Pharmacokinetics of single-dose rivaroxaban under fed state in obese vs. non-obese subjects: An open-label controlled clinical trial (RIVOBESE-PK).

The evidence of rivaroxaban's pharmacokinetics in obese compared with non-obese populations remains inconclusive. We aimed to compare the pharmacokinetic profile of rivaroxaban between obese and non-obese populations under fed state. Participants who met the study's eligibility criteria were assigned into one of two groups: obese (body mass index ≥35 kg/m2) or non-obese (body mass index 18.5-24.9 kg/m2). A single dose of rivaroxaban 20 mg was orally administered to each participant. Nine blood samples over 48 h, and multiple urine samples over 18 h were collected and analyzed for rivaroxaban concentration using ultra-performance liquid chromatography coupled with tandem mass detector. Pharmacokinetic parameters were determined using WinNonlin software. Thirty-six participants were recruited into the study. No significant changes were observed between obese and non-obese participants in peak plasma concentration, time to reach peak plasma concentration, area under the plasma concentration-time curve over 48 h or to infinity, elimination rate constant, half-life, apparent volume of distribution, apparent clearance, and fraction of drug excreted unchanged in urine over 18 h. Rivaroxaban's exposure was similar between the obese and non-obese subjects, and there were no significant differences in other pharmacokinetic parameters between the two groups. These results suggest that dose adjustment for rivaroxaban is probably unwarranted in the obese population.

Clinical versus fixed warfarin dosing and the impact on quality of anticoagulation (The ClinFix trial).

Different dosing strategies exist to initiate warfarin, most commonly fixed warfarin dosing (FWD), clinical warfarin dosing (CWD), and genetic-guided warfarin dosing (GWD). Landmark trials have shown GWD to be superior when compared to FWD in the EU-PACT trial or CWD in the GIFT trial. COAG trial did not show differences between GWD and CWD. We aim to compare the anticoagulation quality outcomes of CWD and FWD. This is a prospective cohort study with a retrospective comparator. Recruited subjects in the CWD (prospective) arm were initiated on warfarin according to the clinical dosing component of the algorithm published in www.warfarindosing.org. The primary efficacy outcome was the percentage time in the therapeutic range (PTTR) from day 3 to 6 till day 28 to 35. The study enrolled 122 and 123 patients in the CWD and FWD, respectively. The PTTR did not differ statistically between CWD and FWD (62.2 ± 26.2% vs. 58 ± 25.4%, p = 0.2). There was also no difference between both arms in the percentage of visits with extreme subtherapeutic international normalized ratio (INR) (<1.5; 15 ± 18.3% vs. 16.8 ± 19.1%, p = 0.44) or extreme supratherapeutic INR (>4; 7.7 ± 14.7% vs. 7.5 ± 12.4%, p = 0.92). We conclude that CWD did not improve the anticoagulation quality parameters compared to the FWD method.

QPGx-CARES: Qatar pharmacogenetics clinical applications and research enhancement strategies.

Pharmacogenetic (PGx)-informed medication prescription is a cutting-edge genomic application in contemporary medicine, offering the potential to overcome the conventional "trial-and-error" approach in drug prescription. The ability to use an individual's genetic profile to predict drug responses allows for personalized drug and dosage selection, thereby enhancing the safety and efficacy of treatments. However, despite significant scientific and clinical advancements in PGx, its integration into routine healthcare practices remains limited. To address this gap, the Qatar Genome Program (QGP) has embarked on an ambitious initiative known as QPGx-CARES (Qatar Pharmacogenetics Clinical Applications and Research Enhancement Strategies), which aims to set a roadmap for optimizing PGx research and clinical implementation on a national scale. The goal of QPGx-CARES initiative is to integrate PGx testing into clinical settings with the aim of improving patient health outcomes. In 2022, QGP initiated several implementation projects in various clinical settings. These projects aimed to evaluate the clinical utility of PGx testing, gather valuable insights into the effective dissemination of PGx data to healthcare professionals and patients, and identify the gaps and the challenges for wider adoption. QPGx-CARES strategy aimed to integrate evidence-based PGx findings into clinical practice, focusing on implementing PGx testing for cardiovascular medications, supported by robust scientific evidence. The current initiative sets a precedent for the nationwide implementation of precision medicine across diverse clinical domains.

