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Vol. 69. Issue 10.
Pages 995-996 (October 2016)
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Vol. 69. Issue 10.
Pages 995-996 (October 2016)
Letter to the Editor
DOI: 10.1016/j.rec.2016.06.008
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Consensus Document on Polypill and Secondary Prevention. Does It Include Patients With Stents? Response
Documento de consenso del policomprimido en prevención secundaria. ¿Incluye a los pacientes con stent? Respuesta
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José R. González-Juanatey, on behalf of the authors of the Consensus Document on Clinical Use of the Polypill in Secondary Prevention
Servicio de Cardiología y UCC, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
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Rev Esp Cardiol. 2016;69:99510.1016/j.rec.2016.06.002
Iñigo Lozano, José M. Vegas, Juan Rondán, Eduardo Segovia
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To the Editor,

We appreciate the comments by Lozano et al.1 on the consensus document and editorial published in the Revista Española de Cardiología about the use of the polypill.2 This consensus document made some recommendations based on current evidence and, when no evidence was available, the consensus opinion of the authors. As a possible use of the polypill, the consensus mentions patients with a recent coronary event who, given their characteristics, may have a low adherence to therapy. Lozano et al.1 question basic aspects of clinical use of the polypill: bioequivalence of acetylsalicylic acid and the results with this new therapeutic strategy after thrombosis in patients with recent coronary stent placement, particularly, when a new drug-eluting stent was used. Despite the difficulties in establishing causality due to multiple factors that could be related to drug-eluting or bare-metal stent thrombosis, we think the following considerations should be taken into account.

A test formulation is considered bioequivalent to a reference medication if the 90% confidence interval (CI) of the geometric mean for the area under the curve (AUC) and maximum plasma concentration (Cmax) is between 80% and 125%. In the case of the polypill approved in Spain, a bioequivelence trial was conducted. The 90% CI of the geometric means for both AUC and Cmax were within these limits and so bioequivalence was demonstrated according to the accepted criterion. Specifically, in the case of acetylsalicylic acid, the 90% CIs were 96.92%-104.47% for AUC and 84.51%-95.78% for Cmax.3

These results, which demonstrate bioequivalence for acetylsalicylic acid in the polypill compared to separate pills, suggest the polypill can be used in the same indications as acetylsalicylic acid, in this case, as a strategy for secondary prevention in patients with ischemic heart disease, regardless of the clinical presentation (after acute coronary syndrome or in chronic phase) and treatment (after percutaneous revascularization or surgery or in patients without revascularization). In different clinical trials with polypills in patients with ischemic heart disease, which include the FOCUS study,4 there was no evidence of increased ischemic complications compared with the separate components, although that study excluded patients with drug-releasing stents. These patients were, however, included in the SECURE (Secondary Prevention of Cardiovascular Disease in the Elderly Trial, NCT 02596126) study that randomized patients over 65 years of age with recent myocardial infarction to the polypill or the individual components.

CONFLICTS OF INTEREST

J.R. Gonzalez-Juanatey is a speaker for Ferrer International.

References
[1]
I. Lozano, B. Vega, L.I. Sanchez, J. Rondan, J.M. Vegas, E. Segovia.
Long-term antiplatelet therapy with the polypill after stenting: More information is necessary.
Int J Cardiol., 207 (2016), pp. 87-88
[2]
J.R. González-Juanatey, J.M. Mostaza, J.M. Lobos, B. Abarca, J.L. Llisterri.
Un paso más allá en la prevención secundaria del riesgo cardiovascular. Documento de consenso del uso clínico del policomprimido.
Rev Esp Cardiol., 69 (2016), pp. 547-550
[3]
J. Tamargo, J.M. Castellano, V. Fuster.
The Fuster-CNIC-Ferrer Cardiovascular Polypill: a polypill for secondary cardiovascular prevention.
Int J Cardiol., 201 (2015), pp. S1-S8
[4]
J.M. Castellano, G. Sanz, J.L. Penalvo, S. Bansilal, A. Fernandez-Ortiz, L. Alvarez, et al.
A polypill strategy to improve adherence: results from the FOCUS project.
J Am Coll Cardiol., 64 (2014), pp. 2071-2082
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Revista Española de Cardiología (English Edition)

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