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• W2102764516 abstract "HomeCirculationVol. 123, No. 25Response to Letter Regarding Article, “Acetaminophen Increases Blood Pressure in Patients With Coronary Artery Disease” Free AccessReplyPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReplyPDF/EPUBResponse to Letter Regarding Article, “Acetaminophen Increases Blood Pressure in Patients With Coronary Artery Disease” Isabella Sudano, Andreas J. Flammer, Daniel Périat, Frank Enseleit, Matthias Hermann, Mathias Wolfrum, Astrid Hirt, Priska Kaiser, David Hurlimann, Johannes Holzmeister, Ulf Landmesser, Roberto Corti, Thomas F. Lüscher, Georg Noll and Frank Ruschitzka Pavani Mocharla Sarah R. Haile Michel Neidhart and Steffen Gay Juerg Nussberger Paul M. Vanhoutte Isabella SudanoIsabella Sudano Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Andreas J. FlammerAndreas J. Flammer Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Daniel PériatDaniel Périat Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Frank EnseleitFrank Enseleit Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Matthias HermannMatthias Hermann Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Mathias WolfrumMathias Wolfrum Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Astrid HirtAstrid Hirt Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Priska KaiserPriska Kaiser Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , David HurlimannDavid Hurlimann Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Johannes HolzmeisterJohannes Holzmeister Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Ulf LandmesserUlf Landmesser Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Roberto CortiRoberto Corti Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Thomas F. LüscherThomas F. Lüscher Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author , Georg NollGeorg Noll Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author and Frank RuschitzkaFrank Ruschitzka Cardiovascular Center, Cardiology University Hospital Zurich Zurich, Switzerland Search for more papers by this author Pavani MocharlaPavani Mocharla Cardiovascular Research Institute of Physiology University of Zurich Zurich, Switzerland Search for more papers by this author Sarah R. HaileSarah R. Haile Institute for Social and Preventive Medicine Division of Biostatistics University of Zurich Zurich, Switzerland Search for more papers by this author Michel NeidhartMichel Neidhart Department of Rheumatology University Hospital Zurich Zurich, Switzerland Search for more papers by this author and Steffen GaySteffen Gay Department of Rheumatology University Hospital Zurich Zurich, Switzerland Search for more papers by this author Juerg NussbergerJuerg Nussberger Department of Internal Medicine Division of Angiology and Hypertension University Hospital Lausanne Lausanne, Switzerland Search for more papers by this author Paul M. VanhouttePaul M. Vanhoutte Department of Pharmacology and Pharmacy University of Hong Kong Hong Kong, China Search for more papers by this author Originally published28 Jun 2011https://doi.org/10.1161/CIRCULATIONAHA.111.027185Circulation. 2011;123:e646We thank Dr Nguyen for his interest in our study and share his view that the findings may have major public health implications. As is usual for multiple end points, a Bonferroni correction was made at the end of the study. Bonferroni corrections for an interim analysis are important to decide whether to stop a study preliminarily, but are not necessarily useful for extending a study that is not dependent on statistical significance values alone but rather on trends and power analysis. We disagree with Dr Nguyen's statement about P values, given that statistical significance was defined as P<0.05, and P values of 0.021 and 0.024 for systolic and diastolic blood pressure (BP), respectively, were observed.1 Of note, the crossover design allowed for exposing all 33 patients to acetaminophen, thus substantially increasing the power of the study and the validity of the results. As already outlined,1 the number of patients and the time of exposure to acetaminophen had to be limited to the minimum required by sample size calculation because the patients included in this study did not present with arthritis or chronic pain and thus would potentially not benefit from the study drug.The “biological and mechanistic basis to explain the BP effect of acetaminophen” was discussed in the article: There is an increasing body of evidence indicating that the hypertensive effect of acetaminophen