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Effect of effervescent paracetamol on blood pressure: a crossover randomized clinical trial

Benitez-Camps, Mènciaa; Morros Padrós, Rosab,c,d,e; Pera-Pujadas, Helenab,c,e; Dalfó Baqué, Antonia; Bayó Llibre, Joanf; Rebagliato Nadal, Oriola; Cortès Martinez, Jordib,c,d,g; García Sangenís, Annab,c,e; Roca Saumell, Carmef; Coll de Tuero, Gabrielh; Vinyoles-Bargalló, Ernestb,i,j in representation of Paracetamol Investigators

doi: 10.1097/HJH.0000000000001733
ORIGINAL PAPERS: Epidemiology

Objective: To evaluate the effect of effervescent paracetamol on office and ambulatory blood pressure (BP) compared with noneffervescent paracetamol in hypertensive patients.

Design: This was a multicenter open crossover randomized clinical trial.

Setting: Primary care centers in Catalonia and the Basque Country.

Participants: Inclusion criteria were office BP 150/95 mmHg or less and daytime ambulatory BP 140/90 mmHg or less, stable pharmacologic or nonpharmacologic antihypertensive treatment, and concomitant chronic osteoarticular pain.

Interventions: Baseline randomized assignment to 3-week periods of effervescent paracetamol (1 g three times a day) first and noneffervescent paracetamol later, or inversely, during a 7-week study period. At the start and end of each treatment period, 24-h ambulatory BP monitoring was performed.

Main outcome measures: Differences in 24-h SBP between baseline and end of both treatment periods. The main analyses were performed according to the intention-to-treat principle.

Results: In intention-to-treat analysis, 46 patients were analyzed, 21 were treated with paracetamol effervescent and noneffervescent later, and 25 followed the opposite sequence. The difference in 24-h SBP between the two treatments was 3.99 mmHg (95% confidence interval 1.35–6.63; P = 0.004), higher in the effervescent paracetamol treatment period. Similarly, the per-protocol analysis showed a difference in 24-h SBP between the two groups of 5.04 mmHg (95% confidence interval 1.80–8.28; P = 0.004), higher in the effervescent paracetamol treatment period. Self-reported pain levels did not differ between groups and did not vary by treatment period. No serious adverse events were reported in either study arm.

Conclusion: Effervescent paracetamol tablets are responsible for a significant daytime and overall increase in ambulatory 24-h SBP.

Trial registration: NCT: 02514538 EudraCT: 2010-023485-53.

aEAP Gòtic, Institut Català de la Salut

bInstitut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol)

cUniversitat Autònoma de Barcelona

dInstitut Català de la Salut

eUICEC del IDIAP Jordi Gol, Plataforma SCReN

fCAP El Clot, Institut Català de la Salut

gDepartament d’Estadística i Investigació Operativa, Universitat Politècnica de Catalunya, Barcelona

hCAP Anglès, Institut Català de la Salut, Girona

iCAP La Mina, Institut Català de la Salut, Sant Adrià de Besòs

jUniversitat de Barcelona, Barcelona, Spain

Correspondence to Mència Benitez-Camps, EAP Gòtic, Institut Catala De La Salut, Barcelona, Catalonia, Spain. E-mail: alexpben2010@gmail.com

Abbreviations: ABPM, ambulatory blood pressure monitoring; BP, blood pressure; CI, confidence interval; VAS, visual analog scale

Received 12 October, 2017

Revised 2 February, 2018

Accepted 23 February, 2018

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.