RESUMEN
BACKGROUND AND AIMS: The multichannel blocker dronedarone is currently indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF), with careful monitoring of cardiac, hepatic and renal function. We aimed to investigate patients' quality of life (QoL) and tolerability and effectiveness of dronedarone under real life conditions. METHODS: In the 1-year prospective, non-interventional IMPULS study, 161 office-based cardiologists, general practitioners and internists throughout Germany documented 549 patients with AF who were currently or newly prescribed dronedarone (safety set, SS). Of those, 342 patients (full analysis set, FAS) provided data on QoL at baseline, 6 months and 12 months). RESULTS: Mean age of patients was 67.6/66.3 years; 53.0 %/57.3 % were men (SS/FAS). AF type at inclusion in the SS/FAS was paroxysmal in 71.9 %/71.3 % and persistent in 26.0 %/26.6 % (missing in 2.0 %/2.0 %). The proportion of patients in sinus rhythm increased from 44.6 % at baseline to 70.2 % (SS). The mean value on the 100-point visual analogue scale (EuroQol EQ-5D) increased from 62.3 ± 17.1 at baseline by 11.4 ± 18.7 points (FAS, p<0.0001). The AF-QoL Psychological Domain improved from 44.6 ± 22.6 at baseline by 16.0 ± 23.5 points at 1 year (p<0.0001), the AF-QoL physical domain from 49.5 ± 22.1 by 10.9 ± 22.5 points (p<0.0001), and the AF-QoL sexual domain from 61.8 ± 27.1 by 6.6 ± 28.2 points (p<0.0001). In all, 136 patients (24.8 % of all patients in the safety set) had at least one adverse drug reaction (ADR) causally related to dronedarone. CONCLUSIONS: Various dimensions of quality of life of patients with AF were improved on dronedarone under clinical practice conditions. No previously unknown safety issues were noted.
Asunto(s)
Amiodarona/análogos & derivados , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Satisfacción del Paciente/estadística & datos numéricos , Calidad de Vida , Adulto , Anciano , Anciano de 80 o más Años , Atención Ambulatoria , Amiodarona/uso terapéutico , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/diagnóstico , Dronedarona , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Femenino , Alemania/epidemiología , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Prevalencia , Estudios Prospectivos , Medición de Riesgo , Resultado del TratamientoRESUMEN
1. All children should receive one form of systemic fluoride and appropriate forms of topical fluoride. 2. If a child is not receiving optimally fluoridated water, the physician or dentist should prescribe dietary fluoride supplements (tablets or drops). 3. The correct dosage must be determined based on patient age and fluoride content of the patient's main water source(s). 4. Special attention is necessary concerning fluoride intake for children breast-feeding or consuming infant formula. 5. To determine the correct fluoride dose, these steps should be followed: A. Always have a sample of the main drinking water source (usually home water) analyzed for the fluoride content before prescribing a fluoride supplement, if you do not have other specific knowledge of water fluoride content. The Ohio Department of Health, Division of Laboratories can provide water fluoride-testing services. B. When the fluoride content of the water has been determined, the fluoride level and the child's age should be compared to the Supplemental Fluoride Dosage Schedule to identify the correct supplement dose. 6. The Division of Dental Health, Ohio Department of Health can provide a list of communities that are optimally fluoridated. Please contact: Ohio Department of Health Division of Dental Health 246 N. High Street Columbus, Ohio 43266-0588 (614) 466-4180