- Email: [email protected]
AHA on the diagnostic prevalence of hypertension
G Model
ARTICLE IN PRESS Med Clin (Barc). 2020;xxx(xx):xxx–xxx
www.elsevier.es/medicinaclinica
Brief report
Impact of the new criteria of the ACC/AHA on the diagnostic prevalence of hypertension夽 José Miguel Baena Díez a,b,∗ , Maria Carrera Morodo a , Miriam Corral Roca a , Eva Calatayud Subías a , Iris Flores Jiménez a , Ana María de la Arada Acebes a a b
Centro de Salud La Marina, SAP Esquerra Barcelona, Institut Català de la Salut, Barcelona, Spain IDIAP Jordi Gol, Institut Català de la Salut, Barcelona, Spain
a r t i c l e
i n f o
Article history: Received 9 April 2019 Accepted 6 June 2019 Available online xxx Keywords: Hypertension Prevalence Diagnosis Practice guidelines
a b s t r a c t Objective: To study the impact on the prevalence of hypertension with the criteria (2017) of the American College of Cardiology/American Heart Association (ACC/AHA). Patients and methods: Cross-sectional study, including 370 patients ≥18 years, randomly selected in a Health Centre, with at least one visit and a measurement of systolic (SBP) and diastolic blood pressure (DBP) recorded the last 2 years. Previous hypertension was considered if the diagnosis was confirmed or they had an SBP ≥ 140 or DBP ≥ 90 mmHg and as ACC/AHA AHT criteria in any of these cases or an SBP between 130−139 mmHg or DBP between 80 and 89 mmHg. Results: The average age was 52.3 years (58.6% women). Forty-one point nine percent had previous hypertension, increasing to 67.8% with the ACC/AHA criteria (p < .05). Pharmacological treatment was received by 32.2% of the population, increasing to 38.4% with the ACC/AHA criteria (p > .05). The newly diagnosed patients (p < .05) were younger (mean difference 19.6 years) and less obese (23% vs 41.4%). Conclusions: The ACC/AHA criteria would represent an increase of 25.9% in the prevalence of hypertension, considering 2 out of 3 adults hypertensive. ˜ S.L.U. All rights reserved. © 2019 Elsevier Espana,
Impacto de los nuevos criterios de la ACC/AHA sobre la prevalencia diagnóstica de hipertensión arterial r e s u m e n Palabras clave: Hipertensión Prevalencia Criterios diagnósticos Guías de práctica clínica
Objetivo: Estudiar el impacto sobre la prevalencia de hipertensión arterial (HTA) con los criterios (2017) del American College of Cardiology/American Heart Association (ACC/AHA). ˜ Pacientes y métodos: Estudio descriptivo transversal, incluyendo 370 pacientes ≥18 anos, seleccionados aleatoriamente en un Centro de Salud, al menos con una visita y una medida de presión arterial sistólica ˜ (PAS) y diastólica (PAD) registrada los últimos 2 anos. Se consideró HTA previa si constaba el diagnóstico o tenían una PAS ≥ 140 ó PAD ≥ 90 mmHg y como HTA criterios ACC/AHA en cualquiera de estos supuestos o constaba una PAS entre 130−139 mmHg ó PAD entre 80−89 mmHg. ˜ Resultados: La edad media fue 52,3 anos (58,6% mujeres). El 41,9% tenían HTA previa, aumentando al 67,8% con los criterios ACC/AHA (p < 0,05). Recibía tramiento farmacológico el 32,2% de la población, aumentando al 38,4% con los criterios ACC/AHA (p > 0,05). Los nuevos diagnósticos (p < 0,05) eran más ˜ jóvenes (diferencia medias 19,6 anos) y menos obesos (23% vs 41,4%). Conclusiones: Los criterios ACC/AHA supondrían un aumento del 25,9% en la prevalencia de HTA, considerando hipertensas 2 de cada 3 personas adultas. ˜ S.L.U. Todos los derechos reservados. © 2019 Elsevier Espana,
夽 Please cite this article as: Baena Díez JM, Carrera Morodo M, Corral Roca M, Calatayud Subías E, Flores Jiménez I, de la Arada Acebes AM. Impacto de los nuevos criterios de la ACC/AHA sobre la prevalencia diagnóstica de hipertensión arterial. Med Clin (Barc). 2019. https://doi.org/10.1016/j.medcli.2019.06.021 ∗ Corresponding author. E-mail address: [email protected] (J.M. Baena Díez). ˜ S.L.U. All rights reserved. 2387-0206/© 2019 Elsevier Espana,
MEDCLE-4954; No. of Pages 3
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ARTICLE IN PRESS J.M. Baena Díez et al. / Med Clin (Barc). 2020;xxx(xx):xxx–xxx
