Thromboembolic safety profile of low-dose estradiol (valerate) in combined hormonal preparations: Implications for the development of new hormonal endometriosis and uterine fibroid therapies

2021 ◽  
pp. 228402652110195
Author(s):  
Clare Barnett ◽  
Anja Bauerfeind ◽  
Sophia von Stockum ◽  
Klaas Heinemann
Keyword(s):  
Confidence Interval ◽  
Safety Profile ◽  
Low Dose ◽  
Cox Model ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Estradiol Valerate ◽  
Event Analysis ◽  
Venous Thromboembolic Events ◽  
Norethindrone Acetate

Background: Several promising new medications containing low-dose estradiol (E2) in combination with a progestin and an additional component, such as gonadotropin-releasing hormone antagonists, are currently being developed for use in pre-menopausal women. Objective: This pooled analysis was designed to estimate the thromboembolic safety profile of E2 and its ester, estradiol valerate (E2Val), when used in combined hormonal treatments in a pre-menopausal population. Methods: Data regarding users of combined oral contraceptives (COCs) and combined menopausal hormonal therapy (MHT) containing either E2/E2Val or ethinylestradiol (EE) ⩽ 30 µg were retrieved from five large prospective, non-interventional, cohort studies in Europe, US, and Canada with similar study design but differing medication cohorts. Propensity score sub-classification was applied to balance baseline parameters between cohorts and time-to-event analysis of venous thromboembolic events (VTE) was carried out based on the extended Cox model to calculate crude and adjusted hazard ratios (HR). Results: (1) Crude incidence rates of VTE were higher in MHT users compared to pre-menopausal COC users, (2) the VTE risk in menopausal users of E2/E2Val-norethindrone acetate was not higher than that in menopausal users of E2/E2Val-progestin (adjusted HR 0.71; 95% confidence interval, 0.41-1.26) and (3) the VTE risk in pre-menopausal users of E2/E2Val-progestin was similar, or lower, than pre-menopausal users of EE⩽30µg-progestin (adjusted HR 0.49; 95% confidence interval, 0.28–0.84). Conclusion: Our data presents a solid safety assessment of combined hormonal preparations containing E2/E2Val. We conclude that the risk of E2/E2Val-norethindrone acetate in pre-menopausal users is unlikely to be higher than the known risk of COCs containing EE ⩽ 30 µg-progestin.

scholarly journals Safety profile of anifrolumab in patients with active SLE: an integrated analysis of phase II and III trials

2021 ◽  
Vol 8 (1) ◽  
pp. e000464
Author(s):  
Raj Tummala ◽  
Gabriel Abreu ◽  
Lilia Pineda ◽  
M Alex Michaels ◽  
Rubana N Kalyani ◽  
...  
Keyword(s):  
Phase Ii ◽  
Safety Profile ◽  
Human Monoclonal Antibody ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Risk Difference ◽  
Integrated Analysis ◽  
Type I ◽  
Tract Infections ◽  
Phase Ii And Iii

ObjectiveIn phase II and III trials, anifrolumab, a human monoclonal antibody that binds type I interferon receptor subunit 1, has shown efficacy in adults with moderate to severe SLE. We evaluated the safety and tolerability of anifrolumab using data pooled from these trials to more precisely estimate the rate and severity of adverse events (AEs).MethodsData were pooled from patients receiving monthly intravenous anifrolumab 300 mg or placebo in MUSE, TULIP-1 and TULIP-2. Key safety endpoints included percentages and exposure-adjusted incidence rates (EAIRs) of patients who experienced AEs, serious AEs (SAEs), AEs leading to discontinuation and AEs of special interest.ResultsDuring treatment, 86.9% of patients receiving anifrolumab 300 mg (n=459) experienced AEs (≥1) versus 79.4% receiving placebo (n=466), and 4.1% versus 5.2% experienced an AE leading to discontinuation of investigational product. SAEs (≥1) were experienced by 11.8% and 16.7% of patients receiving anifrolumab and placebo, respectively (EAIR risk difference (95% CI) −7.2 (−12.5 to –1.9)), including lupus exacerbations classified as SAEs (1.5% and 3%, respectively). Infections occurred in 69.7% and 55.4% of patients receiving anifrolumab and placebo, respectively; difference in reported rates was driven by herpes zoster (HZ) and mild and moderate respiratory (excluding pneumonia) infections. The risk of HZ was increased with anifrolumab versus placebo (6.1% vs 1.3%, respectively; EAIR risk difference (95% CI) 5.4 (2.8 to 8.4)); most HZ events were mild or moderate, cutaneous and resolved without treatment discontinuation. Serious infections occurred in 4.8% and 5.6% of patients receiving anifrolumab and placebo, respectively.ConclusionsIn this pooled analysis of 925 patients with moderate to severe SLE, monthly intravenous anifrolumab 300 mg was generally well tolerated over 52 weeks with an acceptable safety profile. Anifrolumab was associated with an increased incidence of HZ and respiratory tract infections and lower reported rate of SLE worsening as SAEs.

