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Study finds paracetamol use increases systolic blood pressure

23rd June 2022

Regular paracetamol use in both normotensive and hypertensive patients has been found to increase systolic but not diastolic blood pressure

Paracetamol use over a period of only two to three weeks seems to be enough to produce a significant increase in systolic blood pressure in normotensive and hypertensive patients according to the findings of a meta-analysis by researchers from New York, US.

Paracetamol (acetaminophen) is a widely for its analgesic and anti-pyretic properties and is considered to be generally safe unless taken in large quantities at which point, liver toxicity can occur. Though it is well established that non-steroidal anti-inflammatory drugs (NSAIDs), increase blood pressure in patients with controlled-hypertension, much less is known about the effect of paracetamol use on blood pressure. Currently, some evidence suggests that paracetamol use, particularly, the effervescent form, is responsible for a significant daytime and overall increase in ambulatory 24 hour systolic blood pressure. However, in contrast, a review of the use of intravenous paracetamol, it was concluded that the drug actually has a hypotensive effect. Moreover, this hypotensive effect has been shown in a study of 160 patients, to necessitate a therapeutic intervention in 34.9% of participants. While in a study of over 2,000 nursing home residents, paracetamol use was found to be safe for most, this was not the case for all residents.

With conflicting results, for the present analysis, the US team performed a systematic review and meta-analysis to investigate the effect of paracetamol use compared to placebo on systolic and diastolic ambulatory blood pressure. They undertook a search of three major databases (PubMed, EMBASE and the Cochrane Library records) for randomised, controlled trials that included patients with or without cardiovascular disease and where changes in both systolic and diastolic pressure changes were reported.

Paracetamol use and changes in blood pressure

The search revealed only 3 relevant studies that included a total of 172 patients with a mean age of 59.9 years (73% male) and in which paracetamol was given daily over the course of two to three weeks.

Overall, paracetamol use resulted in a significantly higher systolic blood pressure compared to placebo (standardised mean difference, SMD = 0.35, 95% CI 0.08 – 0.63, p = 0.01). In a subgroup analysis of hypertensive patients, this difference was also significant (SMD = 0.38, 95% CI 0.05 – 0.71, p = 0.02).

Interestingly, there was no significant effect on diastolic blood pressure either overall (SMD = 0.18, 95% CI – 0.09 to 0.45, p = 0.19) or in the subgroup of hypertensive patients(SMD = 0.09, 95% CI -0.34 to 0.52, p = 0.68).

The authors suggested that while there is an underlying assumption that paracetamol use is generally safe, these findings challenge that assumption.

They concluded that there was a significant correlation between the use of paracetamol and systolic blood pressure in both normotensive and hypertensive patients.

Citation
Gupta R et al. Effect of acetaminophen on blood pressure: a systematic review and meta-analysis of randomized controlled trials Eur J Prev Cardiol 2022

No effect of systolic BP on cardiovascular outcomes in heart failure treated with empagliflozin

4th October 2021

Systolic BP has been shown not to effect the reduction in cardiovascular outcomes for heart failure patients treated with empagliflozin.

As a drug class, the sodium-glucose cotransporter-2 inhibitors (SGLT2is) have been shown in a systematic review to have a moderate effect on major adverse cardiovascular events in patients with established atherosclerotic cardiovascular disease. Moreover, the same review identified how SGLT2is can also reduce hospitalisation for heart failure (HF) and progression of renal disease regardless of existing atherosclerotic cardiovascular disease. In addition to these positive effects on cardiovascular outcomes, SGLT2is have been shown to reduce 24-hour blood pressure (BP) in diabetic patients. Nevertheless, this blood pressure-lowering effect is of concern in those with HF, especially as between 15 and 20% of HF patients have low systolic BP and therefore at a higher risk of in-hospital and post-discharge mortality.

In an effort to evaluate whether the baseline systolic BP affected outcomes associated with the use of empagliflozin, an international team, led by researchers from Saarland University, Germany, enrolled patients in the Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction (EMPEROR-Reduced) trial. Patients with class II, III, or IV heart failure and an ejection fraction of less than 40% were randomised in a 1:1 fashion to either empagliflozin (10mg daily) or placebo in addition to their usual therapy for heart failure. For the study, patients were grouped according to their baseline systolic BP, as <110mmHg, 110–130mmHg or > 130mmHg and the primary outcome in the EMPEROR-Reduced trial was a composite of adjudicated cardiovascular death or hospitalisation for heart failure. For the present study, the researchers focused on whether the baseline systolic BP influenced the outcomes of cardiovascular death and hospitalisations for HF in patients given empagliflozin compared to placebo.

Findings

A total of 3730 patients were randomised to either empagliflozin (1863) or placebo and all patients had a left ventricular ejection fraction of less than 30%. Over a median of 16 months, the event rate per 100 patients years (pys) of follow-up, the primary outcome increased from 16.5 among the high SBP group to 20.8 for the intermediate group, and to 26.3 per 100 among the patients with low SBP (p=0.0015). Compared with placebo, treatment with empagliflozin significantly decreased the risk of cardiovascular death among the low systolic BP (hazard ratio, HR = 0.78, 95% CI 0.61–1.00), intermediate (HR = 0.71, 95% CI 0.58–0.87) and high (HR = 0.82. 95% CI 0.62–1.09) groups. However, while there were reductions in rates of HF hospitalisation with empagliflozin compared with placebo, this was only significant for patients with intermediate (110–130mmHg) systolic BP (HR = 0.66, 95% CI 0.50–0.88).

The authors concluded that empagliflozin reduced the risk of cardiovascular death and the number of HF hospitalisations and that this effect occurred independently of the baseline systolic BP.

Citation

Bohm M et al. Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure. J Am Coll Cardiol 2021.