TY - JOUR
T1 - Effect of effervescent paracetamol on blood pressure: A crossover randomized clinical trial
AU - Benitez-Camps, Mència
AU - Padrós, Rosa Morros
AU - Pera-Pujadas, Helena
AU - Baqué, Antoni Dalfó
AU - Llibre, Joan Bayó
AU - Nadal, Oriol Rebagliato
AU - Martinez, Jordi Cortès
AU - Sangenís, Anna García
AU - Saumell, Carme Roca
AU - De Tuero, Gabriel Coll
AU - Vinyoles-Bargalló, Ernest
PY - 2018/8/1
Y1 - 2018/8/1
N2 - © 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.
AB - © 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.
KW - control
KW - effervescent paracetamol
KW - hypertension
U2 - 10.1097/HJH.0000000000001733
DO - 10.1097/HJH.0000000000001733
M3 - Article
VL - 36
SP - 1656
EP - 1662
JO - Journal of Hypertension
JF - Journal of Hypertension
SN - 0263-6352
IS - 8
ER -