Trends in prescribing and outcomes in obese versus non-obese patients receiving rivaroxaban therapy: an observational study using real-world data.

PURPOSE: To investigate real-world prescribing trends and clinical outcomes based on body mass index (BMI) categorization in patients who received rivaroxaban therapy. METHODS: This was a retrospective cohort study involving all patients who received rivaroxaban therapy across all Hamad Medical Corporation (HMC) hospitals from 2015 to 2020. RESULTS: The number of patients initiated on rivaroxaban therapy significantly increased from 152 (3.3%) in 2015 to 1342 (28.9%) in 2020 (p <0.001). Within BMI categories, a similar increasing trend was observed in underweight, normal, and overweight patients, while from 2018 to 2020, there was a decreasing trend in rivaroxaban prescribing in all obese classes. The prevalence rate of all-cause mortality differed significantly between the BMI groups, with the highest mortality being among morbidly obese patients (BMI ≥ 40 kg/m2) (p< 0.001). On the other hand, no significant differences were found between the BMI groups in terms of bleeding, pulmonary embolism, deep vein thrombosis and stroke incidences. Multivariate logistic regression analyses showed that the likelihood of all-cause mortality was significantly higher in overweight and all categories of obese patients compared to underweight patients: overweight (OR: 5.3, 95% CI: 2.3-11.9, p< 0.001); obese class 1 (OR: 5.4, 95% CI: 2.3 - 12.2, p< 0.001); obese class 2 (OR: 6.5, 95% CI: 2.7 - 15.6, p< 0.001); and obese class 3 (OR: 3.7, 95% CI: 1.6 - 8.7, p = 0.003). CONCLUSIONS: Rivaroxaban prescribing has significantly increased over the years across general population, with a noticeable decline in obese population during the last few years (from 2018 onwards). Furthermore, an appreciable association was evident between all-cause mortality and BMI of these patients.

Prescribing patterns of antihypertensive medications: A systematic review of literature between 2010 and 2020.

Background: Hypertension has affected over 1.13 billion people worldwide in 2015 and it's one of the most preventable risk-factors for morbidity and mortality. Antihypertensives significantly reduce cardiovascular risks. Several studies on antihypertensives' prescribing patterns were conducted worldwide, and guidelines were developed on hypertension management. However, no systematic reviews were conducted globally to synthesize the evidence from these studies. This review aims to evaluate antihypertensives' prescription patterns, and adherence to international guidelines for hypertension management worldwide. Methods: Full-text antihypertensives' prescribing patterns evaluation studies were included. Reviews, commentaries, guidelines, and editorials were excluded. Various databases were searched including PubMed, Embase, and others. Studies were limited to English only and to articles published from (01/01/2010) to (20/03/2020). Crowe Critical Appraisal Tool (CCAT) was used for quality assessment. Results: The most commonly prescribed antihypertensives as monotherapy in adult patients with no comorbidities were ACEIs/ARBs (Angiotensin converting enzyme inhibitors/Angiotensin receptor blockers), followed by CCBs (Calcium channel blockers), and BBs (Beta Blockers). Most commonly prescribed dual combinations were thiazide diuretics+ACEIs/ARBs, BBs + CCBs and CCBs+ACEIs/ARBs. Among diabetic patients, the most common agents were ACEIs/ARBs. Among patients with heart diseases, CCBs were prescribed frequently. While patients with kidney diseases, CCBs and ARBs were most prescribed. Of the 40 studies included in the review, only four studies directly assessed the prescribing patterns of antihypertensives in adherence to clinical practice guidelines. And only two studies confirmed adherence to guidelines. Furthermore, the quality of the majority of studies was moderate (50%), while 25% of articles were reported as either high or low quality. Conclusion: This review revealed that there are areas for improvement for prescribing practices of antihypertensives in concordance with the latest evidence and with clinical practice guidelines.

Genetic Factors Associated with Morphine Consumption in Women Undergoing Laparoscopic Cholecystectomy: A Prospective Cohort Study.

