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TAK0010.1177/1753944716684463Therapeutic Advances in Cardiovascular DiseaseM. Kelly et al.

Therapeutic Advances in Cardiovascular Disease Original Research

Assessment of achieved systolic blood


Ther Adv Cardiovasc Dis

2017, Vol. 11(2) 63­–71

pressure in newly treated hypertensive DOI: 10.1177/


1753944716684463

patients aged 60–79 years before and


© The Author(s), 2016.
Reprints and permissions:
http://www.sagepub.co.uk/

after Eighth Joint National Committee


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recommendations
Michael S. Kelly, Joseph J. Saseen and Joel C. Marrs

Abstract
Objective: To determine whether patients who were newly prescribed antihypertensive
therapy after the Eighth Joint National Committee (JNC 8) update were treated to a
relaxed systolic blood pressure (SBP) goal compared with patients treated before the
update.
Methods: A retrospective cohort study approved by the Colorado Multiple Institutional Review
Board. Patients aged 60–79 years, without diabetes or chronic kidney disease (CKD), newly
treated for hypertension at a University of Colorado primary care clinics were included. The
mean first-achieved and last-stable SBPs of patients newly prescribed antihypertensive
medications from 1 January 2012 to 31 December 31 2013 (before cohort) were compared
with patients newly prescribed antihypertensive therapy from 1 January 2014 to 1 October
2015 (after cohort). The mean number of antihypertensive medications at first-achieved SBP,
the time to first-achieved SBP, and the class of initial antihypertensive medications were also
evaluated.
Results: A total of 128 patients were included, 64 patients in each cohort. The coprimary
outcome of first-achieved mean SBP did not differ between the groups (131.3 mmHg versus
130.2 mmHg; p = 0.65). Last-stable mean SBP values were also similar between the groups
(130.2 mmHg versus 129.5 mmHg; p = 0.74). Angiotensin converting enzyme inhibitors (ACE-I)
were the most frequently initiated antihypertensive agent in both cohorts (43.8% versus 48.4%;
p = 0.72).
Conclusions: Our findings suggest that the JNC 8 recommendations did not alter SBP goals
among patients aged 60–79 years newly treated for hypertension at University of Colorado
primary care clinics.
Correspondence to:
Joel C. Marrs, PharmD
Skaggs School
Keywords:  blood pressure goal, Eighth Joint National Committee (JNC 8), elderly, of Pharmacy and
hypertension Pharmaceutical Sciences,
University of Colorado,
12850 E. Montview Blvd.,
Room V20-2128, Aurora,
CO 80045, USA
Introduction diagnostic criteria for hypertension [Mozaffarian joel.marrs@ucdenver.edu

Hypertension is a major modifiable risk factor for et al. 2016]. A greater percentage of patients aged Michael S. Kelly, PharmD
Chapman University
cardiovascular disease (CVD), stroke, and ⩾60 years have controlled hypertension (blood School of Pharmacy,
chronic kidney disease (CKD). Nearly one-third pressure <140/90 mmHg) compared with Irvine, CA, USA
Joseph J. Saseen, PharmD
of US adults aged ⩾20 years have recognized younger patients, but receive suboptimal man- Skaggs School
hypertension [Mozaffarian et  al. 2016]. The agement based on a blood pressure (BP) control of Pharmacy and
Pharmaceutical Sciences,
prevalence of hypertension increases with age, rate of 54.1% in this population [Mozaffarian University of Colorado,
with 65% of patients aged ⩾60 years meeting et al. 2016]. Aurora, CO, USA

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Therapeutic Advances in Cardiovascular Disease 11(2)

