Rosenkranz, Stephan, Channick, Richard, Chin, Kelly M., Jenner, Bartosz, Gaine, Sean, Galie, Nazzareno, Ghofrani, Hossein-Ardeschir, Hoeper, Marius M., McLaughlin, Vallerie V., Du Roure, Camille, Rubin, Lewis J., Sitbon, Olivier, Tapson, Victor and Lang, Irene M. . The impact of comorbidities on selexipag treatment effect in patients with pulmonary arterial hypertension: insights from the GRIPHON study. Eur. J. Heart Fail.. HOBOKEN: WILEY. ISSN 1879-0844

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Abstract

Aims The number of pulmonary arterial hypertension (PAH) patients with comorbidities is increasing and there are limited data on response to PAH-targeted therapies in this population. These post hoc analyses explored the effect of selexipag in PAH patients with cardiovascular comorbidities in the GRIPHON study. Methods and results Randomized patients (n = 1156) were classified using three methods: (i) by subgroups defined according to previously published comorbidity count and restrictive haemodynamic criteria: Subgroup A (n = 962) and Subgroup B (>= 3 comorbidities and/or haemodynamic criteria not met; n = 144); comorbidities included body mass index >= 30 kg/m(2), essential hypertension, diabetes, history of coronary artery disease; (ii) by number of comorbidities, with addition of atrial fibrillation (0, 1, 2, 3, 4, or 5); (iii) by presence of individual comorbidities. Selexipag to placebo hazard ratios (HR) and 95% confidence intervals (CI) for morbidity/mortality (primary composite endpoint) were estimated using Cox regression adjusting selexipag effect for baseline covariates. Approximately half of the patients in GRIPHON (n = 584; 50.5%) had comorbidities. Selexipag reduced the risk of a morbidity/mortality event compared with placebo in both Subgroup A (HR 0.66, 95% CI 0.53, 0.82) and Subgroup B (HR 0.50, 95% CI 0.26, 0.96), with no evidence of an inconsistent treatment effect between subgroups (interaction p = 0.432). Consistent results were observed in analyses by number and by specific type of comorbidity. Conclusion Selexipag reduces the risk of a morbidity/mortality event vs. placebo irrespective of patient comorbidity status, suggesting that comorbidity status does not influence the treatment effect of selexipag.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Channick, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chin, Kelly M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jenner, BartoszUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaine, SeanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Galie, NazzarenoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghofrani, Hossein-ArdeschirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoeper, Marius M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McLaughlin, Vallerie V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Du Roure, CamilleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rubin, Lewis J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sitbon, OlivierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tapson, VictorUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lang, Irene M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-605014
DOI: 10.1002/ejhf.2369
Journal or Publication Title: Eur. J. Heart Fail.
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1879-0844
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SURVIVAL; REGISTRY; EPIDEMIOLOGYMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60501

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