Introduction Hypertension (HT) is a cardiovascular risk factor associated with an increased risk of cardiovascular diseases. Its diagnosis, treatment and control have contributed in recent decades to reduce the incidence of these diseases. The DARIOS study estimated a prevalence of HT in Spain of 47% in men and 39% in women.1 Recently the American College of Cardiology and the American Heart Association (ACC/AHA) have modified2 the diagnostic criteria of HT after the publication of the SPRINT study,3 lowering the cut-off point for diagnosis to 130/80 mmHg, also introducing modifications in its treatment. This proposal has not been accepted by the European Cardiovascular Societies,4 which continue to maintain the 140/90 mmHg figure. We do not know the magnitude of the possible increase in the diagnostic prevalence of HT in our country. The main objective of the present study is to analyse the impact of the new of the ACC/AHA diagnostic criteria for HT on the diagnostic prevalence of HT in the population of an urban healthcare center. Also, as secondary objectives, whether the application of these criteria would increase the population treated with drugs and analyse the factors associated with the new diagnoses of HT.
Patients and methods A cross-sectional descriptive study was carried out, selecting patients by simple randomized sampling from the electronic primary care health records ePCHR of an urban Health Center with 15,725 people assigned >14 years. The study was approved by the Ethics Committee Fundació Jordi Gol, code P18/156. Assigned persons ≥18 years of age with at least one visit in the last two years were included. Patients were considered losses if there was no systolic blood pressure (SBP) and diastolic (DBP) measurements recorded in the ePCHR in the last two years. The descriptive variables of the study were collected from the ePCHR and were the following: age (years), sex, smoking (non-smoker, smoker, ex-smoker >1 year), diabetes mellitus, hypercholesterolemia, obesity (body mass index ≥30), previous cardiovascular diseases (ischemic heart disease, heart failure, stroke and peripheral vascular disease of the lower limbs), chronic renal failure and 10-year coronary risk with the REGICOR (Spanish acronym for Girona Heart Registry) function (between 35 and 74 years). The outcome variables were: SBP and DBP in mmHg (valid if they were taken in the last 2 years in people ≥40 years of age and within the last 4 years in < 40 years of age), prior HT if recorded in ePCHR or had SBP figures ≥140 mmHg of SBP or DBP ≥ 90 mmHg, HT according to the ACC/AHA criteria in the previous cases or if there were SBP figures between 130 and 139 mmHg or DBP between 80 and 89 mmHg and pharmacological treatment of HT. A descriptive analysis of the variables was carried out; qualitative variables expressed as number and percentage and quantitative ones as mean and standard deviation. The estimate of the prevalence of HT was accompanied by its 95% confidence interval. Proportions were compared using the chi-square test and the Student-Fischer t-test for the means, using the corresponding statistical tests if its application conditions were not met. Whether the new ACC/AHA criteria could mean an increase in the proportion of people treated with antihypertensive drugs was also studied, taking into account the ACC/AHA2 assumptions, considering those who had a ≥10% risk with the REGICOR function as patients of high cardiovascular risk. The variables associated with the new ACC/AHA diagnostic criteria for HT were studied, performing a logistic regression analysis, adjusting for age, sex and the variables associated with a p-value < 0.2. The sample size was calculated using the GRANMO software, accepting an alpha risk of 5%, a population per-
Table 1 Study participants characteristics (n = 370). Variables Age (years) Sex (women) Diabetes mellitus Hypercholesterolemia Smoking Non-smoker Smoker Former smoker 10-year coronary risk (REGICOR)a Low (<5%) Intermediate (5-9.9%) High (≥10%) Obesityb Ischemic heart disease Heart failure Cerebrovascular disease Peripheral artery disease lower limbs Chronic renal failure Systolic blood pressure Diastolic blood pressure Prior HT HT ACC/AHA criteria Previous HT drug treatment Pharmacological treatment HT ACC/AHA criteria
52.3 (19.2) 217 (58.6) 67 (18.1) 159 (43.0) 256 (69.2) 67 (18.1) 47 (12.7) 86 (64.7) 38 (28.5) 9 (6.8) 87 (29.7) 19 (5.1) 14 (3.8) 23 (6.2) 18 (4.9) 13 (3.5) 125.6 (15.8) 76.6 (10.6) 155 (41.9) 251 (67.8) 119 (32.2) 142 (38.4)
Variables expressed as number and (percentage) and mean and (standard deviation). a Calculated in 133 participants, after excluding those under 35 years of age, those over 74 years of age and cases in which not all the variables required for calculation were included. b Calculated in 293 participants.