Introduction: Morphine has been a crucial analgesic agent used perioperatively in various surgical procedures. Genetic factors can lead to morphine dose requirement interpatient variability. Our objective was to determine the contribution of genetic polymorphisms in human µ-opioid receptor gene (OPRM1), ATP binding cassette gene (ABCB1) and rs2952768 to the variation of the perioperative morphine consumption in women undergoing laparoscopic cholecystectomy. Methods: This is a prospective cohort study that included 102 adult Arab females undergoing laparoscopic cholecystectomy. The exposures were carrying the genetic variants of OPRM1, ABCB1 and rs2952768. Our primary outcome was total morphine or morphine equivalent dose required perioperatively. The secondary outcomes were pain score during the first 24 hours and adverse drug reactions. A standardized, general anaesthesia was used for all subjects. In addition to the genetic factors, we also investigated non-genetic factors influencing post-operative pain sensitivity and morphine consumption. Results: Both (rs1799971, A>G) in OPRM1 and (rs2952768, T>C) showed statistically significant association with intra-operative total morphine dose requirements. Patients carrying the "G" allele in OPRM1 had a significantly higher total morphine mean rank dose compared to the AA genotype [62.9 vs 47.1, p=0.008]. Furthermore, patients homozygous for the rs2952768 (T>C) minor allele "CC" had a higher mean rank compared to the other genotypes [72.7 vs 50.1, p=0.046]. Conclusion: OPRM1 (rs1799971) and rs2952768 are associated with variation of intra-operative morphine consumption in laparoscopic cholecystectomy. Clinical Trial Identifier: This study was registered at ClinicalTrials.gov, NCT04621864. https://clinicaltrials.gov/ct2/show/NCT04621864.

Cisplatin-induced ototoxicity: a novel approach to an ancient problem.

With the scarcity of pharmacological otoprotective agents against cisplatin-induced ototoxicity (CIO), researchers find themselves compelled to look at and navigate all possible strategies to identify ways to prevent CIO. One of these promising strategies is pharmacogenomic implementation. This strategy aims for identifying and detecting high-risk genetic variants to tailor cisplatin therapy to reach the best survival outcomes with the least risk of ototoxicity.

Warfarin-Rifampin-Gene (WARIF-G) Interaction: A Retrospective, Genetic, Case-Control Study.

Warfarin is extensively metabolized by cytochrome P450 2C9 (CYP2C9). Concomitant use with the potent CYP2C9 inducer, rifampin, requires close monitoring and dosage adjustments. Although, in theory, warfarin dose increase should overcome this interaction, most reported cases over the last 50 years have not responded even to high warfarin doses, but some have responded to modest doses. To investigate the genetic polymorphisms' impact on this unexplained interpatient variability, we performed genotyping of CYP2C9, VKORC1, and CYP4F2 for warfarin and rifampin concomitant receivers from 2016 to 2022 at Hamad Medical Corporation, Doha, Qatar. We identified and included 36 patients: 22 responders and 14 nonresponders. Warfarin-responders were significantly more likely to have one or more warfarin-sensitizing CYP2C9/VKORC1 alleles than nonresponders (odds ratio = 23.2, 95% confidence interval = 3.2-195.6; P = 0.0001). The mean genetic-based pre-interaction calculated dose was significantly lower for responders than for nonresponders (P < 0.001); and was negatively correlated with warfarin sensitivity index (WSI) (r = -0.58; P = 0.0002). The median percentage time in therapeutic range and mean WSI were significantly higher in the warfarin-sensitizing CYP2C9/VKORC1 alleles carriers than noncarriers (P = 0.017 and 0.0004, respectively). Whereas the warfarin-sensitizing CYP2C9/VKORC1 genotypes were associated with modest on-rifampin warfarin dose requirements, the noncarriers would have required more than double these doses to respond. Warfarin-sensitizing CYP2C9/VKORC1 genotypes and low genetic-based warfarin calculated doses were associated with higher warfarin sensitivity and better anticoagulation quality in patients receiving rifampin concomitantly.

Cost-Benefit Analysis of Genotype-Guided Interruption Days in Warfarin Pre-Procedural Management.

