P5589Patterns of extended apixaban treatment for unprovoked venous thromboembolism in routine clinical practice

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Keshishian ◽  
T Lee ◽  
G Wygant ◽  
L Rosenblatt ◽  
P Hlavacek ◽  
...  
Keyword(s):  
Selection Criteria ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
P Value ◽  
Extended Treatment ◽  
Beneficial Effects ◽  
Younger Age ◽  
Coagulation Defects ◽  
Comorbidity Index ◽  
Baseline Characteristics

Abstract Background Current CHEST guidelines recommend extended anticoagulation therapy without a scheduled stop in patients with unprovoked VTE and low bleeding risk following initial anticoagulation treatment of 3 months. AMPLIFY-EXT suggests that extended treatment with apixaban beyond 6 months reduces the risk of recurrent VTE without increasing major bleeding rates. This study evaluated patterns of extended apixaban treatment among unprovoked VTE patients. Methods Utilizing 4 US commercial claims databases, this retrospective study assessed unprovoked VTE patients (VTE events that were not preceded by a provoked factor or event) who initiated apixaban within 30 days from the VTE event (01SEPT2014–31MAR2018). Patients were required to have ≥6 months continuous apixaban treatment (without a gap of >30 days). Characteristics of patients treated beyond 6 months and those who discontinued at 6 months were evaluated respectively. An additional analysis was conducted to assess proportion with apixaban treatment for ≥3 months. Results Among unprovoked VTE patients, 60.8% and 34.6% had apixaban treatment for ≥3 and ≥6 months, respectively. Of those treated for ≥6 months (3,015 after applying additional selection criteria), 75.6% continued treatment beyond 6 months and 24.4% discontinued at 6 months. Younger age and having thrombophilia were associated with a higher likelihood of treatment beyond 6 months (Table). Among patients with treatment beyond 6 months, 7.5% of patients switched from apixaban 5mg to 2.5mg, 36.5% discontinued therapy, and 1.1% switched to another oral anticoagulant (Figure). Baseline characteristics Variables Discontinued at 6 months Continued treatment beyond 6 months P-value N=735 N=2,280 Age, Mean (SD) 63.0 (15.2) 61.7 (14.3) 0.037 Gender – Female, n (%) 307 (41.8%) 892 (39.1%) 0.203 Setting of Unprovoked VTE Event – Ambulatory, n (%) 592 (80.5%) 1,834 (80.4%) 0.950 VTE Diagnosis – DVT Only, n (%) 494 (67.2%) 1,498 (65.7%) 0.452 Deyo-Charlson Comorbidity Index, Mean (SD) 1.3 (1.9) 1.3 (1.8) 0.305 Thrombophilia, n (%) 54 (7.3%) 296 (13.0%) <0.001 Coagulation Defects, n (%) 38 (5.2%) 153 (6.7%) 0.136 Baseline Bleed, n (%) 77 (10.5%) 210 (9.2%) 0.309 KM curve after 6 months of apixaban use Conclusion Among unprovoked VTE patients treated with apixaban, a large proportion did not receive ≥3 months of treatment. Although AMPLIFY-EXT showed beneficial effects of extended treatment, the percentage of patients with ≥6 months of treatment was low. Thrombophilia was the only meaningful predictor of treatment beyond 6 months. Acknowledgement/Funding This study was funded by Bristol-Myers Squibb and Pfizer Inc

P4748HASBLED score, frailty index or comorbidity index for bleeding risk assessment in patients with atrial fibrillation?

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Fauchier ◽  
A Bisson ◽  
A Bodin ◽  
N Clementy ◽  
B Pierre ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Frailty Index ◽  
Bleeding Risk ◽  
Risk Scores ◽  
P Value ◽  
Bleeding Events ◽  
Predictive Values ◽  
Comorbidity Index

