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Seth J Baum,1,2 Rolin L Wade,3 Pin Xiang,4 Jorge Arellano,4 Cesar Cerezo Olmos,5 Sasikiran Nunna,6 Chi-Chang Chen,6 Cathryn M Carter,7 Nihar R Desai8 1Department of Integrated Medical Sciences, Charles E Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA; 2Preventive Cardiology Inc, Boca Raton, FL, USA; 3Medical and Scientific Services, IQVIA, Plymouth Meeting, PA, USA; 4Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA; 5US Medical, Amgen Inc, Thousand Oaks, CA, USA; 6Real-World Evidence Solutions, IQVIA, Plymouth Meeting, PA, USA; 7Global Publications, Amgen Inc, Thousand Oaks, CA, USA; 8Section of Cardiovascular Medicine, Center for Outcomes Research and Evaluation, Yale School of Medicine, New Haven, CT, USACorrespondence: Rolin L WadeIQVIA, One IMS Drive, Plymouth Meeting, PA 19462, USATel +1 215 434 812 2958Email Rolin.Wade@iqvia.comPurpose: 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.Keywords: cardiovascular risk, lipid-lowering therapy, low-density lipoprotein, PCSK9 inhibitor, real-world treatment patterns

Resumen Fundamento y objetivo El efecto de bata blanca (EBB) es uno de los principales sesgos que pueden modificar la medida de la presion arterial (PA) en consulta, por lo que se debe considerar para evitar errores diagnostico-terapeuticos en los pacientes hipertensos. La utilizacion de aparatos automatizados en consulta podria disminuir dicho efecto. Metodo Se disenaron 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 ® , asi como su influencia en el EBB. El primero de los estudios, TRUE-ESP, incluyo pacientes normotensos e hipertensos atendidos en consultas especializadas de Cardiologia, Nefrologia, Medicina Interna, Endocrinologia y Medicina Familiar. El segundo, TRUE-HTA, incluyo pacientes hipertensos atendidos en una Unidad de HTA, protocolizada, con personal entrenado. Resultados El estudio TRUE-ESP incluyo 300 pacientes, 76% hipertensos. Se observo una diferencia significativa entre la medida clinica y la medida BPTru ® (media [DE] de PA sistolica/PA diastolica [PAS/PAD] de 9,8 [6,11]/3,4 [7,9] mmHg, p ® (media [DE] de PAS/PAD de 5,7 [3,9]/2,1 [3,5] mmHg, p Conclusiones El empleo de aparatos automatizados de medida de PA en consulta, como el BPTru ® , puede colaborar a disminuir el EBB y mejorar la precision de la medida de la PA en consulta.

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.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.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%.Use of AOBP devices can contribute to decrease WCE and to improve accuracy of office BP measurement.