Application of CMO (capacity, motivation, and opportunity) methodology in pharmaceutical care to optimize the pharmacotherapy in older people living with HIV. DISPIMDINAC project.

OBJECTIVE: To determine the effectiveness of a pharmaceutical intervention, based on the CMO methodology (capacity, motivation and opportunity), to decrease the prevalence of the PIMDINAC concept (potentially inappropriate medication+drug interactions+non-adherence to concomitant medication) in people living with HIV infection. METHODS: Longitudinal prospective multicenter study, conducted between October 2021 and October 2022. Patients living with HIV older than 65 years, on antiretroviral treatment and concomitant drug prescription were included. Demographic, clinical, and pharmacotherapeutic variables were collected. Pharmaceutical care was provided for6 months according to the CMO model in each patient. The main variable was the percentage of patients who simultaneously fulfilled the PIMDINAC concept, comparing the baseline value with the same value at the end of the study. In addition, the percentage of patient's adherent to concomitant and antiretroviral treatment and the percentage of patients meeting the pharmacotherapeutic targets established for the prescribed medicationat 24 weeks of follow-up were compared. RESULTS: Sixty-eight patients were included. Seventy-two percent were men, with a median age of 68 years. The median number of concomitant drugs was 7. A 60.6% of the patients had polypharmacy. The prevalence of the presence of the PIMDINAC concept decreased significantly (10.3 vs. 0%). In isolation, each of the aspects also decreased significantly (p<0.031). The percentage of patients who met the objectives improved significantly from 48,5 at baseline to 88.2 (p<0.001). CONCLUSIONS: The pharmaceutical intervention based onarmaceutical intervention based on the CMO methodology significantly decreased the prevalence of the PIMDINAC concept and increased the number of patients who achieved the objectives, optimising their pharmacotherapy.

Real life study of sacubitril valsartan combined therapy in chronic heart failure / Estudio en vida real de la terapia combinada de sacubitril valsartán en insuficiencia cardíaca crónica

Objectives: Sacubitril/valsartan is a drug for chronic heart failure (CHF), approved by Drugs Regulatory Agencies based on the results of the PARADIGM-HF, which could have several limitations on internal validity and applicability. Furthermore, this drug has a high economic impact. The objectives of this study are to evaluate effectiveness and safety of sacubitril/valsartan in CHF, as well as to evaluate adequation to use criteria stablished in a Health Management Area (HMA). Methods: Retrospective, observational study including adult patients with CHF who were receiving sacubitril/valsartan during 2017 in an HMA. The treatment effectiveness was assesed by death and/or hospitalization rates related to CHF. Frequency of adverse events was used to safety evaluation. Furthermore, adequation rate was assessed. Findings: A total of 68 patients were included. Death or hospitalization rates due to CHF at 12 months were 32.3% globally (2.9% and 29.4% respectively). Among patients analyzed, 33.8% presented hypotension, during the first year after treatment initiation. Overall adequation rate was 67.6%. Conclusions: A high percentage of death and/or hospitalization due to CHF was observed. Hypotension is a frequent adverse event which leads to dose adjustment and/or drug withdrawal. Overall adequation rate of sacubitril/valsartan prescription is acceptable. (AU)

Objetivos: El sacubitril/valsartán es un medicamento para la insuficiencia cardíaca crónica (ICC), aprobado por las agencias reguladoras de medicamentos en base a los resultados del ensayo pivotal PARADIGM-HF, que podría tener varias limitaciones en la validez interna y la aplicabilidad. Además, este fármaco tiene un alto impacto económico. Los objetivos de este estudio son evaluar la efectividad y la seguridad de sacubitril/valsartán en la ICC, así como evaluar la adecuación a los criterios establecidos en un Área de Gestión de Salud (AGS). Métodos: Estudio observacional retrospectivo que incluye pacientes adultos con ICC que recibieron sacubitril/valsartán durante 2017 en una AGS. La efectividad del tratamiento fue evaluada mediante la tasa de mortalidad y/o hospitalización relacionadas con la ICC. La frecuencia de los eventos adversos se utilizó para la evaluación de seguridad. Además, se evaluó la tasa de adecuación. Resultados: Se incluyeron un total de 68 pacientes. Las tasas de mortalidad u hospitalización por ICC a los 12 meses fueron del 32,3% a nivel global (2,9% y 29,4%, respectivamente). Entre los pacientes analizados, el 33,8% presentó hipotensión durante el primer año después del inicio del tratamiento. La tasa de adaptación global fue del 67,6%. Conclusiones: Se observó un alto porcentaje de muerte y/o hospitalización por ICC. La hipotensión es un evento adverso frecuente que conduce al ajuste de la dosis y/o a la retirada del medicamento. La tasa general de adecuación de la prescripción de sacubitril/valsartán es aceptable. (AU)

A multidisciplinary intervention to reduce potential prescription problems related to kidney damage in chronic patients / Intervención multidisciplinar para reducir los posibles problemas de prescripción relacionados con el daño renal en pacientes crónicos

