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.

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.