Abstract Background Charlson comorbidity index (CCI) is a tool to measure comorbid disease status and a strong estimator of mortality. The quantifiable frailty phenotype has also been validated as predictive of mortality and disability. Claims data can be used to classify individuals as frail and non-frail using the Claims-based Frailty Index (CFI). We evaluated whether these tools may help to predict the risk of bleeding in patients with atrial fibrillation (AF). Methods All patients with AF seen in an academic institution were identified and followed up for mortality, stroke and bleeding events. HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT scores, CCI and CFI were calculated for each patient. Hazard ratios were calculated and predictive abilities of the scores were compared using the c-statistic in the whole population and then separately in elderly patients (>75 yo). Results Among 8962 patients with AF, 274 major bleeding events were recorded during a follow-up of 874±1054 days. Bleeding occurred more commonly in patients with higher bleeding risk scores, CCI and CFI. The 4 bleeding risk scores significantly had lower c-statistics than CCI and CFI for predicting major bleeding (table). Results were similar whether patients were treated with OAC or no OAC. In elderly patients, the c-statistics were all lower and were not significantly different for the 4 scores, CCI and CFI scores (0.594, 0,572, 0.595, 0.594, 0.616 and 0.591 for HAS-BLED, HEMORR2HAGES, ATRIA, ORBIT, CCI and CFI, respectively). Predictive values for major bleeding ROC Area 95% Conf. Interval P value vs CCI/CFI HASBLED 0.588 0.555–0.621 0.002/0.003 HEMORR2HAGES 0.564 0.531–0.598 <0.0001/<0.0001 ATRIA 0.559 0.522–0.595 <0.0001/<0.0001 ORBIT 0.577 0.542–0.612 0.0002/0.0003 Charlson, CCI 0.652 0.619–0.684 –/0.58 Frailty index, CFI 0.648 0.615–0.681 0.58/– Conclusion Comorbidities and frailty, respectively assessed with CCI and CFI, demonstrated statistically better performances in predicting major bleeding than the 4 established bleeding risk scores in AF, although all c-indexes were broadly similar. The 4 bleeding risk scores, CCI and CFI showed lower performance in predicting bleeding within elderly patients in whom they all performed equally to predict bleeding events. Given their simplicity and similar performances, the user-friendly bleeding risk scores remain attractive tools for the estimation of bleeding risk in elderly patients with AF.

Abstract TMP102: Inappropriate Dosing of Oral Anticoagulants among Patients With Non-Valvular Atrial Fibrillation

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Sulena Shrestha ◽  
Onur Baser ◽  
Xinxiang Zhou ◽  
W J Kwong
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Body Weight ◽  
Stroke Risk ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Fixed Dose ◽  
Comorbidity Index ◽  
Baseline Characteristics ◽  
Prescribing Information

Introduction: Non-vitamin K antagonist oral anticoagulants (NOACs) are fixed dose regimens indicated for stroke prevention in non-valvular atrial fibrillation (NVAF) patients. Dose adjustment is necessary in patients with renal insufficiency to optimize efficacy and safety. Objective: To assess NOAC dosing appropriateness and its effect on clinical outcomes in NVAF patients. Methods: Adult NVAF patients with ≥1 NOAC claim from 1/1/2013 to 12/31/2014, who were continuously enrolled for ≥12 months after index NOAC claim and had a documented creatinine clearance (CrCl) within 3 months before index date in the Optum/Humedica SmartFile™ database were eligible. NOAC dosage was classified as inappropriate or appropriate by level of renal function, age, and body weight per U.S prescribing information (USPI). Cox proportional models were used to assess the risks of bleeding and stroke associated with inappropriate NOAC dosing while adjusting for baseline characteristics. Results: Of the 388 eligible patients, 69 (17.8%) were inappropriately dosed. Rivaroxaban was the most commonly prescribed NOAC and had the highest inappropriate dosing rate (19.9% of 251 pts), followed by dabigatran (15.5% of 58 pts), and apixaban (12.7% of 79 pts). Most inappropriately dosed patients (73.9%) were under-dosed. Inappropriately dosed patients were older (p<0.0001), more likely to be female (p=0.008), had body weight ≤60kg (p=0.005), higher mean CHA 2 DS 2 -VASc scores (4.3 vs. 3.1, p<0.001), and higher mean Charlson Comorbidity Index (3.7 vs. 2.4, p<0.001). Inappropriately dosed patients had higher bleeding risk (15.9% vs. 5.6%, p=0.003) and similar stroke risk (7.2% vs. 5.3%, p=0.483) compared to appropriately dosed patients. Over-treated patients had a higher elevated risk of bleeding relative to appropriately dosed patients (HR=5.4, p=0.006) than under-dosed patients (HR=3.1, p=0.025). Risks of stroke for under-treated patients (HR=2.1, p=0.259) and over-treated patients (HR=0.6, p=0.690) were similar to appropriately dosed patients. Conclusion: Inappropriate dosing occurred in both patients with normal and insufficient renal function. Consideration of other factors beyond renal function is necessary to reduce bleeding risk associated with NOAC therapy.

