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Controlling Systolic Blood Pressure below 140 mm Hgin Most Hypertensive Patients matches Systolic BloodPressure Intervention Trial Intensive Treatment:Practical Implications for Patient Care
  JOHTN
TRENDS IN HYPERTENSION TREATMENT GOALS
Controlling Systolic Blood Pressure below 140 mm Hg
in Most Hypertensive Patients matches Systolic Blood
Pressure Intervention Trial Intensive Treatment:
Practical Implications for Patient Care
1Brent M Egan, 2Jiexiang Li, 3C Shaun Wagner
1,2Professor, 3Assistant Professor
1Department of Biomedical Sciences, School of MedicineGreenville, University of South Carolina; Care Coordination Instituteand Greenville Health System, Greenville, South Carolina, USA
2Department of Mathematics, College of Charleston, CharlestonSouth Carolina, USA
3Department of Biomedical Sciences, School of Medicine GreenvilleUniversity of South Carolina, Greenville, South Carolina, USA
Correspondence Author: Brent M Egan, Professor, Departmentof Biomedical Sciences, School of Medicine Greenville, Universityof South Carolina, Greenville, South Carolina, USA
Phone: +18645222260
e-mail: began@ccihealth.org
 
ABSTRACT
The Systolic Blood Pressure Intervention Trial (SPRINT)investigators concluded that most hypertensive patients wouldbenefit from treating systolic blood pressure (SBP, mm Hg)to a target below 140 benchmark, as intensive treatment(SBP, 121.5) led to 25% fewer cardiovascular endpoints thanstandard treatment (SBP, 134.6) in high-risk patients. Thisconclusion reflects at least three assumptions addressed inthis report. First, SBP with SPRINT standard was similar to orlower than SBP of treated adults in usual care. Second, SBPwith SPRINT intensive treatment was lower than in adults withtreated hypertension controlled to < 140 with usual care. Third,SPRINTs rigorous blood pressure (BP) measurement methodstranslate to most care settings. Systolic blood pressure ina representative sample of US adults [National Health andNutrition Examination Survey ≥18 years with treated hypertensionfell from 137.1 in 1999-2002 to 130.1 in 2009-2012 ascontrol to SBP < 140 rose from 60 to 72%. Over the time, SBPin treated adults controlled to < 140 fell from 123.0 to 120.9as percentages with SBP < 130 rose from 66.1 to 74.7%. TheSPRINT BP measurement protocol led to SBP ∼3 and ∼7 belowdaytime ambulatory SBP for standard and intensive treatmentrespectively, whereas usual clinic SBP is ∼5 above daytimeambulatory SBP. Thus, SBP 134.6 and 121.5 with SPRINTstandard and intensive treatment are comparable to usual clinicSBP of 142.6 and 133.5 respectively. Systolic blood pressureintervention trial Intensive Treatment standard and intensivetreatment fall short of SBP with usual care, especially whenmeasurement methodologies are considered. Systolic bloodpressure intervention trial supports the current SBP goal < 140based on usual clinic measurement methods.
Keywords: Blood pressure, Cardiovascular disease, Hypertension
How to cite this article: Egan BM, Li J, Wagner CS.Controlling Systolic Blood Pressure below 140 mm Hg inMost Hypertensive Patients matches Systolic Blood Pressure Intervention Trial Intensive Treatment: Practical Implicationsfor Patient Care. Hypertens J 2017;3(1):12-19.
Source of support: This work was supported in part by contractsfrom the CDC through the South Carolina Departmentof Health and Environmental Control.
Conflict of interest: None
 
 

INTRODUCTION

The systolic blood pressure intervention trial (SPRINT)showed that intensive treatment with a systolic bloodpressure (SBP, mm Hg) target < 120 rather than < 140 withstandard treatment reduced the major cardiovascularevents to 25% in high-risk patients without diabetes orprior stroke.1 Systolic blood pressure intervention trialinvestigators concluded that the results supported a SBPgoal below the benchmark of < 140 for most adults withhypertension. The conclusion reflects four assumptions.First, SBP with SPRINT standard treatment was at leastas low as SBP achieved with usual care. Second, SBP withSPRINT intensive treatment is lower than SBP amongtreated hypertensive adults with SBP < 140 in usual care.Third, SBP with the rigorous measurement methodologiesin SPRINT translate to SBP measured in most caresettings. Fourth, benefits of better SBP in a subgroup ofpatients at high risk for cardiovascular events translateto other groups of hypertensive adults.