centage of HT in the worst possible case (0.5), an accuracy of 5% and a 30% loss, with a sample of 531 people being necessary. Results After excluding 30.3% due to lack of blood pressure records, a total of 370 people was studied. Significant differences were only found in the age variable (mean difference of 4.1 years) regarding those included in the study. The average age was 52.3 years, with 58.6% being women. The rest of the characteristics are shown in Table 1. This table details the changes in diagnostic prevalence and in the population with antihypertensive treatment. It can be seen that 155 people, that is, 41.9% (95% CI 36.9–46.9) had previous HT. 119 were under pharmacological treatment, which represented 32.2% (95% CI 27.6–37.1) of the population studied. 96 cases were additionally diagnosed with the ACC/AHA criteria, assuming a proportion of 67.8% (95% CI 63.1–72.6), that is, an absolute increase of 25.9% in the prevalence of HT (p < 0.05). Of these people, pharmacological treatment should be initiated in 23 of them, so that 142 people would receive treatment, 38.4% of the population studied (95% CI 33.6–43.4), assuming a non-significant increase of 6.2 % (p > 0.05). Table 2 details the differences between the cases with previous HT and with the new ACC/AHA criteria. People diagnosed with the ACC/AHA criteria with respect to those who had previous HT were significantly younger (p < 0.05), with a lower proportion of women, diabetes mellitus, hypercholesterolemia, obesity, some cardiovascular disease and chronic renal failure. Only age and obesity maintained statistical significance in the logistic regression analysis. The new diagnoses also had a lower SBP (7 mmHg, p < 0.001), without differences in DBP. Discussion The results of the study suggest a significant increase in the diagnostic prevalence of HT if the new ACC/AHA criteria were applied,
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ARTICLE IN PRESS J.M. Baena Díez et al. / Med Clin (Barc). 2020;xxx(xx):xxx–xxx
Table 2 Differences between patients with previous HT and exclusively with the ACC/AHA criteria according to the descriptive variables of the study. Variable
Previous HT N = 155
HT ACC/AHA criteria N = 96
p-value
Age (years) Female Diabetes mellitus Hypercholesterolemia Smokers High coronary riska Obesityb Some type of cardiovascular disease Chronic renal failure Systolic blood pressure Diastolic blood pressure
66.3 (13.8) 91 (58.7) 50 (32.3) 94 (60.6) 26 (16.8) 7 (9.3) 58 (41.4) 37 (23.9)
46.6 (16.8) 42 (43.8) 10 (10.4) 44 (45.8) 21 (21.9) 2 (5.7) 15 (23.1) 8 (8.3)
<0.001 0.021 <0.001 0.022 0.314 0.519 0.011 0.002
12 (4.8) 135.1 (14.5) 81.0 (11.5)
0 (0) 128.1 (8.4) 79.4 (6.9)
0.005 <0.001 0.152
Variables expressed as number y (percentage) and mean y (standard deviation). Values in bold p < 0.05. a Calculated in 110 participants, after excluding those under 35 years of age, those over 74 years of age and cases in which not all the variables required for calculation were included. b Calculated in 205 participants.
