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BMC Cardiovasc Disord. 2015 Dec 10;15:167. doi: 10.1186/s12872-015-0161-7.

Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial.

Author information

1
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. alexpben2010@gmail.com.
2
CAP La Mina, Institut Català de la Salut, Barcelona, Spain. 23561evb@comb.cat.
3
Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain. 23561evb@comb.cat.
4
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. oriolreba@gmail.com.
5
Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain. rmorros@idiapjgol.org.
6
Departament de farmacologia i terapèutica Universitat Autònoma de Barcelona, Barcelona, Spain. rmorros@idiapjgol.org.
7
Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain. hpera@idiapjgol.org.
8
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. 932324800@telefonica.net.
9
CAP Santa Coloma de Gramenet, Institut Català de la Salut, Barcelona, Spain. ilopezp.bnm.ics@gencat.cat.
10
CAP Santa Coloma de Gramenet, Institut Català de la Salut, Barcelona, Spain. croca.ics@gencat.cat.
11
CAP El Maresme, Institut Català de la Salut, Barcelona, Spain. rosamcoma@gmail.com.
12
CAP Sardenya, Barcelona, Spain. 14733mfw@comb.cat.
13
CAP Badia, Institut Català de la Salut, Badia del Vallès, Barcelona, Spain. lucasmengual@comb.cat.
14
CAP Badia, Institut Català de la Salut, Badia del Vallès, Barcelona, Spain. mcyuste.mn.ics@gencat.cat.
15
CAP Badia, Institut Català de la Salut, Badia del Vallès, Barcelona, Spain. mteixido.mn.ics@gencat.cat.
16
CAP Baix Ebre, Institut Català de la Salut, Tarragona, Spain. jmpepio.ebre.ics@gencat.cat.
17
CAP Baix Ebre, Institut Català de la Salut, Tarragona, Spain. rciurana.ebre.ics@gencat.cat.
18
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. 16608mpv@comb.cat.
19
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. mavilacoll@gmail.com.
20
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. jmbordas.bcn.ics@gencat.cat.
21
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. raragonesf.bcn.ics@gencat.cat.
22
CAP Gòtic, Institut Català de la Salut, Barcelona, Spain. fjpr1985@hotmail.com.
23
CAP La Mina, Institut Català de la Salut, Barcelona, Spain. jagudo.bcn.ics@gencat.cat.
24
CS Mina del Morro, País Vasco, Spain. carlos.blancomata@osakidetza.net.
25
CS Bolueta, País Vasco, Spain. jonjoseba.delaiglesiaberrojalbiz@osakidetza.net.
26
Clinical Trial Monitoring, Pais Vasco, Spain. natalia.burgosalonso@osakidetza.net.
27
Clinical Trial Monitoring and Coordination, País Vasco, Spain. macruz.gomezfernandez@osakidetza.net.

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 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.

PMID:
26654907
PMCID:
PMC4676099
DOI:
10.1186/s12872-015-0161-7
[Indexed for MEDLINE]
Free PMC Article

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