TY - JOUR
T1 - Evaluation of the relationship between effervescent paracetamol and blood pressure: Clinical trial
AU - Benitez-Camps, Mencia
AU - Vinyoles-Bargalló, Ernest
AU - Rebagliato-Nadal, Oriol
AU - Morros-Pedrós, Rosa
AU - Pera-Pujadas, Helena
AU - Dalfó-Baqué, Antoni
AU - López-Pavón, Ignacio
AU - Roca-Sánchez, Carlos
AU - Coma-Carbó, Rosa Maria
AU - De La Figuera Von Wichmann, Mariano
AU - Mengual-Martínez, Lucas
AU - Yuste-Marco, Carmen
AU - Teixidó-Colet, Montserrat
AU - Pepió i Vilaubí, Josep M.
AU - Ciurana-Tost, Riera
AU - Pou-Vila, Rosa
AU - Vila-Coll, Ma Antònia
AU - Bordas-Julve, Josep Maria
AU - Aragonès-Forès, Rosa
AU - Pelegrina-Rodríguez, Francisco Javier
AU - Agudo-Ugena, Josep
AU - Blanco-Mata, Carlos
AU - de la Iglesia Berrojalbiz, Jon
AU - Burgos-Alonso, Natalia
AU - Gómez-Fernández, Maria Cruz
PY - 2015/12/10
Y1 - 2015/12/10
N2 - © 2015 Benitez-Camps et al. 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 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 Trial registration: NCT 02514538.
AB - © 2015 Benitez-Camps et al. 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 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 Trial registration: NCT 02514538.
KW - Control
KW - Effervescent paracetamol
KW - Hypertension
U2 - 10.1186/s12872-015-0161-7
DO - 10.1186/s12872-015-0161-7
M3 - Article
SN - 1471-2261
VL - 15
JO - BMC Cardiovascular Disorders
JF - BMC Cardiovascular Disorders
IS - 1
M1 - 167
ER -