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Selexipag has a Role to Play" "tieneTextoCompleto" => true "saludo" => "Dear Editor," "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "102" "paginaFinal" => "103" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "María Lázaro Salvador, Finn Akerström, Pilar Escribano Subías, Alejandro Berenguel Senèc)n, Virgilio Martinez Mateo, Luis Rodriguez Padial" "autores" => array:6 [ 0 => array:4 [ "nombre" => "María" "apellidos" => "Lázaro Salvador" "email" => array:1 [ 0 => "maria.lasal@gmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Finn" "apellidos" => "Akerström" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "Pilar" "apellidos" => "Escribano Subías" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 3 => array:3 [ "nombre" => "Alejandro" "apellidos" => "Berenguel Senèc)n" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 4 => array:3 [ "nombre" => "Virgilio" "apellidos" => "Martinez Mateo" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 5 => array:3 [ "nombre" => "Luis" "apellidos" => "Rodriguez Padial" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Department of Cardiology, Hospital Virgen de la Salud, Toledo, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Department of Cardiology, Hospital Universitario 12 de Octubre, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Department of Cardiology, Hospital La Mancha Centro, Alcazar de San Juan, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "¿Viviendo con hipertensión arterial pulmonar grave sin una bomba de infusión? Selexipag tiene un papel" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Pulmonary arterial hypertension (PAH) is a rare disease characterized by cellular proliferation and vasoconstriction of the pulmonary arterial bed. PAH is a devastating disease with a high mortality despite available therapy.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">1</span></a> Three well-known pathways are involved in PAH pathophysiology (endothelin, nitric oxide, and prostacyclin), which are all therapeutic targets. The updated ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension recommend prostacyclin analogues in patients suffering from severe PAH, referring to WHO functional class (FC) III and IV.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">1</span></a> Prostacyclin is an endogenous prostanoid, that induces vasodilatation and inhibits platelet aggregation and cell proliferation, and patients with PAH present decreased prostacyclin production.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">2</span></a> Treprostinil, as prostacyclin analogue, is metabolically stable, long-acting, and can be administered subcutaneously using a portable small delivery system.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">3</span></a> Although subcutaneous administration implies less risk of systemic infection or catheter dislocation, subcutaneous infections and severe pain at infusion site are common and may make further treatment impossible in 7%•10% of the patients.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">3</span></a> Selexipag is a novel orally available non-prostacyclin selective prostacyclin receptor (IP receptor) agonist. Following absorption, it is hydrolyzed to an active more potent metabolite, which has a 7.9-h half-life, allowing for twice daily dosing. Common side effects (all drug class related) include headache, diarrhea, jaw pain, nausea, myalgia, vomiting, and flushings. Selexipag has shown efficacy in PAH, even in sequential triple combination,<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">4</span></a> and it is currently approved for the treatment of PAH patients in WHO FC II-III, both in combination with endothelin receptor antagonist (ERA) and/or phosphodiesterase 5 inhibitors (iPDE-5) or in monotherapy.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">1</span></a> Given its oral administration, selexipag avoids the complications related to continuous parenteral administration. Hence, switching to selexipag maybe an attractive option in patients who were once started on a parental prostacyclin. However, little is known with regards to the aforementioned drug switch.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">5</span></a> Here, we present a successful case of transition from subcutaneous treprostinil to selexipag in a PAH patient reporting unbearable adverse events associated with treprostinil subcutaneous administration (<a class="elsevierStyleCrossRef" href="#sec0010">Appendix A</a>).