 
We previously examined the first two implicitassumptions in SPRINT.2 In fact, a representative sampleof treated adults with hypertension had lower meanSBP than participants in SPRINT standard treatment.Moreover, SPRINT intensive treatment did not lead tolower SBP than adults in usual care who were treated forhypertension and controlled to SBP < 140 mm Hg.

In this report, we examine the first two assumptionsin greater depth by analyzing changes in SBP over threetime periods as author in a representative sample of USadults to estimate the direction and potential impact oftemporal trends in SBP of adults with treated hypertension.We also assess in greater depth, the practical clinicaltranslation of SBP values obtained in SPRINT with arigorous and time-consuming protocol as compared toSBP measurements in usual care.3,4 The fourth assumptionis not assessed in this report.
 
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Controlling SBP in Hypertensive Patients matches SPRINT Intensive Treatment

MATERIALS AND METHODS

The National Health and Nutrition Examination Surveys(NHANESs) assess health and nutritional status of theUS civilian noninstitutionalized population. Participantsare selected using a multistage, probability samplingdesign. All adults provided written consent approvedby the National Center for Health Statistics.

Participants for this analysis included all adults≥18- years old in NHANES 1999-2012 having at least onevalid blood pressure (BP).5,6 In addition to a descriptiveanalysis of all patients, analyses were also conductedon two subsets of patients with hypertension including:(i) Individuals without diabetes mellitus or chronic kidneydisease (CKD), since these two groups had a target SBPof < 130 according to Joint National Committee (JNC) VIand JNC VII in effect from 1999-20127,8 and (ii) individualsthat met SPRINT-like inclusion and exclusion criteria.9

As NHANES data do not directly translate to SPRINTinclusion and exclusion criteria,2,9 the following approachwas used. Adults included in the analysis were ≥50 yearswith hypertension and one or more of the following:(i) History of myocardial infarction or angina, (ii) CKDwith estimated glomerular filtration rate 20 to 59 mL/1.73 m2/minute, (iii) 10-year Framingham cardiovasculardisease risk score ≥15%, and (iv) age ≥75 years. Exclusioncriteria were: (i) < 50 years of age, (ii) diabetes mellitus,(iii) history of stroke, (iv) history of heart failure, and(v) SBP ≥180, ≥170 on more than two BP medicines, ≥160on more than three BP medicines, ≥150 on more than fourBP medicines, and (vi) 0 to 1 health care encounters inthe previous year (proxy for nonadherence). Data werealso analyzed on all adults ≥18 years with hypertension.

Blood pressure was measured by trained professionalsusing sphygmomanometry and appropriately sizedarm cuffs in volunteers after 5 minutes seated rest. Thefirst BP was excluded in estimating mean systolic anddiastolic values for individuals with more than one valueas recommended in NHANES procedure manuals.5,6

Hypertension was defined by: SBP ≥140 and/or diastolicBP (DBP) ≥90 mm Hg and/or positive response to"Are you currently taking prescribed medication to loweryour BP?"Adults with SBP ≥130 and who denied treatmentfor hypertension were not included in the SPRINT-likesample, although some of them would have met SPRINTinclusion criteria.9 However, under JNC VII, they werenot considered hypertensive and, with the exception ofthose with diabetes, who were excluded from SPRINT,and those with CKD, did not have an indication for antihypertensivetherapy.7,8

Treatment of hypertension was defined by the percentageof adults with prevalent hypertension reporting thatthey were taking prescription medication to lower BP.5,6

 
Hypertension control was defined as SBP < 140 forall adults.

Percentage of treated hypertension controlled wascalculated as the number of adults on antihypertensivemedications with SBP < 140 divided by the number withhypertension.

