was constructed to simulate hypothetical patient on six treatment options: a current mix of 60% liraglutide and 40% dulaglutide, semaglutide, liraglutide, dulaglutide, exenatide, and lixisenatide. We estimated the relative amounts of SAR spend to achieve HbA1c targets (≤6.5% or < 7.0%). For each treatment option, annual treatment cost, proportion of patients achieving HbA1c targets, and cost to treat major adverse cardiovascular events (MACE) were aggregated to estimate the cost of control per patient per year (CCPPPY) over 5-year horizon (2021-2025). Probabilistic sensitivity analysis (PSA) was performed as a confirmatory analysis. Results: The CCPPPY to achieve HbA1c ≤ 6.5%/<7.0% using current mix, semaglutide, liraglutide, dulaglutide, exenatide, and lixisenatide were SAR 17,097/SAR 14,113, SAR 12,889/SAR 11,123, SAR 15,594/SAR 12,892, SAR 19,184/SAR 15,940, SAR 580,211/SAR 380,936, and SAR 246,570/SAR 143,759, respectively. The relative amounts of SAR spend to achieve HbA1c ≤ 6.5%/<7.0% relative to 1 SAR on semaglutide in case of adopting current mix, liraglutide, dulaglutide, exenatide, and lixisenatide were SAR 1.42/SAR 1.18, SAR 1.30/SAR 1.07, SAR 1.60/SAR 1.33, SAR 48.33/SAR 31.73, and SAR 20.54/SAR 11.97, respectively. These results were confirmed in the PSA. Conclusions: Semaglutide 1 mg once weekly was the most economically favorable GLP1RA; associated with the least CCPPPY, and amount of SAR spent to achieve HbA1c of ≤6.50%/<7.00% versus all other GLP1RAs.

The use of direct oral anticoagulants for thromboprophylaxis or treatment of cancer-associated venous thromboembolism: a meta-analysis and review of the guidelines.

BACKGROUND: Venous thromboembolism (VTE) is a common complication among patients with cancer and is one of the most common causes of increased morbidity and mortality. The use of direct oral anticoagulants (DOACs) for thromboprophylaxis and treatment of cancer-associated venous thromboembolism (CA-VTE) has been evaluated in several randomized clinical trials (RCTs). The aim of this meta-analysis was to assess efficacy and safety of using DOACs for thromboprophylaxis and treatment of CA-VTE and provide a summary for available guidelines' recommendations. METHODS: MEDLINE was searched to identify studies evaluating the use of DOACs for thromboprophylaxis or treatment in patients with cancer. Search was limited to peer-reviewed studies published in English. Studies were excluded if they were not RCTs or subgroup analyses of data derived from RCTs, if they did not report efficacy and safety data on patients with active cancer, or if they were published as an abstract. New VTE or VTE recurrence, and major or clinically relevant non-major bleeding (CRNMB) were used to assess the efficacy and safety, respectively. The Mantel-Haenszel random-effects model risk ratios (RRs) and the corresponding 95% confidence intervals (CIs) were calculated to estimate the pooled treatment effects of DOACs. RESULTS: Four studies evaluating DOACs use for thromboprophylaxis and four - for treatment of CA-VTE were included. Thromboprophylaxis with DOACs was associated with a significant reduction in the risk of symptomatic VTE (RR = 0.58; 95%CI 0.37,0.91) but with an incremental risk of major bleeding or CRNMB (RR = 1.57; 95%CI 1.10,2.26). CA-VTE treatment with DOACs was linked with a significant reduction in VTE recurrence (RR = 0.62; 95%CI 0.44,0.87) but with an incremental risk of CRNMB (RR = 1.58; 95%CI 1.11,2.24). CONCLUSIONS: The DOACs are associated with a lower risk of symptomatic VTE and VTE recurrence, but the risk of bleeding remains a considerable concern. Clinical decisions should be made by assessing individual patient's risk of VTE and bleeding.

Patients' knowledge about epilepsy in a tertiary medical center: A cross-sectional study from Riyadh, Saudi Arabia.

