Good agricultural practice and integrated plant protection in the new Plant Protection Law

Das am 14.02.2012 in Kraft getretene Pflanzenschutz­gesetz (PflSchG) (1) setzt in erster Linie europarecht­liche Vorgaben um. Im § 3 PflSchG – der die gute fach­liche Praxis und den integrierten Pflanzenschutz regelt – finden sich die Vorgaben des Art. 14 der Richtlinie 2009/128/EG (RL) (2) wieder. Beide Vorschriften stehen im Fokus dieses Beitrages, denn gerade die gute fachliche Praxis und der integrierte Pflanzenschutz haben einen hohen steuernden Einfluss beim praktischen Pflanzenschutz. Die Ziele dieser Vorschrift, wie auch deren Bedeutungsgehalt im Gesamtkontext der Gesetze werden dargestellt.    The new Plant Protection Law which came into force on 14th February 2012 transfers especially European law standards. In § 3 PflSchG – which rules the good agri­cultural practice and the integrated plant protection – the essential content of Art. 14 Directive 2009/128/EC turns up again. Both regulations are in the focus of the publication, the good agricultural practice and the integrated plant protection have a high steering influence on the practical plant protection. The aims of this paragraph and also the meaning in the overall context of the laws will be shown.   &nbsp

The use of plant protection products on areas intended for the public

Am 14.02.2012 ist das neue Pflanzenschutzgesetz (PflSchG) (1) in Kraft getreten. Durch das Gesetz werden in erster Linie europarechtliche Vorgaben umgesetzt. Damit sind zugleich zahlreiche Neuerungen verbunden, auch im Bereich der Anwendung von Pflanzenschutz­mitteln. Eine der neu eingeführten Vorschriften ist § 17 PflSchG, der die Anwendung von Pflanzenschutzmitteln auf Flächen, die für die Allgemeinheit bestimmt sind, regelt. Der Rechtsbegriff, Flächen, die für die Allgemeinheit bestimmt sind, wird in der Einordnung des euro­päischen Rechts und in der Umsetzung in das deutsche Recht beleuchtet. Schließlich werden der Regelungsumfang in einer Gesamtschau gewertet und Problembereiche erläutert. Eine Harmonisierungsmöglichkeit dieses Rechtsbegriffes wird aufgezeigt.    The new Plant Protection Law came into force on 14th February 2012. By that law European standards are implemented. Many news are regulated also in the use of plant protection products. One of the new implemented regulations is § 17 PflSchG, which rules the use of plant protection products on areas intended for the public. The legal term “areas intended for the public” will be analyzed in the light of European Directive and on the implementation into German law. After all the term will be evaluated in an overview and problems are discussed. A possibility of harmonization of this legal term will be illustrated.   &nbsp

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure

BACKGROUND The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016 -002299-28.)