Clinical Outcomes of Incidental Venous Thromboembolism in Cancer and Noncancer Patients: The SWIss Venous ThromboEmbolism Registry (SWIVTER)

2020 ◽  
Author(s):  
David Spirk ◽  
Tim Sebastian ◽  
Stefano Barco ◽  
Martin Banyai ◽  
Jürg H. Beer ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Mortality Rate ◽  
Recurrence Rate ◽  
Anticoagulation Therapy ◽  
Early Mortality ◽  
Recurrence Rates ◽  
Patients With Cancer ◽  
Risk Of Death ◽  
All Cause Mortality ◽  
Baseline Characteristics

Abstract Objective In patients with cancer-associated venous thromboembolism (VTE), the risk of recurrence is similar after incidental and symptomatic events. It is unknown whether the same applies to incidental VTE not associated with cancer. Methods and Results We compared baseline characteristics, anticoagulation therapy, all-cause mortality, and VTE recurrence rates at 90 days between patients with incidental (n = 131; 52% without cancer) and symptomatic (n = 1,931) VTE included in the SWIss Venous ThromboEmbolism Registry (SWIVTER). After incidental VTE, 114 (87%) patients received anticoagulation therapy for at least 3 months. The mortality rate was 9.2% after incidental and 8.4% after symptomatic VTE for hazard ratio (HR) 1.10 (95% confidence interval [CI] 0.49–2.50). After adjustment for competing risk of death, recurrence rate was 3.1 versus 2.8%, respectively, for sub-HR 1.07 (95% CI 0.39–2.93). These results were consistent among cancer (mortality: 15.9% vs. 12.6%; HR 1.32, 95% CI 0.67–2.59; recurrence: 4.8% vs. 4.7%; HR 1.02, 95% CI 0.30–3.42) and noncancer patients (mortality: 2.9% vs. 2.1%; HR 1.37, 95% CI 0.33–5.73; recurrence: 1.5% vs. 2.3%; HR 0.63, 95% CI 0.09–4.58). Patients with incidental VTE who received anticoagulation therapy for at least 3 months had lower mortality (4% vs. 41%) and recurrence rate (1% vs. 18%) compared with those who did not. Conclusion In SWIVTER, more than half of incidental VTE events occurred in noncancer patients who often received anticoagulation therapy. Among noncancer patients, early mortality and recurrence rates were similar after incidental versus symptomatic VTE. Our findings suggest that anticoagulation therapy for incidental VTE may be beneficial regardless of the presence of cancer.

scholarly journals Social determinants of telemedicine utilization in ambulatory cardiovascular patients during the COVID-19 pandemic

2021 ◽  
Author(s):  
Kemar J Brown ◽  
Njambi Mathenge ◽  
Daniela Crousillat ◽  
Jaclyn Pagliaro ◽  
Connor Grady ◽  
...  
Keyword(s):  
Statistical Significance ◽  
The Elderly ◽  
P Value ◽  
Chi Square ◽  
Cardiovascular Patients ◽  
Baseline Characteristics ◽  
Racial Ethnic ◽  
Cardiovascular Care ◽  
Zip Code ◽  
Hispanic White

Abstract Background The coronavirus disease 2019 (COVID-19) pandemic has resulted in the rapid uptake of telemedicine (TM) for routine cardiovascular care. Objectives To examine the predictors of TM utilization among ambulatory cardiology patients during the COVID-19 pandemic. Methods In this single centre retrospective study, all ambulatory cardiovascular encounters occurring between March 16th - June 19th, 2020 were assessed. Baseline characteristics by visit type (in-person, TM-phone, TM-video) were compared using Chi-square and student t-tests, with statistical significance defined by p value &lt; 0.05. Multivariate logistic regression was used to explore the predictors of TM versus in-person care. Results 8446 patients (86% Non-Hispanic White, 42% female, median age 66.8 +/- 15.2 years) completed an ambulatory cardiovascular visit during the study period. TM-phone (n = 4,981, 61.5%) was the primary mode of ambulatory care followed by TM-video (n = 2693, 33.2%). Non-Hispanic Black race (OR 0.56; 95% CI: 0.35 - 0.94, p-value=0.02), Hispanic ethnicity (OR 0.53; 95% CI: 0.29 - 0.98, p = 0.04), public insurance (Medicaid OR 0.50; 95% CI:0.32 – 0.79, p = 0.003, Medicare OR 0.65; 95% CI: 0.47– 0.89, p = 0.009), zip-code linked median household income (MHI) of &lt;$75,000, age &gt;85 years, and patients with a diagnosis of heart failure were associated with reduced access to TM-video encounters and a higher likelihood of in-person care. Conclusions Significant disparities in TM-video access for ambulatory cardiovascular care exist among the elderly, lower income, as well as Black and Hispanic racial/ethnic groups.