so that 2 out of every 3 adults would be considered hypertensive, although the population susceptible to receive antihypertensive drugs would not increase significantly. As expected, these new hypertensive patients would be quite young. However, the results could be overvalued because they were based on a single blood pressure measurement and those who were not included in the study were somewhat younger, although this methodology is generally accepted in epidemiological studies. Likewise, its external validity is limited as it is a local study and does not include patients from other territories. These results coincide with other studies. In the United States, the prevalence of hypertension in adults would rise from 31.9% to 45.6% and the treated population from 34.3% to 36.2%.5 In Bangladesh, in > 35 years the prevalence would go from 25.7% to 48%.6 In China, in >18 years, the results are similar (from 24.5% to 46.9%), increasing the proportion of young hypertensive patients.7 Another study8 has analysed the impact of the ACC/AHA criteria on the 45–74-year-old participants of the NHANES cohort of the United States and CHARLS cohort of China. In the United States, the prevalence would be 63%, and 55% in China, increasing 26.8% and 45.1%, respectively. In both countries the number of people treated pharmacologically would increase.8 Recently, a population study in Spain9 has shown that in > 18 years the prevalence would go from 33.1% to 46.9%, increasing the proportion of people treated with drugs by 3.7%. The application of the ACC/AHA criteria would have a great impact on public health policies. Almost half of the world’s population would be considered hypertensive, increasing the population treated pharmacologically, increasing the risk of adverse effects, in addition to the psychological impact and the implications on health expenditure. Although the increase in the proportion of people treated pharmacologically was not significant due to a statistical power problem, Gijón-Conde et al.8 have pointed out that the ACC/AHA criteria would mean treating 1.4 million more peo-
3
ple in Spain, a figure that would be even higher with our study. As the new hypertensive patients would be younger (almost 20 years in our study), the number of patients to be treated to avoid a cardiovascular event would be greater, being up to 13 times more in 40 year-old patients compared to 70 year-olds,8 so the benefit/risk balance of drug treatment could be unfavorable,8 at least in younger patients. It is important to remember that the benefits of the SPRINT study3 are only applicable to people with high cardiovascular risk and without diabetes. The American Academy of Family Medicine10 has warned about the overdiagnosis implied in adopting the ACC/AHA criteria, which were also highly criticized methodologically, also pointing out the important conflicts of interest of the SPRINT study.3 In summary, implementation of the ACC/AHA criteria would have a significant impact on the diagnostic prevalence of HT, considering almost 70% of the adult population of a health center as hypertensive. The significant public health implications and the questions about the relevance of this change suggest being cautious before deciding to modify the diagnostic criteria for HT. Conflict of interests The authors declare no conflict of interest. References 1. Grau M, Elosua R, Cabrera de León A, Guembe MJ, Baena-Díez JM, Vega Alonso T, et al. Cardiovascular risk factors in Spain in the first decade of the 21st Century, a pooled analysis with individual data from 11 population-based studies: the DARIOS study. Rev Esp Cardiol. 2011;64:295–304. 2. Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:1269–324. 3. SPRINT Research Group, Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, et al. Randomized trial of intensive versus standard blood-pressure control. N Eng J Med. 2015;373:2103–16. 4. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 Practice Guidelines for the management of arterial hypertensionof the European Society of Cardiology and the European Society of Hypertension. Blood Press. 2018;27:314–40. 5. Muntner P, Carey RM, Gidding S, Jones DW, Taler SJ, Wright JT Jr, et al. Potential U.S. population impact of the 2017 ACC/AHA high blood pressure guideline. J Am Coll Cardiol. 2018;71:109–18. 6. Kibria GMA, Swasey K, Choudhury A, Burrowes V, Stafford KA, Uddin SMI, et al. The new 2017 ACC/AHA guideline for classification of hypertension: changes in prevalence of hypertension among adults in Bangladesh. J Hum Hypertens. 2018;32:608–16. 7. Li D, Zeng X, Huang Y, Lei H, Li G, Zhang N, et al. Increased risk of hypertension in young adults in Southwest China: impact of the 2017 ACC/AHA high blood pressure guideline. Curr Hypertens Rep. 2019;21:21. 8. Khera R, Lu Y, Lu J, Saxena A, Nasir K, Jiang L, et al. Impact of 2017 ACC/AHA guidelines on prevalence of hypertension and eligibility for antihypertensive treatment in United States and China: nationally representative cross sectional study. BMJ. 2018;362:k2357. 9. Gijón-Conde T, Sanchez-Martínez M, Graciani A. Impact and the European and American guidelines of hypertension prevalence, treatment, and cardiometabolic goals. J Hypertens. 2019 (en prensa). 10. Miyazaki K. Overdiagnosis or not? 2017 ACC/AHA high blood pressure clinical practice guideline: Consequences of intellectual conflict of interest. J Gen Fam Med. 2018;19:123–6.
