Low-dose telmisartan/amlodipine/chlorthalidone SPC reduced systolic BP by 4.0 mm Hg more than standard-dose telmisartan after 8 weeks, with similar safety.
Does a low-dose single-pill combination of telmisartan, amlodipine, and chlorthalidone reduce blood pressure more effectively than standard-dose telmisartan monotherapy in patients with essential hypertension?
A low-dose triple single-pill combination of telmisartan, amlodipine, and chlorthalidone provides superior blood pressure reduction compared to standard-dose telmisartan monotherapy without increasing adverse events.
Absolute Event Rate: 0% vs 0%
BACKGROUND: Although low-dose triple single-pill combination therapies show promising efficacy and safety, studies comparing them to standard-dose monotherapies remain limited. This phase III, randomized, double-blind trial evaluated the efficacy and safety of a low-dose single-pill combination of telmisartan, amlodipine, and chlorthalidone versus standard-dose telmisartan monotherapy in patients with essential hypertension. METHODS: After a 4-week placebo run-in period, 314 eligible subjects were randomized to either receive telmisartan/amlodipine/chlorthalidone 20/2.5/6.25 mg or telmisartan 40 mg for 8 weeks. The primary efficacy end point was the change in mean sitting systolic blood pressure from baseline to week 8, with noninferiority assessed in the per-protocol set (PPS), followed by superiority testing in the full analysis set using a gatekeeping approach to control for type I error. RESULTS: At week 8, the combination group demonstrated significant mean sitting systolic blood pressure reduction compared with monotherapy in the per-protocol set analysis (least squares mean difference, −3.8 mm Hg 95% CI: −6.7 to −0.9; P =0.01), establishing its noninferiority. Furthermore, the superiority of the combination therapy was confirmed in the full analysis set (LS mean difference, −4.0 mm Hg 95% CI, −6.8 to −1.3; P <0.01). Mean sitting diastolic BP, BP normalization rates, and response rates also favored the combination group at weeks 4 and 8 (all P <0.01). Subgroup analyses showed consistent efficacy across clinical strata, including age and prior antihypertensive treatment. The incidence of adverse events was comparable between groups, with no serious drug-related events reported. CONCLUSIONS: Low-dose triple single-pill combination of telmisartan/amlodipine/chlorthalidone demonstrated superior BP-lowering efficacy with well-tolerated and comparable safety to standard-dose telmisartan monotherapy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT06348576.
Ahn et al. (Fri,) reported a other. Low-dose telmisartan/amlodipine/chlorthalidone SPC reduced systolic BP by 4.0 mm Hg more than standard-dose telmisartan after 8 weeks, with similar safety.