Inventi Impact: Clinical Research

Inventi:pcr/211/13

SINGLE-PILL COMBINATION OF TELMISARTAN/AMLODIPINE VERSUS TELMISARTAN/HYDROCHLOROTHIAZIDE IN STAGE-1 HYPERTENSIVE PATIENTS: AN 8 WEEKS-RANDOMIZED, PARALLEL GROUP, SINGLE BLIND TRIAL

Stage-1 hypertensive patients often require combination therapy to achieve a blood pressure (BP) goal and evidence suggests that time to BP goal is crucial to decrease cardiovascular risk. The aim of the study was to investigate whether the single-pill combination of Telmisartan and Amlodipine was superior to Telmisartan and Hydrochlorothiazide as initial antihypertensive therapy in patients with stage-1 hypertension. An 8-week, randomized, parallel-group, single-blind trial comparing the once daily Single-pill combination of Telmisartan 40 mg and Amlodipine 5 mg (T40/A5; n=30) with once-daily Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg (T40/H12.5: n=30) in patients with stage-1 hypertension. Patient demographics were similar between treatment groups, with MeanSEM of age was 57.21.882 for T40/A5 group and 51.831.851 for T40/H12.5H group, the MeanSEM of body mass index was 24.250.5310 for T40/A5 group and 26.230.9600 for T40/H12.5 group. Significantly greater reduction in the MeanSEM of SBP and DBP (25.790.6962 mmHg and 14.480.3545 mmHg) for T40/A5 group as compared to T40/H12.5 group (19.290.7289 mmHg and 7.920.3274 mmHg) were achieved (P< 0.0001). After 8 weeks, 89.5% versus 76.8% of patients achieved the BP goal (<140/90 mm Hg) with T40/A5 versus T40/H12.5. The most common adverse events were peripheral edema, headache, and dizziness, observed. In the patients with stage-1 hypertension, T40/A5 provided significant and greater BP reduction compared with T40/H12.5 therapy, with the majority of patients achieving the BP goal (<140/90 mm Hg).