Low-Dose TEL/AML/CHTD SPC Versus Standard-Dose TEL in Hypertension: Phase III RCT - PubMed
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- #combination-therapy
- #hypertension
- #clinical-trial
- Study compared low-dose triple single-pill combination (telmisartan/amlodipine/chlorthalidone) vs. standard-dose telmisartan monotherapy in hypertension.
- 314 subjects randomized after a 4-week placebo run-in to either combination therapy (20/2.5/6.25 mg) or telmisartan (40 mg) for 8 weeks.
- Primary endpoint: change in mean sitting systolic blood pressure (SBP) at week 8, assessed for noninferiority (per-protocol set) and superiority (full analysis set).
- Combination therapy showed significant SBP reduction vs. monotherapy (LS mean difference: -3.8 mmHg, P=0.01), confirming noninferiority and superiority (-4.0 mmHg, P<0.01).
- Secondary outcomes (diastolic BP, normalization rates, response rates) also favored combination therapy at weeks 4 and 8 (all P<0.01).
- Subgroup analyses confirmed consistent efficacy across age and prior treatment groups.
- Safety profiles were comparable, with no serious drug-related adverse events.
- Conclusion: Low-dose triple combination is superior in BP reduction with comparable safety to monotherapy.