Open-label single center clinical trial of early-morning blood pressure reduction in patients with mild to moderate hypertension with controlled office blood pressure and uncontrolled morning blood pressure surge by telmisartan (Telsartan) therapy with
Background. The purpose of our study was to evaluate the effectiveness of reduction of morning blood pressure (BP) by ambulatory blood pressure monitoring (ABPM) after 12 weeks of treatment in patients with mild to moderate arterial hypertension, who had controlled office BP and uncontrolled morning BP surge. Materials and methods. The study involved 67 patients with mild to moderate hypertension who had controlled office BP and uncontrolled morning BP surge. General blood test, biochemical blood test, measurement of office blood pressure, outpatient 24-hour blood pressure monitoring, blood pressure measurement, morning blood pressure rise, determination of central blood pressure, PWV, were performed. Patients were switched to telmisartan 40 or 80 mg tablets (Telsartan, Dr. Reddy’s Laboratories Ltd), or to combined tablets of telmisartan 40 or 80 mg with hydrochlorothiazide 12.5 mg (Telsartan-H, Dr. Reddy’s Laboratories Ltd), for morning once daily intake (Subgroup 1) or evening once daily intake (Subgroup 2). If after 4 weeks of treatment BP was not controlled at the level less than 140/90 mm Hg, amlodipine 5 or 10 mg once daily was prescribed on top. Primary and final examination after 3 months of therapy was performed. Results. The office SBP/DBP at 8 weeks reduced at the average by 16.92/9.56 mm Hg (p < 0.05), and after 12 weeks of treatment — 21.26/12.12 mm Hg (p < 0.05). Office heart rate (HR) did not significantly change. The therapy with Telsartan and Telsartan-H was associated with a significant decrease in average daily SBP (from 134.45 ± 1.39 to 122.01 ± 1.16 mm Hg; p < 0.05) and DBP (from 81.51 ± 1.15 to 71.62 ± 1.01 mm Hg; p < 0.05), which averaged 12.44/9.89 mm Hg. The average daily SBP and DBP indicators significantly decreased from 138.92 ± 1.38 and 85.22 ± 1.20 to 126.35 ± 1.20 and 75.70 ± 1.11 mm Hg (p < 0.05), respectively, which averaged 12.57 and 9.52 mm Hg; and average nocturnal SBP and DBP lowered from 126.13 ± 1.18 and 74.28 ± 1.46 to 113.37 ± 1.40 and 63.73 ± 1.09 mm Hg (p < 0.05), respectively (12.76 and 11.05 mm Hg). There were no significant changes in 24-hour HR. The target blood pressure level by a switch to Telsartan or Telsartan-H alone or in combination with amlodipine at office measurement was achieved in 80.6 % of cases and at daily monitoring in 75.61 %. Thus, in patients with mild to moderate hypertension who had controlled office BP and uncontrolled morning BP surge, the treatment with studied drugs Telsartan and Telsartan-H showed high antihypertensive efficacy both in single-use and in combination with amlodipine. Telmisartan more effectively reduced both the daytime and nighttime SBP and DBP at morning intake compared to the evening. There was a significant decrease in the average SBP, DBP in the morning hours from 140.14 ± 1.51 and 87.19 ± 1.56 to 124.77 ± 1.40 and 73.23 ± 1.31 mm Hg (p < 0.05) by 15.37 and 13.96 mm Hg, respectively. There was also a reduction in the rate of increase of SBP in the morning by 3.67 mm Hg/h after therapy with Telsartan and Telsartan-H. There was a decrease in the value of the morning rise of SBP by 11.34 mm Hg (p < 0.05). Conclusions. Telsartan and Telsartan-H single-use or use in combination with Stamlo (amlodipine) in patients with mild to moderate hypertension who had controlled office BP and uncontrolled morning BP surge significantly reduced both office BP and BP at ABPM and contributed to the reduction of BP morning surge and a decrease of the rate of morning BP surge.
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1999 WHO — ISH guidelines for the management of hypertension. J. Hypertension. 1999. Vol. 11. P. 905-916.
Bartter F.C., Delea C.S., Baker W. Chronobiology in the diagnosis and treatment of hypertension. Chronobiologia. 1976. Vol. 3(3). 199-213.
Bowles N.P., Thosar S.S., Herzig M.X., Shea S.A. Chronotherapy for Hypertension. Current Hypertension Reports. 2018. Vol. 20. Р. 97. URL: https://doi.org/10.1007/s11906-018-0897-4.
Elliott H.L. 24-hour control of cardiovascular disease. Science Press: London, 1995. P. 48.
Formes K.J., Wray D.W., O-Yurvati A.H., Weiss M.S., Shi X. Sympathetic cardiac influence and arterial blood pressure instability. Auton. Neurosci. 2005. Vol. 1–2. P. 116-124.
