Telmisartan/amlodipine 20/2.5 mg was superior to its monocomponents for reducing systolic BP and non-inferior to telmisartan 40 mg (LSM difference -3.88 mmHg; 95% CI -6.67 to -1.09).
RCT
Double-blind
Does low-dose telmisartan/amlodipine 20/2.5 mg single-pill combination improve blood pressure reduction in patients with essential hypertension compared to monotherapies?
Low-dose telmisartan/amlodipine (20/2.5 mg) single-pill combination provides superior blood pressure lowering compared to respective low-dose monotherapies and is non-inferior to standard-dose telmisartan (40 mg) with a comparable safety profile.
Effect estimate: LSM difference -3.88 mmHg (95% CI -6.67 to -1.09)
Low-dose single-pill combinations (SPCs) are gaining recognition as an efficient therapeutic strategy for mild hypertension. However, evidence from randomized controlled trials regarding the efficacy and safety of half-dose telmisartan/amlodipine SPCs remains limited. In this randomized, double-blind, active-controlled phase III trial, patients with essential hypertension mean sitting systolic blood pressure (MSSBP) ≥ 140 and < 180 mmHg were allocated to four treatment arms to receive either telmisartan/amlodipine 20/2.5 mg SPC (TEL/AML 20/2.5), or monotherapy with telmisartan 20 mg (TEL 20), amlodipine 2.5 mg (AML 2.5), or telmisartan 40 mg (TEL 40) once daily for 8 weeks. The primary endpoint was the change in MSSBP from baseline to week 8. A gatekeeping approach was used to test the superiority of TEL/AML 20/2.5 over TEL 20 and AML 2.5, followed by non-inferiority versus TEL 40. At week 8, TEL/AML 20/2.5 showed significantly greater MSSBP reductions compared with TEL 20 least squares mean (LSM) differences: -5.79 mmHg; p = 0.0003 and AML 2.5 (-8.57 mmHg; p < 0.0001). Non-inferiority to TEL 40 was established, with an LSM difference of -3.88 mmHg (95% Confidence Interval: -6.67 to -1.09), which met the pre-specified 3 mmHg margin. The overall incidence of adverse events was 8.05%, with no statistically significant differences between groups. Overall, TEL/AML 20/2.5 SPC provided superior BP-lowering efficacy compared with TEL 20 and AML 2.5 monotherapies and was non-inferior to TEL 40. With a comparable safety profile across treatment groups, these findings suggest that TEL/AML 20/2.5 is a practical and effective option for hypertension management. Trial Registration: ClinicalTrials.gov, NCT06052748.
Ahn et al. (Fri,) conducted a rct in Essential hypertension. Telmisartan/amlodipine single-pill combination vs. Telmisartan 20 mg, amlodipine 2.5 mg, or telmisartan 40 mg once daily was evaluated on Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8 (LSM difference -3.88 mmHg, 95% CI -6.67 to -1.09). Telmisartan/amlodipine 20/2.5 mg was superior to its monocomponents for reducing systolic BP and non-inferior to telmisartan 40 mg (LSM difference -3.88 mmHg; 95% CI -6.67 to -1.09).