Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials.

Using an I.M.S.

All-cause mortality and use of antithrombotics within 90 days of discharge in acutely ill medical patients.

Conflicting evidence exists regarding predictors of and antithrombotic benefit on mortality in hospitalised acutely-ill medical patients. We compared mortality risk within 90 days post-discharge among medically ill patients who did and did not receive antithrombotics. This retrospective claims analysis included patients ≥ 40 years with nonsurgical hospitalisation ≥ 2 days between 2005 and 2009 using the HealthCore Integrated Research Database.

International normalized ratio stability in warfarin-experienced patients with nonvalvular atrial fibrillation.

Background: Maintaining stable levels of anticoagulation using warfarin therapy is challenging. Few studies have examined the stability of the international normalized ratio (INR) in patients with nonvalvular atrial fibrillation (NVAF) who have had ≥6 months' exposure to warfarin anticoagulation for stroke prevention.

Objective: Our objective was to describe INR control in NVAF patients who had been receiving warfarin for at least 6 months.

Back to first principles: a new model for the regulation of drug promotion.

The US Food and Drug Administration's ('FDA' or the 'Agency') current regulatory framework for drug promotion, by significantly restricting the ability of drug manufacturers to communicate important, accurate, up-to-date scientific information about their products that is truthful and non-misleading, runs afoul of the First Amendment and actually runs counter to the Agency's public health mission. Our article proposes a New Model that represents an initial proposal for a modern, sustainable regulatory framework that comprehensively addresses drug promotion while protecting the public health, protecting manufacturers' First Amendment rights, establishing clear and understandable rules, and maintaining the integrity of the FDA approval process. The New Model would create three categories of manufacturer communications-(1) Scientific Exchange and Other Exempt Communications, (2) Non-Core Communications, and (3) Core Communications-that would be regulated consistent with the First Amendment and according to the strength of the government's interest in regulating the specific communications included within each category.

Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban.

Background: In nonvalvular atrial fibrillation (NVAF), rivaroxaban is used to prevent stroke and systemic embolism.

Objective: To evaluate major bleeding (MB) in NVAF patients treated with rivaroxaban in a real-world clinical setting.

Methods: From January 1, 2013, to March 31, 2014, US Department of Defense electronic health care records were queried to describe MB rates and demographics.

International normalized ratio stabilization in newly initiated warfarin patients with nonvalvular atrial fibrillation.

Background: Warfarin is effective for stroke prevention in patients with atrial fibrillation (AF), but international normalized ratio (INR) levels fluctuate and frequent monitoring is necessary.

Methods: This study used data from a large anticoagulation management service database to analyze the relationship between INR stabilization and warfarin utilization for >1 year in patients with nonvalvular AF (NVAF). Anticoagulation records from a large US electronic database collected from 2006 to 2010 were analyzed.

Rationale and design of VENTURE-AF: a randomized, open-label, active-controlled multicenter study to evaluate the safety of rivaroxaban and vitamin K antagonists in subjects undergoing catheter ablation for atrial fibrillation.

Purpose: To evaluate the safety of uninterrupted rivaroxaban, a novel oral anticoagulant that directly inhibits factor Xa, and a vitamin K antagonist (VKA) in eligible adult patients with nonvalvular AF (NVAF) who are scheduled for a catheter ablation.

Methods/design: This is a prospective, randomized, open-label, active-controlled, global multicenter safety study of up to 250 randomized patients. Eligible patients with paroxysmal or persistent NVAF, a left ventricular ejection fraction >40 %, and a creatinine clearance >50 mL/min will be randomized 1:1 to rivaroxaban 20 mg orally once daily or to dose-adjusted oral VKA (recommended international normalized ratio (INR) 2.

Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.

Purpose: Because some patients have difficulty swallowing a whole tablet, we investigated the relative bioavailability of a crushed 20 mg rivaroxaban tablet and of 2 alternative crushed tablet dosing strategies.

Methods: Stability and nasogastric (NG) tube adsorption characteristics of a crushed rivaroxaban tablet were assessed. Then, in 55 healthy adults, relative bioavailability of rivaroxaban administered orally as a whole tablet (Reference [Whole-Oral]), crushed tablet in applesauce suspension (Crushed-Oral), or crushed tablet in water suspension via NG tube (Crushed-NG) were determined.

Thromboprophylaxis patterns, risk factors, and outcomes of care in the medically ill patient population.

Introduction: Medically ill, hospitalized patients are at increased risk for venous thromboembolism (VTE) after discharge. This study aimed to examine thromboprophylaxis patterns, risk factors, and post-discharge outcomes.

Methods: This was a retrospective claims analysis involving administrative claims data and in-patient data abstracted from a sample of hospital charts.

Impact of co-morbidities and patient characteristics on international normalized ratio control over time in patients with nonvalvular atrial fibrillation.

This study determined the association between co-morbidities, including heart failure (HF) and time in therapeutic range (TTR), in patients with nonvalvular atrial fibrillation. Longitudinal patient-level anticoagulation management records collected from 2006 to 2010 were analyzed. Adult patients with nonvalvular atrial fibrillation who used warfarin for a 12-month period with no gap of >60 days between visits were identified.

One-year adherence to warfarin treatment for venous thromboembolism in high-risk patients and its association with long-term risk of recurrent events.

Backgrounds: Warfarin is the predominant oral anticoagulant used for the prevention of recurrent venous thromboembolism (VTE) events. However, its long-term use is complicated by the need to manage the drug within a narrow therapeutic range and by possible food and drug interactions.

Objective: To examine the association between 1-year adherence, measured through compliance with and persistence on warfarin treatment for VTE, and long-term risk of recurrent events among patients at high risk.

Antithrombotic medication use and bleeding risk in medically ill patients after hospitalization.

Background: Hospitalized medically ill patients receiving antithrombotic medications experience increased risk of bleeding. We examined antithrombotic use, bleeding rates, and associated risk factors at 30 days post discharge.

Methods: This retrospective database analysis included nonsurgical patients aged ≥40 years hospitalized for ≥2 days during 2005 to 2009.

Trends in hypertension prevalence, awareness, treatment, and control rates in United States adults between 1988-1994 and 1999-2004.

This study assesses trends in hypertension prevalence, blood pressure distributions and mean levels, and hypertension awareness, treatment, and control among US adults, age >or=18 years, between the third National Health and Nutrition Examination Survey (1988-1994) and the 1999-2004 National Health and Nutrition Examination Survey, a period of approximately 10 years. The age-standardized prevalence rate increased from 24.4% to 28.

Absolute stroke mortality burden for non-Hispanic non-Latino whites was disproportionately higher than expected simply based on the US population in 2001.

Background And Purpose: The absolute burden of stroke is a major determinant of health care costs and should also be considered when developing and implementing effective health policy. This study evaluated the impact of specific racial-ethnic categorization on absolute stroke mortality burden and population percentages.

Methods: In this population-based analysis, 2001 US data was used to compute absolute values of population and stroke mortality burden for white and black, and other racial-ethnic groups.

The burden of adult hypertension in the United States 1999 to 2000: a rising tide.

This study aims to estimate the absolute number of persons with hypertension (the hypertension burden) and time trends using data from the National Health and Nutrition Examination Survey of United States resident adults who had hypertension in 1999 to 2000. This information is vitally important for health policy, medical care, and public health strategy and resource allocation. At least 65 million adults had hypertension in 1999 to 2000.