Warfarin is commonly used in thromboembolic conditions. Warfarin interruption represents a significant challenge in pre-operative warfarin management as it is associated with major consequences. Genetics polymorphism demonstrated to be a significant predictor of the required days of warfarin interruption. This study sought to assess the economic benefit of implementing a pharmacogenetic-guided approach in the preprocedural warfarin management. From the hospital's perspective, a cost-benefit analysis was conducted based on a 1-year decision-analytic follow-up model of the economic implications of using a pharmacogenetic algorithm vs standard of care in pre-operative warfarin management in the Hamad Medical Corporation, Qatar. The benefit of the interventional algorithm was based on estimated reduction in the probabilities of clinical events and their cost, added to the avoided cost because of canceled procedures. The cost of the algorithm was the cost of the genotyping assay. The model event probability inputs were extracted from major literature clinical trials, and the setting-specifc and cost inputs were locally obtained. The model was based on a multivariate analysis at its base case. As per 10.3% prevalence of genetic variants, 82% bridging, and a calculated 20% optimization in the preparative period of warfarin management, the benefit to cost ratio was 4.0 in favor genotype-guided approach. This positive benefit to cost ratio was maintained in 100% of the simulated study cases. Sensitivity analyses confirmed the robustness and generalizability of the study conclusion. A pharmacogenetic- guided pre-operative warfarin interruption management is a cost-beneficial approach in the Qatari practice.

A 5-year trend in the use of sodium-glucose co-transporter 2 inhibitors and other oral antidiabetic drugs in a Middle Eastern country.

BACKGROUND: Sodium glucose co-transporter 2 inhibitors (SGLT2is) are a novel class of oral antidiabetic drugs. To date, there are no pharmacoepidemiologic studies investigating the pattern of use of SGLT2is compared to other oral antidiabetic drugs in the Middle East, including Qatar. AIM: This study aimed to explore the trends in the use of SGLT2is compared to other oral antidiabetic drugs in Qatar from 2016 to 2020. METHOD: This is a descriptive, retrospective cross-sectional study where information on all oral antidiabetic drugs dispensed as in- or out-patient prescriptions from 2016 to 2020 in Hamad Medical Corporation hospitals, Qatar were collected. Outcomes included the number and relative frequency of quarterly prescriptions of different oral antidiabetic drug classes [biguanides, sulfonylureas, dipeptidyl peptidase 4 inhibitors, thiazolidinediones, meglitinides, α-glucosidase inhibitors, and SGLT2is] prescribed from 2016 to 2020. RESULTS: SGLT2is prescriptions increased from 1045 (2.13%) in 2017 to 8375 (12.39%) in 2020, while sulfonylureas prescriptions declined from 10,436 (21.25%) to 9158 (13.55%) during the same period. Metformin use decreased from 23,926 (48.71%) in 2017 to 30,886 (45.70%) in 2020. The proportions of thiazolidinediones, meglitinides, α-glucosidase inhibitors prescriptions remained stable over the years. Among SGLT2is, empagliflozin prescriptions showed an increase from 537 (10.65%) to 2881 (34.40%) compared to dapagliflozin, which decreased by the end of 2018 from 4505 (89.35%) to 5494 (65.6%). CONCLUSION: SGLT2is have largely replaced sulfonylureas in Qatar. The increasing trend in their use over the years is similar to that reported in other countries. The trend among SGLT2is suggests greater preference for empagliflozin over dapagliflozin.

The design and implementation of an undergraduate health professional degree elective course on scientific writing, peer assessment, and critical appraisal.

BACKGROUND AND PURPOSE: Strong writing skills are critical to the pharmacy profession. This paper describes the design, delivery, and impact of a course intended to develop pharmacy students' scientific writing, peer assessment, and critical appraisal skills. EDUCATIONAL ACTIVITY AND SETTING: The course was offered in the final year of an undergraduate pharmacy program with students whose first language is not English. In this course, students write two structured pharmacy review articles (PRA) based on assigned scientific research articles and peer assess each others' written PRAs. Students also critically appraise scientific research articles on a weekly basis, complete one pre-journal club written reflective critique based on a assigned scientific research article, and moderate one journal club session. FINDINGS: Course rubrics were developed and validated by the course coordinators. A survey administered to students enrolled in the course identified that 85% of the students perceived that they gained adequate writing skills in the course. More than 70% of the students indicated they had the necessary skills to evaluate their peers' written assessments, and 93% felt comfortable providing and receiving feedback from peers. More than 90% of the students indicated that writing PRAs and the peer assessment improved their critical and analytical skills. SUMMARY: This course improved students' scientific writing, peer assessment, and critical appraisal skills. Further practice is required to reinforce the skills learned and to strengthen the writing skills of students.

