Triple therapy with valsartan, amlodipine, and chlorthalidone significantly reduced mean sitting systolic blood pressure compared to valsartan/amlodipine (mean difference -10.99 mmHg; P<0.0001).
RCT (n=193)
Double-blind
1:1
Sí
Does triple therapy with valsartan, amlodipine, and chlorthalidone reduce systolic blood pressure in patients with essential hypertension inadequately controlled on valsartan/amlodipine?
Triple combination therapy with valsartan, amlodipine, and chlorthalidone provides significantly greater blood pressure reduction than dual therapy in patients with inadequately controlled essential hypertension.
Mean Difference: -10.99 (95% CI -14.56–-7.41)
Tasa de eventos absoluta: -19.7% vs -8.71%
valor p: p=< 0.0001
Objective: Many patients with hypertension require three or more agents to achieve target blood pressure (BP). This randomized, double-blind study evaluated the efficacy/safety of triple therapy with valsartan (Val), amlodipine (Aml), and chlorthalidone (CTD) in patients with essential hypertension who did not achieve adequate BP control with Val/Aml combination therapy. Design and method: A randomized, double-blind, multicenter, phase 3 clinical trial was conducted in South Korea. Patients who failed to respond adequately to 4 weeks of Val/Aml 80/5 mg were randomized in a 1:1 ratio to either Val/Aml/CTD 80/5/12.5 mg and placebo for Val/Aml 80/5 mg (study group) or placebo for Val/Aml/CTD 80/5/12.5 mg and Val/Aml 80/5 mg (control group) using a double-dummy design to maintain blinding. After 2 weeks of administering assigned investigational medicinal products, participants in the study group received Val/Aml/CTD 160/5/25 mg and placebo for Val/Aml 160/5 mg, while those in the control group received placebo for Val/Aml/CTD 160/5/25 mg and Val/Aml 160/5 mg for 6 weeks. Primary endpoint was determined by how mean sitting systolic blood pressure (MSSBP) varied between the baseline and week 8. The incidence of adverse events was also evaluated. Results: Of the 193 randomized patients, 193 conducted efficacy analyses, and 178 competed the study. The least squares (LS) mean (standard error SE) change in MSSBP was -19.70 (1.31) mmHg in the Val/Aml/CTD group and -8.71 (1.26) mmHg in the control group. The LS mean difference (SE) in MSSBP change between the two groups was -10.99 (1.81) mmHg (95% confidence interval CI, -14.56 to -7.41), indicating a statistically significant greater reduction in the Val/Aml/CTD group compared with the control group (p < 0.0001). The incidence of serious adverse events was 1.98% in the control group, whereas no serious adverse events were reported in the Val/Aml/CTD group (p = 0.4985). Conclusions: In patients with essential hypertension who exhibited an inadequate response to Val/Aml combination therapy, the triple combination of Val/Aml/CTD demonstrated favorable efficacy and safety profiles.
Pyun et al. (Fri,) conducted a rct in essential hypertension (n=193). valsartan, amlodipine, and chlorthalidone vs. valsartan/amlodipine was evaluated on change in mean sitting systolic blood pressure (MSSBP) between baseline and week 8 (MD -10.99, 95% CI -14.56 to -7.41, p=< 0.0001). Triple therapy with valsartan, amlodipine, and chlorthalidone significantly reduced mean sitting systolic blood pressure compared to valsartan/amlodipine (mean difference -10.99 mmHg; P<0.0001).