Efficacy of Adjuvant Fluorouracil and Folinic Acid in B2 Colon Cancer

1999 ◽  
Vol 17 (5) ◽  
pp. 1356-1356 ◽  
Keyword(s):  
Colon Cancer ◽  
Confidence Interval ◽  
Folinic Acid ◽  
Cox Model ◽  
Pooled Analysis ◽  
Treatment Control ◽  
Data Set ◽  
Poorly Differentiated ◽  
Small Benefit

PURPOSE: The goal of this analysis was to determine whether fluorouracil (FU) and folinic acid (leucovorin, LV) is an effective adjuvant therapy for patients after potentially curative resection of colon cancer in patients with B2 tumors. PATIENTS AND METHODS: One thousand sixteen patients with B2 colon cancer entered onto five separate trials were randomized to FU + LV or observation. A pooled analysis for event-free (EFS) and overall survival (OS) using a stratified log-rank and Cox model was performed. RESULTS: The median follow-up duration was 5.75 years. Patients receiving FU + LV did not experience a significant increase in EFS or OS. The hazards ratio at 5 years was 0.83 (90% confidence interval, 0.72 to 1.07) for EFS and 0.86 (90% confidence interval, 0.68 to 1.07) for OS. The 5-year EFS was 73% for controls and 76% for FU + LV. The 5-year OS was 80% for controls and 82% for FU + LV. Increasing age and poorly differentiated tumors were significant indicators of poor prognosis (P < .02). CONCLUSION: This data set does not support the routine use of FU + LV in all patients with B2 colon cancer. Longer follow-up may identify a small benefit. At present, studies in B2 colon cancer designed with a no-treatment control arm should be considered appropriate.

Use of a low-dose oral contraceptive containing norethindrone acetate and ethinyl estradiol in the treatment of moderate acne vulgaris

2001 ◽  
Vol 1 (3) ◽  
pp. 123-131 ◽  
Author(s):  
J. Michael Maloney ◽  
Deborah I. Arbit ◽  
Mary Flack ◽  
Constance McLaughlin-Miley ◽  
Cynthia Sevilla ◽  
...  
Keyword(s):  
Oral Contraceptive ◽  
Low Dose ◽  
Ethinyl Estradiol ◽  
Acne Vulgaris ◽  
Dose Oral ◽  
Dose Oral Contraceptive ◽  
Norethindrone Acetate

scholarly journals O09 Safety profile of baricitinib for the treatment of RA up to 8.4 years: an updated integrated safety analysis

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Kevin L Winthrop ◽  
Tsutomu Takeuchi ◽  
Gerd Burmester ◽  
Walter Deberdt ◽  
Douglas Schlichting ◽  
...  
Keyword(s):  
Safety Profile ◽  
Incidence Rates ◽  
Janus Kinase ◽  
Major Adverse Cardiovascular Events ◽  
Stock Ownership ◽  
Research Support ◽  
Vein Thrombosis ◽  
Non Melanoma Skin Cancer ◽  
Deep Vein

