Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial
Background: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of tha...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2015 |
| País: | España |
| Institución: | Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
| Repositorio: | r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
| OAI Identifier: | oai:iibsantpau.fundanetsuite.com:p7813 |
| Acceso en línea: | https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=7813 |
| Access Level: | acceso abierto |
| Palabra clave: | Hypertension Effervescent paracetamol Control |
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Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trialBenitez-Camps, MVinyoles-Bargallo, ERebagliato-Nadal, OMorros-Pedros, RPera-Pujadas, HDalfo-Baque, ALopez-Pavon, IRoca-Sanchez, CComa-Carbo, RMVon Wichmann, MDMengual-Martinez, LYuste-Marco, CTeixido-Colet, MVilaubi, JMPICiurana-Tost, RPou-Vila, RVila-Coll, MABordas-Julve, JMAragones-Fores, RPelegrina-Rodriguez, FJAgudo-Ugena, JBlanco-Mata, CBerrojalbiz, JDBurgos-Alonso, NGomez-Fernandez, MCHypertensionEffervescent paracetamolControlBackground: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. Methods/Design: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundacio Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. Discussion: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practiceBMC2015info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=7813BMC Cardiovascular DisordersISSN: 14712261reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p78132026-06-14T12:41:47Z |
| dc.title.none.fl_str_mv |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial |
| title |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial |
| spellingShingle |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial Benitez-Camps, M Hypertension Effervescent paracetamol Control |
| title_short |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial |
| title_full |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial |
| title_fullStr |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial |
| title_full_unstemmed |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial |
| title_sort |
Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial |
| dc.creator.none.fl_str_mv |
Benitez-Camps, M Vinyoles-Bargallo, E Rebagliato-Nadal, O Morros-Pedros, R Pera-Pujadas, H Dalfo-Baque, A Lopez-Pavon, I Roca-Sanchez, C Coma-Carbo, RM Von Wichmann, MD Mengual-Martinez, L Yuste-Marco, C Teixido-Colet, M Vilaubi, JMPI Ciurana-Tost, R Pou-Vila, R Vila-Coll, MA Bordas-Julve, JM Aragones-Fores, R Pelegrina-Rodriguez, FJ Agudo-Ugena, J Blanco-Mata, C Berrojalbiz, JD Burgos-Alonso, N Gomez-Fernandez, MC |
| author |
Benitez-Camps, M |
| author_facet |
Benitez-Camps, M Vinyoles-Bargallo, E Rebagliato-Nadal, O Morros-Pedros, R Pera-Pujadas, H Dalfo-Baque, A Lopez-Pavon, I Roca-Sanchez, C Coma-Carbo, RM Von Wichmann, MD Mengual-Martinez, L Yuste-Marco, C Teixido-Colet, M Vilaubi, JMPI Ciurana-Tost, R Pou-Vila, R Vila-Coll, MA Bordas-Julve, JM Aragones-Fores, R Pelegrina-Rodriguez, FJ Agudo-Ugena, J Blanco-Mata, C Berrojalbiz, JD Burgos-Alonso, N Gomez-Fernandez, MC |
| author_role |
author |
| author2 |
Vinyoles-Bargallo, E Rebagliato-Nadal, O Morros-Pedros, R Pera-Pujadas, H Dalfo-Baque, A Lopez-Pavon, I Roca-Sanchez, C Coma-Carbo, RM Von Wichmann, MD Mengual-Martinez, L Yuste-Marco, C Teixido-Colet, M Vilaubi, JMPI Ciurana-Tost, R Pou-Vila, R Vila-Coll, MA Bordas-Julve, JM Aragones-Fores, R Pelegrina-Rodriguez, FJ Agudo-Ugena, J Blanco-Mata, C Berrojalbiz, JD Burgos-Alonso, N Gomez-Fernandez, MC |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Hypertension Effervescent paracetamol Control |
| topic |
Hypertension Effervescent paracetamol Control |
| description |
Background: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. Methods/Design: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundacio Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. Discussion: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice |
| publishDate |
2015 |
| dc.date.none.fl_str_mv |
2015 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
| status_str |
publishedVersion |
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https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=7813 |
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https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=7813 |
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Inglés |
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Inglés |
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info:eu-repo/semantics/openAccess |
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openAccess |
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BMC |
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BMC |
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BMC Cardiovascular Disorders ISSN: 14712261 reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
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Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
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r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
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r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
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