SUMMARYObjective: To compare the effectiveness of controlled-released carbamazepine (CR-CBZ) to levetiracetam (LEV) and to lamotrigine (LTG) in elderly patients with newly diagnosed focal epilepsy. Methods: Randomized, double-blind, parallel-group trial conducted between January 2007 and August 2011, in 47 ambulatory or hospital sites in Germany, Austria, or Switzerland. Eligible participants were aged ≥60, had new-onset epilepsy, had no acute illness as the cause of their seizures, and had no contraindication to the drugs in the trial. Patients were randomized 1:1:1 to CR-CBZ, LTG, or LEV. Doses were up-titrated for 6 weeks and could be maintained or adjusted depending on seizure relapse or tolerability over an additional period of 52 weeks. Primary outcome was the retention to treatment at week 58; secondary measures related to seizure and adverse event frequency. Results: Of 361 randomized patients, 359 were included (CR-CBZ n = 121, LTG n = 117, LEV n = 122) in the modified intent-to-treat population (mean age [range] 71.4 [60-95] years). At week 58, the retention rate for LEV was significantly higher than for CR-CBZ (61.5% vs. 45.8%, p = 0.02), and similar to LTG (55.6%). Seizure freedom rates at weeks 30 and 58 were not different across the groups. Twice as many patients receiving CR-CBZ discontinued due to adverse events or death compared to those in the LEV group (32.2% vs. 17.2%; odds ratio 2.28, 95% confidence interval [CI] 1.25-4.19, p = 0.007), whereas discontinuation was intermediate for LTG (26.3%). Median daily doses of completers (n = 195) were CR-CBZ 380.0 mg/day (333.0-384.0), LTG 95 mg/day (94.0-97.0), and LEV 950 mg/day (940.0-985.0). Significance: In the initial monotherapy of focal epilepsy in the elderly, 1-year retention to LEV was higher compared to CR-CBZ due to better tolerability. Retention of LTG was intermediate and close to LEV, but did not differ significantly from either comparators. NCT00438451, www.clinicaltrials.gov.
<b><i>Introduction:</i></b> Door-to-CT scan time (DCT) and door-to-needle time (DNT) are important process measures in acute ischemic stroke (AIS) patients undergoing intravenous thrombolysis (IVT). We examined the impact of a telemedical prenotification by emergency medical service (EMS) (called the “Stroke Angel” program) on DCT and DNT and IVT rate compared to standard of care. <b><i>Patients and Methods:</i></b> Two prospective observational studies including AIS patients admitted via EMS from 2011 to 2013 (cohort I; <i>n</i> = 496) and from January 1, 2015 to May 31, 2018 (cohort II; <i>n</i> = 349) were conducted. After cohort I, the 4-Item Stroke Scale and a digital thrombolysis protocol were added. Multivariable logistic and linear regression analysis was performed. <b><i>Results:</i></b> In cohort I, DCT was lower in the intervention group (13 vs. 26 min using standard of care; <i>p</i> < 0.001), but no significant difference in median DNT (35 vs. 39 min; <i>p</i> = 0.24) was observed. In cohort II, a reduction of DCT (8 vs. 15 min; <i>p</i> < 0.001) and DNT (25 vs. 29 min <i>p</i> = 0.003) was observed in the intervention group. Compared to standard of care, the likelihood of DCT ≤10 min or DNT ≤20 min in the intervention group was 2.7 (adjusted odds ratio [aOR] 2.7; 95% CI: 2.1–3.5) and 1.8 (aOR 1.8; 95% CI: 1.1–2.9), respectively. In cohort II, IVT rate was higher (aOR 1.4; 95% CI: 1.1–1.9) in the intervention group. <b><i>Conclusion:</i></b> Although the positive effects of Stroke Angel in AIS provided a rationale for implementation in routine care, larger studies of practice implementation will be needed. Using Stroke Angel in the prehospital management of AIS impacts on important process measures of IVT delivery.
Summary Introduction. The correct diagnosis of epileptic seizures and non-epileptic attacks has a decisive influence on treatment, counseling and duration of possible work limitations. Diagnostic efforts should aim towards classifying the seizure as precisely as possible. For risk assessments, e.g. at the workplace, a close cooperation and networking of all professionals involved in the epilepsy treatment, care and consultation processes is required. Aim. To present guidelines for assessment of occupational capacity of persons with epilepsy and to discuss their value in clinical practice. Method and Material. The German employer’s liability insurance association has recently published the new revised BGI 585 Risk Assessment Guidelines (DGUV information 250-001) framework and assistance in epilepsy in view of protection against unfair dismissal. These guidelines provide information on safety and health in the workplace. Throughout all the German federal states, 24 Network teams were established. During the period January 2010 and December 2013, 374 employees with epilepsy were consulted by an expert member of Network Epilepsy and Work (NEA) Team, of which 80 were prospectively included in a study and scientifically evaluated. Guidelines and discussion. While conducting the risk assessment, a special medical fact check in accordance with the guidelines was used. In addition to medical aspects, the individual vocational and occupational situation was considered. Based on this assessment an individual recommendation was made relating to continuation of employment. The project NEA established regional teams of physicians, therapists, consultants from social services, employment offices and rehabilitation authorities across Germany in order to link by networks the complex medical and social aspects of reducing the risk of people with epilepsy losing their job. Results. It was shown that support and consultation through the NEA team led to an endangered position of employment being maintained in 70% of cases. Conclusion. In many cases, loss of employment can be prevented by consequent application of DGUV information 250-001 (recently revised from BGI 585) for risk assessment of epilepsy in employment, together with improved networking between medical professionals, occupational health professionals and social services.
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