Abstract Background/Aims  Baricitinib (BARI) is an oral selective inhibitor of Janus kinase (JAK)1/2, approved for treatment of moderate-to-severe- rheumatoid arthritis (RA) in adults. Here, we update the drug’s safety profile with data up to 8.4 years of treatment. Methods  Long-term safety of BARI was assessed from 9 completed randomized trials(5 Ph3, 3 Ph2, 1 Ph 1b) and 1 ongoing long-term extension(LTE) study. Incidence rates(IRs) per 100 patient-years (PY) were calculated for all RA patients treated with ≥1 dose of BARI through 1-Sep-2019(All-BARI-RA set). IRs for deep vein thrombosis(DVT), pulmonary embolism(PE), and DVT and/or PE(DVT/PE) were also calculated for groups of patients while receiving BARI 2mg/4mg within All-BARI-RA. Major adverse cardiovascular events(MACE) were adjudicated in 5 Ph3 studies and the LTE. Results  3770 pts received BARI for 13,148 PY, with median and maximum exposure: 4.2 and 8.4 years, respectively. Overall IRs per 100 PY were: for any treatment-emergent adverse event (AE)(25.8); serious AE (including death)(7.2); temporary interruption due to AE (9.5); permanent discontinuation due to AE (4.8); death (0.52); serious infection (2.7); opportunistic infection (0.46)(excluding tuberculosis [TB], including multidermatomal herpes zoster [HZ]); TB (0.15); HZ (3.0); MACE (0.50); DVT (0.31); PE (0.24); DVT/PE (0.46); malignancies excluding non-melanoma skin cancer (NMSC)(0.91); NMSC (0.33); lymphoma (0.07); and gastrointestinal perforation (0.04). (IRs)[95% confidence intervals] for patients while receiving BARI 2mg (N = 1077) and BARI 4mg (N = 3400) were DVT 2mg (0.38)[0.18, 0.73] and 4mg (0.30)[0.21, 0.43]; PE 2mg (0.26)[0.09, 0.56] and 4mg (0.25)[0.16, 0.36]; and DVT/PE 2mg (0.47)[0.23, 0.84] and 4mg (0.46)[0.34, 0.61]. IRs for death tended to increase in later time intervals (beyond 192 weeks). No particular cause of death contributed to this increase. For all other safety topics of interest, across 48-week treatment intervals, IRs remained stable over time. Across safety topics, IRs were consistent with previous analyses. Conclusion  In this update, with 3021 additional PY of exposure, BARI maintained a safety profile similar to that previously reported, with no increase of IRs across safety topics through exposures up to 8.4 years. Disclosure  K.L. Winthrop: Consultancies; AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly and Company, Pfizer, and UCB Pharma. Grants/research support; Bristol Myers Squibb and Pfizer. T. Takeuchi: Consultancies; AbbVie, Asahi Kasei Medical, Astellas, AstraZeneca, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly and Company, GlaxoSmithKline, Janssen, Mitsubishi Tanabe Pharma, Nippon Kayaku, Novartis, Pfizer Japan, Taiho Pharmaceutical, Taiho Toyama Pharmaceutical, Takeda, and UCB Japan. G. Burmester: Consultancies; Eli Lilly and Company, Janssen, Novartis, and Pfizer. Grants/research support; Eli Lilly and Company. W. Deberdt: Shareholder/stock ownership; Eli Lilly and Company. D. Schlichting: Shareholder/stock ownership; Eli Lilly and Company. D. Mo: Shareholder/stock ownership; Eli Lilly and Company. C. Walls: Shareholder/stock ownership; Eli Lilly and Company. J.S. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro Pharma, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Eli Lilly and Company, Gilead Sciences, ILTOO Pharma, Janssen, MedImmune, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB Pharma. Grants/research support; AbbVie, Eli Lilly and Company, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche.

scholarly journals POS0774 INFLUENZA INFECTION AS A TRIGGER FOR SYSTEMIC LUPUS ERYTHEMATOSUS FLARES RESULTING IN HOSPITALIZATION

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 641.1-641
Author(s):  
Y. B. Joo ◽  
Y. J. Park
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Confidence Interval ◽  
Lupus Erythematosus ◽  
Influenza Infection ◽  
Age Groups ◽  
Case Series ◽  
Incidence Rates ◽  
Systemic Lupus ◽  
Control Interval ◽  
The Impact