In 2014, two US hypertension guidelines were Methods


published – the American Society of
Hypertension and the International Society of Study design
Hypertension (ASH/ISH) guideline and a report This retrospective cohort study compared the
from panel members appointed to the Eighth SBP values of patients newly prescribed antihy-
Joint National Committee (JNC 8) [Weber et al. pertensive therapy for a new diagnosis of hyper-
2014; James et al. 2014]. Both of these guidance tension in one of seven University of Colorado
documents provided recommendations on BP Health (UCH) primary care clinics. These seven
thresholds for initiating antihypertensive treat- clinics included family medicine and internal
ment, preferred initial pharmacologic options, medicine clinics, three of which are medical resi-
and goal BP values in specific patient popula- dent training sites, and most have clinical phar-
tions [Weber et  al. 2014; James et  al. 2014]. macy services. Two primary endpoints were used
While both recommended a less aggressive sys- as surrogate markers for SBP goals between
tolic blood pressure (SBP) goal of <150 mmHg cohorts, and include the mean first-achieved SBP
in elderly patients, they recommended different and mean last-stable SBP. First-achieved SBP
ages cutoffs at which the SBP goal should be was defined as the SBP value, obtained during a
relaxed The JNC 8 report recommends a SBP primary care clinic visit in which hypertension
target of <150 mmHg in adults aged ⩾60 years, was assessed after prescribing antihypertensive
without diabetes or CKD. This recommenda- therapy, and no modifications were made to the
tion was given a Grade A recommendation, antihypertensive treatment plan. Last-stable SBP
using a grading system developed by the was defined as the most recent in-office SBP
National Heart, Lung, and Blood Institute’s reading in the study period, where hypertension
Evidence-Based Methodology Lead [James was assessed and no medication modifications
et al. 2014]. Although graded as a strong recom- were made to the antihypertensive treatment
mendation, the age at which to relax the SBP plan. SBP values recorded during clinic visits
goal differs from several other hypertension where hypertension was not assessed (i.e. acute
guidelines within and outside of the US which illness visits) were not included. Secondary end-
recommend relaxing the SBP goal to <150 points included the time to first-achieved SBP,
mmHg for patients aged ⩾80 years [Leung et al. the number of antihypertensive medications pre-
2016; Mancia et al. 2013; Weber et al. 2014]. scribed to reach first-achieved SBP, the class of
antihypertensive medication prescribed following
Several cardiovascular groups, including a minor- hypertension diagnosis, and the number of anti-
ity of JNC 8 panel members, expressed concern hypertensive medications at last-stable SBP.
that evidence supporting the relaxed SBP target is
insufficient [Krakoff et  al. 2014; Wright et  al.
2014]. Moreover, the less aggressive SBP target Patient population
may lead to under treatment of high-risk elderly Patients aged 60–79 years with newly prescribed
patients. Additionally, several registry analyses treatment for hypertension during the study
have compared the proportion of patients meet- period of 1 January 2012 to 1 October 2015 were
ing BP targets as recommended by JNC 8 with eligible for this study. Additional inclusion crite-
previous JNC 7 recommendations. These analy- ria included a new diagnosis of hypertension
ses found that 6.8–11.6% of adults aged ⩾60 (ICD-9 code 401.x) and at least one additional
years without diabetes or CKD would be reclassi- visit to a University of Colorado primary care
fied as meeting BP targets by targeting a less clinic after being prescribed antihypertensive
aggressive SBP goal of <150 mmHg [Borden therapy, where hypertension was assessed and no
et al. 2014; Navar-Boggan et al. 2014; Miedema changes were made to patients’ antihypertensive
et  al. 2015]. Given the controversy surrounding regimen. Exclusion criteria included a diagnosis
the relaxed SBP goal in patients aged ⩾60 years, of diabetes mellitus (ICD-9 code 250.x), CKD
and several other hypertension guidelines recom- (ICD-9 code 585.x), or a kidney transplant
mending a less aggressive SBP goal starting at age (ICD-9 code V42.0). Patients receiving antihy-
80, the objective of this study was to determine pertensive therapy for indications other than
whether patients newly prescribed antihyperten- hypertension (i.e. atrial fibrillation, benign pros-
sive therapy after the JNC 8 report were treated to tate hypertrophy, edema) prior to the new hyper-
a relaxed SBP compared with patients newly tension diagnosis were also excluded. A list of
treated before the JNC 8 report. potentially eligible patients was generated from

64 http://tac.sagepub.com
MS Kelly, JJ Saseen et al.