Diabetes included: (a) Diagnosed diabetes definedby positive response(s) to one or more questions, "Haveyou ever been told by a doctor that you have diabetes?","Are you now taking insulin?", or "Are you now takingdiabetic pills to lower your blood sugar?" and (b) undiagnoseddiabetes defined by fasting glucose ≥126 mg/dLand/or glycohemoglobin ≥6.5%.10

Cardiovascular disease included: (i) Coronary heartdisease (CHD) defined as described.11 (ii) stroke wasdefined by endorsement of "Has a doctor ever told youthat you had a stroke?"12, and (iii) congestive heart failurewas defined by affirmative response to "Has a doctorever told you that you had congestive heart failure?"12

Data analysis: SAS Enterprise Guide 7.1 (Cary, NC)survey procedures were used for within survey analysesand appropriate weights accounting for unequal probabilitiesof selection, oversampling, and nonresponse.Age-dependent descriptors were age adjusted withweight calculated from NHANES 2009-2012 data. Dataare reported as mean and one standard error of the mean.The SD of SBP for all treated adults in each time periodwas calculated based on guidance in an online resource.13

RESULTS

The process for identifying adults with hypertension inNHANES 1999-2012 (Flow Chart 1) and the subset meetingSPRINT-like inclusion criteria (Flow Chart 2) is shown.

Flow Chart 1 : Process for selecting all adults 18 years and olderwith treated hypertension from NHANES participants; BP: Bloodpressure; SBP: Systolic blood pressure; NHANES: National healthand nutrition examination survey
Controlling Systolic Blood Pressure below 140 mm Hgin Most Hypertensive Patients matches Systolic BloodPressure Intervention Trial Intensive Treatment:Practical Implications for Patient Care

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Brent M Egan et al

Flow Chart 2 : Process for selecting SPRINT-like adults (left side) 50 years and older;(BP: Blood pressure; SBP: Systolic blood pressure; NHANES: National health and nutritionexamination survey; FRS: Framingham risk score; eGFR: Estimated glomerul filtration rate
Controlling Systolic Blood Pressure below 140 mm Hgin Most Hypertensive Patients matches Systolic BloodPressure Intervention Trial Intensive Treatment:Practical Implications for Patient Care

Selected data for all US adults with treated hypertension,the subset without diabetes or CKD, and theSPRINT-like subset are provided in Table 1. The estimatednumber of all US adults with treated hypertension, thesubset without diabetes or CKD, and the SPRINT-likesample increased from 1999 to 2002. The mean age of USadults with treated hypertension and the subset withoutdiabetes or CKD was lower than in SPRINT-like adults.

In all treated adults with hypertension, mean SBPdeclined 7 from 137.1 [standard deviation (SD) 22.1 mm Hg]in 1999-2002 to 130.1 (SD 19.3 mm Hg) during 2009-2012as control to SBP < 140 rose from 60.0 to 72.2%. In treated adults without diabetes or CKD, i.e., the subset with JNC 7goal SBP < 130, SBP declined 6.6 from 136.1 to 129.5 as SBPcontrol to < 140 rose from 61.6 to 74.1%. Among SPRINT-likeadults, mean SBP declined 7.2 from 140.2 to 133.0 over thesame time periods, and control to SBP < 140 rose from 51.5to 66.2%. Systolic blood pressure was lower and control to< 140 higher in all adults and the subset without diabetesor CKD than the SPRINT-like subset.
 
The majority of all adults with treated hypertensionand the subset without diabetes or CKD was femaleacross time periods, whereas females comprised < 50%of treated SPRINT-like adults in the latter two time periods. While the majority of all adults with treatedhypertension, including the subset without diabetes orCKD, were white in the three NHANES time periods, thewhite majority was larger among the SPRINT-like subset.

Table 1: Selected characteristics of three groups of US adults with treated hypertension in three NHANES time periods
Controlling Systolic Blood Pressure below 140 mm Hgin Most Hypertensive Patients matches Systolic BloodPressure Intervention Trial Intensive Treatment:Practical Implications for Patient Care
Data are presented as mean and one standard error. NHANES data for 1999-2002 and 2003-2008 are age-adjusted to the US 2010population; CKD: Chronic kidney disease; NHANES: National health and nutrition examination survey; SPRINT: Systolic blood pressureintervention trial
 
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Controlling SBP in Hypertensive Patients matches SPRINT Intensive Treatment

