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Title: Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial
Author: Benitez-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
Keywords: Assaigs clínics de medicaments
Pressió sanguínia
Drug testing
Blood pressure
Issue Date: 10-Dec-2015
Publisher: BioMed Central
Abstract: 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
Note: Reproducció del document publicat a:
It is part of: BMC Cardiovascular Disorders, 2015, vol. 15, p. 167
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ISSN: 1471-2261
Appears in Collections:Articles publicats en revistes (Medicina)

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