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Fixed-dose therapy of Efonidipine and Telmisartan has additive anti-hypertensive effects.
As per the outcomes of a recent randomized clinical study, the use of Efonidipine and Telmisartan (both dosed at 40 mg each) combination therapy can be safe and effective for lowering high blood pressure (BP) in patients with Stage II hypertension.
To investigate the anti-hypertensive effectiveness of a fixed-dose combination (FDC) of Efonidipine and Telmisartan in hypertensive patients, Bhupesh Dewan et al. conducted this multicentric, randomized, double-blind, parallel, comparative Phase III clinical trial at 6 geographically distributed sites throughout India and registered 240 patients with Stage II hypertension. These patients were randomized into groups:
The mean decrease in sitting systolic BP (SBP) and diastolic BP (DBP) from day 1 to day 90 was regarded as a primary endpoint. The mean decrease in BP from baseline to day 30 and day 60, patients achieving target BP (less than 140/90 mmHg), and tolerability and safety of the investigational products on the basis of incidences of adverse events (AEs) reported were the secondary endpoints assessed.
Overall, 118 people were randomly assigned to the E+T group wherein the mean (±Standard Deviation) SBP and DBP at baseline was 167.25 ± 4.68/107.26 ± 5.19 mmHg. Following 30 days of treatment with the E+T group, the mean decrease in SBP/DBP of 29.37/18.06 mm Hg was noted whereas at Day 60, decrease of 38.55/22.69 mmHg was noted from the baseline. At Day 90, SBP/DBP decreased to 119.41±14.99/81.67±4.29 mmHg with a mean drop of 47.94/25.89 mmHg in the E+T group. During the trial period, the difference in systolic blood pressure between the treatments with E+T and C+T was -0.48 mmHg while the corresponding difference in diastolic blood pressure was -0.77 mm Hg.
The upper limit of the 95% CI was lower than the margin of 10 mmHg, verifying that the E+T group is not inferior to the C+T group. The target BP goal was achieved in 92% of patients in the E+T group. Only 1 patient reported as having an adverse event with E+T therapy. As there were no unexpected AEs in the E+T group, therefore it was regarded as being safe with good tolerability.
Cardiology and Angiology: An International Journal
Efficacy and Safety of Fixed-Dose Combination of Efonidipine and Telmisartan in Stage II Hypertensive Patients: Results from Randomized Clinical Trial
Bhupesh Dewan et al.
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