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Background
Guideline-directed medical therapy (GDMT) is the cornerstone in the treatment of patients with heart failure and reduced ejection fraction (HFrEF) and novel substances such as sacubitril/valsartan (S/V) and sodium-glucose co-transporter-2 inhibitors (SGLT2i) have demonstrated marked clinical benefits. We investigated their implementation into real-world HF care in Germany before, during, and after the COVID-19 pandemic period.
Methods
The IQVIA LRx data set is based on ∼80% of 73 million people covered by the German statutory health insurance. Prescriptions of S/V were used as a proxy for HFrEF. Time trends were analysed between Q1/2016 and Q2/2023 for prescriptions for S/V alone and in combination therapy with SGLT2i.
Findings
The number of patients treated with S/V increased from 5260 in Q1/2016 to 351,262 in Q2/2023. The share of patients with combination therapy grew from 0.6% (29 of 5260) to 14.2% (31,128 of 219,762) in Q2/2021, and then showed a steep surge up to 54.8% (192,429 of 351,262) in Q2/2023, coinciding with the release of the European Society of Cardiology (ESC) guidelines for HF in Q3/2021. Women and patients aged >80 years were treated less often with combined therapy than men and younger patients. With the start of the COVID-19 pandemic, the number of patients with new S/V prescriptions dropped by 17.5% within one quarter, i.e., from 26,855 in Q1/2020 to 22,145 in Q2/2020, and returned to pre-pandemic levels only in Q1/2021.
Interpretation
The COVID-19 pandemic was associated with a 12-month deceleration of S/V uptake in Germany. Following the release of the ESC HF guidelines, the combined prescription of S/V and SGLT2i was readily adopted. Further efforts are needed to fully implement GDMT and strengthen the resilience of healthcare systems during public health crises.
Die COVID-19 Pandemie ist die bisher verheerendste Pandemie des 21. Jahrhunderts. Durch die Einführung neuer mRNA-basierter Impfstoffe sowie der hohen Rate natürlicher Infektionen konnte die weltweite SARS-CoV-2-Immunität gesteigert werden. Trotz aller Erfolge zur Eindämmung der Pandemie kann eine Infektion auch heute noch zu schweren Verläufen und Tod führen. Eine adäquate COVID-19-Therapie ist folglich auf potente Virostatika angewiesen. Eine durch Umgehung zeitaufwändiger klinischer Studien schnell verfügbare Alternative zu neu entwickelten Arzneimitteln ist die Anwendung etablierter Medikamente. Wir isolierten und charakterisierten ein von einem Patienten stammendes SARS-CoV-2-Virus. Dieses Virusisolat wurde bisher in elf Publikationen verwendet. Mittels quantitativer Echtzeit-Polymerasekettenreaktion untersuchten wir eine Substanzbibliothek mit mehr als 300 neuen und bereits zugelassenen Wirkstoffen auf ihre Wirksamkeit gegen SARS-CoV-2. Dabei konnten wir zeigen, dass der selektive Serotonin-Wiederaufnahmehemmer Fluoxetin die SARS-CoV-2-Replikation ab einer Dosis von 0,8 μg/ml signifikant inhibiert, einer bei der Behandlung von Depressionen häufig angewandten Dosierung. Der EC50-Wert lag bei 387 ng/ml. Die Behandlung mit Fluoxetin resultierte in einer reduzierten Zahl an Virusprotein-produzierenden Zellen, was darauf hindeutet, dass es die virale Reinfektion und/oder Proteinexpression inhibiert. Fluoxetin ist ein racemisches Gemisch, wobei das (S)-Enantiomer der potentere Serotonin-Wiederaufnahmehemmer ist. Wir konnten zeigen, dass beide Enantiomere einen vergleichbaren antiviralen Effekt gegen SARS-CoV-2 aufweisen, wodurch das (R)-Enantiomer bei virologischer Indikation gegebenenfalls präferiert werden sollte. Fluoxetin hat keinen Einfluss auf die Replikation des Tollwut-Virus und des Humanen Respiratorischen Synzytial-Virus, was auf eine Virusspezifität hindeutet. Weitere aus der Bibliothek stammende signifikante Inhibitoren der SARS-CoV-2-Replikation sind die am Institut für Organische Chemie Würzburg entwickelten Substanzen AKS 232 und AKS 128. Neben der medikamentösen Therapie ist die akkurate Bestimmung neutralisierender Antikörper gegen SARS-CoV-2 zur Quantifizierung des bestehenden (Re-) Infektionsschutzes sowie zur Planung zukünftiger Impfstrategien von großer Bedeutung. Im Rahmen dieser Arbeit entwickelten wir unter Verwendung der quantitativen Echtzeit-Polymerasekettenreaktion erfolgreich ein zuverlässiges Testverfahren zur Detektion neutralisierender anti-SARS-CoV-2 Antikörper.
This compilation focuses on adolescent mental disorders and their prevention. It comprises three distinct studies, each contributing to a deeper understanding of this critical topic. This work addresses a critical gap in the understanding of, and approach to, adolescent mental health, and as a result reveals a critically important and urgently needed policy implication for action. The thematic structure of these studies begins with an examination of the epidemiology of child and adolescent mental disorders. Baseline data were collected from N = 877 adolescents with a mean age of 12.43 years (SD = 0.65). Mental health problems, such as depressive symptoms, non-suicidal self-injury, suicidal ideation, symptoms of eating disorders, and gender differences, are thoroughly examined. Results revealed a significant portion of our sample displaying mental health problems as early as the 6th and 7th grades, with girls generally being more affected than boys. The findings underscore the importance of early adolescence in the emergence of mental health problems and thereby emphasize the need for preventive measures. Moving beyond prevalence estimates, the compilation delves into the etiology of these disorders, exploring their potential correlation with a COVID-19 infection. Understanding the early signs and risk factors is crucial for timely support. While numerous studies have investigated potential risk and protective factors during the pandemic, our focus shifts to adolescents’ coping when an infection with the virus was involved (N = 2,154, M = 12.31, SD = 0.67). We hypothesized that students infected or with close family members infected, would exhibit an increased psychopathology and a decreased functioning of protective factors such as self-efficacy or self-esteem. We found no connection between infection and the mental health status within our sample, but protective factors and mental well-being were positively associated. Thus, universal primary prevention appears to be the preferred approach for promoting mental health. Lastly, the compilation introduces LessStress, a noteworthy contribution to more evidence-based prevention programs. This universal approach is designed to reduce stress in schools, accompanied by a cluster-randomized trial to evaluate its effectiveness (estimated sample size N = 1,894). Existing studies have demonstrated the effectiveness of stress prevention, leading us to introduce a short and easy-to-implement prevention program. There is positive evidence for one-lesson interventions in schools for promoting well-being and health behaviors among adolescents. LessStress is designed based on a life skills approach that not only imparts psychoeducational content but also teaches skills relevant to everyday life and directly applicable. Throughout these studies, a common thread emerges: the pressing need to address mental disorders during childhood and adolescence. These formative years play a pivotal role in the development of mental health problems. These formative years play a crucial role in the development of mental health problems. They highlight the importance of epidemiological data collection and analysis based on the latest models to develop prevention interventions that are not only effective but also reach young people on a global level.