Single-pill combination of telmisartan/amlodipine in patients with severe hypertension: results from the TEAMSTA severe HTN study

Abstract

This 8-week, randomized, double-blind, controlled study compared efficacy and tolerability of telmisartan/amlodipine (T/A) single-pill combination (SPC) vs the respective monotherapies in 858 patients with severe hypertension (systolic/diastolic blood pressure [SBP/DBP] ≥180/95 mm Hg). At 8 weeks, T/A provided significantly greater reductions from baseline in seated trough cuff SBP/DBP (-47.5 mm Hg/-18.7 mm Hg) vs T (P<.0001) or A (P=.0002) monotherapy; superior reductions were also evident at 1, 2, 4, and 6 weeks. Blood pressure (BP) goal and response rates were consistently higher with T/A vs T or A. T/A was well tolerated, with less frequent treatment-related adverse events vs A (12.6% vs 16.4%) and a numerically lower incidence of peripheral edema and treatment discontinuation. In conclusion, treatment of patients with substantially elevated BP with T/A SPCs resulted in high and significantly greater BP reductions and higher BP goal and response rates than the respective monotherapies. T/A SPCs were well tolerated.

Figure 1

Patient disposition.

Figure 2

Mean reductions (±standard error of mean [SEM]) from baseline in seated trough cuff systolic blood pressure (SBP) (panel A) and diastolic blood pressure (DBP) (panel B) by treatment week (note that some SEMs may not be visible as they are too small to reach beyond the border of the symbol), mean seated trough cuff SBP (panel C) and DBP (panel D) by treatment week, and patients assigned to the telmisartan/amlodipine (T/A) or amlodipine (A) groups received telmisartan 80 mg (T80)/ amlodipine 5 mg (A5) or A5 for the first 2 weeks, then T80/amlodipine 10 mg (A10) or A10 for the remaining 6 weeks; patients in the T80 group remained on the same treatment for the entire 8 weeks.

Figure 3

Mean reductions in mean seated trough cuff systolic blood pressure (SBP) from baseline to end of study (week 8) per baseline SBP category; 10‐mm Hg increments. Patients assigned to the telmisartan/amlodipine (T/A) or amlodipine (A) groups received telmisartan 80 mg (T80)/amlodipine 5 mg (A5) or A5 for the first 2 weeks, then T80/amlodipine 10 mg (A10) or A10 for the remaining 6 weeks; patients in the T80 group remained on the same treatment for the entire 8 weeks. DBP indicates diastolic blood pressure.

Figure 4

Mean reductions from baseline in seated trough cuff systolic blood pressure across hypertensive patient subpopulations.

Figure 5

Proportion of patients (%) achieving systolic blood pressure (SBP), diastolic blood pressure (DBP), and blood pressure (BP) goal at study end (week 8).