Efficacy and Safety of Combined Therapy Based on Chlorthalidone and Atenolol in One Tablet (Tenoric) in Patients with Essential Hypertension: First Results of a All-Ukrainian Research Project TRUST

Yu.N. Sirenko, I.M. Gorbas, S.A. Andriievskaia, A.N. Gulenko, A.G. Oparin, A.A. Oparin, A.V. Shabilianov


The aim of this work was to evaluate the efficacy and safety of combined therapy based on chlorthalidone and atenolol in one tablet (tenoric) in patients with essential hypertension.
The study involved 330 primary contact physicians from different regions of Ukraine. A total of 3,000 patients with blood pressure (BP) level of 140/90 mmHg or more were enrolled. This article is based on an analysis of the first 1,798 patients enrolled in the study. The primary endpoint was reduction of BP in patients included in this study.
The six-week therapy with tenoric provided an effective reduction of BP in 97.7 % of patients with essential hypertension stage I–II with the 1st-3rd degree of blood pressure increase. Thus, target blood pressure level (less than 140/90 mmHg) was achieved in 53.9 % of patients. The treatment showed progressive (increasing with the duration of drug administration) significant decrease in both systolic and diastolic BP towards the level of 135/80 mmHg on the 4th visit at 6th week. So, the reduction of BP was 31/19 mmHg. In addition, there was a decrease in heart rate by 17 bpm, which reached an average of 71 bpm at the final visit.
The most common side effects were headache (17.7 %), as well as skin redness (8 %). Both side effects did not require drug withdrawal. The number of patients who initially had hypokalemia (serum potassium level of less than 3.5 mmol/l) was 8.3 % (21 patients). During the treatment, lowering in serum potassium level below this limit has been observed in another 6 patients, which totally reached 11.7 % (27 patients). The evaluation of bradycardia (5.2 %) and heart blockade (0.5 %) incidence requires special attention. These are the most severe side effects that required revision of dosage or even drug withdrawal. The drug was withdrawn in 51 patients (3.1 %) in total.
Thus, therapy with tenoric according to the scheme within 6 weeks provided an effective reduction of BP in 97.7 % of patients with essential hypertension stage I–II with the 1st-3rd degree of BP increase.


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DOI: https://doi.org/10.22141/2224-1485.6.38.2014.82796


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