Achieving blood pressure control targets in hypertensive patients of rural China - a pilot randomized trial

Xiao Huang, Lishun Liu, Yun Song, Lan Gao, Min Zhao, Huihui Bao, Xianhui Qin, Yanqing Wu, Qinghua Wu, Chonglei Bi, Aiping Yue, Chongqian Fang, Hai Ma, Yimin Cui, Genfu Tang, Ping Li, Yan Zhang, Jianping Li, Binyan Wang, Xiping Xu, Hong Wang, Gianfranco Parati, J David Spence, Xiaobin Wang, Yong Huo, Guangliang Chen, Xiaoshu Cheng, investigators of intensive BP control in China, Xiao Huang, Lishun Liu, Yun Song, Lan Gao, Min Zhao, Huihui Bao, Xianhui Qin, Yanqing Wu, Qinghua Wu, Chonglei Bi, Aiping Yue, Chongqian Fang, Hai Ma, Yimin Cui, Genfu Tang, Ping Li, Yan Zhang, Jianping Li, Binyan Wang, Xiping Xu, Hong Wang, Gianfranco Parati, J David Spence, Xiaobin Wang, Yong Huo, Guangliang Chen, Xiaoshu Cheng, investigators of intensive BP control in China

Abstract

Background: This study aimed to test the feasibility and titration methods used to achieve specific blood pressure (BP) control targets in hypertensive patients of rural China.

Methods: A randomized, controlled, open-label trial was conducted in Rongcheng, China. We enrolled 105 hypertensive participants aged over 60 years, and who had no history of stroke or cardiovascular disease. The patients were randomly assigned to one of three systolic-BP target groups: standard: 140 to < 150 mmHg; moderately intensive: 130 to < 140 mmHg; and intensive: < 130 mmHg. The patients were followed for 6 months.

Discussion: The optimal target for systolic blood pressure (SBP) lowering is still uncertain worldwide and such information is critically needed, especially in China. However, in China the rates of awareness, treatment and control are only 46.9%, 40.7%, and 15.3%, respectively. It is challenging to achieve BP control in the real world and it is very important to develop population-specific BP-control protocols that fully consider the population's characteristics, such as age, sex, socio-economic status, compliance with medication, education level, and lifestyle. This randomized trial showed the feasibility and safety of the titration protocol to achieve desirable SBP targets (< 150, < 140, and < 130 mmHg) in a sample of rural, Chinese hypertensive patients. The three BP target groups had similar baseline characteristics. After 6 months of treatment, the mean SBP measured at an office visit was 137.2 mmHg, 131.1 mmHg, and 124.2 mmHg, respectively, in the three groups. Home BP and central aortic BP measurements were also obtained. At 6 months, home BP measurements (2 h after drug administration) showed a mean SBP of 130.9 mmHg in the standard group, 124.9 mmHg in the moderately intensive group, and 119.7 mmHg in the intensive group. No serious adverse events were recorded over the 6-month study period. Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups. This trial provided real-world experience and laid the foundation for a future, large-scale, BP target study.

Trial registration: Feasibility Study of the Intensive Systolic Blood Pressure Control; ClinicalTrials.gov, ID: NCT02817503. Registered retrospectively on 29 June 2016.

Keywords: Feasibility; Home blood pressure measurement; Intensive blood pressure control; Rural China.

Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form and have declared the following:

Dr. Xiping Xu reports grants from the Science and Technology Planning Project of Guangzhou, China (201707020010), the National Key Research and Development Program (2016YFE0205400, 2018ZX09739, 2018ZX09301034003). Dr. Yong Huo reports grants from the National Key Research and Development Program (2016YFC0903103). Dr. Yimin Cui reports grants from the National Key Research and Development Program (2016YFC0904900). Dr. Xiao Huang reports grants from the National Natural Science Foundation of China (81500233), and Major Projects of the Science and Technology Department, Jiangxi, China (20171BAB205008). Dr. Qinghua Wu reports grants from the Major Projects of the Science and Technology Department, Jiangxi, China (20161ACG70012). The other authors report no conflicts of interest.

