A novel cross-sector telemedical approach to detect arrhythmia in primary care patients with palpitations using a patient-activated event recorder.

BACKGROUND: Patient-activated event recorders (ER) can facilitate diagnosis in unclear palpi-tations, however impact of ER screening on further treatment in clinical routine is unknown. We investigated the feasibility and clinical value of a network-based telemetric monitoring using a patient activated ER. METHODS: The network consisted of 12 general practitioners (GP) and a department of car-diology (DC). GP-patients sent electrocardiograms (ECGs) twice daily and in case of palpitations. ECGs were transferred by email to GP and DC and analyzed independently by both. The therapeutic strategy was discussed between GP and DC. The monitoring period ended after 4 weeks or in case of detected arrhythmia. RESULTS: A group of 184 consecutive patients were retrospectively analyzed. Mean age was 57.5 ± 14.4 years (range 17-82), 104 (56.5%) were female. Significant arrhythmia occurred in 71 (38.5%) patients: Recurrence of known paroxysmal atrial fibrillation (AF; n = 27, 14.7%), de novo AF (n = 19, 10.3%), premature complexes/bigeminus (n = 13, 7.1%), sinus tachycar-dia (n = 7, 3.8%), atrioventricular nodal reentrant tachycardia (n = 3, 1.6%), and ventricular tachycardia (n = 2, 1.1%). A therapeutic consequence resulted in 63 (88.7%) patients with de-tected arrhythmia: new oral anticoagulation (n = 29, 40.8%), new antiarrhythmic medication (n = 27, 38.0%), behavioral intervention (n = 19, 26.8%), electrophysiology-study/catheter ablation (n = 4, 5.6%), cardioversion (n = 2, 2.8%), implantable cardioverter-defibrillator- -implantation (n = 1, 1.4%), and left atrial appendage occluder (n = 1, 1.4%). CONCLUSIONS: The investigated cross-sector telemetric network is a feasible approach to detect arrhythmia in patients with palpitations and may have high impact on further treatment, notably in those at risk for stroke due to AF.

Phase I clinical and pharmacokinetic study of the Novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors.

PURPOSE: BAY 43-9006 is a novel dual-action Raf kinase and vascular endothelial growth factor receptor inhibitor that inhibits tumor cell proliferation and angiogenesis. This study established the safety and pharmacokinetics of BAY 43-9006 in 69 patients with advanced refractory solid tumors. PATIENTS AND METHODS: BAY 43-9006 (50 to 800 mg) was administered once or twice daily on a varying weekly schedule. Pharmacokinetic sampling was performed in all patients; preliminary tumor response was also assessed. The effect of BAY 43-9006 on phorbol myristate acetate-stimulated ERK phosphorylation in peripheral blood lymphocytes was studied using flow cytometry. RESULTS: Mild to moderate diarrhea was the most common (55%) treatment-related adverse event. The maximum-tolerated dose was 400 mg bid continuous. Dose-limiting toxicities were grade 3 diarrhea and fatigue at 800 mg bid, and grade 3 skin toxicity at 600 mg bid. BAY 43-9006 pharmacokinetics were highly variable for single and multiple dosing, and toxicity did not appear to be dose dependent. Significant decreases of phorbol myristate acetate-stimulated ERK phosphorylation (P < .01) were identified at doses >/= 200 mg bid continuous. Forty-five patients were assessable for efficacy; one patient had a partial response (hepatocellular carcinoma at 400 mg bid continuous), 25 patients had stable disease, with eight lasting > 6 months and five for >12 months. Eighteen patients had progressive disease, and tumor response could not be evaluated in one patient. CONCLUSION: Oral BAY 43-9006 was well tolerated and appeared to provide some clinical benefits. Based on the results of this study, BAY 43-9006 at 400 mg bid continuous is recommended for ongoing and future studies.