Regular acetaminophen use and blood pressure in people with hypertension The PATH-BP Trial

Iain MacIntyre; Emma J. Turtle; Tariq E. Farrah; Catriona  Graham; James W Dear; David J Webb; for the PATH-BP (Paracetamol in Hypertension–Blood Pressure) Investigators; Vanessa Melville; Tom M. Caparrotta

doi:10.1161/CIRCULATIONAHA.121.056015

Regular acetaminophen use and blood pressure in people with hypertension The PATH-BP Trial

Iain MacIntyre, Emma J. Turtle, Tariq E. Farrah, Catriona Graham, James W Dear, David J Webb, for the PATH-BP (Paracetamol in Hypertension–Blood Pressure) Investigators, Vanessa Melville (Member of Consortium), Tom M. Caparrotta (Member of Consortium)

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

Background
Acetaminophen is widely used as first-line therapy for chronic pain due to its perceived safety and the assumption that, unlike non-steroidal anti-inflammatory drugs, it has little or no effect on blood pressure (BP). Although observational studies suggest that acetaminophen may increase BP, clinical trials are lacking. We therefore studied the effects of regular acetaminophen dosing on BP in individuals with hypertension.

Methods
In this double-blind, placebo-controlled, crossover study, 110 individuals were randomized to receive acetaminophen 1g four times daily or matched placebo for 2 weeks followed by a 2-week washout period before crossing over to the alternate treatment. 24-hour ambulatory BP was measured at the beginning and end of each treatment period. The primary outcome was a comparison of the change in mean daytime systolic BP from baseline to end of treatment between placebo and acetaminophen arms.

Results
103 patients completed both arms of the study. Regular acetaminophen, compared to placebo, resulted in a significant increase in mean daytime systolic BP (132.8±10.5 to 136.5±10.1 mmHg vs. 133.9±10.3 to 132.5±9.9, p<0.0001) with a placebo-corrected increase of 4.7 mmHg (95% confidence interval [CI] 2.9-6.6) and mean daytime diastolic BP (81.2±8.0 to 82.1±7.8 mmHg vs. 81.7±7.9 to 80.9±7.8, p=0.005) with a placebo-corrected increase of 1.6 mmHg (95% CI 0.5-2.7). Similar findings were seen for 24-hr ambulatory and clinic BP.

Conclusion
Regular acetaminophen intake of 4g daily increases systolic BP in individuals with hypertension by around 5 mmHg when compared to placebo, increasing cardiovascular risk and calling into question the safety of regular acetaminophen use in this situation.

Original language	English
Journal	Circulation
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.121.056015
Publication status	Published - 7 Feb 2022

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PAracetamol Treatment in Hypertension: effect on Blood Pressure (PATH-BP) study
Webb, D.
UK-based charities
1/11/14 → 31/07/19
Project: Research

Cite this

@article{33b4517966cd43a4b50fcf45ba7aab46,

title = "Regular acetaminophen use and blood pressure in people with hypertension The PATH-BP Trial",

abstract = "BackgroundAcetaminophen is widely used as first-line therapy for chronic pain due to its perceived safety and the assumption that, unlike non-steroidal anti-inflammatory drugs, it has little or no effect on blood pressure (BP). Although observational studies suggest that acetaminophen may increase BP, clinical trials are lacking. We therefore studied the effects of regular acetaminophen dosing on BP in individuals with hypertension. MethodsIn this double-blind, placebo-controlled, crossover study, 110 individuals were randomized to receive acetaminophen 1g four times daily or matched placebo for 2 weeks followed by a 2-week washout period before crossing over to the alternate treatment. 24-hour ambulatory BP was measured at the beginning and end of each treatment period. The primary outcome was a comparison of the change in mean daytime systolic BP from baseline to end of treatment between placebo and acetaminophen arms. Results103 patients completed both arms of the study. Regular acetaminophen, compared to placebo, resulted in a significant increase in mean daytime systolic BP (132.8±10.5 to 136.5±10.1 mmHg vs. 133.9±10.3 to 132.5±9.9, p<0.0001) with a placebo-corrected increase of 4.7 mmHg (95% confidence interval [CI] 2.9-6.6) and mean daytime diastolic BP (81.2±8.0 to 82.1±7.8 mmHg vs. 81.7±7.9 to 80.9±7.8, p=0.005) with a placebo-corrected increase of 1.6 mmHg (95% CI 0.5-2.7). Similar findings were seen for 24-hr ambulatory and clinic BP.ConclusionRegular acetaminophen intake of 4g daily increases systolic BP in individuals with hypertension by around 5 mmHg when compared to placebo, increasing cardiovascular risk and calling into question the safety of regular acetaminophen use in this situation. ",

author = "Iain MacIntyre and Turtle, {Emma J.} and Farrah, {Tariq E.} and Catriona Graham and Dear, {James W} and Webb, {David J} and {for the PATH-BP (Paracetamol in Hypertension–Blood Pressure) Investigators} and Vanessa Melville and Caparrotta, {Tom M.}",

note = "Funding Information: We thank all those involved in making the PATH-BP study a success, and particularly all of the participants and local general practices that supported the study. Recruitment to this study was facilitated by the Scottish Primary Care Research Network and Scottish Health Research Register, both of which are supported by National Health Service Research Scotland and the Scottish Government{\textquoteright}s Chief Scientist Office. Funding Information: This study was funded by a grant (PG/13/26/3012 8) from the British Heart Foundation. The authors had complete control over design, analysis, and the decision to submit the article for publication. The sponsor had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the article; or decision to submit the article for publication. Publisher Copyright: {\textcopyright} 2022 Lippincott Williams and Wilkins. All rights reserved.",

year = "2022",

month = feb,

day = "7",

doi = "10.1161/CIRCULATIONAHA.121.056015",

language = "English",

journal = "Circulation",

issn = "0009-7322",

publisher = "AMER HEART ASSOC",

}

TY - JOUR

T1 - Regular acetaminophen use and blood pressure in people with hypertension The PATH-BP Trial

AU - MacIntyre, Iain

AU - Turtle, Emma J.