Figures

Fig. 1
Fig. 1
Design and flow chart of the feasibility study
Fig. 2
Fig. 2
Mean systolic blood pressure (BP) of three treatment groups during the study visits. Panel a: mean systolic blood pressure (SBP) during the treatment period in the standard-BP-control group, the moderate-BP-control group, and the intensive-BP-control group was 137.2 mmHg, 131.1 mmHg, and 124.2 mmHg, respectively, while the corresponding DBP was 77.6 mmHg, 74.9 mmHg. and 71.5 mmHg in each of the three groups, respectively, by the end of 6 months of follow-up. Panel b: the mean number of antihypertensive drugs prescribed at enrollment was 1.4, 1.4, and 1.5 among the standard-BP-control group, the moderate-BP-control group, and the intensive-BP-control group, respectively. After 6 months of follow-up, the mean number of drugs prescribed was 1.4, 2.2, and 2.5, per group, respectively. Panel C: the distribution of antihypertensive drugs used in the different groups

References

    1. Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, Chen J, He J. Global disparities of hypertension prevalence and control: a systematic analysis of population-based studies from 90 countries. Circulation. 2016;134:441–450. doi: 10.1161/CIRCULATIONAHA.115.018912.
    1. Wang Z, Chen Z, Zhang L, Wang X, Hao G, Zhang Z, Shao L, Tian Y, Dong Y, Zheng C, Wang J, Zhu M, Weintraub WS, Gao R, China Hypertension Survey Investigators Status of hypertension in China: results from the China hypertension survey, 2012–2015. Circulation. 2018;137(22):2344–2356. doi: 10.1161/CIRCULATIONAHA.117.032380.
    1. Lu J, Lu Y, Wang X, Li X, Linderman GC, Wu C, Cheng X, Mu L, Zhang H, Liu J, Su M, Zhao H, Spatz ES, Spertus JA, Masoudi FA, Krumholz HM, Jiang L. Prevalence, awareness, treatment, and control of hypertension in China: data from 1·7 million adults in a population-based screening study (China PEACE Million Persons Project) Lancet. 2017;390:2549–2558. doi: 10.1016/S0140-6736(17)32478-9.
    1. GBD Causes of Death Collaborators Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390:1151–1210. doi: 10.1016/S0140-6736(17)32152-9.
    1. SHEP Cooperative Research Group Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP) JAMA. 1991;265(24):3255–3264. doi: 10.1001/jama.1991.03460240051027.
    1. Benavente OR, Coffey CS, Conwit R, the SPS3 Study Group et al. Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomized trial. Lancet. 2013;382(9891):507–515. doi: 10.1016/S0140-6736(13)60852-1.
    1. Lewington S, Lacey B, Clarke R, et al. The burden of hypertension and associated risk for cardiovascular mortality in China. JAMA Intern Med. 2016;176(4):524–532. doi: 10.1001/jamainternmed.2016.0190.
    1. Wright JT, Jr, Bakris G, Greene T, the African American Study of Kidney Disease and Hypertension Study Group et al. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002;288(19):2421–2431. doi: 10.1001/jama.288.19.2421.
    1. James PA, Oparil S, Carter BL, et al. 2014 Evidence-based guideline for the management of high blood pressure in adults: report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) JAMA. 2013;311:507–520. doi: 10.1001/jama.2013.284427.
    1. SPRINT Research Group A randomized trial of intensive versus standard blood-pressure control. N Engl J Med. 2015;373(22):2103–2116. doi: 10.1056/NEJMoa1511939.
    1. Whelton PK, Carey RM, Aronow WS, Casey DE, Collins KJ, Dennison HC, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA, Williamson JD, Wright JT. 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. Circulation. 2018;138(17):e426–83.
    1. Spence JD. Systolic blood pressure targets, diastolic J curve and cuff artefact in blood pressure measurement: a note of caution. Eur J Neurol. 2017;24(11):1323–1325. doi: 10.1111/ene.13442.