Figure 1.  Study cohorts by date.

our electronic health record (EHR) based on Software (http://graphpad.com/quickcalcs/con-


study criteria. tingency2/). A sample size calculation (http://clin-
calc.com/Stats/SampleSize.aspx) determined that
Potentially eligible patients were assigned to one a total of 128 patients (64 per group) would be
of two cohorts (Figure 1: Study cohorts by date). necessary to provide 80% power (α = 0.05) for
The before JNC 8 group consisted of patients detecting a clinically significant 6 mmHg SBP
newly prescribed antihypertensive therapy during difference (standard deviation 12 mmHg)
the period 1 January 2012 to 31 December 2013, between groups, similar to the BP parameters
while patients newly prescribed antihypertensive reported in the Valsartan in Elderly Isolated
therapy during the period 1 January 2014 to 1 Systolic Hypertension (VALISH) study [Ogihara
October 2015 comprised the after JNC 8 group. et al. 2010]. Patient EHRs were reviewed until a
The cohort time periods were chosen to provide total of 64 patients meeting inclusion criteria in
an approximately equal time frame, and to allow each cohort were identified. This study received
time for the JNC 8 report to be disseminated to expedited approval by Colorado Multiple
primary care providers. The online JNC 8 report Institutional Review Board.
was first available on 18 December 2013. The ini-
tial date of 1 January 2014 was chosen for the
after JNC cohort, in the belief that enough time Results
had passed since the online publication of the Of the 671 patients reviewed, 128 patients met
report for providers to be aware of the JNC 8 study criteria (Figure 2: Patients screened and
recommendations. included in analysis). Most patients (67.2%)
were excluded for having a previous diagnosis of
Patients in each cohort were randomly sorted, hypertension at their initial visit when establish-
then EHRs were manually reviewed to ascertain if ing care at one of the primary care clinics.
each patient met the criteria. The following Baseline characteristics were similar between
patient data were extracted and collected for anal- groups (Table 1), which included a majority of
ysis: age, gender, ethnicity/race, current tobacco non-Hispanic white patients, mean age of 66
use, date of newly prescribed antihypertensive years, and low prevalence of reported tobacco
agent, initial in-clinic SBP, antihypertensive agent use. Patients with known CVD were excluded
prescribed, unique number of antihypertensive from this study population, as they would have
medications at primary care visits, dates at which likely been receiving one or more antihyperten-
BP is assessed in clinic visit and where no changes sive agents as recommended by CVD secondary
were made to antihypertensive regimen, and SBP prevention guidelines [Fihn et al. 2012]. Patients
on eligible dates. in both cohorts had a similar initial SBP, which
trended higher in the after JNC 8 group, but this
was not statistically different (153.7 mmHg ver-
Statistical analysis sus 157.7 mmHg; p = 0.07).
Primary and secondary continuous endpoints
were compared with Microsoft Excel between The coprimary endpoint (Table 2) of mean first-
cohorts using an unpaired t test. Categorical data achieved SBP did not differ significantly between
were analyzed using two-tailed chi-square or groups (131.3 versus 130.2 mmHg; p = 0.65).
Fisher’s exact tests, calculated with GraphPad Additionally, no statistical difference in the

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Therapeutic Advances in Cardiovascular Disease 11(2)

Figure 2.  Patients screened and included in analysis.


HTN, hypertension; JNC 8, Eighth Joint National Committee.

Table 1.  Patient demographics.

Characteristic Before JNC 8 After JNC 8 p value


(n = 64) (n = 64)
Mean age in years (SD) 65.8 (4.9) 66.2 (4.6) 0.33
Female sex (%) 64.1 64.1 1.00
Race/Ethnic group (%) 0.82
  Non-Hispanic white 79.7 78.1  
  Non-Hispanic black 10.9 7.8  
 Hispanic 3.1 4.7  
 Other 6.3 9.4  
Current tobacco use (%) 17.2 9.4 0.30
Initial SBP in mmHg* 153.7 ± 11.0 157.7 ± 13.3 0.07
Initial DBP in mmHg* 87.0 ± 9.5 89.2 ± 8.6 0.16

*Values are mean ± standard deviation.


