Metabolic effects of the generic drug telmisartan (HYPotel) or its combination with S-amlodipine (Samlopin) or hydrochlorothiazide in the ThERapy of patients with mild to moderate arterial hypertension (results of the HYPSTER-AH study)

Yu.M. Sirenko, O.L. Rekovets, E.P. Svischenko, L.M. Ena, E.A. Torbas, S.M. Kushnir, O.V. Gulkevych, I.V. Mudruk


The purpose of the study: to evaluate the metabolic effects of a generic drug telmisartan (Hypotel manufactured by Kusum Pharm, Ukraine) in monotherapy or in combination with S-amlodipine (Samlopin manufactured by Kusum Pharm, Ukraine) in patients with mild to moderate hypertension. Materials and methods. The study included 40 patients with mild to moderate hypertension. After a seven-day period of withdrawal of all medications, all patients underwent initial examination and distribution into the groups using blinding method, depending on the prescribed antihypertensive therapy. At the end of the withdrawal period, inclusion criteria were evaluated again. If patients met inclusion criteria and had no exclusion criteria, the patient’s randomization was performed. Hypotel was administered at a dose of 40–80 mg once daily for 2 weeks. If failure to reach target blood pressure (BP) less than 140/90 mmHg occurred, Samlopin 2.5–5 mg once a day was added for 1 more month. If target blood pressure was not achieved, hydrochlorothiazide 12.5 mg once daily was added. Follow-up duration was 6 months. At the beginning and at the end of the study, patients underwent 24-hour BP monitoring, evaluation of glucose, insulin blood levels, НОМА, blood lipids, biochemical blood test, common blood and urine tests. Results. The average age of patients was 55.85 ± 2.09 years. The average body weight was 87.30 ± 2.77 kg. Average body mass index — 29.41 ± 0.63 kg/m2. Average office systolic (SBP) and diastolic BP (DBP) at baseline were 155.88 ± 1.63 mmHg and 92.60 ± 1.43 mmHg, respectively. The average office heart rate (HR) — 71.40 ± 1.29 bpm. Mean blood pressure during ambulatory monitoring was 139.37 ± 1.49 mmHg for SBP, 82.47 ± 1.84 mmHg — for DBP. Average daily HR — 71.38 ± 1.32 bpm. Hypotel 40–80 mg in our study as monotherapy or in combination with Samlopin and/or hydrochlorothiazide have a neutral effect on insulin sensitivity, glucose and insulin blood levels within 24 weeks of treatment. There was no negative impact of treatment on the level of blood lipids. In the subgroup of patients without insulin resistance, there was noted a significant reduction in central BP, and augmentation index (АІх) tended to decrease. In the subgroup of patients with insulin resistance, we observed a significant reduction in both central BP and augmentation index. Central SBP (cSBP) is associated with elastic properties of the arteries, blood pressure indices and the degree of its decline, degree of left ventricular hypertrophy, indicators of systemic inflammation and erectile function in men. Metabolic blood parameters were associated with values of arterial stiffness, cSBP, office SBP, the degree of pulse pressure (PP) reduction in daily monitoring. The degree of HOMA reduction correlated with АІх growth at the end of the treatment (r = –0.451, p = 0.018); glomerular filtration rate after the treatment (r = –0.362, p = 0.042); the degree of PP reduction in 24-hour blood pressure monitoring (r = –0.484, p = 0.004). The degree of HOMA reduction depended on lowering blood levels of insulin, which correlated with the degree of PP reduction in daily monitoring (r = –0.485, p = 0.004). Blood glucose level before the treatment correlated with office SBP after the treatment (r = 0.439, p = 0.005); glucose levels after the treatment correlated with the level of office SBP after the treatment (r = 0.357, p = 0.03). The degree of glucose reduction correlated with cSBP at baseline (r = –0.445, p = 0.018); with the level of office DBP after 4 weeks of treatment (r = 0.461, p = 0.004); with the degree of cSBP reduction (r = 0.559, p = 0.002). The more significantly blood glucose decreased at the end of the study, the greater was the degree of cSBP reduction at the end of treatment. Conclusion. Telmisartan as monotherapy or in combination with S-amlodipine in the subgroup of patients without insulin resistance contributed to the significant reduction in central blood pressure, and augmentation index tended to decrease. In the subgroup of patients with insulin resistance, we observed a significant reduction in both central blood pressure and augmentation index. Glucose, blood insulin and HOMA were associated with indicators of arterial stiffness, central SBP, office SBP, the degree of PP reduction in daily monitoring.


arterial hypertension; telmisartan; S-amlodipine; HOMA; insulin resistance


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