Background:Infections have been associated with a higher risk of systemic lupus erythematosus (SLE) flares, but the impact of influenza infection on SLE flares has not been evaluated.Objectives:We evaluated the association between influenza infection and SLE flares resulting in hospitalization.Methods:SLE flares resulting in hospitalization and influenza cases were ascertained from the Korean national healthcare insurance database (2014-2018). We used a self-controlled case series design. We defined the risk interval as the first 7 days after the influenza index date and the control interval was defined as all other times during the observation period of each year. We estimated the incidence rates of SLE flares resulting in hospitalization during the risk interval and control interval and compared them using a Poisson regression model.Results:We identified 1,624 influenza infections among the 1,455 patients with SLE. Among those, there were 98 flares in 79 patients with SLE. The incidence ratio (IR) for flares during the risk interval as compared with the control interval was 25.75 (95% confidence interval 17.63 – 37.59). This significantly increased the IRs for flares during the risk interval in both women (IR 27.65) and men (IR 15.30), all age groups (IR 17.00 – 37.84), with and without immunosuppressive agent (IR 24.29 and 28.45, respectively), and with and without prior respiratory diseases (IR 21.86 and 26.82, respectively).Conclusion:We found significant association between influenza infection and SLE flares resulting in hospitalization. Influenza infection has to be considered as a risk factor for flares in all SLE patients regardless of age, sex, medications, and comorbidities.References:[1]Kwong, J. C. et al. Acute Myocardial Infarction after Laboratory-Confirmed Influenza Infection. N Engl J Med 2018:378;345-353.Table 1.Incidence ratios for SLE flares resulting in hospitalization after influenza infectionRisk intervalIncidence ratio95% CIDuring risk interval for 7 days / control interval25.7517.63 – 37.59Days 1-3 / control interval21.8114.71 – 32.35Days 4-7 / control interval7.563.69 – 15.47SLE, systemic lupus erythematosus; CI, confidence intervalDisclosure of Interests:None declared

scholarly journals Flunarizine as prophylaxis for episodic migraine: a systematic review with meta-analysis

Ból ◽  
2019 ◽  
Vol 20 (1) ◽  
pp. 25-38
Author(s):  
Anker Stubberud ◽  
Nikolai Melseth Flaaen ◽  
Douglas C. McCrory ◽  
Sindre Andre Pedersen ◽  
Mattias Linde
Keyword(s):  
Confidence Interval ◽  
Meta Analysis ◽  
Episodic Migraine ◽  
Pooled Analysis ◽  
Risk Of Bias ◽  
Current Guideline ◽  
Data Synthesis ◽  
Randomized Controlled ◽  
The Mean ◽  
Meta Analyses

Based on few clinical trials, flunarizine is considered a first-line prophylactic treatment for migraine in several guidelines. In this meta-analysis, we examined the pooled evidence for its effectiveness, tolerability, and safety. Prospective randomized controlled trials of flunarizine as a prophylaxis against migraine were identified from a systematic literature search, and risk of bias was assessed for all included studies. Reduction in mean attack frequency was estimated by calculating the mean difference (MD), and a series of secondary outcomes –including adverse events (AEs) – were also analyzed. The database search yielded 879 unique records. Twentyfive studies were included in data synthesis. We scored 31/175 risk of bias items as “high”, with attrition as the most frequent bias. A pooled analysis estimated that flunarizine reduces the headache frequency by 0.4 attacks per 4 weeks compared with placebo (5 trials, 249 participants: MD 20.44; 95% confidence interval 20.61 to 2 0.26). Analysis also revealed that the effectiveness of flunarizine prophylaxis is comparable with that of propranolol (7 trials, 1151 participants, MD 20.08; 95% confidence interval 20.34 to 0.18). Flunarizine also seems to be effective in children. The most frequent AEs were sedation and weight increase. Meta-analyses were robust and homogenous, although several of the included trials potentially suffered from high risk of bias. Unfortunately, reporting of AEs was inconsistent and limited. In conclusion, pooled analysis of data from partially outdated trials shows that 10- mg flunarizine per day is effective and well tolerated in treating episodic migraine – supporting current guideline recommendations.