DBP, diastolic blood pressure; JNC 8, Eighth Joint National Committee; SBP, systolic blood pressure; SD, standard deviation.

second coprimary endpoint of mean last-stable thiazides were initiated as initial antihypertensive
SBP (Table 2) was found between study groups therapies in non-Hispanic black patients at a sim-
(130.2 versus 129.5 mmHg; p = 0.74). No signifi- ilar frequency in both the before and after cohorts,
cant different in diastolic BP was noted between 57.1% versus 60.0% respectively (p = 1.0).
the two cohorts.

Table 3 reports the frequencies of each antihyper- Discussion


tensive agent prescribed as initial therapy. This retrospective study of patients aged 60–79
Angiotensin converting enzyme inhibitors (ACE- years newly prescribed antihypertensive treat-
I) were the most frequently prescribed initial ment found no difference in our primary end-
antihypertensive agent in both the before and points of first-achieved SBP and last-stable SBP
after cohorts, 43.8% versus 48.4% respectively among patients treated before and after the JNC
(p = 0.72). Calcium channel blockers (CCBs) or 8 report. Both cohorts reached a mean SBP of
66 http://tac.sagepub.com
MS Kelly, JJ Saseen et al.

Table 2.  Primary endpoints.

Before JNC 8 After JNC 8 p value


(n = 64)* (n = 64)*
First-achieved SBP (mmHg) 131.3 ± 13.6 130.2 ± 11.7 0.65
First-achieved DBP (mmHg) 76.6 ± 10.2 79.0 ± 8.4 0.15
Last-stable SBP (mmHg) 130.2 ± 12.2 129.5 ± 11.8 0.74
Last-stable DBP (mmHg) 78.1 ± 7.2 77.2 ± 8.6 0.53

*Values are mean ± standard deviation.


DBP, diastolic blood pressure; JNC 8, Eighth Joint National Committee; SBP, systolic blood pressure.

Table 3.  Secondary endpoints.

Before JNC 8 After JNC 8 p value


(n = 64)* (n = 64)*
Time to first-achieved SBP (days) 83.7 77.1 0.65
Medications to reach first-achieved SBP (No.) 1.23 1.17 0.41
Medications at last-stable SBP (No.) 1.16 1.25 0.33
Class of medication initiated (%) 0.50
 ACE-I 43.8 48.4 0.72
 ARB 7.8 10.9 0.76
 CCB 12.5 10.9 1.00
  Thiazide diuretic 26.6 15.6 0.19
 Beta-blocker 6.2 3.1 0.68
  Aldosterone antagonist 0.00 1.6 1.00
Combination medication (%)  
 ACE-I/HCTZ 3.1 7.8 0.21
 ARB/HCTZ 0.0 1.6 1.00
*Values are means.
ACE-I, angiotensin converting enzyme inhibitor; ARB, angiotensin receptor blocker; CCB, calcium channel blocker; HCTZ,
hydrochlorothiazide; JNC 8, Eighth Joint National Committee; No., number; SBP, systolic blood pressure.

approximately 130 mmHg with minimal antihy- and have no adverse effects associated with anti-
pertensive medications (mean 1.2 antihyperten- hypertensive treatment (Grade E – expert opin-
sive agents). This suggests a high degree of goal ion) [James et al. 2014]. Thus, in patients with a
attainment, regardless of the BP goal value SBP goal of <150 mmHg who achieved a SBP
selected. Both cohorts demonstrated a consider- <140 mmHg, modification of antihypertensive
able reduction in SBP (−22.4 mmHg in the before therapy would not be necessary, unless they
JNC 8 cohort and −27.5 mmHg in the after JNC experience adverse effects. Patients in both
8 cohort), easily meeting an SBP goal of <140 cohorts achieved and maintained well-controlled
mmHg and <150 mmHg. Based on this finding, SBP values which did not appear to be associ-
the achieved SBP may not serve as the best sur- ated with any adverse effects that would require
rogate for the SBP goal as providers may have modifications to antihypertensive therapy.
relaxed their SBP goal for patients but not
changed therapy, despite patients having a SBP Our results suggest that patients included in our
dramatically lower than goal as long as they were study may have been treated to a more intense
not having complications from treatment. This is SBP goal than recommended by the JNC 8
supported by the JNC 8 report recommendation report. Recently, the Systolic Blood Pressure
that antihypertensive treatment need not be mod- Intervention Trial (SPRINT) found that target-
ified if patients achieve a SBP of <140 mmHg ing a more intensive SBP goal (<120 mmHg)