scholarly journals 752. Timing of Antibiotics Administration in Emergency Department and Mortality in Sepsis by Sepsis-3 Definition

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S335-S336
Author(s):  
Hyeri Seok ◽  
Ju-Hyun Song ◽  
Ji Hoon Jeon ◽  
Hee Kyoung Choi ◽  
Won Suk Choi ◽  
...  
Keyword(s):  
Emergency Department ◽  
Sofa Score ◽  
Lactate Level ◽  
P Value ◽  
Antibiotic Administration ◽  
Risk Of Mortality ◽  
Administration Time ◽  
Comorbidity Index ◽  
Time To Antibiotics ◽  
The Mean

Abstract Background Even after the introduction of the Sepsis-3 definition, there is still debate on the ideal antibiotic administration time in patients with sepsis. This study was performed to evaluate the association between the timing of antibiotic administration and mortality in sepsis patients who visited the emergency room. Methods A prospective cohort study was conducted on patients who were diagnosed as sepsis with Sepsis-3 definition among patients who visited the emergency department (ED) of Korea University Ansan Hospital from September 2017 to January 2019. The timing of antibiotic administration was defined as the time in hours from ED arrival until the first antibiotic administration. Cox logistic regression analysis was used to estimate the association between time to antibiotics and 7-, 14-, and 28-day mortality. Results During the study period, a total of 251 patients were enrolled with a 7-, 14-, and 28-day mortality of 16.7%, 36.3%, and 57.4%, respectively. The median time to antibiotic administration was 247 minutes (interquartile range 72 – 202 minutes). The mean age was 72 ± 15 years old and 122 patients (48.6%) were female. The most common site of infection was respiratory infection. The timing of antibiotic administration were not associated with 7-, 14-, and 28-day mortality. Female (adjusted hazard ratio [HR] 2.06 [95% confidence interval (CI) 1.21 – 3.53]; P value = 0.008), SOFA score (aHR 1.17 [95% CI 1.05 - 1.31]; P = 0.005), and initial lactate level (aHR 1.13 [95% CI 1.05 - 1.22]; P = 0.001) increased the risk of 7-day mortality. Female (aHR 2.07 [95% CI 1.48 – 2.89]; P ≤ 0.001), Charlson comorbidity index (aHR 1.12 [95% CI 1.02 - 1.24]; P = 0.025), and initial lactate level (aHR 1.19 [95% CI 1.02 - 1.16]; P = 0.011) increased the risk of 14-day mortality. Female (aHR 1.95 [95% CI 1.50 – 2.54]; P = 0.001) increased the risk of 28-day mortality in patients with sepsis. Conclusion The timing of antibiotic administration did not increase the risk of mortality in the treatment of sepsis patients who visited ED. Rather, the SOFA score, lactate, female, and comorbidity increased the mortality associated with sepsis. Disclosures All authors: No reported disclosures.

Abstract 77: Balancing Risks and Benefits of Anticoagulation Therapy in Atrial Fibrillation in Community Practice: Results from the ORBIT-AF Registry

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Michael W Cullen ◽  
Sunghee Kim ◽  
Jonathan P Piccini ◽  
Alan S Go ◽  
Gregg C Fonarow ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Risk ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
Community Practice ◽  
Chads2 Score ◽  
Risk Patients ◽  
Study Population ◽  
Risk Treatment ◽  
The Cost

