[OP.4C.08] ROLE OF THE FIXED-DOSE TRIPLE COMBINATION THERAPY IN THE MANAGEMENT OF UNCONTROLLED HYPERTENSION: FROM THE RANDOMIZED CLINICAL TRIALS TO CLINICAL PRACTICE.

OBJECTIVE: Blood pressure (BP) control is difficult to achieve with current BP-lowering drugs. Therefore, uncontrolled hypertension (HT) despite drug treatment with free recommended combinations remains the main goal in clinical practice. In this study the efficacy of a triple fixed-combination (TFC) of anti-hypertensive drugs in hypertensive subjects with uncontrolled HT was evaluated.(Figure is included in full-text article.)

DESIGN AND METHOD: : Forty-one hypertensives (mean age 59.2 ± 12.7 years, 63.4% males) with uncontrolled essential HT (clinic systolic BP > = 140 or diastolic BP > = 90 mmHg) previously treated with anti-hypertensive therapy with a renin-angiotensin-aldosterone system (RAAS) inhibitor (ramipril 5 to 10 mg or olmesartan 10 to 40 mg daily) plus hydrochlorothiazide (12.5 to 25 mg daily) were switched to once daily TFC therapy with perindopril (5 to 10 mg), indapamide (1.25 to 2.5 mg) and amlodipine (5 to 10 mg). These subjects were age-sex- matched with hypertensive patients taking a free-combination therapy including a RAAS inhibitor, a diuretic and a calcium channel blocker (CCB). Clinic BP and ambulatory BP (ABPM) were evaluated at baseline and after 1-month follow-up. Analysis of variance for repeated measures was provided.

RESULTS: In both treatment groups, a significant reduction of all the components of clinic and ABPM values was found (data not shown) at the end of follow-up. When ABPM values were considered, at the follow-up a significant reduction of the 24 h, daytime and night-time systolic and pulse pressure was found in the TFC group than in the free combination therapy group (Figure). Diastolic BP and heart rate remained unchanged. No patients were lost at the follow-up and no side effects were observed.

CONCLUSIONS: A TFC of perindopril, amlodipine and indapamide appears to be safe, well tolerated and effective in reducing systolic and pulse pressure in hypertensive patients uncontrolled by a free antihypertensive therapy including a RAAS inhibitor, a diuretic and a CCB.