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Therapeutic Advances in Cardiovascular Disease 11(2)

compared with standard SBP (<140 mmHg) in Group, 1991; Staessen et al. 1997; Beckett et al.
patients with CVD risk factors resulted in a sig- 2008; JATOS Study Group, 2008; Ogihara et al.
nificantly lower rate of major CVD events and 2010]. Our patients had few comorbidities, as our
all-cause mortality [Wright et  al. 2015]. Our exclusion criteria did not include patients with
study population differed from patients included diabetes or CKD, and patients with known CVD
in SPRINT in many ways. First, our study popu- receiving recommended medical therapy would
lation did not include patients with CKD and have been excluded. Of the five trials reviewed
known CVD, while the SPRINT trial included a by the JNC 8 members that included patients
high percentage of patients with CKD (28%) and aged ⩾60 years, four trials included patients
known CVD (20%). Additionally, most patients (range 7–13.7%) with diabetes mellitus [SHEP
in the SPRINT trial (>90%) were receiving anti- Cooperative Research Group, 1991; Beckett et al.
hypertensive treatment at baseline with a mean 2008; JATOS Study Group, 2008; Ogihara et al.
SBP of 140 mmHg. Our patient population 2010]. The Systolic Hypertension in Europe trial
included patients with newly diagnosed, did not report the percentage of patients with dia-
untreated hypertension with a low CVD risk. betes, but did report that nearly 30% of included
Recently, a subgroup analysis of patients aged patients had a history of cardiovascular complica-
⩾75 years from the SPRINT trial reported a tions at baseline [Staessen et al. 1997].
>30% reduction in all-cause mortality and the
primary composite endpoint of major cardiovas- It is possible that a portion of our study patients
cular events in the group treated to intensive SBP may not have had true hypertension, but instead
goal <120 mmHg, compared with SBP < 140 presented with white-coat hypertension (WCH).
mmHg [Williamson et al. 2016]. Given evidence It is estimated that up to 30% of patients with
from the SPRINT trials, the JNC 8 recommen- elevated in-clinic BP values may have WCH
dation to target an SBP of <150 mmHg in all [Siu and U.S. Preventive Services Task Force,
individuals over the age of 60 is not consistent 2015]. In 2015, the US Preventive Services
with the current clinical trial data. Task Force released recommendations to con-
firm the diagnosis of hypertension with the
A previous study conducted at the same aca- use of out-of-clinic BP values [Siu and U.S.
demic health system found no difference in Preventive Services Task Force, 2015]. A recent
mean BP and the number of antihypertensive subgroup analysis examined the prevalence of
agents between a similar cohort of patients aged WCH in patients with in-clinic hypertension
60–79 years treated for hypertension 1-year (BP ⩾140/90 mmHg) who also underwent
before and 1-year after the JNC 8 report [Fixen 24-h ambulatory blood pressure monitoring
et  al. 2016]. Of note, patients in the previous (ABPM) [Tanner et al. 2016]. In the subset of
study had an existing diagnosis of hypertension patients without diabetes or CKD, patients aged
and were currently receiving antihypertensive ⩾60 years had a significantly greater in office
therapy. Additionally, most patients (86%) were SBP compared with patients aged <60 years
included in both the before and after cohort. (149.9 mmHg versus 140.9 mmHg, respectively;
Our current study excluded patients with a prior p < 0.001), but similar SBP measured by ABPM
diagnosis of hypertension as well as those cur- (134.8 mmHg versus 132.2 mmHg; p = 0.22).
rently receiving antihypertensive medications. In The prevalence of patients in our study with
addition, our study design did not permit WHC cannot be determined given the retro-
patients to be included in both the before and spective study design.
after cohorts. Therefore, our results are a better
measure of how the JNC 8 report has influenced Both the ASH/ISH guidelines and the JNC 8
primary care providers in treating newly diag- report recommend one of four classes of antihy-
nosed hypertension in an elderly population. pertensive agents as initial therapy in non-His-
panic black patients. Our study found that ACE-I
One possible explanation for the substantial were the most frequently prescribed initial agent
reduction in SBP seen in both cohorts may be in both cohorts, and also noted several other
due to the health status of the patients studied. trends in prescribed initial antihypertensive ther-
Patients in our study had a mean age of 66 years, apy. First, the frequency of beta-blockers as initial
which is younger than patients studied in previ- therapy in the before JNC 8 cohort trended down
ous isolated systolic hypertension trials (mean age in the after JNC 8 cohort (6.3% versus 3.1%;
range 70–84 years) [SHEP Cooperative Research p = 0.68), which is in line with recommendations

