Purpose: Investigate the efficacy and safety of the single-pill combination of telmisartan 80 mg/amlodipine 10 mg (T80/A10) vs. its respective monotherapy components in patients with severe hypertension.
Methods: An eight-week, double-blind, parallel-group study, in 858 patients aged ≥18 years with severe hypertension (i.e. SBP ≥180 and DBP ≥95 mm Hg) randomised to T80/A10 (n = 421) or to monotherapy with T80 (n = 217) or A10 (n = 220). The primary endpoint was change from baseline in seated trough cuff SBP.
Results: Baseline characteristics were comparable between the treatment groups. At eight weeks, significantly greater reductions from baseline in seated trough SBP/DBP were observed with T80/A10 vs. T80 or A10 monotherapy, with superior reductions evident at one week. BP control and response rates were consistently higher with T80/A10 vs. T80 or A10 alone. T80/A10 was well tolerated, with similar rates of common adverse events (AEs) vs. T80 or A10 monotherapy. Treatment-related AEs were less frequent with T80/A10 (12.6%) vs. A10 (16.4%), with a numerically lower incidence of peripheral oedema and rate of treatment discontinuation.
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| T80/A10 single-pill | T80 | A10 | |
|---|---|---|---|
| Baseline SBP/DBP (±SD, mm Hg) | 185.4 ± 4.6/103.2 ± 6.3 | 185.6 ± 4.5/103.5 ± 6.8 | 185.1 ± 4.5/103.5 ± 6.2 |
| Adjusted mean SBP/DBP change from baseline (±SD, mm Hg) | −47.5 ± 13.3,/−18.7 ± 8.1, | −36.9 ± 16.3/−13.8 ± 8.5 | −43.2 ± 12.4/−16.3 ± 7.9 |
| SBP control (<140 mm Hg, %) | 57.0 | 29.2 | 44.9 |
| BP control (<140/<90 mm Hg, %) | 50.4 | 35.6 | 24.1 |
| SBP/DBP response (<140 mm Hg or ≥10 mm Hg decrease/DBP <90 mm Hg or ≥10 mm Hg decrease, %) | 99.7/91.4 | 91.5/69.3 | 98.5/83.9 |
a p < 0.0001 to T80 alone.
b p = 0.0002 to A10 alone.
c p = 0.0006 to A10 alone.
Conclusions: Treatment of severe hypertensive patients with a single-pill combination containing T80/A10 results in significantly greater BP reductions (−47.5/−18.7 mm Hg) and higher BP control/response rates than the respective monotherapies. The safety profile of T80/A10 single-pill combination was comparable to that of its respective components.
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© 2011 Published by Elsevier Inc.
