Letter to the Editor
The PARADIGM-HF population may be very different from real-world heart failure patients
A população do PARADIGM-HF pode ser muito diferente do mundo real dos pacientes com insuficiência cardíaca
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"Hospital Nacional “Ramiro Prialé Prialé”, Internal Medicine Service, Huancayo, Essalud, Peru" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Univesidad Continental, Huancayo, Peru" "etiqueta" => "b" "identificador" => "aff0010" ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "A população do PARADIGM-HF pode ser muito diferente do mundo real dos pacientes com insuficiência cardíaca" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleSmallCaps">I</span> have read with great interest the article by Rodrigues et al.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a> and the editorial comment<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">2</span></a> about the use of sacubitril/valsartan in patients with systolic heart failure, and <span class="elsevierStyleSmallCaps">I</span> share the same concerns about the target population of this drug.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In an epidemiological study in Lima, Peru,<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> of 1075 patients with heart failure, 46% had normal ejection fraction and only 39% had heart failure with reduced ejection fraction (≤40%) (HFrEF). Overall, 30% of patients with heart failure also had chronic renal disease, leaving only 20-25% of patients eligible for treatment with sacubitril/valsartan.</p><p id="par0015" class="elsevierStylePara elsevierViewall">In a high-altitude population like Huancayo (3250 meters above sea level), the profile of heart failure patients is even more dissimilar,<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">4</span></a> with 89.9% of patients having a normal ejection fraction, while around 25% of individuals have heart failure and chronic lung disease, leaving only 2.2% of patients eligible for this drug.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Another concern is about how many patients will tolerate the target dose of 97/103<span class="elsevierStyleHsp" style=""></span>mg, because as Antol et al.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a> pointed out, only 17.4% of patients in their retrospective study could achieve this goal. Despite this result, the hospitalization rate, symptoms and weight gain decreased in those who were treated with sacubitril/valsartan.</p><p id="par0025" class="elsevierStylePara elsevierViewall">In search of an answer about the profile of patients who will benefit from sacubitril/valsartan, the PARAGON-HF trial<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> is currently under way and will try to determine if the drug is useful for patients with preserved ejection fraction (HFpEF). Caution must be exercised because drugs used for HFrEF that showed promise for HFpEF did not improve prognosis for this condition when tested in large clinical trials.<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">7–9</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">As Ricardo Fontes-Carvalho pointed out in his editorial comment,<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">2</span></a> we must recognize that sacubitril/valsartan is an important advance for heart failure therapy, even though its benefits have not been proved in a broader, real-world heart failure population. Taking this into account, new drugs are needed for patients with heart failure who have chronic renal or pulmonary conditions or have normal or intermediate ejection fraction.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0035" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:9 [ 0 => array:3 [ "identificador" => "bib0050" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Será a coorte do PARADIGM-HF representativa da população do mundo real de doentes com insuficiência cardíaca?" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "G. Rodrigues" 1 => "A. Tralhão" 2 => "C. Aguiar" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.repc.2017.09.023" "Revista" => array:6 [ "tituloSerie" => "Rev Port Cardiol" "fecha" => "2018" "volumen" => "37" "paginaInicial" => "491" "paginaFinal" => "496" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/29779951" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0055" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Sacubitril-valsartan in the real world: from theory to clinical practice" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "R. 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| 2020 December | 29 | 10 | 39 |
| 2020 November | 21 | 11 | 32 |
| 2020 October | 20 | 16 | 36 |
| 2020 September | 23 | 5 | 28 |
| 2020 August | 14 | 8 | 22 |
| 2020 July | 21 | 11 | 32 |
| 2020 June | 11 | 15 | 26 |
| 2020 May | 18 | 3 | 21 |
| 2020 April | 14 | 2 | 16 |
| 2020 March | 16 | 12 | 28 |
| 2020 February | 64 | 16 | 80 |
| 2020 January | 16 | 13 | 29 |
| 2019 December | 20 | 10 | 30 |
| 2019 November | 15 | 5 | 20 |
| 2019 October | 11 | 4 | 15 |
| 2019 September | 25 | 13 | 38 |
| 2019 August | 16 | 0 | 16 |
| 2019 July | 12 | 6 | 18 |
| 2019 June | 21 | 23 | 44 |
| 2019 May | 24 | 12 | 36 |
| 2019 April | 28 | 28 | 56 |
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