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Acta medica Medianae
2013, vol. 52, iss. 1, pp. 16-24
article language: English
document type: Original Scientific Paper

Efficacy and safety of fixed ramipril + felodipine combination in treatment of arterial hypertension: A retrospective study-forecast
aUniverzitet u Nišu, Medicinski fakultet, Institut za prevenciju, lečenje i rehabilitaciju reumatičkih i kardioloških bolesti 'Niška Banja' - Niška Banja
bCardiology Unit, Health Center, Leskovac


Approximately 30-50% of the world's adult population suffer from arterial hypertension, and only 30-35% is successfully treated. A large number of patients with arterial hypertension require a combination of antihypertensive medications to achieve target blood pressure. The ESH/ESC recommendations suggest the use of fixed dose combinations for treatment simplification and improved adherence to treatment. The aim of this study was to evaluate efficacy and safety of fixed ramipril + felodipine combination in therapy of essential arterial hypertension. This multicentric, cross-sectional, non-interventional study evaluated 1.341 adult patients with essential arterial hypertension, defined by systolic and diastolic blood pressure increase (BP≥140/90 mmHg), only systolic blood pressure increase or antihypertensive therapy usage. All patients were treated with fixed-dose combination therapy ramipril + felodipine (5+5mg and 2.5+2.5mg) (Triapin® and Triapin mite®) therapy for at least two months. Efficacy was evaluated by proportion of patients who achieved target blood pressure values (<140/90 mmHg and <130/80 mmHg in diabetics) or defined blood pressure reduction (≥15/10mmHg). Safety of ramipril + felodipine therapy was evaluated based on the incidence of adverse events (AE) and therapy discontinuation rate during observational period. Therapy prescription was based on physician decision according to everyday clinical practice and 15 consecutive eligible patients were enrolled by each physician from the cohort of hypertensive patients treated in ambulatory setting. Patient population consisted of 647 (48.4%) males and 690 (51.7%) females (mean age 60.15±11.84 and mean duration of hypertension 9.5±7.34 years). Males were significantly younger (58.74±15.5 vs. 61.45±11.04, p<0.01) without difference in body mass index. There were 47.5% of patients with stage II, 29.2% with stage I and 23.3% with stage III. There was a significant reduction of systolic/diastolic BP and heart rate in patients with ramipril + felodipine combination (162.6±17/97.2±9 mmHg and 79.4±12/min) compared to baseline values prior to treatment (136.9±17/84.2±9 mmHg and 73.2±10 /min, p<0.01). Group with Triapin mite had lower reduction of systolic/diastolic BP compared to Triapin 21.4±15.9/11.6±9.8 vs. 28.9±19.2/14.1±11.0 mmHg and lower reduction of heart rate 6.1 vs. 6.3 /min (p<0.01). In total, 39.3% of patients reached target BP with or without target BP reduction, 30.0% reached only BP reduction and 30.7% did not reach target values. More patients reached target BP (48.4 vs 32.%) and less achieved defined BP reduction (18.8 vs. 38.9%) on Triapin mite therapy compared to Triapin (p<0.01). The proportion of patients who failed to reach any of these endpoints is similar in both treatment modalities. AEs were present in 34 patients (2.5%): headache in 9 (0.7%), lower leg swelling in 8 (0.6%) and dry cough in 4 (0.2%) cases - these were reported as the most frequent. None of reported adverse events was serious. Therapy continuation was reported in 92.6% of patients. Reasons for therapy discontinuation were insufficient drug efficacy in 29 (2.2%) patients; AE in 28 (2.1%) patients and other reasons in 34 (2.6%) patients. Triapin therapy efficacy and safety evaluated by physicians were: excellent efficacy in 824 (61.4%) patients and excellent safety in 870 (64.9%) patients. Fixed dose combination of ramipril + felodipine was shown to be an effective antihypertensive therapy in patients with essential arterial hypertension and an alternative approach to monotherapy for the initial management of essential hypertension. Small proportion of patients discontinued from ramipril+felodipine therapy and rare AEs indicate excellent safety profile.



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