Objectives: Andalusian Health Service (AHS) established the RP4 program, based on the review of potential prescription problems (PPPs) in order to improve patient’s safety. Some of these PPPs are related to kidney damage (PPPKDs). The main objective of this study is to evaluate the percentage of acceptance of the pharmaceutical intervention (PI) developed in a Health Management Area (HMA) for reducing PPPKDs. We also aimed to describe these PPPKDS and to analyze the evolution of these data between 2015-2019. Methods: Retrospective study conducted by the Pharmacy Service of an HMA which offers health coverage to 406,768 patients. All the PPPKDs detected in these patients were included. Data were collected through an AHS Web Application. A descriptive analysis of variables was developed. Results: In 2019, 466 PPPKDs (involving 460 patients) were detected. Overall percentage of acceptance of the PI was 90.7% and, according to type of PPPKD, was: 92.8% for NSAIDs duplication, 90.7% for double renin-angiotensin-aldosterone system (RAAS) blockade and 89.8% for triple Whammy. During 2015-2019, detected PPPKDs have decreased from 634 to 466, and the percentage of acceptance has been adequate every year. Conclusion: The acceptance of the PI, framed in the RP4 program, was optimal. The number of PPPKDs detected has decreased and the percentage of acceptance has remained elevated during the study period, which would support the utility of this program for the improvement of patients’ safety. (AU)

Objetivos: El Sistema Andaluz de Salud (SAS) estableció el programa RP4, basado en la revisión de potenciales problemas de prescripción (PPPs) a fin de mejorar la seguridad de los pacientes. Algunos de los PPPs están relacionados con el daño renal (PPPKDs). El objetivo principal de este estudio es evaluar el porcentaje de aceptación de la intervención farmacéutica (PI) llevada a cabo en un Área de Gestión Sanitaria (HMA) para reducir los PPPKDs. Otros objetivos son describir estos PPPKDs y analizar la evolución de estos datos entre 2015-2019. Métodos: Estudio retrospectivo desarrollado por el Servicio de Farmacia de un HMA que ofrece atención sanitaria a 406.768 pacientes. Todos los PPPKDs detectados en estos pacientes se incluyeron. Los datos se rcogieron a través de una aplicación web del SAS. Se realizó un análisis descriptivo de las variables. Resultados: En 2019, se detectaron 466 PPPKDs (involucrando a 460 pacientes). El porcentaje global de aceptación de la PI fue del 90,7% y, según el tipo de PPPKD, fue: 92,8% para la duplicidad de AINEs, el 90,7% para el doble bloqueo del eje renina-angiotensina-aldosterona (RAAS) y del 89,7% para la triple Whammy. Durante 2015-2019, los PPPKDs detectados han descendidio de 634 a 466 y el porcentaje de aceptación ha sido adecuado cada año. Conclusión: La aceptación de la PI, enmarcada en el programa RP4, ha sido óptima. El número de PPPKDs detectado ha descendido y el porcentaje de aceptación se ha mantenido elevado durante el periodo de estudio, lo que podría avalar la utilidad de este programa para mejorar la seguridad de los pacientes. (AU)

Emergence of inflammatory bowel disease during treatment with sitagliptin / Debut de enfermedad inflamatoria intestinal durante el tratamiento con sitagliptina

We present one clinical case of diagnosed inflammatory bowel disease, as a probable adverse reaction to sitagliptin. Sitagliptin is a dipeptidylpeptidase (DPP)-4 inhibitor authorised for the type II diabetes mellitus treatment in adult patients who do not achieve good blood glucose control and if other therapeutic alternatives are not correctly tolerated. In addition to the DPP-4 role in the gastric hormones release and glucose homeostasis, the DPP-4 involvement in the inflammatory response is known. However, the relationship between inflammatory bowel disease (IBD) and inhibition of PPD-4 is controversial. On the one hand, the T lymphocytes of patients with this pathology seem to express high levels of the enzyme DPP-4, so their inhibition could be associated with a decrease in the activity of IBD. On the other hand, in a cohort study of patients treated with oral antidiabetics an increased risk of IBD was observed and there are different published cases of IBD occurrence during the use of sitagliptin

Presentamos un caso de debut de enfermedad inflamatoria intestinal (EII) como probable reacción adversa a la administración de sitagliptina. Sitagliptina es un inhibidor de la dipeptidilpeptidasa 4 (DPP-4) autorizado para el tratamiento de la diabetes mellitus tipo II en pacientes adultos que no consiguen buen control de la glucemia, o si el resto de alternativas terapéuticas no son bien toleradas. Además del papel de la DPP-4 en la liberación de hormonas gástricas y en la homeostasis de la glucosa, se sabe que esta enzima también está implicada en la respuesta inflamatoria. Sin embargo, la relación entre la EII y la inhibición de la DPP-4 es controvertida. Por un lado, los linfocitos T de los pacientes con esta patología parecen expresar altos niveles de la enzima DPP-4, por lo que su inhibición se podría asociar a un descenso en la actividad de la EII. Por otro lado, en un estudio de cohortes de pacientes tratados con antidiabéticos orales se observó un aumento del riesgo de EII y existen diferentes casos publicados de aparición de IBD durante el uso de sitagliptina