68 http://tac.sagepub.com
MS Kelly, JJ Saseen et al.

against the use of beta-blocking agents as first- our assessment to only SBP values during clinic
line antihypertensive agents without a compelling visits which were assessing patients’ hypertension
indication [Weber et al. 2014; James et al. 2014]. disease state, patients who achieved a SBP below
Second, we found an increased frequency of angi- their goal value without adverse effects would be
otensin receptor blockers (ARBs) use as initial recommended to continue current antihyperten-
therapy from 7.8% in the before cohort to 10.9% sive therapy, based upon the JNC 8 corollary rec-
in the after cohort (p = 0.76). This trend may be ommendation [James et  al. 2014]. Lastly, our
explained by the fact that several ARBs became study included a limited number of primary care
available as generic products after the release of clinics, all of which are affiliated with a single aca-
JNC 8, making ARBs a more cost-effective demic health system and have clinical pharmacy
option. Due to ASH/ISH and JNC 8 recommen- services available. Several clinics have collabora-
dations specifying initial antihypertensive therapy tive drug therapy management protocols, which
in non-Hispanic black patients, a prespecified allow pharmacists to manage and modify patients’
subgroup analysis was conducted to determine if antihypertensive therapy in collaboration with
more non-Hispanic black patients in the after primary care providers. Whether the availability
JNC 8 cohort were initially prescribed a CCB or of clinical pharmacy services influenced the SBP
thiazide compared with non-Hispanic black goal of patients included in this study cannot be
patients in the before JNC 8 cohort. A total of 12 determined. Future studies comparing the
non-Hispanic black patients were included in the achieved SBP values for patients initiating antihy-
patient sample, (7 in the before cohort and 5 in pertensive treatment in primary clinics affiliated
the after cohort) with no statistical difference with an academic health center compared with
between groups. Based on the small numbers of primary care clinics not affiliated with academic
non-Hispanic black patients in our study, a future health centers may be of value.
study including only non-Hispanic black patients
may be useful to determine if initial antihyperten-
sive therapy follows the recommendations from Conclusion
both US hypertension guidelines [Weber et  al. Our findings did not identify a change in overall
2014; James et al. 2014]. intensity of BP lowering among patients with
newly diagnosed hypertension. Our findings were
There are several limitations of this study, most limited to patients aged 60–79 years, without
notably our retrospective design. First, medica- CKD or diabetes, who were receiving care from
tion adherence could not be assessed due to our primary care providers of an academic health sys-
study design, which may have falsely increased tem. Overall, treatment of this population does
our secondary endpoint of time to first-achieved not appear to have been negatively influenced
SBP. In a study assessing adherence to antihyper- by the JNC 8 recommendations to target a less
tensive medications among patients newly treated aggressive SBP goal among these patients.
for hypertension, <10% of subjects had an adher-
ence rate ⩾80% (portion of days covered) at 6 Funding
months [Mazzaglia et  al. 2009]. Secondly, we This research received no specific grant from any
cannot ensure that BP was measured using the funding agency in the public, commercial, or not-
recommended technique described by hyperten- for-profit sectors.
sion guidelines [Weber et al. 2014]. Current prac-
tice for BP measurement at most UCH primary Conflict of interest statement
care clinics involves a medical-assistant rooming The authors declare that there is no conflict of
the patient and obtaining vitals with an auto- interest.
mated BP cuff, while the patient is sitting.
Providers are free to remeasure BP manually, at
their discretion, and may record this value in the
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