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 journalArticlepeer-review

Abstract / Description of output

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.

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.

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.

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 languageEnglish
Publication statusPublished - 7 Feb 2022


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