OBJECTIVE: Epilepsy is a noncommunicable disease that affects approximately 65 million people worldwide. Its management depends greatly on the self-management capacity of the individual. Patients with epilepsy (PWE) who have a good level of knowledge about their disease tend to have better coping mechanisms, as well as better compliance in taking their antiepileptic drugs (AEDs), which improves overall control of symptoms. This study aimed to evaluate the current patients' knowledge about epilepsy and identify factors associated with knowledge of different aspects of epilepsy and its management in a tertiary medical center in Riyadh, Saudi Arabia. METHODS: A cross-sectional study was carried out at a tertiary medical center in Riyadh, Saudi Arabia. Participants were included if they had a documented diagnosis of epilepsy and excluded if they were non-Saudi or had nonepileptic seizures. The Arabic version of the Epilepsy Patient Knowledge Questionnaire (EPKQ) was used to assess patient's knowledge of epilepsy definition and etiology, safety concerns, medication compliance, social activities, and legal issues of employment and driving. Fisher's exact and Chi-Square tests were used to investigate differences in knowledge of epilepsy among different segments of participants. Data management and statistical analyses were carried on using the IBM SPSS Statistics for Windows, version 25. RESULTS: A total of 126 PWE were enrolled in the study. About two-thirds of them were females, and about 68% of them were at least high-school graduates. About one-half of PWE had good knowledge of their condition (>75%), and females had better knowledge than males (p = 0.004). The majority (75.4%) of PWE were knowledgeable about the etiology of epilepsy, about 70% knew that putting a foreign object in a seizing patients' mouth was inappropriate, and only 38% of them did not have adequate knowledge of situations that increase the risk of seizure. About 40% of PWE thought pregnant women should discontinue their AEDs, 53.2% of participants knew what to do when they experience side effects from AEDs, but most of them recognized that they should not automatically stop taking their medications when they stop having seizures. Patients older than 50 years or younger than 21 years of age were less likely to recognize that it was safe for PWE to engage in different social activities (p = 0.042). About 30% of respondents believed that PWE cannot engage in most types of jobs, and more than 50% of participants did not know under which situation PWE can drive. CONCLUSION: This study revealed that about half of PWE had inadequate knowledge about their disorder. Patients with epilepsy had better knowledge about the causes of their condition compared with safety concerns and the treatment of epilepsy, whereas the majority of participants knew the types of jobs and activities that they could engage in. Hence, educational interventions are needed to promote patients' knowledge, especially in terms of safety and the legalities of employment and driving.

Student and educator perspectives on virtual institutional introductory pharmacy practice experience (IPPE).

BACKGROUND: The COVID-19 pandemic has required governments around the world to suspend face-to-face learning for school and university students. Colleges of pharmacy are faced with the challenge of training students in hospitals that are under considerable pressure at this time. The government of Saudi Arabia has moved all classes and training online to limit the spread of the virus. This study describes the experience of the Introductory and Advanced Pharmacy Practice Experience (IPPE and APPE) students and preceptors engaged in the virtual IPPE training. METHODS: A cross-sectional study was conducted to describe and appraise the implemented virtual IPPE training from the experiences of IPPE and APPE students, and their preceptor. The IPPE students described their experiences in close-ended questionnaires, while APPE students in open-ended questionnaires, and the preceptor described the experiences in narrative. The study focused on highlighting the advantages, opportunities, challenges, and shortcomings of the virtual training. RESULTS: Two preceptors and seven APPE students participated in the preparation and administration of the virtual training. The IPPE students' experiences, based on 87 respondents, were mostly positive. Although IPPE students enjoyed the time flexibility that allowed the learning of new skills and reflection on previous experiences, 15% experienced difficulty finding quiet places with a reliable internet connection or had difficulty working on team-based activities. Moreover, some were anxious about the lack of adequate patient-care experience. On the other hand, the APPE students found the experience enriching as they gained experience and understanding of academic workflow, gained skills, and overcame the challenges they faced during this virtual training experience. CONCLUSIONS: Future training programs should be organized to overcome the challenges and to maximize the benefits of training experiences. Schools of pharmacy may benefit from the training materials constructed, prepared, and administered by APPE students to improve IPPE students' learning experiences and outcomes.

Orthopedic Surgeons' Views of Hyaluronic Acid Formulations in the Management of Knee Osteoarthritis: A Questionnaire-Based Cross-Sectional Study.

