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Including adolescents of childbearing potential in clinical trials with possible exposure to teratogenic medication: a challenge for paediatricians and researchers
This article reviews how to address practical and ethical questions regarding minor adolescents of childbearing potential enrolled in a clinical trial that may involve teratogenic medication and offers a series of concrete advice and tools for dealing with problematic situations.
Use of SGLT2 inhibitors in cardiovascular diseases: why, when and how?
The authors present an up-to-date narrative literature review of the physiological mechanisms of action, current indications, therapeutic utility and side effects of SGLT2 inhibitors.
Understanding the mechanisms of placebo and nocebo effects
The placebo effect represents an elegant model to understand how the brain works. It is worth knowing that there is not a single but many placebo effects, with different mechanisms across different systems, medical conditions and therapeutic interventions.
PedAMINES: a disruptive mHealth app to tackle paediatric medication errors
Medication errors are among the most common medical adverse events and an important cause of patient morbidity and mortality, affecting millions of people worldwide each year. This problem is especially acute in paediatric settings, where most drugs given intravenously to children are provided in vials prepared for the adult population.
Beta-blocker use and up-titration after acute ST-segment elevation myocardial infarction: a cohort study
Beta-blocker prescription after STEMI remains prevalent, but most doses are low and up-titration within one year is rare. This raises concern, particularly for patients with LVEFs <40%.
Oral antibiotic therapy in people who inject drugs (PWID) with bacteraemia
Treatment of bacteraemia in people who inject drugs remains very complex, and an interdisciplinary approach is essential in order to select the best therapy for this vulnerable group of patients.
Swiss experience of atezolizumab for platinum-pretreated urinary tract carcinoma: the SAUL study in real-world practice
Atezolizumab is an approved therapy for urothelial carcinoma based on results from phase II and III trials. The global SAUL study evaluated atezolizumab in a broader patient population more representative of real-world populations.
Early off-label treatment during pandemics? A dilemma
Decisions for or against off-label treatment need to be based on clearly defined selection and treatment criteria, a strong biological rationale, a critical appraisal of prior evidence, and the estimated harm-benefit ratio.
Five reasons why data on compassionate use of remdesivir deserved publication (and are worth reading)
Although pre-clinical data are still scarce and results from clinical trials currently underway are awaited, remdesivir has been and is still used in many patients for the treatment of forms of COVID-19 of differing severity, as part of compassionate use or expanded access programmes. Despite these premises, the recent publication in a prestigious journal of the first case-series of COVID-19 patients treated with remdesivir under a compassionate use programme has been welcomed with considerable scepticism, if not open hostility
An independent appraisal and re-analysis of hydroxychloroquine treatment trial for COVID-19
A recent open-label study claimed that hydroxychloroquine and azithromycin represent promising new options for the treatment of SARS-CoV-2. This re-analysis reveals severe limitations in the methodology of this study, including ambiguous inclusion/exclusion of participant data and inconsistent analysis techniques, and yielded nonsignificant differences between control and treatment groups across any treatment days.