ARTICLE IN PRESS Med Clin (Barc). 2020;xxx(xx):xxx–xxx
www.elsevier.es/medicinaclinica
Brief report
Impact of the new criteria of the ACC/AHA on the diagnostic prevalence of hypertension夽 José Miguel Baena Díez a,b,∗ , Maria Carrera Morodo a , Miriam Corral Roca a , Eva Calatayud Subías a , Iris Flores Jiménez a , Ana María de la Arada Acebes a a b
Centro de Salud La Marina, SAP Esquerra Barcelona, Institut Català de la Salut, Barcelona, Spain IDIAP Jordi Gol, Institut Català de la Salut, Barcelona, Spain
a r t i c l e
i n f o
Article history: Received 9 April 2019 Accepted 6 June 2019 Available online xxx Keywords: Hypertension Prevalence Diagnosis Practice guidelines
a b s t r a c t Objective: To study the impact on the prevalence of hypertension with the criteria (2017) of the American College of Cardiology/American Heart Association (ACC/AHA). Patients and methods: Cross-sectional study, including 370 patients ≥18 years, randomly selected in a Health Centre, with at least one visit and a measurement of systolic (SBP) and diastolic blood pressure (DBP) recorded the last 2 years. Previous hypertension was considered if the diagnosis was confirmed or they had an SBP ≥ 140 or DBP ≥ 90 mmHg and as ACC/AHA AHT criteria in any of these cases or an SBP between 130−139 mmHg or DBP between 80 and 89 mmHg. Results: The average age was 52.3 years (58.6% women). Forty-one point nine percent had previous hypertension, increasing to 67.8% with the ACC/AHA criteria (p < .05). Pharmacological treatment was received by 32.2% of the population, increasing to 38.4% with the ACC/AHA criteria (p > .05). The newly diagnosed patients (p < .05) were younger (mean difference 19.6 years) and less obese (23% vs 41.4%). Conclusions: The ACC/AHA criteria would represent an increase of 25.9% in the prevalence of hypertension, considering 2 out of 3 adults hypertensive. ˜ S.L.U. All rights reserved. © 2019 Elsevier Espana,
Impacto de los nuevos criterios de la ACC/AHA sobre la prevalencia diagnóstica de hipertensión arterial r e s u m e n Palabras clave: Hipertensión Prevalencia Criterios diagnósticos Guías de práctica clínica
Objetivo: Estudiar el impacto sobre la prevalencia de hipertensión arterial (HTA) con los criterios (2017) del American College of Cardiology/American Heart Association (ACC/AHA). ˜ Pacientes y métodos: Estudio descriptivo transversal, incluyendo 370 pacientes ≥18 anos, seleccionados aleatoriamente en un Centro de Salud, al menos con una visita y una medida de presión arterial sistólica ˜ (PAS) y diastólica (PAD) registrada los últimos 2 anos. Se consideró HTA previa si constaba el diagnóstico o tenían una PAS ≥ 140 ó PAD ≥ 90 mmHg y como HTA criterios ACC/AHA en cualquiera de estos supuestos o constaba una PAS entre 130−139 mmHg ó PAD entre 80−89 mmHg. ˜ Resultados: La edad media fue 52,3 anos (58,6% mujeres). El 41,9% tenían HTA previa, aumentando al 67,8% con los criterios ACC/AHA (p < 0,05). Recibía tramiento farmacológico el 32,2% de la población, aumentando al 38,4% con los criterios ACC/AHA (p > 0,05). Los nuevos diagnósticos (p < 0,05) eran más ˜ jóvenes (diferencia medias 19,6 anos) y menos obesos (23% vs 41,4%). Conclusiones: Los criterios ACC/AHA supondrían un aumento del 25,9% en la prevalencia de HTA, considerando hipertensas 2 de cada 3 personas adultas. ˜ S.L.U. Todos los derechos reservados. © 2019 Elsevier Espana,
夽 Please cite this article as: Baena Díez JM, Carrera Morodo M, Corral Roca M, Calatayud Subías E, Flores Jiménez I, de la Arada Acebes AM. Impacto de los nuevos criterios de la ACC/AHA sobre la prevalencia diagnóstica de hipertensión arterial. Med Clin (Barc). 2019. https://doi.org/10.1016/j.medcli.2019.06.021 ∗ Corresponding author. E-mail address: [email protected] (J.M. Baena Díez). ˜ S.L.U. All rights reserved. 2387-0206/© 2019 Elsevier Espana,
MEDCLE-4954; No. of Pages 3
G Model 2
ARTICLE IN PRESS J.M. Baena Díez et al. / Med Clin (Barc). 2020;xxx(xx):xxx–xxx