AU - Farrah, Tariq E.

AU - Graham, Catriona

AU - Dear, James W

AU - Webb, David J

AU - for the PATH-BP (Paracetamol in Hypertension–Blood Pressure) Investigators

A2 - Melville, Vanessa

A2 - Caparrotta, Tom M.

N1 - Funding Information: We thank all those involved in making the PATH-BP study a success, and particularly all of the participants and local general practices that supported the study. Recruitment to this study was facilitated by the Scottish Primary Care Research Network and Scottish Health Research Register, both of which are supported by National Health Service Research Scotland and the Scottish Government’s Chief Scientist Office. Funding Information: This study was funded by a grant (PG/13/26/3012 8) from the British Heart Foundation. The authors had complete control over design, analysis, and the decision to submit the article for publication. The sponsor had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the article; or decision to submit the article for publication. Publisher Copyright: © 2022 Lippincott Williams and Wilkins. All rights reserved.

PY - 2022/2/7

Y1 - 2022/2/7

N2 - BackgroundAcetaminophen is widely used as first-line therapy for chronic pain due to its perceived safety and the assumption that, unlike non-steroidal anti-inflammatory drugs, it has little or no effect on blood pressure (BP). Although observational studies suggest that acetaminophen may increase BP, clinical trials are lacking. We therefore studied the effects of regular acetaminophen dosing on BP in individuals with hypertension. MethodsIn this double-blind, placebo-controlled, crossover study, 110 individuals were randomized to receive acetaminophen 1g four times daily or matched placebo for 2 weeks followed by a 2-week washout period before crossing over to the alternate treatment. 24-hour ambulatory BP was measured at the beginning and end of each treatment period. The primary outcome was a comparison of the change in mean daytime systolic BP from baseline to end of treatment between placebo and acetaminophen arms. Results103 patients completed both arms of the study. Regular acetaminophen, compared to placebo, resulted in a significant increase in mean daytime systolic BP (132.8±10.5 to 136.5±10.1 mmHg vs. 133.9±10.3 to 132.5±9.9, p<0.0001) with a placebo-corrected increase of 4.7 mmHg (95% confidence interval [CI] 2.9-6.6) and mean daytime diastolic BP (81.2±8.0 to 82.1±7.8 mmHg vs. 81.7±7.9 to 80.9±7.8, p=0.005) with a placebo-corrected increase of 1.6 mmHg (95% CI 0.5-2.7). Similar findings were seen for 24-hr ambulatory and clinic BP.ConclusionRegular acetaminophen intake of 4g daily increases systolic BP in individuals with hypertension by around 5 mmHg when compared to placebo, increasing cardiovascular risk and calling into question the safety of regular acetaminophen use in this situation.

AB - BackgroundAcetaminophen is widely used as first-line therapy for chronic pain due to its perceived safety and the assumption that, unlike non-steroidal anti-inflammatory drugs, it has little or no effect on blood pressure (BP). Although observational studies suggest that acetaminophen may increase BP, clinical trials are lacking. We therefore studied the effects of regular acetaminophen dosing on BP in individuals with hypertension. MethodsIn this double-blind, placebo-controlled, crossover study, 110 individuals were randomized to receive acetaminophen 1g four times daily or matched placebo for 2 weeks followed by a 2-week washout period before crossing over to the alternate treatment. 24-hour ambulatory BP was measured at the beginning and end of each treatment period. The primary outcome was a comparison of the change in mean daytime systolic BP from baseline to end of treatment between placebo and acetaminophen arms. Results103 patients completed both arms of the study. Regular acetaminophen, compared to placebo, resulted in a significant increase in mean daytime systolic BP (132.8±10.5 to 136.5±10.1 mmHg vs. 133.9±10.3 to 132.5±9.9, p<0.0001) with a placebo-corrected increase of 4.7 mmHg (95% confidence interval [CI] 2.9-6.6) and mean daytime diastolic BP (81.2±8.0 to 82.1±7.8 mmHg vs. 81.7±7.9 to 80.9±7.8, p=0.005) with a placebo-corrected increase of 1.6 mmHg (95% CI 0.5-2.7). Similar findings were seen for 24-hr ambulatory and clinic BP.ConclusionRegular acetaminophen intake of 4g daily increases systolic BP in individuals with hypertension by around 5 mmHg when compared to placebo, increasing cardiovascular risk and calling into question the safety of regular acetaminophen use in this situation.

U2 - 10.1161/CIRCULATIONAHA.121.056015

DO - 10.1161/CIRCULATIONAHA.121.056015

M3 - Article

SN - 0009-7322

JO - Circulation

JF - Circulation

ER -

Regular acetaminophen use and blood pressure in people with hypertension The PATH-BP Trial

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PAracetamol Treatment in Hypertension: effect on Blood Pressure (PATH-BP) study

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