Table 2: Characteristics of all and SPRINT-like US adults with treated and controlled hypertension in three NHANES time periods
Controlling Systolic Blood Pressure below 140 mm Hgin Most Hypertensive Patients matches Systolic BloodPressure Intervention Trial Intensive Treatment:Practical Implications for Patient Care
Data are age-adjusted to 2010 and presented as mean and one standard error; Cont: Controlled; Rx: Treated; R& × & Cont/R × : Percentof treated patients controlled to SBP < 140 mm Hg; SBP: Systolic blood pressure; SPRINT: Systolic blood pressure intervention trial

Data for all adults and the SPRINT-like subset withtreated hypertension controlled to SBP < 140 (Table 2).Mean SBP values were slightly lower, rather than higher,in adults ≥18 years when excluding individuals with diabetesand CKD who had a SBP goal < 130. Thus, analysesof adults with controlled hypertension focused on alladults and the SPRINT-like subset. As expected, amongadults with SBP < 140, the SPRINT-like subset was older,less likely to be female, and more likely to be white.Mean SBP values fell 2.1 over the time among all adults(123.0-120.9) with treated and controlled hypertensionand 2.5 (125.8-123.3) in SPRINT-like adults. Percentageswith hypertension controlled to various SBP targetranging from < 120 to < 135 rose with time and were higherin all than SPRINT-like adults.

The distribution of SBP in all treated adults and thetwo subsets with controlled (SBP < 140) and uncontrolledhypertension are shown in Graphs 1A to F. The graphichighlights that a substantial majority of adults with SBP< 140 has SBP < 130 and that a substantial minority haveSBP < 120. The graphic also highlights the decliningcategorical and cumulative percentages of adults withSBP ≥140 and especially the subsets with SBP =160 and≥180 mm Hg.

DISCUSSION

Systolic blood pressure intervention trial is a landmarkstudy, which could support changes in hypertensionguidelines leading to a SBP target substantially belowthe target of < 140 for most patients as proposed bySPRINT authors.1 We previously evaluated two critical assumptions in SPRINT that could lead to a lower SBPrequiring more intensive treatment for millions ofhypertensive adults.2 One implicit assumption was thatSPRINT participants randomized to standard treatmentattained SBP comparable to or lower than US adults withtreated hypertension. In this report, we find that treatedhypertensive adults in the US attained lower mean SBPthan SPRINT standard treatment participants in both2003-2008 and 2009-2012 (Table 1). Moreover, as thepercentage of US adults with hypertension treated andcontrolled has increased from 60% 1999-2002 to 72.2%in 2009-2012, mean SBP of all treated adults has fallenprogressively from 137.1 to 130.1. Our previous estimatessuggested that the mean SBP in all treated hypertensiveadults would approach values attained with SPRINTintensive treatment if SBP were controlled to < 140 in88% of them,2 the implied US Healthy People 2020 target.

 
It could be argued that US adults with hypertensionand diabetes or CKD were treated to a SBP goal < 130,7,8which, in turn, contributed to the lower mean SBP forall adults with treated hypertension than in SPRINTstandard treatment. To address this possibility, adultswith diabetes or CKD were removed from all treatedhypertensives and the analysis repeated. In fact, SBP fellafter excluding these two groups with a lower treatmentgoal (Table 1).

The higher SBP with SPRINT standard treatmentthan usual care likely reflects the specific SBP goaland protocol for attaining it. Rather than a SBP goalof < 140 consistent with most guidelines, the SPRINTstandard-treatment SBP goal was 135 to 139.9 Unlike thehypertension guidelines, the SPRINT protocol specifiedreducing antihypertensive medication on any singlevisit when SBP was < 130 and on consecutive visits whenSBP was < 135.9
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Controlling Systolic Blood Pressure below 140 mm Hgin Most Hypertensive Patients matches Systolic BloodPressure Intervention Trial Intensive Treatment:Practical Implications for Patient Care
Graphs 1A to F : Percentages of all US adults with treated hypertension (top), treated and controlled hypertension (SBP < 140, middle),and treated and uncontrolled hypertension (SBP ≥140, bottom). Panels on the left side show the percentages of treated hypertensivesin each SBP band, whereas panels on the right display cumulative percentages above or below each of the SBP cut-points shown;SBP: Systolic blood pressure]