Introduction Hypertension (HT) is a cardiovascular risk factor associated with an increased risk of cardiovascular diseases. Its diagnosis, treatment and control have contributed in recent decades to reduce the incidence of these diseases. The DARIOS study estimated a prevalence of HT in Spain of 47% in men and 39% in women.1 Recently the American College of Cardiology and the American Heart Association (ACC/AHA) have modified2 the diagnostic criteria of HT after the publication of the SPRINT study,3 lowering the cut-off point for diagnosis to 130/80 mmHg, also introducing modifications in its treatment. This proposal has not been accepted by the European Cardiovascular Societies,4 which continue to maintain the 140/90 mmHg figure. We do not know the magnitude of the possible increase in the diagnostic prevalence of HT in our country. The main objective of the present study is to analyse the impact of the new of the ACC/AHA diagnostic criteria for HT on the diagnostic prevalence of HT in the population of an urban healthcare center. Also, as secondary objectives, whether the application of these criteria would increase the population treated with drugs and analyse the factors associated with the new diagnoses of HT.
Patients and methods A cross-sectional descriptive study was carried out, selecting patients by simple randomized sampling from the electronic primary care health records ePCHR of an urban Health Center with 15,725 people assigned >14 years. The study was approved by the Ethics Committee Fundació Jordi Gol, code P18/156. Assigned persons ≥18 years of age with at least one visit in the last two years were included. Patients were considered losses if there was no systolic blood pressure (SBP) and diastolic (DBP) measurements recorded in the ePCHR in the last two years. The descriptive variables of the study were collected from the ePCHR and were the following: age (years), sex, smoking (non-smoker, smoker, ex-smoker >1 year), diabetes mellitus, hypercholesterolemia, obesity (body mass index ≥30), previous cardiovascular diseases (ischemic heart disease, heart failure, stroke and peripheral vascular disease of the lower limbs), chronic renal failure and 10-year coronary risk with the REGICOR (Spanish acronym for Girona Heart Registry) function (between 35 and 74 years). The outcome variables were: SBP and DBP in mmHg (valid if they were taken in the last 2 years in people ≥40 years of age and within the last 4 years in < 40 years of age), prior HT if recorded in ePCHR or had SBP figures ≥140 mmHg of SBP or DBP ≥ 90 mmHg, HT according to the ACC/AHA criteria in the previous cases or if there were SBP figures between 130 and 139 mmHg or DBP between 80 and 89 mmHg and pharmacological treatment of HT. A descriptive analysis of the variables was carried out; qualitative variables expressed as number and percentage and quantitative ones as mean and standard deviation. The estimate of the prevalence of HT was accompanied by its 95% confidence interval. Proportions were compared using the chi-square test and the Student-Fischer t-test for the means, using the corresponding statistical tests if its application conditions were not met. Whether the new ACC/AHA criteria could mean an increase in the proportion of people treated with antihypertensive drugs was also studied, taking into account the ACC/AHA2 assumptions, considering those who had a ≥10% risk with the REGICOR function as patients of high cardiovascular risk. The variables associated with the new ACC/AHA diagnostic criteria for HT were studied, performing a logistic regression analysis, adjusting for age, sex and the variables associated with a p-value < 0.2. The sample size was calculated using the GRANMO software, accepting an alpha risk of 5%, a population per-
Table 1 Study participants characteristics (n = 370). Variables Age (years) Sex (women) Diabetes mellitus Hypercholesterolemia Smoking Non-smoker Smoker Former smoker 10-year coronary risk (REGICOR)a Low (<5%) Intermediate (5-9.9%) High (≥10%) Obesityb Ischemic heart disease Heart failure Cerebrovascular disease Peripheral artery disease lower limbs Chronic renal failure Systolic blood pressure Diastolic blood pressure Prior HT HT ACC/AHA criteria Previous HT drug treatment Pharmacological treatment HT ACC/AHA criteria
52.3 (19.2) 217 (58.6) 67 (18.1) 159 (43.0) 256 (69.2) 67 (18.1) 47 (12.7) 86 (64.7) 38 (28.5) 9 (6.8) 87 (29.7) 19 (5.1) 14 (3.8) 23 (6.2) 18 (4.9) 13 (3.5) 125.6 (15.8) 76.6 (10.6) 155 (41.9) 251 (67.8) 119 (32.2) 142 (38.4)
Variables expressed as number and (percentage) and mean and (standard deviation). a Calculated in 133 participants, after excluding those under 35 years of age, those over 74 years of age and cases in which not all the variables required for calculation were included. b Calculated in 293 participants.