Survival analysis

2020 ◽  
pp. 181-218
Author(s):  
Bendix Carstensen
Keyword(s):  
Survival Analysis ◽  
Competing Risks ◽  
Cox Model ◽  
Survival Function ◽  
Event Analysis ◽  
Time To Event ◽  
Poisson Models ◽  
Kaplan Meier ◽  
Analysis Survival ◽  
Event Rates

This chapter describes survival analysis. Survival analysis concerns data where the outcome is a length of time, namely the time from inclusion in the study (such as diagnosis of some disease) till death or some other event — hence the term 'time to event analysis', which is also used. There are two primary targets normally addressed in survival analysis: survival probabilities and event rates. The chapter then looks at the life table estimator of survival function and the Kaplan–Meier estimator of survival. It also considers the Cox model and its relationship with Poisson models, as well as the Fine–Gray approach to competing risks.

Effects of dopamine and domperidone on ventilatory sensitivity to hypoxia after 8 h of isocapnic hypoxia

1999 ◽  
Vol 86 (1) ◽  
pp. 222-229 ◽  
Author(s):  
Michala E. F. Pedersen ◽  
Keith L. Dorrington ◽  
Peter A. Robbins
Keyword(s):  
Confidence Interval ◽  
Lower Limit ◽  
Analysis Of Variance ◽  
Significant Interaction ◽  
Low Dose ◽  
Ventilatory Response ◽  
Hypoxic Ventilatory Response ◽  
Dopaminergic Activity ◽  
Sustained Hypoxia

Acclimatization to altitude involves an increase in the acute hypoxic ventilatory response (AHVR). Because low-dose dopamine decreases AHVR and domperidone increases AHVR, the increase in AHVR at altitude may be generated by a decrease in peripheral dopaminergic activity. The AHVR of nine subjects was determined with and without a prior period of 8 h of isocapnic hypoxia under each of three pharmacological conditions: 1) control, with no drug administered; 2) dopamine (3 μg ⋅ min−1 ⋅ kg−1); and 3) domperidone (Motilin, 40 mg). AHVR increased after hypoxia ( P ≤ 0.001). Dopamine decreased ( P ≤ 0.01), and domperidone increased ( P ≤ 0.005) AHVR. The effect of both drugs on AHVR appeared larger after hypoxia, an observation supported by a significant interaction between prior hypoxia and drug in the analysis of variance ( P ≤ 0.05). Although the increased effect of domperidone after hypoxia of 0.40 l ⋅ min−1 ⋅ %saturation−1[95% confidence interval (CI) −0.11 to 0.92 l ⋅ min−1 ⋅ %−1] did not reach significance, the lower limit for this confidence interval suggests that little of the increase in AHVR after sustained hypoxia was brought about by a decrease in peripheral dopaminergic inhibition.

Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma

2017 ◽  
Vol 35 (34) ◽  
pp. 3815-3822 ◽  
Author(s):  
Mario Sznol ◽  
Pier Francesco Ferrucci ◽  
David Hogg ◽  
Michael B. Atkins ◽  
Pascal Wolter ◽  
...  
Keyword(s):  
Median Time ◽  
Safety Profile ◽  
Progression Free Survival ◽  
Pooled Analysis ◽  
Advanced Melanoma ◽  
Cytotoxic T Cell ◽  
Programmed Death ◽  
Programmed Death 1 ◽  
Grade 3 ◽  
Time To Onset