Effect of CYP2C19 genetic variants on bleeding and major adverse cardiovascular events in a cohort of Arab patients undergoing percutaneous coronary intervention and stent implantation.

INTRODUCTION: One-third of patients have clopidogrel resistance that may lead to major adverse cardiac events (MACEs). By contrast, it was found that some clopidogrel-treated patients have hyperresponsive platelets that are associated with higher bleeding risk. Several studies have shown that polymorphisms in the gene encoding the CYP2C19 contribute to the variability in response to clopidogrel. Data on genetic and nongenetic factors affecting clopidogrel response in the Arab population are scarce. In this prospective cohort study, we sought to assess the association between the increased function allele (CYP2C19*17) and bleeding events, and validate the effect of the CYP2C19 genetic variants and nongenetic factors on the incidence of MACEs. METHODS: Blood samples were collected from patients that were undergoing percutaneous coronary intervention and receiving clopidogrel at the Heart Hospital, a specialist tertiary hospital in Doha, Qatar. Patients were followed for 12 months. Genotyping was performed for CYP2C19*2, *3, and *17 using TaqMan assays. RESULTS: In 254 patients, the minor allele frequencies were 0.13, 0.004, and 0.21 for *2, *3, and *17, respectively. Over a 12-month follow-up period, there were 21 bleeding events (8.5 events/100 patient-year). CYP2C19*17 carriers were found to be associated with increased risk of bleeding (OR, 21.6; 95% CI, 4.8-96.8; P < 0.0001). CYP2C19*2 or *3 carriers were found to be associated with increased risk of baseline and incident MACE combined (OR, 8.4; 95% CI, 3.2-23.9; P < 0.0001). CONCLUSION: This study showed a significant association between CYP2C19*17 allele and the increased risk of bleeding, and CYP2C19*2 or *3 with MACE outcomes.

Warfarin dosing strategies evolution and its progress in the era of precision medicine, a narrative review.

Background For decades, vitamin K antagonists and specifically warfarin, have been the sole agents used orally to manage thromboembolic conditions, including stroke and venous thromboembolism (VTE). Several factors lead to warfarin dose variability, including genetic and non-genetic factors which made warfarin management challenging especially at the initiation phase. To overcome the challenges with warfarin dosing at initiation, strategies other than conventional or fixed dosing were introduced and explored. Aim In this narrative review, we aim to discuss and critique the different dosing strategies for warfarin at initiation with more focus on genotype-guided warfarin dosing and the most recent supporting evidence for and against its use. Method Medline database was searched from 1965 to July 2021. Articles addressing different warfarin dosing methods were screened for inclusion. Results A number of methods exist for warfarin initiation. Studies comparing different dosing methods for initiation yielded conflicting outcomes due to differences in study design, population studied, comparator, and outcomes measured. Conclusions Looking at the big picture, the use of genetic dosing for warfarin initiation can lead to better outcomes. Whether these better outcomes are clinically or economically beneficial remains controversial.

Genomewide association analysis of warfarin dose requirements in Middle Eastern and North African populations.

To date, there has been no genomewide association study (GWAS) from the Middle East and North African (MENA) region to identify genetic variants associated with warfarin dose variability using this approach. In this study, we aimed to conduct the first GWAS of warfarin dose requirements in patients from the MENA region. A total of 132 Qatari (discovery) and 50 Egyptians (replication) were genotyped using Illumina Multi-Ethnic Global BeadChip Array. A GWAS was performed on log-transformed weekly warfarin dose in the studied population, adjusting for clinical characteristics and ancestry. The genomewide signals from the discovery cohort were tested in the Egyptian cohort. A GWAS meta-analysis, including the Qatari and Egyptian cohorts, was also performed and the output from this analysis was used in a gene-based analysis. The discovery analysis in Qatari identified five genomewide single-nucleotide polymorphisms (SNPs) in chromosome 16. These signals were replicated in the Egyptian cohort. Combining the two data through a GWAS meta-analysis strengthened the association in chromosome 16 with VKORC1 rs9934438 being the lead genomewide signal (ß = -0.17, 6 × 10-15 ). Other SNPs were identified in chromosome 10 at a p value less than 1 × 10-5 . The genetic variants within VKORC1 rs9934438 and CYP2C9 rs4086116 explained 39% and 27% of the variability in the weekly warfarin dose requirement in the Qatari and Egyptians, respectively. This is the first GWAS of warfarin dose variability in the MENA region. It confirms the importance of VKORC1 and CYP2C9 variants in warfarin dose variability among patients from the MENA region.

