Real-World Outcomes of Proprotein Convertase Subtilisin Kexin-9 Inhibitor Use.

ABSTRACT: Although the proprotein convertase subtilisin kexin-9 inhibitors (PCSK9i) were shown to significantly lower low-density lipoprotein and reduce atherosclerotic cardiovascular disease events in clinical trials, there is a dearth of use data on these agents in real-world settings. This study compares PCSK9i use in a population of real-world patients with atherosclerotic cardiovascular disease or familial hypercholesterolemia. This was a matched cohort study of adult patients who were dispensed a PCSK9i along with adult patients who did not receive a PCSK9i. PCSK9i patients were matched on a propensity to have received a PCSK9i score up to 1:10 to non-PCSK9i patients. The primary outcomes were changes in cholesterol levels. Secondary outcomes included a composite outcome of all-cause mortality, major cardiovascular events, and ischemic strokes along with health care utilization during follow-up. Adjusted conditional, multivariate Cox proportional hazards, and negative binomial modeling were performed. Ninety-one PCSK9i patients were matched to 840 non-PCSK9i patients. Seventy-one percent of PCSK9i patients either discontinued or switched PCSK9i therapy. PCSK9i patients had greater median reductions in low-density lipoprotein (-73.0 mg/dL vs. -30.0 mg/dL) and total (-77.0 vs. -31.0) cholesterol (both P < 0.001). No adjusted between-group differences in the composite outcome or individual components of the composite outcome were identified (all P > 0.05). PCSK9i patients had a lower rate of medical office visits during follow-up (adjusted incidence rate ratio = 0.61, P = 0.019). These findings support the effectiveness of PCSK9i therapy in real-world settings but suggest that use may be limited by PCSK9i adverse reactions and patient cost barriers.

Using pharmacy technicians and electronic health record capabilities to improve outcomes for patients with cardiovascular disease.

OBJECTIVE: This study aimed to compare lipid and blood pressure (BP) control before and after implementing a certified pharmacy technician (CPhT) protocol that optimized electronic health record (EHR) capabilities and shifted work from clinical pharmacy specialists (CPSs) to CPhT. SETTING: Kaiser Permanente Colorado's pharmacist-managed cardiac risk reduction service (which manages dyslipidemia, hypertension, and diabetes for all patients with atherosclerotic cardiovascular disease). PRACTICE DESCRIPTION: In 2019, a protocol that optimized EHR capabilities and allowed work to be offloaded from CPS to CPhT was implemented. Filtered views within the EHR were created that bucketed patients with specific lipid results criteria. The CPhT protocol provided guidance to CPhT on determining whether patients were at low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein (non-HDL) goals, on appropriate statin intensity, adherent to medications, and whether the most recent BP was controlled. The CPhT notified CPS of uncontrolled patients who would assess and manage these patients, as necessary. The CPhT notified controlled patients of their results. PRACTICE INNOVATION: Data on the outcomes of incorporating pharmacy technicians to support CPS clinical activities in ambulatory clinical pharmacy are limited. EVALUATION DETHODS: This retrospective study compared a "Pharmacist-Driven" (index date: January 1, 2016) with a "Tech-Enhanced" (index date: January 1, 2019) group. The primary outcome was the proportion of patients at all goals defined as LDL-C < 70 mg/dL, non-HDL < 100 mg/dL, and BP < 140/90 mm Hg at 1 year after the index dates. RESULTS: There were 6813 patients included (mean age: 70.2 ± 11.1 years, 71.4% male): 3130 and 3683 in the "Pharmacist-Driven" and "Tech-Enhanced" groups, respectively. The proportion of patients who attained LDL-C, non-HDL, and BP goals was higher in the "Tech-Enhanced" group (51.1% vs. 39.7%, P < 0.001) than the "Pharmacist-Driven" group. CONCLUSION: A protocol integrating EHR decision support and CPhTs enabled work to shift to from CPS to CPhT and improved clinical outcomes.

Beta-blocker therapy in patients with left ventricular systolic dysfunction and chronic obstructive lung disease in an ambulatory care setting / Tratamiento con betabloqueantes en pacientes con disfunción sistólica ventricular pulmonar obstructiva crónica en medio ambulatorio