A second key SPRINT assumption is that intensivetreatment with target SBP < 120 leads to a lower SBPthan in treated hypertensives with SBP < 140. If thisassumption is not correct, then the rationale for loweringthe SBP target to < 120 or < 130 for treated adults withhypertension is weakened. As reported, 72.2% of all USadults with treated hypertension were controlled to a SBP < 140 in 2009-2012,2 and their mean SBP was 120.9,which is comparable to 121.4 after 1 year of SPRINTintensive treatment.1 Furthermore, the current reportindicates that mean SBP of treated hypertensive patientscontrolled to < 140 is also declining over time (Table 2 andGraphs 1A to F) and could fall further as control to SBP< 140 improves. The percentages of adults with SBP < 120 and < 130 has also risen over time as SBP control to < 140has improved. In 2009-2012, nearly three of four adultswith treated hypertension and SBP < 140 also had SBP< 130 (Table 2).
 

 
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Controlling SBP in Hypertensive Patients matches SPRINT Intensive Treatment

A third key SPRINT assumption is that SBP obtainedwith rigorous measurement methodologies translate tousual care or that SPRINT measurement methods can beadopted by most primary care settings. Systolic bloodpressure intervention trial used automated office BP(AOBP) measurements, in which a series of measurementswere obtained with the patient alone in the exam room(unattended) using an accurate, automated device andaveraged.3,4,9 Systolic blood pressure intervention trialadded 5 minutes of rest before the AOBP measurement3with the additional time requirement likely limiting broadadoption. Moreover, mean AOBP without rest correlateswell with daytime ambulatory BP values,14 whereas AOBPwith 5 minutes leads to mean values below ambulatorydaytime readings.3,15,16 More specifically, in the SPRINTambulatory BP study, daytime ambulatory SBP was∼7 higher than clinic SBP with intensive treatment and∼3 than SPRINT standard treatment. Daytime ambulatorySBP is typically ∼5 lower than usual clinic SBP.8

Of importance, SPRINT results indicate that SBP valueswell below 140 in adults with treated and controlledhypertension reduce fatal and nonfatal cardiovascularevents with a moderate increase in adverse events, e.g.,hypotension, syncope, hyponatremia, hypokalemia, andacute kidney injury.1 Thus, clinicians should be encouragedto continue and not reduce antihypertensive therapyfor adults controlled to these lower values who are toleratingtherapy. The benefits of good SBP control in SPRINTextended to adults >75 years where the benefits of SBP < 140were less certain.17,18 The current discussion against loweringthe SBP target below the current < 140 based on SPRINTis not intended to detract from these key contributions.

The reason SBP values well below 140 are requiredto obtain high control rates in a group of adults withtreated hypertension reflect the substantial within andbetween individual variability in this important biologicalvariables.2 Unless the variability in BP declines, meanvalues well below the SBP target will be required both tocontrol a single individual on most visits as well as mostindividuals at any time point. For example, in a normaldistribution ∼84% of individuals are included in the areaup to 1 SD above the mean.19 Assuming a normal SBPdistribution and an interindividual SD of SBP is 16, thena mean SBP of 123 to 124 in treated hypertensive adultsis required to control 84% of them to SBP < 140.

There are potential risks of using SPRINT to reviseclinical guidelines and health care quality metrics aimedat SBP targets lower than < 140. First, hypertensive patientstreated to SBP < 140 already attain mean SBP values comparable to SPRINT intensive treatment. Lowering theSBP target could lead to mean systolic BP below SPRINT.A precedence for this concern is documented in thehypertension optimal treatment (HOT) study,20 whichfound that a DBP goal hypertension < 80 mm Hg reducedcardiovascular events ∼50% vs a goal < 90 mm Hg in adultswith diabetes and hypertension. Mean DBP achieved inHOT participants with diabetes and hypertension was81 mm Hg and not < 80. Guideline writers cited HOTwhen setting a DBP < 80 mm Hg for adults with diabetesand hypertenison.21,22 Health care quality metrics weredeveloped and implemented to score physicians andhealth systems on their success at controlling DBP to < 80mm Hg in adults with diabetes, which likely contributedto achieved DBP well below < 80 mm Hg.23