Background Oral anticoagulation (OAC) can reduce stroke risk at the cost of increased bleeding risk in those with atrial fibrillation (AF). Observational data have shown that higher-risk patients with AF most likely to benefit from OAC are less likely to receive OAC at hospital discharge. Methods We used data from ORBIT-AF Registry, a cohort of 9,589 AF patients enrolled among 173 participating outpatient practices. OAC was defined as warfarin or dabigatran use at study enrollment. Stroke and bleeding risk were calculated using the CHADS2 and ATRIA scores, respectively. Results The study population had a mean age of 73.5 years; 57.8% were men. Overall, 76.4% of patients received OAC. Use of OAC rose with increasing CHADS2 stroke risk, from 67% for CHADS2 <1 to 80% for CHADS2 ≥2 (p<0.0001). OAC use fell slightly with increasing ATRIA bleeding risk, from 77% for ATRIA score ≤3 to 74% with ≥5 (p=0.002 for trend). Among patients with low bleeding risk, rates of OAC increased commensurate with stroke risk (p<0.0001 for interaction; see figure). Higher bleeding risk tended to decrease rates of OAC among patients with a CHADS2 score ≥2 (p=0.13 for interaction). Conclusions In community-based outpatients with AF, use of OAC rose with increasing thromboembolic risk and declined with higher bleeding risk. These findings suggest that the risk-treatment paradox may be less that previously reported. Provision of OAC in community practice appears to appropriately consider patients' stroke and bleeding risks. Further research is required to understand how quality improvement initiatives can further improve stroke prevention.

Metabolic Abnormalities in Hypertensive patients and their Risk Factors

2021 ◽  
Vol 15 (7) ◽  
pp. 1494-1496
Author(s):  
M. Imran Ashraf ◽  
Shazana Rana ◽  
M. Salee Makhtar ◽  
Adnan Afzal ◽  
Bushra Suhail ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Selection Criteria ◽  
Hdl Cholesterol ◽  
Serum Glucose ◽  
P Value ◽  
Qualitative Variable ◽  
Hypertensive Patients ◽  
The Metabolic Syndrome ◽  
Gender Based ◽  
Basic Features

Background: Metabolic syndrome is a disorder which is categorized by the presence of various features like hypertension, obesity, insulin resistance and dyslipidemia. One of the basic features of this syndrome is hypertension that may lead to increased incidence of cardiovascular incidents. Aim: To determine the gender based comparison of metabolic syndrome among the hypertensive patients who reported in the outpatient department. Study Time: The present study was conducted from January 2019 to June 2019 over a period of six months. Methods: Known hypertensive patients aged between 20 to 50 years who fulfilled the selection criteria were included in this study. After informed written consent, the physical examination and required laboratory investigation were done. The data was entered and analysed by using SPSS version 23 Mean±standard deviation was recorded for the quantitative variables while frequency was utilized for the qualitative variable. The p-value of ≤0.05 was taken as significant. Results: A total of 85 known patients of hypertension were included in the study comprising (70.12%) males and (35.40%) females. They were evaluated for the metabolic syndrome using the Adult Treatment Panel III- A (ATP –III A) criteria. Their blood pressure was recorded and fasting blood sample were taken to determine the levels of serum glucose, HDL-cholesterol and triglyceride. Conclusion: Metabolic syndrome is more prevalent in the hypertensive patients Keywords: Metabolic syndrome, Hypertension, Dyslipidemia

scholarly journals Do Aspirin and Other Antiplatelet Drugs Reduce the Mortality in Critically Ill Patients?

Thrombosis ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Wolfgang Lösche ◽  
Janina Boettel ◽  
Björn Kabisch ◽  
Johannes Winning ◽  
Ralf A. Claus ◽  
...  
Keyword(s):  
Organ Failure ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Therapeutic Option ◽  
Bleeding Risk ◽  
Antiplatelet Drugs ◽  
Beneficial Effects ◽  
Prospective Trials ◽  
High Bleeding Risk

Platelet activation has been implicated in microvascular thrombosis and organ failure in critically ill patients. In the first part the present paper summarises important data on the role of platelets in systemic inflammation and sepsis as well as on the beneficial effects of antiplatelet drugs in animal models of sepsis. In the second part the data of retrospective and prospective observational clinical studies on the effect of aspirin and other antiplatelet drugs in critically ill patients are reviewed. All of these studies have shown that aspirin and other antiplatelet drugs may reduce organ failure and mortality in these patients, even in case of high bleeding risk. From the data reviewed here interventional prospective trials are needed to test whether aspirin and other antiplatelet drugs might offer a novel therapeutic option to prevent organ failure in critically ill patients.

