Country-based Comparison of Atrial Fibrillation Patients' Preferences for Oral Anticoagulation: An Evaluation of Discrete Choice Experiments in Five Different Countries.

ABSTRACT: The aim of this study was to examine atrial fibrillation (AF) patients' preferences regarding oral anticoagulation (OAC) characteristics and to investigate differences across 5 different countries. A multicenter discrete choice experiment was conducted in Germany, Sweden, Switzerland, Spain, and Taiwan. Study sites enrolled patients with nonvalvular AF who received continuous OAC therapy. The discrete choice experiment design considered the following 4 attributes with 2 attribute levels each: need for bridging (yes/no), interactions with food/alcohol (yes/no), need for regular international normalized ratio (INR) assessments, and frequency of intake (once/twice daily). Generally, patients (n = 1391) preferred treatment alternatives that were characterized by "no need of bridging," "no need for regular INR controls," "no interactions with food/alcohol," and "once daily intake." For this desired treatment regimen, patients were willing to accept a substantially higher travel distance/time. German patients with AF were strongly impacted in their hypothetical treatment decision by the frequency of intake (37.5%). Swedish patients on the other hand gave little importance to intake frequency (12.6%). In Switzerland, patients were especially concerned with food/alcohol interactions of the medication (34.7%), whereas this was the least important attribute for Taiwanese patients (18.9%), who ascribed the most homogenous importance to the different treatment attributes overall. In Spain, the need for regular INR assessments especially impacted the patient's treatment decision (31.9%). Patients of all countries attributed a moderate importance to the need for bridging (25.9%-34.2%). These findings may facilitate country-specific consideration of patients' preferences regarding OAC therapy, potentially increasing treatment acceptance on the patient's side with the ultimate goal of improving treatment adherence and persistence.

Nephrogenic systemic fibrosis risk after liver magnetic resonance imaging with gadoxetate disodium in patients with moderate to severe renal impairment: results of a prospective, open-label, multicenter study.

OBJECTIVE: The objective of this study was to assess the risk of gadoxetate disodium in liver imaging for the development of nephrogenic systemic fibrosis (NSF) in patients with moderate to severe renal impairment. MATERIALS AND METHODS: We performed a prospective, multicenter, nonrandomized, open-label phase 4 study in 35 centers from May 2009 to July 2013. The study population consisted of patients with moderate to severe renal impairment scheduled for liver imaging with gadoxetate disodium. All patients received a single intravenous bolus injection of 0.025-mmol/kg body weight of liver-specific gadoxetate disodium. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period. RESULTS: A total of 357 patients were included, with 85 patients with severe and 193 patients with moderate renal impairment, which were the clinically most relevant groups. The mean time period from diagnosis of renal disease to liver magnetic resonance imaging (MRI) was 1.53 and 5.46 years in the moderate and severe renal impairment cohort, respectively. Overall, 101 patients (28%) underwent additional contrast-enhanced MRI with other gadolinium-based MRI contrast agents within 12 months before the start of the study or in the follow-up. No patient developed symptoms conclusive of NSF within the 2-year follow-up. CONCLUSIONS: Gadoxetate disodium in patients with moderate to severe renal impairment did not raise any clinically significant safety concern. No NSF cases were observed.