Martin Čaprnda, Katarína Novodomská, Ján Farkašovský, Oliver Tlčimuka
Introduction: Arterial hypertension is one of the most important risk factors for cardiovascular diseases. Its diagnosis and treatment belongs to general practitioners as well as specialists. Despite the existence of a number of antihypertensive drugs, many patients are below the blood pressure (BP) target. Telmisartan, as a representative of the angiotensin II receptor antagonist group, is suitable for a wide range of patients with arterial hypertension, both as monotherapy and in combination with other antihypertensive agents. Due to its partial agonist effect on the PPAR-γ receptor its beneficial effects on glycaemia and lipid parameters have also been described.
Objective of the study: The objective of the study was to monitor the effect of telmisartan and the telmisartan + amlodipine fixed combination on the level of systolic and diastolic BP (sBP, dBP), achievement of BP target values and selected metabolic and biochemical parameters in patients below the BP target values.
Patients and methodology: The TELMISTAR I project was conducted in the form of a prospective, non-randomized, open-label study of 6 months duration. The project included a total of 1,438 patients aged 31-91 (604 men and 834 women) who did not reach the BP target values according to ESC/ESH recommendations. At the discretion of the attending physician, they were set up for treatment with telmisartan (group T) or the fixed combination of telmisartan + amlodipine (group TA). Patients were educated about the need to follow ESC/ESH preventive measures, especially non-pharmacological and pharmacological treatment. Blood pressure, lipid levels, blood glucose and safety parameters (ionogram, urea, creatinine) were performed at baseline medical examination and 3 and 6 months later (after the initial examination). The project was supported by a research grant from KRKA.
Results: The mean BP value at study inclusion was 153.55 ± 15.96 / 91.12 ± 10.27 mmHg in the T group, 157.11 ± 15.61 / 92.60 ± 10.06 mmHg in the TA group, and the target systolic BP was achieved in 13.6% (T) patients, respectively 11.0% (TA) patients, diastolic BP 34.2% patients (T) respectively 28.1% (TA) patients.
After 6-month treatment, the T group manifested an average BP decrease of 20.80 / 12.15 mmHg (p<0.001), and in the TA group of 23.03 / 13.15 mmHg (p<0.001), which also led to a systolic BP 57.3% (T) respectively 54.1% (TA) and diastolic BP increase 58.9% (T) respectively 61.9% (TA). There was no significant change in chloride levels and creatinine levels in the patients.
Conclusion: The addition of telmisartan like fixed combination of telmisartan + amlodipine resulted in a significant decrease in BP, as well as an in an increase in the number of patients reaching the target BP. No significant changes in safety parameters (potassium, creatinine) were observed in patients. An improvement in the lipid profile (decrease in total and LDL cholesterol and triacylglycerols) was also observed in the patients. Telmisartan as a stand-alone medicine and also in the fixed combination of telmisartan + amlodipine is an effective and safe antihypertensive suitable for use in a wide variety of arterial hypertension patients.