Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial
Por:
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
Publicada:
10 dic 2015
Resumen:
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
Filiaciones:
Benitez-Camps, M:
Inst Catala Salut, CAP Got, Barcelona, Spain
Vinyoles-Bargallo, E:
Inst Catala Salut, CAP La Got, Barcelona, Spain
Inst Univ Invest Atencio Primaria Jordi Gol, Barcelona, Spain
Rebagliato-Nadal, O:
Inst Catala Salut, CAP Got, Barcelona, Spain
Morros-Pedros, R:
Inst Univ Invest Atencio Primaria Jordi Gol, Barcelona, Spain
Univ Autonoma Barcelona, Dept Farmacol & Terapeut, E-08193 Barcelona, Spain
Pera-Pujadas, H:
Inst Univ Invest Atencio Primaria Jordi Gol, Barcelona, Spain
Dalfo-Baque, A:
Inst Catala Salut, CAP Got, Barcelona, Spain
Lopez-Pavon, I:
Inst Catala Salut, CAP Santa Coloma Gramenet, Barcelona, Spain
Roca-Sanchez, C:
Inst Catala Salut, CAP Santa Coloma Gramenet, Barcelona, Spain
Coma-Carbo, RM:
Inst Catala Salut, CAP El Maresme, Barcelona, Spain
Von Wichmann, MD:
CAP Sardenya, Barcelona, Spain
Mengual-Martinez, L:
Inst Catala Salut, CAP Badia, Barcelona, Spain
Yuste-Marco, C:
Inst Catala Salut, CAP Badia, Barcelona, Spain
Teixido-Colet, M:
Inst Catala Salut, CAP Badia, Barcelona, Spain
Vilaubi, JMPI:
Inst Catala Salut, CAP Baix Ebre, Tarragona, Spain
Ciurana-Tost, R:
Inst Catala Salut, CAP Baix Ebre, Tarragona, Spain
Pou-Vila, R:
Inst Catala Salut, CAP Got, Barcelona, Spain
Vila-Coll, MA:
Inst Catala Salut, CAP Got, Barcelona, Spain
Bordas-Julve, JM:
Inst Catala Salut, CAP Got, Barcelona, Spain
Aragones-Fores, R:
Inst Catala Salut, CAP Got, Barcelona, Spain
Pelegrina-Rodriguez, FJ:
Inst Catala Salut, CAP Got, Barcelona, Spain
Agudo-Ugena, J:
Inst Catala Salut, CAP La Got, Barcelona, Spain
Blanco-Mata, C:
CS Mina Morro, Pais Vasco, Spain
Berrojalbiz, JD:
CS Bolueta, Pais Vasco, Spain
Burgos-Alonso, N:
Clin Trial Monitoring, Pais Vasco, Spain
Gomez-Fernandez, MC:
Clin Trial Monitoring & Coordinat, Pais Vasco, Spain
Gold, Green Published
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