Low-dose telmisartan/S-amlodipine (20/1.25 mg) achieved superior reduction in mean sitting systolic blood pressure compared to amlodipine 5 mg (-17.57 vs -13.90 mmHg; p<0.05).
RCT (n=576)
double-blind
randomized
Yes
Does a low-dose combination of telmisartan and S-amlodipine improve blood pressure reduction compared to monotherapies in patients with mild-to-moderate hypertension?
A low-dose combination of telmisartan 20 mg and S-amlodipine 1.25 mg provides superior blood pressure reduction compared to standard monotherapies in patients with mild-to-moderate hypertension.
Absolute Event Rate: -17.57% vs -13.9%
p-value: p=<0.05
Objective: This study integrated findings from two Korean phase III trials to evaluate the efficacy and safety of a novel low-dose combination of telmisartan 20 mg and S-amlodipine 1.25 mg in patients with mild-to-moderate hypertension. Design and method: Both randomized, double-blind, multicenter trials included patients with uncontrolled hypertension after a >=4-week placebo run-in with lifestyle modification. Eligible patients had mean sitting systolic blood pressure (msSBP) >=140 and <180 mmHg and mean sitting diastolic blood pressure (msDBP) <110 mmHg. Participants were randomized to receive telmisartan/S-amlodipine 20/1.25 mg, amlodipine 5 mg (non-inferiority trial), or telmisartan 20 mg or S-amlodipine 1.25 mg (superiority trial) once daily for 8 weeks. The primary endpoint was change in msSBP from baseline to week 8. Safety was assessed by adverse event monitoring, laboratory tests, and discontinuation rates. Results: A total of 576 patients were analyzed. The mean reduction in msSBP was -17.57 ±11.20 mmHg in combination group, -14.15 ±12.86 mmHg in telmisartan group, -12.19 ±11.80 mmHg in S-amlodipine group, and -13.90 ±11.87 mmHg in amlodipine group. All groups showed significant reductions from baseline (p<0.0001). Between-group differences favored the combination therapy, with statistically significant superiority over each comparator (p<0.05). Notably, although the comparison with amlodipine was originally designed as a non-inferiority study, the combination therapy demonstrated clear superiority in blood pressure reduction, exceeding the predefined non-inferiority margin. The combination was well tolerated, with adverse event rates comparable to monotherapies and no unexpected safety signals. Conclusions: This integrated analysis provides the first robust clinical evidence that low-dose telmisartan/S-amlodipine combination therapy achieves superior blood pressure reduction compared with amlodipine and each component monotherapy, while maintaining good tolerability. Importantly, superiority was demonstrated even in the non-inferiority trial against amlodipine, underscoring the clinical relevance of this regimen. Furthermore, the integrated findings were consistent with the results of each individual trial, confirming the reproducibility and robustness of the observed treatment effect. Taken together, these results suggest that this low-dose combination may serve as an excellent alternative to amlodipine, a widely used first-line therapy, thereby expanding effective options for the initial management of mild-to-moderate hypertension.
Na et al. (2026) conducted an RCT in mild-to-moderate hypertension (n=576). telmisartan/S-amlodipine vs. amlodipine 5 mg, telmisartan 20 mg, or S-amlodipine 1.25 mg was evaluated on change in mean sitting systolic blood pressure (msSBP) from baseline to week 8 (p=<0.05). Low-dose telmisartan/S-amlodipine (20/1.25 mg) achieved superior reduction in mean sitting systolic blood pressure compared to amlodipine 5 mg (-17.57 vs -13.90 mmHg; p<0.05).