scholarly journals The Effect of Aerobic Training and Ginger Extract on Lipid Profiles, Body Composition and Liver Enzymes in Obese Menopausal Women

2020 ◽  
Author(s):  
Mostafa Farhadi ◽  
Hasan Homaee ◽  
Parvin Farzanegi Arkhazlou
Keyword(s):  
Body Composition ◽  
Aerobic Training ◽  
Liver Enzymes ◽  
Training Group ◽  
Lipid Profiles ◽  
P Value ◽  
Ginger Extract ◽  
Significance Level ◽  
Beneficial Effects ◽  
Menopausal Women

Objective: The beneficial effects of exercise and ginger extract have been reported to improve obesity-related indicators. The aim of this study was to evaluate the effect of aerobic training and ginger extract on lipid profiles, body composition and selected liver enzymes in obese menopausal women. Materials and Methods: In this semi-experimental trial, 48 obese menopause women (age; 53-58 yr) were randomly divided into 4 groups including control, ginger extract, aerobic training and aerobic training -ginger extract. Aerobic training was performed 3 sessions a week, 60 minutes, with 50-70% maximum heart rate and for 24 weeks. The subjects consumed ginger extract three times a day in 500 mg capsule for 24 weeks. For analyzing the data, twoway ANOVA and Tukey's post hoc test was used with SPSS–23 and the significance level was P-value≤ 0.05. Results: The results showed that 12 and 24 weeks of training, ginger and ginger - training significantly decreased ALT and AST in obese menopausal women (P-value= 0.001). Also, 12- and 24- weeks’ ginger- training resulted to improve of body composition and lipid profile in obese menopausal women (P-value= 0.001). Conclusion: According to the findings, regular aerobic training and ginger supplementation have a beneficial effect on body composition and improvement of some liver enzymes and lipid profiles in obese menopausal women. These changes were higher in the Ginger-training group after six months of intervention.

scholarly journals Genetic and Non-Genetic Factors Association with Warfarin Long Term Therapy Stability in Sudan

2016 ◽  
Vol 8 (4) ◽  
pp. 100
Author(s):  
Azza A. M. H. Swar Aldahab ◽  
Abdallah. O. Elkhawad
Keyword(s):  
Vitamin K ◽  
Genetic Factors ◽  
Warfarin Therapy ◽  
Anticoagulation Therapy ◽  
Warfarin Dose ◽  
Term Therapy ◽  
P Value ◽  
Retrospective Case ◽  
The Impact

Anticoagulation with warfarin is characterized by a wide inter-individual variations in dose requirements and INR (International Normalised Ratio) stability, as there are evidences that warfarin response variability is associated with CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) and VKORC1 (Vitamin K epoxide reductase complex1) genetic polymorphisms. Carriers of CYP2C9*2 and VKORC11639G&gt;A variant alleles are at greater risk of unstable anticoagulation therapy. Objectives: This retrospective case control study was directed to analyze the impact of genetic and non-genetic factors on warfarin therapy in Sudanese out-patients who were on long term warfarin therapy. Method: 118 Sudanese outpatients receiving warfarin treatment for at least six months, were interviewed for their non-genetic factors that included age, sex, indication for warfarin therapy, compliance, Vitamin K rich foods intake and concomitant drug therapy, in addition to their blood samples which were taken for DNA extraction and genotyping of CYP2C9*2 and VKORC11639G&gt;A gene polymorphisms to study the genetic factors. INR stability % index was calculated, accordingly patients were classified into 2 groups, stable and unstable groups. Results: The frequencies of VKORC11639G&gt;A alleles in Sudanese out-patients who were on long term warfarin therapy were 70.3% and 29.7% for the VKORC1/G and VKORC1/A alleles respectively. The frequencies of CYP2C9*2 alleles in Sudanese out-patients were 92.4% and 7.6% for CYP2C9*1 and CYP2C9*2 alleles respectively. Variables associated with low INR stability were VKCOR1/AA genotype (p-value = 0.028) and sex (p = 0.017). Variables that showed no association with INR stability were age (p-value = 0.259), compliance (p-value = 0.058). Vitamin K rich foods intake (p- value = 0.743), and mean stable warfarin dose (p-value = 0.439). Conclusion: Polymorphism in warfarin drug target gene VKORC1-11639G&gt;A and sex are important elements of INR stability in Sudanese out- patients on long term warfarin therapy.

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