The Dilemma of Peri-Procedural Warfarin Management: A Narrative Review.

Periprocedural vitamin K antagonist management is a complex process and inherently entails multiple clinical issues. Marked variations have been reported in different aspects of this process. These differences were noted at the clinician and institutional levels owing to the lack of evidence-based data leading to many discrepancies in decision-making. This review aims to address the gap of vitamin K antagonist periprocedural management acknowledged by previously published prescribers' questionnaires. One of the components of this process is "bridging," which aims to provide minimal interruption of the anticoagulation period through the use of heparin products. Recent studies showed that bridging is increasing bleeding risk. Secondly, interruption decision relies on the classification of thromboembolism risk which depends on trials that did not include patients with atrial fibrillation. Thirdly, the interruption duration is different among different International normalization ratio levels, which strengthens the difference in the clinical practice of preoperative vitamin K antagonist management. Lastly, the resumption of a vitamin-K antagonist after surgery has many scenarios according to the procedure and patient risk of bleeding. Vitamin-K antagonist periprocedural management is complicated due to individual practice and the lack of strictly implemented institutional standardized protocols to guide, manage and evaluate the process.

Genetic and Non-Genetic Factors Impact on INR Normalization in Preprocedural Warfarin Management.

BACKGROUND: Annually, 10% of warfarin patients will likely need to stop warfarin prior to elective surgery to achieve a baseline international normalization ratio (INR) level (INR ≤ 1.2) at the time of the procedure. This study explores the influence of genetic and non-genetic factors on INR normalization in the Arab (major part of Near Eastern) population in preprocedural warfarin management. METHODS: An observational prospective cohort study was designed to recruit Arab patients taking warfarin and scheduled for an elective procedure. Two INR readings were recorded. DNA extraction and genotyping of variants in CYP2C9*2, CYP2C9*3, CYP4F2*3, VKORC1*2, and FII (rs5896) and FVII (rs3093229) genes using real-time polymerase chain reaction were performed. RESULTS: Data from 116 patients were included in the analysis. CYP2C9 and VKORC1 genetic variants carriers required lower maintenance dose compared to non-carriers. The analysis showed that ciprofloxacin, antiplatelet medications, and INR index (INR at visit 1) are the only factors associated with the INR decline rate. Also, the proportion of CYP2C9*3 carriers with normal INR (≤1.2) on the day of surgery was significantly lower than those with wild-type genotype (28% vs 60%, p=0.013). In addition, heparin bridging, INR target, and Sudanese nationality are significant predictors of INR normalization (≤1.2) on the day of the procedure. CONCLUSION: Despite the confirmed effect of genetic factors on warfarin maintenance dose, the study was not able to find a significant effect of any genetic factor on the rate of INR normalization possibly due to the small sample size. Index INR and interacting medications showed to be significant predictors of INR decline rate.

Drive-up INR testing and phone-based consultations service during COVID-19 pandemic in a pharmacist-lead anticoagulation clinic in Qatar: Monitoring, clinical, resource utilization, and patient- oriented outcomes.