Background and Objectives: Multiple hyaluronic acid (HA) products were approved and marketed to manage osteoarthritis (OA). Although these products are widely prescribed by orthopedic surgeons to manage OA, especially knee OA, the therapeutic value of these products is highly uncertain. Few studies with significant limitations in their designs have indicated positive outcomes among OA patients treated with HA; however, their results were inconclusive. Thus, we aimed to explore the therapeutic value of different HA products in alleviating knee OA pain and improving patients' physical function from the orthopedic surgeons' perspective. Materials and Methods: This was a questionnaire-based cross-sectional study in which practicing orthopedic surgeons in two countries (e.g., Saudi Arabia and Jordan) were invited to participate. The 10-item, newly developed questionnaire inquired about the respondents' sociodemographic characteristics (e.g., age, gender, country, years of experience), and their opinions regarding the efficacy of HA products in the management of OA (e.g., efficacy in improving mobility and alleviating pain). Results: Out of the 200 orthopedic surgeons who were invited to participate, 122 (61%) filled out the questionnaire. Most of the respondents were from Saudi Arabia (58%), aged 35 to 55 years (68%), had at least 10 years of experience (69%), and male (98%). About 80% of the respondents reported prescribing HA, such as Hyalgan®, Orthovisc®, Hyalubrix®, and Crespine Gel®. About 66% of the respondents believed that HA was moderately to highly effective in managing knee OA, and 34% believed that HA was either ineffective or mildly effective. Pain at the site of injection (44.3%) and rash or local skin reactions (22.1%) were the most commonly reported adverse events. Conclusions: The variations in the formulation of different HA brands (e.g., molecular weight and cross-linking) did not seem to offer any therapeutic advantage. HA might have value in the management of knee OA; however, its value is highly uncertain and necessitates more well-designed studies to further examine its therapeutic value.

Safety and effectiveness of thromboprophylaxis use in hospitalized elderly medical patients at a Saudi tertiary care center.

INTRODUCTION: Appropriate prescribing of thromboprophylaxis according to guidelines' recommendations can heighten over- or underutilization risk. The study intended to evaluate the safety and effectiveness of appropriate/inappropriate thromboprophylaxis use among hospitalized elderly medical patients. METHODS: A retrospective observational cohort study was conducted, including patients who were ≥60 years old, hospitalized for an acute medical illness that required hospitalization in a medical ward for >48 h, and received thromboprophylaxis. Against the American College of Chest Physicians guidelines, the thromboprophylaxis use appropriateness was assessed. RESULTS: A total of 370 patients met the inclusion criteria, in 71.9% of whom thromboprophylaxis use was appropriate. The mean age of the included patients was 75 years (±9.1), and 72.4% of them were at high risk of venous thromboembolism (VTE), and almost all these patients received appropriate thromboprophylaxis. The occurrence of bleeding was significantly higher in the appropriate use group during hospitalization than the inappropriate use group (11.7% vs. 2.9%, p = 0.009); the majority of these bleeding events were classified as major. There were no differences in VTE events during hospitalization or 90 days all-cause mortality between the two groups. CONCLUSION: The study demonstrates high prescribers' compliance with recommendations in high-risk patients. In patients at low risk for VTE, the overutilization of thromboprophylaxis did not increase their bleeding risk. This study suggests that the benefits of thromboprophylaxis in elderly patients, regardless of their VTE risk, may outweigh the risk of bleeding.

Demographics, comorbidities, and outcomes among young and middle-aged COVID-19 patients in Saudi Arabia.

The impact of different sociodemographic and clinical characteristics on the COVID-19-related morbidity and mortality rates have been studied extensively around the world; however, there is a dearth of data on the impact of different clinical and sociodemographic variables on the COVID-19-related outcomes in Saudi Arabia. This study aimed to identify those at high risk of worse clinical outcomes, such as hospitalization and longer length of stay (LOS) among young and middle-aged adults (18 to 55 years). In this questionnaire-based cross-sectional study, 706 patients with real-time polymerase chain reaction (RT-PCR) confirmed COVID-19 infection were interviewed. Patients' demographic characteristics, dietary habits, medical history, and lifestyle choices were collected through phone interviews. Patients with chronic health conditions, such as diabetes and hypertension, reported a higher rate of hospitalization, ICU admission, oxygen-support needs, and a longer period of recovery and LOS. Multiple logistic regression showed that diabetes, hypertension, and pulmonary disease (e.g., asthma and chronic obstructive pulmonary disease (COPD)) were associated with a higher risk of hospitalization and longer LOS. Multiple logistic regression showed that symptoms of breathlessness, loss of smell and/or taste, diarrhea, and cough were associated with a longer recovery period. Similarly, breathlessness, vomiting, and diarrhea were associated with higher rates of hospitalization. The findings of this study confirm the similarity of the factors associated with worse clinical outcomes across the world. Future studies should use more robust designs to investigate the impact of different therapies on the COVID-19-related morbidity and mortality in Saudi Arabia.