Efficacy and Safety of Telmisartan 20 mg/ S-Amlodipine 2.5 mg versus Telmisartan 40 mg in Patients with Hypertension, Inadequately Controlled on Telmisartan 20 mg Monotherapy: A Randomized Double-Blind, Multicenter, Phase 3 Trial

초록

Purpose: This 8-week, randomized, double-blind study evaluated the efficacy and safety of low-dose combination of telmisartan 20 mg/S-amlodipine 2.5 mg (T20/SA2.5) versus telmisartan 40 mg (T40) monotherapy in patients with essential hypertension inadequately controlled on T20. Patients and Methods: After a 4-week run-in period with T20 (baseline), patients with uncontrolled blood pressure (BP) were randomized (1:1) to T20/SA2.5 or T40 for 8 weeks. The primary endpoint was the change in mean sitting systolic blood pressure (MSSBP) from baseline to week 8. Secondary endpoints included changes in MSSBP and mean sitting diastolic blood pressure (MSDBP) at weeks 4 and 8, BP control rate, response rate (≥ 20 mmHg reduction in MSSBP and ≥ 10 mmHg in MSDBP), and treatment-emergent adverse events (TEAEs). Results: Overall, 108 patients were randomized. At week 8, least squares (LS) mean (standard error [SE]) reduction in MSSBP from baseline was greater with T20/SA2.5 than with T40 (− 16.97 [2.06] mmHg vs. − 7.42 [2.04] mmHg; P< 0.001). LS mean (SE) reductions in MSDBP at week 8 were also greater with T20/SA2.5 than with T40 (− 7.98 [1.17] mmHg vs. − 4.01 [1.15] mmHg; P=0.006). The BP control rate was significantly higher with T20/SA2.5 than with T40 (53.70% vs. 29.63%; P=0.010); the response rate was numerically higher with T20/SA2.5 (12.96% vs. 5.56%; P=0.182). The incidence of TEAEs was lower with T20/SA2.5 than with T40 (9.26% vs. 20.37%, P=0.104); most events were mild. Conclusion: T20/SA2.5 demonstrated superior BP-lowering efficacy and favorable tolerability compared with T40 in patients inadequately controlled on T20, supporting the value of early low-dose combination therapy. The background section highlights its effectiveness in reducing side effects, facilitating faster blood pressure control and improving long-term adherence. The study population includes patients with essential hypertension, characterized by uncontrolled blood pressure after four weeks of Telmisartan 20 mg treatment, with a mean sitting systolic blood pressure of 140 mmHg or higher. Patients with cardiovascular or chronic kidney disease have a lower blood pressure threshold of 130 mmHg. The study involved 1:1 randomization between two groups: Telmisartan 40 mg (T40, n=54) and Telmisartan 20 mg combined with S-amlodipine 2.5 mg (T20/SA2.5, n=54). The results section shows that at week 8, T20/SA2.5 reduced mean sitting systolic blood pressure by 16.97 mmHg compared to 7.42 mmHg with T40, with a significance level of less than 0.001. Blood pressure control rates were 53.7 percent for T20/SA2.5 versus 29.6 percent for T40, with a significance level of 0.010. Response rates were 12.96 percent for T20/SA2.5 versus 5.56 percent for T40. Treatment-emergent adverse events incidence was lower with T20/SA2.5 at 9.26 percent compared to 20.37 percent for T40, with a significance level of 0.104. The conclusion states that T20/SA2.5 combination therapy showed superior blood pressure-lowering effects and favorable tolerability compared to T40 monotherapy, supporting low-dose combination as a more effective strategy than dose escalation.Infographic on low-dose combination therapy for hypertension, showing study population, results and conclusion.

키워드