Objective: To evaluate beta blocker persistence six months after beta-blocker initiation or dose titration in heart failure (HF) patients with COPD compared to those without COPD. Secondary objectives included comparison of beta-blocker dose achieved, changes in left ventricular ejection fraction (LVEF) and incidence of hospitalizations or emergency department (ED) visits during follow-up. Methods: We conducted a matched, retrospective, cohort study including 86 patients with COPD plus concomitant HF (LVEF <40%) and 137 patients with HF alone. All patients were followed in an outpatient HF clinic. Eligible patients had a documented LVEF <40% and were initiated or titrated on a beta-blocker in the HF clinic. Patients were matched based on LVEF (categorized as < 20% or 21-40%), gender, and age (> or <70 years). The primary outcome was beta blocker persistence at 6 months. Secondary outcomes were dose achieved, LVEF, and incidence of hospitalizations or ED visits. Results: There were no differences between the COPD and non-COPD groups in beta-blocker persistence at six-month follow-up (94.2% vs. 93.4% respectively, adjusted p=0.842). The proportion of patients who achieved a daily metoprolol dose equivalent of at least 100 mg was similar between the groups (adjusted in the six-month post-titration period was substantial but similar between the groups (53.5% and 48.2% for COPD and non-COPD patients, respectively, adjusted p=0.169). Conclusion: Our results support the use of beta-blockers in the population of heart failure patients with COPD and without reactive airway disease (AU)

Objetivo: Evaluar la persistencia de los beta bloqueantes seis meses después de su iniciación o ajuste de dosis en pacientes con fallo cardíaco (FC) con EPOC comparados con los que no tienen EPOC. Los objetivos secundarios incluían la comparación de la dosis de beta bloqueante alcanzada, los cambios en la facción eyectada ventricular izquierda (FEVI) y la incidencia de hospitalizaciones y visitas a urgencias durante el periodo de seguimiento. Métodos: Condujimos un estudio de cohorte emparejada, retrospectivo que incluyó a 86 pacientes con EPOC concomitante de FC (FEVI ≤40%)) y 137 pacientes con sólo FC. Todos los pacientes fueron seguidos en una clínica ambulatoria de FC. Los pacientes elegibles tenían una FEVI ≤40% y habían iniciado o ajustado los beta bloqueantes en la clínica de FC. Los pacientes se emparejaron en función de la FEVI (categorizados como ≤20% o 21-40%), género y edad (> or ≤ 70 años). El resultado primario era la persistencia del beta bloqueante a los 6 meses. Los resultados secundarios eran la dosis alcanzada, la FEVI y la incidencia de hospitalizaciones o visitas a urgencias. Resultados: No hubo diferencias entre los grupos de pacientes con EPOC y sin EPOC en la persistencia de beta bloqueantes a los seis meses de seguimiento (94.2% vs. 93.4% respectivamente, ajustado p=0.842). La proporción de pacientes que alcanzaron una dosis equivalente de metoprolol de al menos 100 mg fue similar entre los grupos (adjusted p=0.188). El porcentaje de pacientes con al menos una visita u hospitalización en los seis meses después del periodo de ajuste fue sustancial pero similar entre los dos grupos (53.5% y 48.2% para pacientes EPOC y no-EPOC, respectivamente, ajustado p=0.169). Conclusión: Nuestros resultados apoyan el uso de beta bloqueantes en la población de pacientes con fallo cardiaco con EPOC y sin enfermedad aérea reactiva (AU)

Beta-blocker therapy in patients with left ventricular systolic dysfunction and chronic obstructive lung disease in an ambulatory care setting.

OBJECTIVE: To evaluate beta blocker persistence six months after beta-blocker initiation or dose titration in heart failure (HF) patients with COPD compared to those without COPD. Secondary objectives included comparison of beta-blocker dose achieved, changes in left ventricular ejection fraction (LVEF) and incidence of hospitalizations or emergency department (ED) visits during follow-up. METHODS: We conducted a matched, retrospective, cohort study including 86 patients with COPD plus concomitant HF (LVEF ≤40%) and 137 patients with HF alone. All patients were followed in an outpatient HF clinic. Eligible patients had a documented LVEF ≤40% and were initiated or titrated on a beta-blocker in the HF clinic. Patients were matched based on LVEF (categorized as ≤ 20% or 21-40%), gender, and age (> or ≤70 years). The primary outcome was beta blocker persistence at 6 months. Secondary outcomes were dose achieved, LVEF, and incidence of hospitalizations or ED visits. RESULTS: There were no differences between the COPD and non-COPD groups in beta-blocker persistence at six-month follow-up (94.2% vs. 93.4% respectively, adjusted p=0.842). The proportion of patients who achieved a daily metoprolol dose equivalent of at least 100 mg was similar between the groups (adjusted p=0.188). The percent of patients with at least one ED visit or hospitalization in the six-month post-titration period was substantial but similar between the groups (53.5% and 48.2% for COPD and non-COPD patients, respectively, adjusted p=0.169). CONCLUSION: Our results support the use of beta-blockers in the population of heart failure patients with COPD and without reactive airway disease.