is at least in part mediated by cyclooxygenase-2 inhibition, in a manner similar to traditional nonsteroidal antiinflammatory drugs.2The 3 previously published studies mentioned by Dr Nguyen, 1 demonstrating a 4-mm Hg increase and 2 no change in BP associated with the use of acetaminophen, were also cited and thoroughly discussed.1 In contrast to our trial, these studies included patients with hypertension only, but excluded patients with established coronary artery disease, in whom the evidence of cardiovascular safety of acetaminophen is still absent.We also disagree with Dr Nguyen that the results of the recently published Action to Control Cardiovascular Risk in Diabetes Blood Pressure (ACCORD-BP) trial3 would suggest that the demonstrated rise in BP induced by acetaminophen in patients with coronary artery disease might not be harmful. Although the results of the ACCORD-BP trial demonstrated that targeting a systolic BP of <120 mm Hg did not further reduce the rate of a composite of cardiovascular events, with the exception of stroke, in patients with type 2 diabetes mellitus,3 there is abundant evidence that BP is strongly and directly related to vascular (and overall) mortality, particularly in patients at increased cardiovascular risk.4,5Notwithstanding that BP is a surrogate of clinical outcomes, randomized, placebo-controlled clinical trials specifically addressing the safety of acetaminophen are currently lacking and probably unlikely to be performed. For this reason, our study, by providing the first prospective evidence that acetaminophen increases ambulatory BP in patients with coronary artery disease to a similar extent as traditional nonsteroidal antiinflammatory drugs, is of particular clinical relevance. The use of acetaminophen should therefore be evaluated as rigorously as all traditional antiinflammatory drugs, and we agree with Dr Nguyen that we may decide to continue prescribing acetaminophen while more closely monitoring BP and adapting the antihypertensive treatment, if necessary.Isabella Sudano, MD, PhDAndreas J. Flammer, MDDaniel Périat, MDFrank Enseleit, MDMatthias Hermann, MDMathias Wolfrum, MDAstrid Hirt, RNPriska Kaiser, RNDavid Hurlimann, MDJohannes Holzmeister, MDUlf Landmesser, MDRoberto Corti, MDThomas F. Lüscher, MDGeorg Noll, MDFrank Ruschitzka, MD Cardiovascular Center, Cardiology University Hospital Zurich Zurich, SwitzerlandPavani Mocharla, MSc Cardiovascular Research Institute of Physiology University of Zurich Zurich, SwitzerlandSarah R. Haile, PhD Institute for Social and Preventive Medicine Division of Biostatistics University of Zurich Zurich, SwitzerlandMichel Neidhart, PhDSteffen Gay, MD Department of Rheumatology University Hospital Zurich Zurich, SwitzerlandJuerg Nussberger, MD Department of Internal Medicine Division of Angiology and Hypertension University Hospital Lausanne Lausanne, SwitzerlandPaul M. Vanhoutte, MD Department of Pharmacology and Pharmacy University of Hong Kong Hong Kong, ChinaDisclosuresNone.References1. Sudano I, Flammer AJ, Périat D, Enseleit F, Hermann M, Wolfrum M, Hirt A, Kaiser P, Hurlimann D, Neidhart M, Gay S, Holzmeister J, Nussberger J, Mocharla P, Landmesser U, Haile SR, Corti R, Vanhoutte PM, Lüscher TF, Noll G, Ruschitzka F. Acetaminophen increases blood pressure in patients with coronary artery disease. Circulation. 2010; 122:1789–1796.LinkGoogle Scholar2. Hinz B, Cheremina O, Brune K. Acetaminophen (paracetamol) is a selective cyclooxygenase-2 inhibitor in man. Faseb J. 2008; 22:383–390.CrossrefMedlineGoogle Scholar3. ACCORD Study GroupCushman WC, Evans GW, Byington RP, Goff DC, Grimm RH, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010; 362:1575–1585.CrossrefMedlineGoogle Scholar4. MacMahon S, Peto R, Cutler J, Collins R, Sorlie P, Neaton J, Abbott R, Godwin J, Dyer A, Stamler J. Blood pressure, stroke, and coronary heart disease, part 1: prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias. Lancet. 1990; 335:765–774.CrossrefMedlineGoogle Scholar5. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R. Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002; 360:1903–1913.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails June 28, 2011Vol 123, Issue 25 Advertisement Article InformationMetrics © 2011 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.111.027185 Originally publishedJune 28, 2011 PDF download Advertisement SubjectsChronic Ischemic Heart DiseaseEndothelium/Vascular Type/Nitric OxideHypertensionTreatment" @default.
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