Demographic And Clinical Characteristics Of Patients Prescribed Proprotein Convertase Subtilisin/kexin Type 9 Inhibitor Therapy And Patients Whose Current Lipid-Lowering Therapy Was Modified.

PURPOSE: Our objective was to describe the demographic and clinical characteristics of real-world patients in the US with elevated low-density lipoprotein cholesterol (LDL-C) whose lipid-lowering therapy (LLT) ─ both proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor and non-PCSK9 inhibitor ─ was actively modified. METHODS: This retrospective cohort study used linked laboratory (Prognos), pharmacy (IMS Formulary Impact Analyzer), and medical claims (IQVIA Dx/LRx or PharMetrics Plus) data. PCSK9 inhibitor-prescribed patients with LDL-C ≥70 mg/dL (multiply by 0.02586 for mmol/L) at the time of prescription were matched by LDL-C test date to patients whose non-PCSK9 inhibitor therapy was modified by intensifying statin therapy, switching statins without intensification, or augmenting with ezetimibe (N=12,345 in each cohort). Baseline demographics, use of LLT, LDL-C values, atherosclerotic cardiovascular disease (ASCVD) diagnoses and cardiovascular comorbidities, and occurrence of major adverse cardiovascular events (MACE) were assessed during the 2-year pre-index period. RESULTS: Mean age was 66.2 years in the PCSK9 inhibitor cohort and 64.1 years in the cohort whose LLT regimen was otherwise modified. Respectively, mean baseline LDL-C values were 150 and 121 mg/dL; 60.3% and 39.0% of patients had ASCVD diagnoses, and 9.6% and 5.1% had experienced a recent MACE. Prevalence of ASCVD diagnoses in the PCSK9 inhibitor and modified non-PCSK9 inhibitor cohorts, respectively, was 15.5% vs 9.1% for acute coronary syndrome, 20.7% vs 8.7% for coronary revascularization, and 22.2% vs 5.1% for possible familial hypercholesterolemia. In addition, 19.8% of patients in the PCSK9 inhibitor cohort were receiving both statins and ezetimibe vs 5.0% in the modified LLT cohort. CONCLUSION: Physicians are prescribing PCSK9 inhibitor therapy to patients with markedly elevated LDL-C levels who also have comorbid risk factors for adverse cardiovascular events. These results may be of interest to payers and policymakers involved in devising access strategies for PCSK9 inhibitors.

Medida de la presión arterial en consulta y automatizada (BPTru®) para evaluar el efecto de bata blanca / Measurement of blood pressure in consultation and automated mesurement (BPTru ®) to evaluate the white coat effect

Fundamento y objetivo: El efecto de bata blanca (EBB) es uno de los principales sesgos que pueden modificar la medida de la presión arterial (PA) en consulta, por lo que se debe considerar para evitar errores diagnóstico-terapéuticos en los pacientes hipertensos. La utilización de aparatos automatizados en consulta podría disminuir dicho efecto. Método: Se diseñaron 2 estudios con el objetivo de evaluar las diferencias entre la medida rutinaria en consulta y la obtenida por el aparato automatizado de medida de PA en consulta, BPTru®, así como su influencia en el EBB. El primero de los estudios, TRUE-ESP, incluyó pacientes normotensos e hipertensos atendidos en consultas especializadas de Cardiología, Nefrología, Medicina Interna, Endocrinología y Medicina Familiar. El segundo, TRUE-HTA, incluyó pacientes hipertensos atendidos en una Unidad de HTA, protocolizada, con personal entrenado. Resultados: El estudio TRUE-ESP incluyó 300 pacientes, 76% hipertensos. Se observó una diferencia significativa entre la medida clínica y la medida BPTru® (media [DE] de PA sistólica/PA diastólica [PAS/PAD] de 9,8 [6,11]/3,4 [7,9] mmHg, p<0,001). El porcentaje de pacientes que cumplió criterios de EBB fue del 27,7%. El estudio TRUE-HTA incluyó 101 pacientes hipertensos. Se observó una diferencia significativa entre la medida clínica y la medida mediante BPTru® (media [DE] de PAS/PAD de 5,7 [3,9]/2,1 [3,5] mmHg, p<0,001) y la medida del período de actividad de la monitorización ambulatoria de la PA (MAPA) (media [DE] de PAS/PAD de 8,5 [6,7]/3,5 [2,5] mmHg, p<0,001). El porcentaje de pacientes que cumplió criterios de EBB fue del 32,1%. Conclusiones: El empleo de aparatos automatizados de medida de PA en consulta, como el BPTru®, puede colaborar a disminuir el EBB y mejorar la precisión de la medida de la PA en consulta (AU)

Background and objective: White coat effect (WCE) is one of the main bias that can affect office blood pressure (BP) measurement. Therefore, it is a factor must be considered in hypertensives to avoid mistakes in diagnosis and/or treatment. Employment of automated office BP (AOBP) devices could diminish that effect. Methods: Two studies were designed with the objective of evaluating differences between routinely office and AOBP measurements. WCE was also assessed. First, the TRUE-ESP study included normotensive and hypertensive patients attending specialized consultations at Cardiology, Nephrology, Internal Medicine, Endocrinology and Family Practice. Second, the TRUE-HTA study included hypertensives attending a protocoled Hypertension Unit, with a trained staff. Results: TRUE-ESP study included 300 patients, 76% being hypertensives. A significant difference between office BP and AOBP measurement (SBP/DBP 9.8±11.6/3.4±7.9mmHg, P<.001) was observed. Percentage of patients gathering WCE criteria was 27.7%. TRUE-HTA study included 101 hypertensive patients. A significant difference between office BP and AOBP measurement (SBP/DBP 5.7±9.3/2.1±5.3mmHg, P<.001) and activity period-ABPM (SBP/DBP 8.5±6.7/3.5±2.5mmHg, P<.001) was observed. Percentage of WCE patients was 32.1%. Conclusions: Use of AOBP devices can contribute to decrease WCE and to improve accuracy of office BP measurement (AU)

[Measurement of blood pressure in consultation and automated mesurement (BPTru(®)) to evaluate the white coat effect]. / Medida de la presión arterial en consulta y automatizada (BPTru®) para evaluar el efecto de bata blanca.

BACKGROUND AND OBJECTIVE: White coat effect (WCE) is one of the main bias that can affect office blood pressure (BP) measurement. Therefore, it is a factor must be considered in hypertensives to avoid mistakes in diagnosis and/or treatment. Employment of automated office BP (AOBP) devices could diminish that effect. METHODS: Two studies were designed with the objective of evaluating differences between routinely office and AOBP measurements. WCE was also assessed. First, the TRUE-ESP study included normotensive and hypertensive patients attending specialized consultations at Cardiology, Nephrology, Internal Medicine, Endocrinology and Family Practice. Second, the TRUE-HTA study included hypertensives attending a protocoled Hypertension Unit, with a trained staff. RESULTS: TRUE-ESP study included 300 patients, 76% being hypertensives. A significant difference between office BP and AOBP measurement (SBP/DBP 9.8±11.6/3.4±7.9 mmHg, P<.001) was observed. Percentage of patients gathering WCE criteria was 27.7%. TRUE-HTA study included 101 hypertensive patients. A significant difference between office BP and AOBP measurement (SBP/DBP 5.7±9.3/2.1±5.3 mmHg, P<.001) and activity period-ABPM (SBP/DBP 8.5±6.7/3.5±2.5 mmHg, P<.001) was observed. Percentage of WCE patients was 32.1%. CONCLUSIONS: Use of AOBP devices can contribute to decrease WCE and to improve accuracy of office BP measurement.