BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.

The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701).

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Now on the market in the United States for almost 3 years and available in 48 countries worldwide, solifenacin 5 mg or 10 mg once daily continues to demonstrate a profile of safety and efficacy as a treatment for incontinence, urgency, and other symptoms of OAB. More than 2.2 million patients have been treated worldwide with solifenacin. Safety and efficacy data across numerous studies in several thousand patients, along with flexible dosing, support the use of this agent as a first-line antimuscarinic treatment for OAB. Data from large randomized controlled trials such as VENUS and STAR show statistically significant superiority compared with placebo and improved outcomes over those achieved with tolterodine ER 4 mg. Solifenacin is an agent of choice for OAB-related incontinence, with more than 50% of incontinent patients reporting no incontinence episodes after 12 weeks of solifenacin therapy. In addition to improved efficacy, solifenacin offers good tolerability with a low incidence of side effects. Once-daily, flexible dosing with this agent provides 24-hour control of OAB symptoms and significantly increases warning time (the period from onset of urgency to voiding), which may also increase a patient's chance of avoiding episodes of incontinence.

In this large group of older patients, flexibly dosed solifenacin was associated with reductions in diary-documented OAB symptoms (VERSUS). In both studies, solifenacin was associated with improvements in measures assessing patients' perception of their bladder problems, symptom bother, and aspects of health-related quality of life. Adverse event rates in older patients were comparable to those in younger patients and the FAS.