    1. Hao L, Ma J, Stampfer MJ, Ren A, Tian Y, Tang Y, Willett WC, Li Z. Geographical, seasonal and gender differences in folate status among Chinese adults. J Nutr. 2003;133:3630–3635. doi: 10.1093/jn/133.11.3630.
    1. Hao L, Ma J, Zhu J, Stampfer MJ, Tian Y, Willett WC, Li Z. High prevalence of hyperhomocysteinemia in Chinese adults is associated with low folate, vitamin B-12, and vitamin B-6 status. J Nutr. 2007;137(2):407–413. doi: 10.1093/jn/137.2.407.
    1. Chen Z, Wang F, Zheng Y, Zeng Q, Liu H. H-type hypertension is an important risk factor of carotid atherosclerotic plaques. Clin Exp Hypertens. 2016;38(5):424–428. doi: 10.3109/10641963.2015.1116547.
    1. Kunes J, Tremblay J, Bellavance F, et al. Influence of environmental temperature on the blood pressure of hypertensive patients in Montréal. Am J Hypertens. 1991;4:422–6.
    1. ACCORD Study Group. Cushman WC, Evans GW, Byington RP. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010;362(17):1575–1585. doi: 10.1056/NEJMoa1001286.
    1. Bulpitt CJ, Beckett NS, Cooke J, Dumitrascu DL, Gil-Extremera B, Nachev C, Nunes M, Peters R, Staessen JA, Thijs L, Hypertension in the Very Elderly Trial Working Group Results of the pilot study for the Hypertension in the Very Elderly Trial. J Hypertens. 2003;21(12):2409–2417. doi: 10.1097/00004872-200312000-00030.
    1. Ogihara T, Saruta T, Rakugi H, Matsuoka H, Shimamoto K, Shimada K, Imai Y, Kikuchi K, Ito S, Eto T, Kimura G, Imaizumi T, Takishita S, Ueshima H, Valsartan in Elderly Isolated Systolic Hypertension Study Group Target blood pressure for treatment of isolated systolic hypertension in the elderly: valsartan in elderly isolated systolic hypertension study. Hypertension. 2010;56(2):196–202. doi: 10.1161/HYPERTENSIONAHA.109.146035.
    1. Benavente OR, Coffey CS, Conwit R, Hart RG, McClure LA, Pearce LA, Pergola PE, Szychowski JM. Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomised trial. Lancet. 2013;382:507–515. doi: 10.1016/S0140-6736(13)60852-1.
    1. Lonn EM, Bosch J, López-Jaramillo P, Zhu J, Liu L, Pais P, Diaz R, Xavier D, Sliwa K, Dans A, Avezum A, Piegas LS, Keltai K, Keltai M, Chazova I, Peters RJ, Held C, Yusoff K, Lewis BS, Jansky P, Parkhomenko A, Khunti K, Toff WD, Reid CM, Varigos J, Leiter LA, Molina DI, McKelvie R, Pogue J, Wilkinson J, Jung H, Dagenais G, Yusuf S, HOPE-3 Investigators Blood-pressure lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016;374(21):2009–2020. doi: 10.1056/NEJMoa1600175.
    1. Son JS, Choi S, Kim K, Kim SM, Choi D, Lee G, Jeong SM, Park SY, Kim YY, Yun JM, Park SM. Association of blood pressure classification in Korean young adults according to the 2017 American College of Cardiology/American Heart Association Guidelines with subsequent cardiovascular disease events. JAMA. 2018;320(17):1783–1792. doi: 10.1001/jama.2018.16501.
    1. Pepine CJ, Handberg EM, Cooper-DeHoff RM, Marks RG, Kowey P, Messerli FH, Mancia G, Cangiano JL, Garcia-Barreto D, Keltai M, Erdine S, Bristol HA, Kolb HR, Bakris GL, Cohen JD, Parmley WW, INVEST Investigators A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-Trandolapril Study (INVEST): a randomized controlled trial. JAMA. 2003;290(21):2805–2816. doi: 10.1001/jama.290.21.2805.
    1. Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomized trials in the context of expectations from prospective epidemiological studies. BMJ. 2009;338:b1665. doi: 10.1136/bmj.b1665.
    1. Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF, CSPPT Investigators Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015;313(13):1325–1335. doi: 10.1001/jama.2015.2274.
    1. Kunes J, Tremblay J, Bellavance F, Hamet P. Influence of environmental temperature on the blood pressure of hypertensive patients in Montréal. Am J Hypertens. 1991;4(5 Pt 1):422–426. doi: 10.1093/ajh/4.5.422.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj