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

Mència Benitez-Camps, Rosa Morros Padrós, Helena Pera-Pujadas, Antoni Dalfó Baqué, Joan Bayó Llibre, Oriol Rebagliato Nadal, Jordi Cortès Martinez, Anna García Sangenís, Carme Roca Saumell, Gabriel Coll De Tuero, Ernest Vinyoles-Bargalló

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3 Citations (Scopus)

Abstract

© 2018 Wolters Kluwer Health, Inc. All rights reserved. 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.
Original languageEnglish
Pages (from-to)1656-1662
JournalJournal of Hypertension
Volume36
Issue number8
DOIs
Publication statusPublished - 1 Aug 2018

Keywords

  • control
  • effervescent paracetamol
  • hypertension

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