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: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:2445/104052 |
| Acceso en línea: | https://hdl.handle.net/2445/104052 |
| Access Level: | acceso abierto |
| Palabra clave: | Assaigs clínics de medicaments Pressió sanguínia Analgèsics Drug testing Blood pressure Analgesics |
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Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trialBenítez Camps, MenciaVinyoles, ErnestRebagliato-Nadal, OriolMorros Pedrós, RosaPera Pujadas, HelenaDalfó Baqué, AntoniLópez Pavón, IgnacioRoca Sánchez, CarlosComa Carbó, Rosa MariaFiguera, Mariano de laMengual Martínez, LucasYuste Marco, CarmenTeixidó Colet, MontserratPepió i Vilaubí, Josep M.Ciurana Tost, RieraPou Vila, RosaVila Coll, Ma AntòniaBordas Julve, Josep MariaAragonès Forès, RosaPelegrina Rodríguez, Francisco JavierAgudo Ugena, JosepBlanco Mata, CarlosBerrojalbiz, Jon de la IglesiaBurgos Alonso, NataliaGómez Fernández, Maria CruzAssaigs clínics de medicamentsPressió sanguíniaAnalgèsicsDrug testingBlood pressureAnalgesicsBackground: 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 Fundació 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 exac tly 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 practiceBioMed Central2016201620152016info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion7 p.application/pdfapplication/pdfhttps://hdl.handle.net/2445/104052Articles publicats en revistes (Medicina)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1186/s12872-015-0161-7BMC Cardiovascular Disorders, 2015, vol. 15, p. 167https://doi.org/10.1186/s12872-015-0161-7cc-by (c) Benitez-Camps, Mencia et al., 2015http://creativecommons.org/licenses/by/3.0/esinfo:eu-repo/semantics/openAccessoai:recercat.cat:2445/1040522026-05-29T05:05:01Z |
| 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 Benítez Camps, Mencia Assaigs clínics de medicaments Pressió sanguínia Analgèsics Drug testing Blood pressure Analgesics |
| 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 |
Benítez Camps, Mencia Vinyoles, Ernest Rebagliato-Nadal, Oriol Morros Pedrós, Rosa Pera Pujadas, Helena Dalfó Baqué, Antoni López Pavón, Ignacio Roca Sánchez, Carlos Coma Carbó, Rosa Maria Figuera, Mariano de la Mengual Martínez, Lucas Yuste Marco, Carmen Teixidó Colet, Montserrat Pepió i Vilaubí, Josep M. Ciurana Tost, Riera Pou Vila, Rosa Vila Coll, Ma Antònia Bordas Julve, Josep Maria Aragonès Forès, Rosa Pelegrina Rodríguez, Francisco Javier Agudo Ugena, Josep Blanco Mata, Carlos Berrojalbiz, Jon de la Iglesia Burgos Alonso, Natalia Gómez Fernández, Maria Cruz |
| author |
Benítez Camps, Mencia |
| author_facet |
Benítez Camps, Mencia Vinyoles, Ernest Rebagliato-Nadal, Oriol Morros Pedrós, Rosa Pera Pujadas, Helena Dalfó Baqué, Antoni López Pavón, Ignacio Roca Sánchez, Carlos Coma Carbó, Rosa Maria Figuera, Mariano de la Mengual Martínez, Lucas Yuste Marco, Carmen Teixidó Colet, Montserrat Pepió i Vilaubí, Josep M. Ciurana Tost, Riera Pou Vila, Rosa Vila Coll, Ma Antònia Bordas Julve, Josep Maria Aragonès Forès, Rosa Pelegrina Rodríguez, Francisco Javier Agudo Ugena, Josep Blanco Mata, Carlos Berrojalbiz, Jon de la Iglesia Burgos Alonso, Natalia Gómez Fernández, Maria Cruz |
| author_role |
author |
| author2 |
Vinyoles, Ernest Rebagliato-Nadal, Oriol Morros Pedrós, Rosa Pera Pujadas, Helena Dalfó Baqué, Antoni López Pavón, Ignacio Roca Sánchez, Carlos Coma Carbó, Rosa Maria Figuera, Mariano de la Mengual Martínez, Lucas Yuste Marco, Carmen Teixidó Colet, Montserrat Pepió i Vilaubí, Josep M. Ciurana Tost, Riera Pou Vila, Rosa Vila Coll, Ma Antònia Bordas Julve, Josep Maria Aragonès Forès, Rosa Pelegrina Rodríguez, Francisco Javier Agudo Ugena, Josep Blanco Mata, Carlos Berrojalbiz, Jon de la Iglesia Burgos Alonso, Natalia Gómez Fernández, Maria Cruz |
| 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 |
Assaigs clínics de medicaments Pressió sanguínia Analgèsics Drug testing Blood pressure Analgesics |
| topic |
Assaigs clínics de medicaments Pressió sanguínia Analgèsics Drug testing Blood pressure Analgesics |
| 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 Fundació 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 exac tly 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 2016 2016 2016 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/2445/104052 |
| url |
https://hdl.handle.net/2445/104052 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Reproducció del document publicat a: https://doi.org/10.1186/s12872-015-0161-7 BMC Cardiovascular Disorders, 2015, vol. 15, p. 167 https://doi.org/10.1186/s12872-015-0161-7 |
| dc.rights.none.fl_str_mv |
cc-by (c) Benitez-Camps, Mencia et al., 2015 http://creativecommons.org/licenses/by/3.0/es info:eu-repo/semantics/openAccess |
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cc-by (c) Benitez-Camps, Mencia et al., 2015 http://creativecommons.org/licenses/by/3.0/es |
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openAccess |
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7 p. application/pdf application/pdf |
| dc.publisher.none.fl_str_mv |
BioMed Central |
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BioMed Central |
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Articles publicats en revistes (Medicina) reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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