centage of HT in the worst possible case (0.5), an accuracy of 5% and a 30% loss, with a sample of 531 people being necessary. Results After excluding 30.3% due to lack of blood pressure records, a total of 370 people was studied. Significant differences were only found in the age variable (mean difference of 4.1 years) regarding those included in the study. The average age was 52.3 years, with 58.6% being women. The rest of the characteristics are shown in Table 1. This table details the changes in diagnostic prevalence and in the population with antihypertensive treatment. It can be seen that 155 people, that is, 41.9% (95% CI 36.9–46.9) had previous HT. 119 were under pharmacological treatment, which represented 32.2% (95% CI 27.6–37.1) of the population studied. 96 cases were additionally diagnosed with the ACC/AHA criteria, assuming a proportion of 67.8% (95% CI 63.1–72.6), that is, an absolute increase of 25.9% in the prevalence of HT (p < 0.05). Of these people, pharmacological treatment should be initiated in 23 of them, so that 142 people would receive treatment, 38.4% of the population studied (95% CI 33.6–43.4), assuming a non-significant increase of 6.2 % (p > 0.05). Table 2 details the differences between the cases with previous HT and with the new ACC/AHA criteria. People diagnosed with the ACC/AHA criteria with respect to those who had previous HT were significantly younger (p < 0.05), with a lower proportion of women, diabetes mellitus, hypercholesterolemia, obesity, some cardiovascular disease and chronic renal failure. Only age and obesity maintained statistical significance in the logistic regression analysis. The new diagnoses also had a lower SBP (7 mmHg, p < 0.001), without differences in DBP. Discussion The results of the study suggest a significant increase in the diagnostic prevalence of HT if the new ACC/AHA criteria were applied,
G Model
ARTICLE IN PRESS J.M. Baena Díez et al. / Med Clin (Barc). 2020;xxx(xx):xxx–xxx
Table 2 Differences between patients with previous HT and exclusively with the ACC/AHA criteria according to the descriptive variables of the study. Variable
Previous HT N = 155
HT ACC/AHA criteria N = 96
p-value
Age (years) Female Diabetes mellitus Hypercholesterolemia Smokers High coronary riska Obesityb Some type of cardiovascular disease Chronic renal failure Systolic blood pressure Diastolic blood pressure
66.3 (13.8) 91 (58.7) 50 (32.3) 94 (60.6) 26 (16.8) 7 (9.3) 58 (41.4) 37 (23.9)
46.6 (16.8) 42 (43.8) 10 (10.4) 44 (45.8) 21 (21.9) 2 (5.7) 15 (23.1) 8 (8.3)
<0.001 0.021 <0.001 0.022 0.314 0.519 0.011 0.002
12 (4.8) 135.1 (14.5) 81.0 (11.5)
0 (0) 128.1 (8.4) 79.4 (6.9)
0.005 <0.001 0.152
Variables expressed as number y (percentage) and mean y (standard deviation). Values in bold p < 0.05. a Calculated in 110 participants, after excluding those under 35 years of age, those over 74 years of age and cases in which not all the variables required for calculation were included. b Calculated in 205 participants.
