{"id":"f7cf2c368682","type":"article","url":"https://hartvaat.nl/2026/04/01/lage-dosis-tel-aml-chtd-combinatietablet-versus-standaard-tel-fase-iii/","title":"Lage-dosis TEL/AML/CHTD combinatietablet versus standaard TEL: fase III","title_en":"Low-Dose TEL/AML/CHTD SPC Versus Standard-Dose TEL in Hypertension: Phase III RCT.","category":"hypertensie","category_label":"Hypertensie","professions":["apotheker","cardioloog","huisarts"],"tags":[],"journal":"Hypertension (Dallas, Tex. : 1979)","doi":"10.1161/HYPERTENSIONAHA.125.25810","source_url":"https://doi.org/10.1161/HYPERTENSIONAHA.125.25810","authors":["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"],"significance":7,"published":"2026-03-01","source_date":"2026-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/combinatietherapie-hypertensie/","https://hartvaat.nl/kennis/farmacologie/polypil-cardiovasculair/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:32:14Z","updated":"2026-07-03T13:31:12Z","licence":"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.","body_markdown":"Fase III trial van een lage-dosis drievoudige combinatietablet (telmisartan/amlodipine/chloortalidone) versus standaarddosis telmisartan. De polypil bereikte sneller bloeddrukcontrole.","abstract_original":"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."}