RESUMEN
INTRODUCTION: The cognitive safety of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) has been established in clinical trials, but not yet in real-world observational studies. We assessed the cognitive function in patients initiating PCSK9i, and differences in cognitive function domains, to analyze subgroups by the low-density lipoprotein cholesterol (LDL-C) achieved, and differences between alirocumab and evolocumab. METHODS: This has a multicenter, quasi-experimental design carried out in 12 Spanish hospitals from May 2020 to February 2023. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). RESULTS: Among 158 patients followed for a median of 99 weeks, 52% were taking evolocumab and 48% alirocumab; the mean change from baseline in MoCA score at follow-up was + 0.28 [95% CI (- 0.17 to 0.73; p = 0.216)]. There were no significant differences in the secondary endpoints-the visuospatial/executive domain + 0.04 (p = 0.651), naming domain - 0.01 (p = 0.671), attention/memory domain + 0.01 (p = 0.945); language domain - 0.10 (p = 0.145), abstraction domain + 0.03 (p = 0.624), and orientation domain - 0.05 (p = 0.224)-but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (p = 0.001). Neither were there any differences in the three stratified subgroups according to lowest attained LDL-C level-0-54 mg/dL, 55-69 mg/dL and ≥ 70 mg/dL; p = 0.454-or between alirocumab and evolocumab arms. CONCLUSION: We did not find effect of monoclonal antibody PCSK9i on neurocognitive function over 24 months of treatment, either in global MoCA score or different cognitive domains. An improvement in delayed recall memory was shown. The study showed no differences in the cognitive function between the prespecified subgroups, even among patients who achieved very low levels of LDL-C. There were no differences between alirocumab and evolocumab. REGISTRATION: ClinicalTtrials.gov Identifier number NCT04319081.
Asunto(s)
Inhibidores de PCSK9 , Proproteína Convertasa 9 , Humanos , LDL-Colesterol , Estudios de Seguimiento , Estudios Prospectivos , Cognición , Anticuerpos Monoclonales/efectos adversosRESUMEN
Home enteral nutrition (HEN) is the choice for patients who can not mantain oral intake but have a functioning gastrointestinal tract when it isn't justify keeping the patient in the hospital. The results of the HEN registry of the NADYA group in 2010 shows information related to the enteral acces route: 51% of the cases used nasogastric tubes, 27% gastrostomies, 10% oral route and 3% jejunostomies. Placement of a needle catheter jejunostomy is recommended for candidates for enteral nutrition undergoing major abdominal surgery, but publications about long-term use of this acces are scarce. We report same cases of patients whom the selected enteral acces was surgical jejunostomy. They represents the 1,14% of our patients with HEN at this moment, with a mean dwelling time of 210 ± 222 days. There has been frequent complications, but they were sligh.
La nutrición enteral domiciliaria (NED) surge de la necesidad de continuar con el soporte nutricional especializado (SNE) en pacientes cuya situación clínica ya no justifica su hospitalización. En el registro del grupo NADYA del año 2010 sobre NED en España la vía de acceso más frecuente era la sonda nasogástrica (51%), seguida por la gastrostomía (27%), vía oral (10%), y por último la yeyunostomía (3%). La yeyunostomía en catéter de aguja es una técnica recomendada en pacientes sometidos a cirugía abdominal mayor candidatos a nutrición enteral en el postoperatorio, pero son escasas las publicaciones relativas a su uso como vía de acceso para NED a largo plazo. Presentamos una serie de casos en que ésta fue la vía seleccionada. En este momento suponen el 1,14% de los episodios de NED abiertos en nuestra unidad, con un tiempo de permanencia media del catéter de 210 ± 222 días. Las complicaciones fueron frecuentes, pero todas ellas poco relevantes.