Background: Coronavirus disease 2019 (COVID-19) pandemic has resulted in unprecedented pressure on healthcare systems and led to widespread utilization of telemedicine or telehealth services. Combined with teleclinics, using drive-up fingerstick International normalized ratio (INR) testing was recommended to decrease exposure risk of anticoagulation patients. Objective: To evaluate the impact of transitioning from clinic-based anticoagulation management services to drive-up and phone-based services during COVID-19 pandemic in Qatar. Methods: The study comprised of two components: a retrospective cohort study of all eligible patients who attended anticoagulation clinic over 1-year period (6 months before and 6 months after service transition) and a cross-sectional survey of eligible patients who agreed to provide data about their satisfaction with the new service. Monitoring parameters, clinical outcomes, and resource utilization related to warfarin therapy were compared before and after service transition. Patients' experience was explored through a structured survey. Results: There was no statistically significant difference between clinic-based and phone-based anticoagulation services in mean time and number of visits within therapeutic range (P = .67; P = .06 respectively); mean number of extreme subtherapeutic and supratherapeutic INR values (P = .32 and P = .34, respectively); incidence of thromboembolic complications and warfarin related hospitalization. There was one reported bleeding and one emergency visit (0.9%) in the phone-based group vs none in the clinic-based group. Frequency of INR testing and compliance to attending clinics appointments declined significantly (P = .002; P = .001, respectively). Overall, patients were highly satisfied with the new service. The majority of patients found it better (51.6%) or just as good as the traditional service (44.5%). Patients who preferred the new service were significantly younger than their counterparts (P = .005). Conclusion: The service of drive-up INR testing and phone-based consultations was shown to be comparable to traditional anticoagulation service, a finding that supports maintaining such services as part of the new normal after the pandemic is over.

Effect of Pharmacogenetic-Based Decision Support Tools in Improving Depression Outcomes: A Systematic Review.

OBJECTIVE: Evidence supporting the utility of pharmacogenetic (PGX) tests in depression is scarce. The main objectives of this study were to summarize, update, and assess the quality of the available evidence regarding PGX testing in depression as well as estimating the impact of using PGX testing tools in depression outcomes in the Middle East/North Africa (MENA) region. METHODOLOGY: Scientific databases were systematically searched from inception to June 30, 2020 for systematic reviews and randomized controlled trials (RCTs) assessing the clinical utility of PGX tests in the treatment of depression. Meta-analyses only and RCTs that were included in eligible systematic reviews were excluded. The quality of the eligible studies was assessed using the Crowe Critical Appraisal Tool (CCAT). RESULTS: Six systematic reviews and three RCTs met the inclusion criteria and were included in this study. The results of the systematic reviews provided weak evidence on the efficacy of PGX testing, especially in patients with moderate-severe depression at 8 weeks. In addition, there was a lack of evidence regarding safety outcomes. Newer RCTs with better quality showed clinical promise regarding efficacy outcomes, especially in patients with gene-drug interactions. No evidence was found regarding PGX testing impact in the MENA region. CONCLUSION: This systematic review is an update and summary of the available literature on the clinical utility of PGX testing in depression. The findings of this study demonstrate that PGX testing prior to treatment initiation or during the course of therapy may improve efficacy outcomes. Further studies are warranted to assess the impact of PGX testing on safety outcomes.

Bridging vs Non-Bridging with Warfarin Peri-Procedural Management: Cost and Cost-Effectiveness Analyses.

The warfarin peri-procedural management in Qatar is predominantly based on bridging (63%), compared to non-bridging. This study sought to perform a first-time cost analysis of current warfarin peri-procedural management practices, including a cost-effectiveness analysis (CEA) of predominant bridging vs predominant non-bridging practices. From the hospital perspective, a one-year decision-analytic model followed the cost and success consequences of the peri-procedural warfarin in a hypothetical cohort of 10,000 atrial fibrillation patients. Success was defined as survival with no adverse events. Outcome measures were the cost and success consequences of the 63% bridging (vs not-bridging) practice in the study setting, ie, Hamad Medical Corporation, Qatar, and the incremental cost-effectiveness ratio (ICER, cost/success) of the warfarin therapy when predominantly bridging based vs when predominantly non-bridging based. The model was based on Monte Carlo simulation, and sensitivity analyses were performed to confirm the robustness of the study conclusions. As per 63% bridging practices, the mean overall cost of peri-procedural warfarin management per patient was USD 3,260 (QAR 11,900), associated with an overall success rate of 0.752. Based on the CEA, predominant bridging was dominant (lower cost, higher effect) over the predominant non-bridging practice in 62.2% of simulated cases, with a cost-saving of up to USD 2,001 (QAR 7,303) at an average of USD 272 (QAR 993) and was cost-effective in 36.9% of cases. Being between cost-saving and cost-effective, compared to predominant non-bridging practices, the predominant use of bridging with warfarin seems to be a favorable strategy in atrial fibrillation patients.