Genova G., Rabbia F., Milan A. et al. Autonomic nervous pattern influence before treatment, on the response to antihypertensive therapy in never treated mild hypertensive patients. J. Hypertens. 2001. Vol. 19. P. 128S.
Hansson L., Hedner T. Hypertension Manual 2000. Layout Bohlin Production AB, 2000. 128 p.
Hermida R.C., Ayala D.E., Mojón A., Fernández J.R. Effects of time of antihypertensive treatment on ambulatory blood pressure and clinical characteristics of subjects with resistant hypertension. Am. J. Hypertens. 2010. Vol. 23. Р. 432-439.
Hong S.J., Choi S.C., Ahn C.M., Park J.H., Kim J.S., Lim D.S. Telmisartan reduces neointima volume and pulse wave velocity 8 months after zotarolimus-eluting stent implantation in hypertensive type 2 diabetic patients. Heart. 2011. Vol. 97. Р. 1425-1432.
Hypertension Primer. The essentials of high blood pressure. From the council on high blood pressure research American Heart Association, 1999. P. 471.
Ishikawa J., Kario K., Hoshide S. еt al. Determinants of exaggerated difference in morning and evening blood pressure measured by self-measured blood pressure monitoring in medicated hypertensive patients: Jichi Morning Hypertension Research (J-MORE) Study. Am. J. Hypertens. 2005. Vol. 7. P. 958-965.
Jatoi N.A. Azra Mahmud, Kathleen Bennett, John Feely. Assessment of arterial stiffness in hypertension: comparison of oscillometric (Arteriograph), piezoelectronic (Complior) and tonometric (SphygmoCor) techniques. J. Hypertens. 2009. Vol. 27. № 11. P. 2186-2191.
Johannesson M., Dahlof B., Lindholm L.H. et al. The cost-effectiveness of treating hypertension in elderly people — an analysis of the Swedish Trial in Old Patients with Hypertension (STOP-Hypertension). J. Intern. Med. 1993. Vol. 234. P. 317-323.
Jonsson B., Hansson L., Stalhammar N.O. Health economics in the Hypertension Optimal Treatment (HOT) study: costs and cost-effectiveness of intensive blood pressure lowering and low-dose aspirin in patients with hypertension. J. Intern. Med. 2003. Vol. 253. P. 472-480.
Kario K. Early morning risk management in hypertension. London: Science press, 2004. P. 3-11.
Kasim N.A., Whitehouse M., Ramachandran C. еt al. Molecular properties of WHO essential drugs and provisional biopharmaceutical classification. Mol. Pharm. 2004. Vol. 1. P. 85-96.
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int. Suppl. 2013. Vol. 3. Р. 100-150.
Marfella R., Siniscalchi M., Nappo F. еt al. Regression of carotid atherosclerosis by control of morning blood pressure peak in newly diagnosed hypertensive patients. Am. J. Hypertens. 2005. Vol. 3. P. 308-318.
Mitchell G.F., Hwang Shih-Jen, Vasan R.S. Arterial stiffness and cardiovascular events: the Framingham heart study. Circulation. 2010. Vol. 121. № 4. P. 505-511.
Sakima A., Takishita S. Therapeutic strategy for morning blood pressure elevation in elderly hypertensives. Nippon. Rinsho. 2005. Vol. 6. P. 1086-1090.
Shimamoto K., Ando K., Fujita T. еt al. Japanese Society of Hypertension Committee for Guidelines for the Management of Hypertension. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2014). Hypertens. Res. 2014. 37. Р. 253-390.
Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J. Renin Angiotensin Aldosterone Syst. 2000. Vol. 1(1). Р. 18-20.
Staessen J., Fagard R., Thijs L., O’Brien. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Lancet. 1997. 350(9080). Р. 757-764.
van der Steen M.S., Lenders J.W., Thien T. Side effects of ambulatory blood pressure monitoring. Blood Press. Monit. 2005. Vol. 3. P. 151-155.
Verdecchia P., Angeli F. How can we use the results of ambulatory blood pressure monitoring in clinical practice? Hypertension. 2005. Vol. 1. Р. 25-26.
White W. Blood pressure monitoring in cardiovascular medicine and therapeutics. New Jersey: Humana Press, 2001. Р. 308.
White W.B., Davidai G., Schumacher H. Impact of angiotensin receptor blockade in combination with hydrochlorothiazide 25 mg in 2121 patients with stage 1–2 hypertension. J. Hum. Hypertens. 2009. Vol. 23. Р. 817-825.
White W.B., Lacourciere Y., Davidai G. Effects of the angiotensin II receptor blockers telmisartan versus valsartan on the circadian variation of blood pressure: impact on the early morning period. Am. J. Hypertens. 2004. Vol. 17. Р. 347-353.
The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018. Vol. 39. Р. 3021-3104.
Gosse P. A review of telmisartan in the treatment of hypertension: blood pressure control in the early morning hours. Vascular Health and Risk Management. 2006. 2(3). Р. 195-201.
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