</p><p id="par0010" class="elsevierStylePara elsevierViewall">In August 2011 a 54-year-old woman was referred to our PAH Unit due to severe idiopathic PAH with a high-risk profile according to the prognosis assessment table suggested by current guidelines<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">1</span></a> (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>A). After six months of combination therapy with the iPDE-5 sildenafil (80<span class="elsevierStyleHsp" style=""></span>mg/8<span class="elsevierStyleHsp" style=""></span>h) and the ERA ambrisentan (10<span class="elsevierStyleHsp" style=""></span>mg/24<span class="elsevierStyleHsp" style=""></span>h), the patient improved and achieved every low risk criteria (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>A). Later on, sildenafil was switched to the iPDE-5 tadalafil 40<span class="elsevierStyleHsp" style=""></span>mg/24<span class="elsevierStyleHsp" style=""></span>h due to nasal congestion. Following this, the patient remained stable in the low risk profile for two additional years. In early 2014, the patient deteriorated to the intermediate risk profile (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>A) and subcutaneous treprostinil was added and titrated up to 30<span class="elsevierStyleHsp" style=""></span>ng/kg/min. With the triple regime (ERA + iPDE-5 + treprostinil), she quickly recovered her previous low-risk profile and remained stable for another 32 months. Unfortunately, our patient insistently complained about unbearable pain around treprostinil infusion site, and several subcutaneous infections were reported. Consequently, we planned progressive transition from subcutaneous treprostinil to oral selexipag after non-invasive risk profile assessment (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>B). Patient refused right heart catheterization. Progressive treprostinil down-titration and simultaneous selexipag up-titration was performed in outpatient clinic, under close supervision, throughout 8 weeks, so that every week, 4<span class="elsevierStyleHsp" style=""></span>ng/kg/min of treprostinil were reduced and 200<span class="elsevierStyleHsp" style=""></span>α/4g/12<span class="elsevierStyleHsp" style=""></span>h were added. During the first 4 days of selexipag intake, patient reported mild diarrhoea, self-limited within the first week. No other side effects were reported. Patient ended up taking maximal doses of oral selexipag 1600<span class="elsevierStyleHsp" style=""></span>α/4g/12<span class="elsevierStyleHsp" style=""></span>h, plus her previous tadalafil and ambrisentan combination therapy unvaried. Six months after treprostinil withdrawal, the patient risk profile had slightly improved (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>B). Her functional capacity was better (both in 6<span class="elsevierStyleHsp" style=""></span>min walking test distance and in cardiopulmonary exercise test) and quality of life drastically increased; not having to carry the infusion pump was a great relief.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">Our case report suggests that transition from subcutaneous treprostinil to oral selexipag under strict clinical supervision may be a safe option for patients with controlled PAH, avoiding the undesirable side effects related to parenteral administration, meanwhile maintaining clinical stability. There is little experience with transition to oral selexipag from parenteral prostacyclin therapy,<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">5</span></a> and our patient represents the first case of a subcutaneous treprostinil to oral selexipag switch. Further investigation is required to clarify whether the route of administration may influence efficacy and safety profile, and to help characterizing the patients that may benefit from this transition.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Finally, it should be noted that, we have relied on non-invasive prognostic markers (WHO FC, NTproBNP and 6MWD) for patient risk profile assessment since they have been validated recently in follow-up,<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">6</span></a> added to patient's refusal to undergo another right heart catheterization. We added echocardiography and CPET in order to increase accuracy taking into account the lack of invasive data.</p><p id="par0025" class="elsevierStylePara elsevierViewall">In conclusion, this case highlights how a safe transition from parenteral to oral prostacyclin pathway therapy in a stable PAH patient is possible. 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Year/Month | Html | Total | |
---|---|---|---|
2024 October | 37 | 24 | 61 |
2024 September | 43 | 23 | 66 |
2024 August | 54 | 40 | 94 |
2024 July | 32 | 28 | 60 |
2024 June | 47 | 36 | 83 |
2024 May | 60 | 36 | 96 |
2024 April | 43 | 34 | 77 |
2024 March | 24 | 24 | 48 |
2024 February | 23 | 20 | 43 |
2023 March | 6 | 4 | 10 |
2023 February | 35 | 22 | 57 |
2023 January | 31 | 40 | 71 |
2022 December | 33 | 41 | 74 |
2022 November | 47 | 28 | 75 |
2022 October | 43 | 37 | 80 |
2022 September | 36 | 34 | 70 |
2022 August | 37 | 52 | 89 |
2022 July | 22 | 42 | 64 |
2022 June | 24 | 39 | 63 |
2022 May | 29 | 30 | 59 |
2022 April | 25 | 34 | 59 |
2022 March | 37 | 38 | 75 |
2022 February | 35 | 36 | 71 |
2022 January | 48 | 34 | 82 |
2021 December | 35 | 54 | 89 |
2021 November | 82 | 55 | 137 |
2021 October | 59 | 45 | 104 |
2021 September | 35 | 52 | 87 |
2021 August | 31 | 53 | 84 |
2021 July | 23 | 34 | 57 |
2021 June | 43 | 45 | 88 |
2021 May | 52 | 38 | 90 |
2021 April | 115 | 70 | 185 |
2021 March | 39 | 22 | 61 |
2021 February | 31 | 24 | 55 |
2020 March | 18 | 3 | 21 |
2020 February | 19 | 16 | 35 |
2020 January | 31 | 20 | 51 |
2019 December | 39 | 9 | 48 |
2019 November | 32 | 16 | 48 |
2019 October | 25 | 10 | 35 |
2019 September | 25 | 11 | 36 |
2019 August | 27 | 8 | 35 |