 
The potential risk is that an analogous sequence ofevents occurs with SBP goals < 120 and lead to mean SBPvalues in treated hypertensive adults below the meanassociated with benefit with SPRINT intensive treatment.While SBP values may be beneficial, evidence-basedstudies can lead to guideline recommendations that exceedthe evidence with potential downside risk. For example,aggressive SBP targets in SPRINT and action to controlcardiovascular risk in diabetes (ACCORD) were associatedwith more adverse events than occurred with standardtreatment with benefits on aggregate cardiovascularoutcomes in SPRINT and fewer strokes in ACCORD.1,24

While our reports focused on changes of SBP andcontrol to < 140 over time, changes in SBP distributionamong adults with uncontrolled SBP ≥140 are also noteworthy.In fact, BP distribution in adults with uncontrolledSBP ≥140 has also shifted toward lower valueswith a progressively smaller proportion having SBP of 160to 179 and ≥180 (Graphs 1A to F). Cardiovascular eventsdouble with each 20 mm Hg increase in SBP above 115.8Intervention studies in isolated systolic hypertensionshowed large benefits of lowering SBP ∼10 even thoughmean values remained >140.18 The downward shift of SBPamong adults with treated, uncontrolled hypertension islikely contributing to fewer cardiovascular events.

Several limitations of our report are noteworthy. InNHANES, BP was measured by trained observers, whichare most likely higher than would have been obtainedwith the SPRINT measurement protocol. If NHANESused SPRINT methods, discussed earlier, then mean SBPvalues in NHANES would likely have been lower andpercentages controlled at various levels of SBP greater.Second, our NHANES analysis did not include untreatedhypertensives as SPRINT was a treatment study. Third,our primary analysis included all adults with treatedhypertension, although SPRINT excluded adults withdiabetes.1,9 One could postulate that including all treatedparticipants with diabetes and CKD, who had a SBP target < 130 during the 1999-2012 time period of the analysis,7,8led to lower SBP. In fact, excluding these two groupsresulted led to a lower treated SBP. Fourth, the SPRINTintensive treatment group included a small percentageof individuals with SBP ≥140, whereas our comparisongroup of treated and controlled hypertensive adultsexcluded individuals with SBP ≥140, which would havecontributed to lower mean SBP among NHANES participants.On the contrary, SPRINT excluded all patients withSBP ≥180 and patients with SBP as low as ≥150 dependingupon the number of antihypertensive medications.9 Ifindividuals with severe and treatment resistant hypertensionhad been excluded from our NHANES analysis,then reported SBP values would have been lower. Finally,while we attempted to select adults in NHANES matchingSPRINT inclusion-exclusion criteria, NHANES datado not permit precise matching for all exclusion criteria,e.g., ejection fraction.9
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In summary, in the US, SBP from 1999 to 2012 hasbeen falling in all treated hypertensive adults and inthe subset controlled to SBP < 140. The SBP distributionamong individuals with SBP ≥140 has also been shiftingfavorably to lower levels. Since 2003, SBP in all treatedhypertensive adults in the US have been lower than SBPvalues achieved with SPRINT standard treatment. Thesedifferences in favor of usual care in the US populationare probably even greater if SPRINT BP measurementmethods were used in NHANES. Adults with treatedhypertension and SBP < 140 are already achieving meanvalues similar to SPRINT intensive treatment and mosthave SBP < 130. Moreover, given measurement different,mean SBP with SPRINT standard treatment likely correspondsto a usual clinic SBP of 142.6, whereas SPRINTintensive treatment SBP corresponds to a usual clinic SBPof ∼133.5. Importantly, SPRINT documents that SBP < 140,and for some SPRINT participants considerably less than140, are beneficial for improving overall cardiovascularoutcomes, including patients ≥75 years.

Disclosures

During the previous 3 years, Dr Egan received grantsfrom the CDC, Medtronic, NIH, and Quintiles andhonoraria as a consultant to AstraZeneca, Medtronic,Merck, Novartis, the University of Iowa, and Valencia androyalties from UpToDate. Dr Li has nothing to disclose.

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