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

Figures

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  Figure 1.. Subject disposition throughout the study. Primary reasons for discontinuation included: (1) withdrawal of consent; (2) use of prohibited concurrent medication; (3) noncompliance with the investigator’s instructions; (4) failure to meet selection criteria; (5) inability to continue study participation due to adverse events; (6) excessive elevation or decrease in blood pressure observed during a scheduled (visit 3) or unscheduled visit; (7) pregnancy during treatment period; (8) loss of follow-up; (9) other reasons as determined by the investigator to warrant discontinuation of the study. AML indicates amlodipine, CHTD, chlorthalidone, N, number of subjects; and TEL, telmisartan.

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  Figure 2.. Change in mean sitting systolic blood pressure from baseline to week 4 and week 8 (full analysis set). Data are presented as least squares (LS) mean differences between treatment groups at each visit, estimated using an ANCOVA model with baseline mean sitting systolic blood pressure (MSSBP) as a covariate. Values in brackets indicate 95% CIs for the LS mean differences. AML indicates amlodipine, CHTD, chlorthalidone, and TEL, telmisartan. *P<0.05; **P<0.01.

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  Figure 3.. Subgroup analysis of least squares mean change in mean sitting systolic blood pressure (BP) at week 8 based on interaction models (full analysis set). Forest plot depicting least squares (LS) mean changes in mean sitting systolic BP (MSSBP) at week 8 comparing telmisartan (TEL)/amlodipine (AML)/chlorthalidone (CHTD) 20/2.5/6.25 mg vs TEL 40 mg across key subgroups: baseline systolic BP (<160 vs ≥160 mm Hg), prior antihypertensive treatment (yes vs no), age (<60 vs ≥60 years), and duration of hypertension (<5 vs ≥5 years). The LS mean differences were estimated from ANCOVA models including baseline MSSBP, subgroup, treatment, and treatment-by-subgroup interaction as fixed effects. Each subgroup displays the LS mean difference with 95% CIs. Negative values favor the TEL/AML/CHTD combination. The treatment effect was consistent across most subgroups, with the largest reductions observed in patients with baseline systolic BP (SBP) ≥160 mm Hg and those aged ≥60 years. No statistically significant treatment-by-subgroup interactions were observed (Table S4). N indicates number of subjects.