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Four-Strata Risk Assessment in Patients with Pulmonary Arterial Hypertension Treated with Selexipag in Real-World Settings (EXPOSURE Study).
Lange, Tobias J; Escribano-Subias, Pilar; Muller, Audrey; Fernandes, Catarina C; Fontana, Martina; Remenova, Tatiana; Söderberg, Stefan; Gaine, Sean.
Afiliación
  • Lange TJ; Department of Pulmonology, Kreisklinik Bad Reichenhall, Riedelstraße 5, 83435, Bad Reichenhall, Germany. Tobias.Lange@kliniken-sob.de.
  • Escribano-Subias P; Faculty of Medicine, Department Internal Medicine II, Regensburg University, Regensburg, Germany. Tobias.Lange@kliniken-sob.de.
  • Muller A; Pulmonary Hypertension Unit, Cardiology Department, CIBERCV, Hospital 12 de Octubre, Madrid, Spain.
  • Fernandes CC; Global Epidemiology, Actelion Pharmaceuticals Ltd, a Johnson & Johnson Company, Allschwil, Switzerland.
  • Fontana M; Global Medical Affairs, Actelion Pharmaceuticals Ltd, a Johnson & Johnson Company, Allschwil, Switzerland.
  • Remenova T; Statistics and Decision Sciences, Janssen-Cilag S.p.A, a Johnson & Johnson Company, Milan, Italy.
  • Söderberg S; Global Medical Safety, Actelion Pharmaceuticals Ltd, a Johnson & Johnson Company, Allschwil, Switzerland.
  • Gaine S; Department of Public Health and Clinical Medicine, Cardiology and Heart Centre, Umeå University, Umeå, Sweden.
Adv Ther ; 41(9): 3645-3663, 2024 Sep.
Article en En | MEDLINE | ID: mdl-39083197
ABSTRACT

INTRODUCTION:

Risk assessment can aid management of pulmonary arterial hypertension (PAH) and clinical decision-making. This analysis describes characteristics, treatment patterns and outcomes of patients with PAH, categorised by risk status at time of treatment escalation with selexipag in clinical settings.

METHODS:

Patients initiating selexipag in the ongoing multicentre, prospective EXPOSURE (EUPAS19085) study were grouped as low, intermediate-low, intermediate-high or high risk of 1-year mortality according to the ESC/ERS 4-strata method.

RESULTS:

As of November 2022, 77% (535/698) of patients initiating selexipag had data allowing for risk calculation; 14% (N = 76) were low, 31% (N = 168) intermediate-low, 34% (N = 182) intermediate-high and 20% (N = 109) high risk of 1-year mortality. Overall, patients were predominantly female (71%), with idiopathic/heritable PAH (56%) or PAH associated with connective tissue disease (CTD-PAH; 27%), median age of 60 years and prevalent (2 years) disease. From low to high risk, proportion of CTD-PAH and age increased (from 12%-40% and 46-68 years, respectively); time from diagnosis decreased and presence of cardiovascular risk factors increased. Most patients across risk groups (74-81%) initiated selexipag as part of triple oral combination therapy. Overall median (Q1, Q3) selexipag exposure duration was 10.1 (3.5, 24.1) months. Proportions of hospitalised patients increased with increasing risk group (16-42% from low to high, respectively); more hospitalisations were PAH-related for the high risk (71%) versus other risk groups (47-54%). Kaplan-Meier survival estimates were 98%, 98%, 93% and 80% at 1-year and 98%, 92%, 81% and 67% at 2-years, from low to high risk, respectively.

CONCLUSIONS:

In clinical settings, selexipag is initiated across all risk groups, predominantly as triple therapy. Only 45% of patients being at low/intermediate-low risk at selexipag initiation suggests an opportunity for more frequent patient monitoring and earlier treatment escalation, given that 4-strata risk assessment was prognostic for hospitalisations and survival in this contemporary PAH cohort. A graphical abstract is available with this article.
Pulmonary arterial hypertension (PAH) is a disease that gets worse over time. To make decisions about treatment, we need to know the stage of the disease. We can do this by measuring the patient's risk of death during the next few years. Selexipag is a medication for PAH. This analysis included patients living in Europe and Canada who started treatment with selexipag for their PAH disease. Our findings suggest that the monitoring of patients' health and the timing of starting selexipag can be improved. This analysis includes 698 patients taking part in the EXPOSURE study (EUPAS19085), which looks at the real-life treatment of patients with PAH. Overall, 71% of patients were female, the median age was 60 years, most had been diagnosed with PAH for around 2 years and were already taking two other medications for their PAH disease. At the beginning of selexipag treatment, 14% of patients were classified as low risk, 31% as intermediate-low risk, 34% as intermediate-high risk and 20% as high risk of mortality within the next year. More high-risk patients were hospitalised compared with the lower risk groups. After 1 year of treatment, more patients in the low (98%) and intermediate-low groups (98%) were alive than those in the intermediate-high (93%) and high risk groups (80%). The same was true after 2 years of treatment with selexipag (98%, 92%, 81% and 67%, respectively). This study confirms that assessing patients' risk levels can indicate how well they will do over time and shows that earlier treatment with selexipag should be considered to potentially prevent worsening of the disease.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirazinas / Acetamidas Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Adv Ther Asunto de la revista: TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirazinas / Acetamidas Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Adv Ther Asunto de la revista: TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos