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

O.L. Rekovets, Yu.M. Sirenko, O.O. Torbas, S.M. Kushnir, G.F. Primak


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.


arterial hypertension; morning blood pressure surge; central blood pressure; chronotherapy; evening drug intake; mor-ning drug intake; telmisartan; amlodipine; hydrochlorothiazide


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