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Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy
This study is a multicentre, randomised, non-inferiority trial conducted in both inpatient and outpatient settings in Switzerland, France and the Netherlands, targeting patients using statins for primary prevention. 1800 participants are randomly assigned 1:1 to either discontinue (intervention arm) or continue (control arm) statin therapy. The primary objective is to compare the primary composite endpoint of major CV events (non-fatal myocardial infarction or non-fatal ischaemic stroke) and all-cause death between the control and intervention groups over a follow-up duration of up to 48 months. We hypothesise that discontinuing statins does not result in shorter event-free survival, with a non-inferiority margin set at 5.2 weeks over a 2-year observation period. Secondary objectives are to compare patient-centred outcomes (health-related quality of life, muscle pain symptoms, falls and sarcopenia) and all-cause death, non-CV death, major CV events and coronary and peripheral artery revascularisation. The study is open-labelled, with blinded outcome adjudication of the primary endpoints.
The trial protocol has received approval from the local ethics committees in Switzerland, France and the Netherlands. Results will be published in a peer-reviewed journal.
Clinicaltrials.gov: NCT05178420; BASEC (Swiss Ethics Commission): 2021-01513; FOPH (Swiss national portal): SNCTP000005172; Netherlands Trial Register: NL83907.058.23; France Trial Register: 22.04747.000158– IDRCB 2022-A02481-42.
Objetivo principal: cuantificar el ruido ambiental en una unidad de cuidados intensivos y detectar las fuentes que generan los picos más altos de ruido. Metodología: se llevó a cabo un estudio observacional descriptivo en una unidad de cuidados intensivos de adultos. Se realizaron veinticinco mediciones del ruido ambiental, no consecutivas, aleatorias, durante las 24 horas del día. El nivel de ruido fue medido en decibelios. Los datos obtenidos fueron analizados descriptivamente. Resultados principales: la media de los picos máximos de ruido registrados fue de 80.8 ± 4.05 decibelios y la media de los picos mínimos fue de 37.8 ± 1.3 decibelios. El nivel de significación considerado para todos los contrastes fue p< 0.05. Los picos máximos de ruido coincidieron con las alarmas de los monitores, las llamadas telefónicas, con algunas conversaciones y con el paso del carro de las comidas. Conclusión principal: los niveles de ruido ambiental registrados fueron elevados y estuvieron muy por encima de las recomendaciones dictadas por la Organización Mundial de la Salud. Existe la necesidad de establecer estrategias educativas y estructurales para la reducción del ruido. Se proponen una serie de medidas para disminuir el ruido en nuestra unidad.
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