so that 2 out of every 3 adults would be considered hypertensive, although the population susceptible to receive antihypertensive drugs would not increase significantly. As expected, these new hypertensive patients would be quite young. However, the results could be overvalued because they were based on a single blood pressure measurement and those who were not included in the study were somewhat younger, although this methodology is generally accepted in epidemiological studies. Likewise, its external validity is limited as it is a local study and does not include patients from other territories. These results coincide with other studies. In the United States, the prevalence of hypertension in adults would rise from 31.9% to 45.6% and the treated population from 34.3% to 36.2%.5 In Bangladesh, in > 35 years the prevalence would go from 25.7% to 48%.6 In China, in >18 years, the results are similar (from 24.5% to 46.9%), increasing the proportion of young hypertensive patients.7 Another study8 has analysed the impact of the ACC/AHA criteria on the 45–74-year-old participants of the NHANES cohort of the United States and CHARLS cohort of China. In the United States, the prevalence would be 63%, and 55% in China, increasing 26.8% and 45.1%, respectively. In both countries the number of people treated pharmacologically would increase.8 Recently, a population study in Spain9 has shown that in > 18 years the prevalence would go from 33.1% to 46.9%, increasing the proportion of people treated with drugs by 3.7%. The application of the ACC/AHA criteria would have a great impact on public health policies. Almost half of the world’s population would be considered hypertensive, increasing the population treated pharmacologically, increasing the risk of adverse effects, in addition to the psychological impact and the implications on health expenditure. Although the increase in the proportion of people treated pharmacologically was not significant due to a statistical power problem, Gijón-Conde et al.8 have pointed out that the ACC/AHA criteria would mean treating 1.4 million more peo-
3
ple in Spain, a figure that would be even higher with our study. As the new hypertensive patients would be younger (almost 20 years in our study), the number of patients to be treated to avoid a cardiovascular event would be greater, being up to 13 times more in 40 year-old patients compared to 70 year-olds,8 so the benefit/risk balance of drug treatment could be unfavorable,8 at least in younger patients. It is important to remember that the benefits of the SPRINT study3 are only applicable to people with high cardiovascular risk and without diabetes. The American Academy of Family Medicine10 has warned about the overdiagnosis implied in adopting the ACC/AHA criteria, which were also highly criticized methodologically, also pointing out the important conflicts of interest of the SPRINT study.3 In summary, implementation of the ACC/AHA criteria would have a significant impact on the diagnostic prevalence of HT, considering almost 70% of the adult population of a health center as hypertensive. The significant public health implications and the questions about the relevance of this change suggest being cautious before deciding to modify the diagnostic criteria for HT. Conflict of interests The authors declare no conflict of interest. References 1. Grau M, Elosua R, Cabrera de León A, Guembe MJ, Baena-Díez JM, Vega Alonso T, et al. Cardiovascular risk factors in Spain in the first decade of the 21st Century, a pooled analysis with individual data from 11 population-based studies: the DARIOS study. Rev Esp Cardiol. 2011;64:295–304. 2. Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:1269–324. 3. SPRINT Research Group, Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, et al. Randomized trial of intensive versus standard blood-pressure control. N Eng J Med. 2015;373:2103–16. 4. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 Practice Guidelines for the management of arterial hypertensionof the European Society of Cardiology and the European Society of Hypertension. Blood Press. 2018;27:314–40. 5. Muntner P, Carey RM, Gidding S, Jones DW, Taler SJ, Wright JT Jr, et al. Potential U.S. population impact of the 2017 ACC/AHA high blood pressure guideline. J Am Coll Cardiol. 2018;71:109–18. 6. Kibria GMA, Swasey K, Choudhury A, Burrowes V, Stafford KA, Uddin SMI, et al. The new 2017 ACC/AHA guideline for classification of hypertension: changes in prevalence of hypertension among adults in Bangladesh. J Hum Hypertens. 2018;32:608–16. 7. Li D, Zeng X, Huang Y, Lei H, Li G, Zhang N, et al. Increased risk of hypertension in young adults in Southwest China: impact of the 2017 ACC/AHA high blood pressure guideline. Curr Hypertens Rep. 2019;21:21. 8. Khera R, Lu Y, Lu J, Saxena A, Nasir K, Jiang L, et al. Impact of 2017 ACC/AHA guidelines on prevalence of hypertension and eligibility for antihypertensive treatment in United States and China: nationally representative cross sectional study. BMJ. 2018;362:k2357. 9. Gijón-Conde T, Sanchez-Martínez M, Graciani A. Impact and the European and American guidelines of hypertension prevalence, treatment, and cardiometabolic goals. J Hypertens. 2019 (en prensa). 10. Miyazaki K. Overdiagnosis or not? 2017 ACC/AHA high blood pressure clinical practice guideline: Consequences of intellectual conflict of interest. J Gen Fam Med. 2018;19:123–6.