# Lage-dosis TEL/AML/CHTD combinatietablet versus standaard TEL: fase III

*geplaatst 2026-03-01 · Hypertensie · Hypertension (Dallas, Tex. : 1979) · doi 10.1161/HYPERTENSIONAHA.125.25810 · https://hartvaat.nl/2026/04/01/lage-dosis-tel-aml-chtd-combinatietablet-versus-standaard-tel-fase-iii/*

Fase III trial van een lage-dosis drievoudige combinatietablet (telmisartan/amlodipine/chloortalidone) versus standaarddosis telmisartan. De polypil bereikte sneller bloeddrukcontrole.

## English: Low-Dose TEL/AML/CHTD SPC Versus Standard-Dose TEL in Hypertension: Phase III RCT.

This phase III RCT confirmed the superior blood pressure-lowering efficacy of a low-dose triple combination (telmisartan/amlodipine/chlorthalidone) versus standard-dose telmisartan monotherapy for hypertension treatment.

## Abstract (original, from the publication)

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.

Auteurs: Jeong Cheon Ahn, Cheol Whan Lee, Jong-Hwa Ahn, Kyung Hee Lim, Il Suk Sohn, Ki-Chul Sung, Kye Hun Kim, Jang-Ho Bae, Seung Pyo Hong, Won-Young Jang, Sang-Ho Jo, Seung Hwan Han, Ji Bak Kim, Chan Joo Lee, Ju-Hee Lee, Namkyun Kim, Eun Joo Cho, Jung-Hoon Sung, Hyo-Suk Ahn, Seok-Yeon Kim, Jinho Shin, Suk Min Seo, Soon Jun Hong, Weon Kim, Chang-Gyu Park

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Bron: Hypertension (Dallas, Tex. : 1979), https://doi.org/10.1161/HYPERTENSIONAHA.125.25810. Bijgewerkt 2026-07-03T13:31:12Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.