Purpose The addition of nivolumab (anti–programmed death-1 antibody) to ipilimumab (anti–cytotoxic T-cell lymphocyte–associated 4 antibody) in patients with advanced melanoma improves antitumor response and progression-free survival but with a higher frequency of adverse events (AEs). This cross-melanoma study describes the safety profile of the approved nivolumab plus ipilimumab regimen. Methods This retrospective safety review on data from three trials (phase I, II, and III) included patients with advanced melanoma who received at least one dose of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks × 4 and then nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity while following established guidelines for AE management. Analyses were of all treatment-related AEs, select (immune-related) AEs, time to onset and resolution, and use of immune-modulating agents and their effects on outcome. Results Among 448 patients, median duration of follow-up was 13.2 months. Treatment-related grade 3/4 AEs occurred in 55.5% of patients; 35.7% had treatment-related AEs that led to discontinuation. The most frequent treatment-related select AEs of any grade were skin (64.3%) and GI (46.7%) and of grade 3/4, hepatic (17.0%) and GI (16.3%); 30.1% developed a grade 2 to 4 select AE in more than one organ category. Median time to onset of grade 3/4 treatment-related select AEs ranged from 3.1 (skin) to 16.3 (renal) weeks, and with the exclusion of endocrine AEs, median time to resolution from onset ranged from 1.9 (renal) to 4.5 (pulmonary) weeks, with resolution rates between 79% and 100% while using immune-modulating agents. Four (< 1%) on-study deaths were attributed to therapy. Conclusion Frequency of grade 3/4 treatment-related AEs was higher with nivolumab plus ipilimumab and occurred earlier than historical experience with either agent alone, but resolution rates were similar.

P4794Comparative effectiveness and safety of non-VKA oral anticoagulants versus warfarin in non-valvular atrial fibrillation patients with differential treatment duration: an ARISTOPHANES study analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Deitelzweig ◽  
A Keshishian ◽  
A Kang ◽  
A Dhamane ◽  
X Luo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Treatment Duration ◽  
Oral Anticoagulants ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Duration Of Treatment ◽  
Cox Models ◽  
Hazard Ratios

Abstract Background The ARISTOPHANES (Anticoagulants for Reduction In STroke: Observational Pooled analysis on Health outcomes ANd Experience of patientS) study showed that non-vitamin K antagonist oral anticoagulants (NOACs) were associated with lower risks of stroke/systemic embolism (S/SE) and variable comparative risks of major bleeding (MB) versus warfarin. Purpose To assess long-term use of non-VKA oral anticoagulants (NOACs) vs. warfarin in ARISTOPHANES by evaluating the risk of S/SE and MB among non-valvular atrial fibrillation (NVAF) patients by duration of treatment (<1 and ≥1 year). Methods In the ARISTOPHANES study, NVAF patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from 01/01/2013–09/30/2015 were identified from the CMS Medicare data and four US commercial claims databases, covering >180 million beneficiaries annually (∼56% of US population). After 1:1 propensity score matching (PSM) in each database between NOACs and warfarin (apixaban-warfarin, dabigatran-warfarin, and rivaroxaban-warfarin), the resulting patient records were pooled. Treatment duration was defined as time between the day after the treatment index date and discontinuation (30 days after a 30-day gap in the prescription), treatment switch, death, end of study period, or end of continuous medical and pharmacy enrollment, whichever occurred first. Matched patients with observed treatment duration <1 or ≥1 year were separately examined. Cox models were used to estimate hazard ratios of S/SE and MB (identified by inpatient claims) during observed treatment duration. Results The mean treatment duration for patients with shorter (<1 year) vs longer (≥1 year) duration was 4–5 months vs 18–21 months across the three matched cohorts. All the matched baseline variables remained balanced. The incidence rates of S/SE and MB and the proportion of patients with treatment discontinuation were higher in patients with shorter treatment duration. Regardless of treatment duration, apixaban patients had a lower risk of S/SE and MB versus warfarin; dabigatran patients had a lower risk of MB versus warfarin; and rivaroxaban patients had a lower risk of S/SE versus warfarin. Compared to warfarin patients, dabigatran patients with treatment duration <1 year had a similar risk of S/SE, while those with treatment duration ≥1 year had lower S/SE risk; rivaroxaban patients with treatment duration <1 year had a higher risk of MB, while those with treatment duration ≥1 year had similar MB risk. Conclusions Among NVAF patients with duration of treatment <1 and ≥1 year in the ARISTOPHANES study, apixaban and rivaroxaban were associated with lower risk of S/SE, while apixaban and dabigatran were associated with lower risk of MB, compared to warfarin. These findings indicate varying long-term effectiveness and safety outcomes between NOACs and warfarin. Acknowledgement/Funding This study was funded by Bristol-Myers Squibb and Pfizer Inc.

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