Heart, Lung and Circulation
47| Volume 20, SUPPLEMENT 2, S20-S21, 2011

Single-pill Combination of Telmisartan 80mg/Amlodipine 10mg Provides Superior Blood Pressure Reductions in Patients with Severe Hypertension: Teamsta Severe HTN Study

      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.
      Tabled 1
      T80/A10 single-pillT80A10
      Baseline SBP/DBP (±SD, mm Hg)185.4 ± 4.6/103.2 ± 6.3185.6 ± 4.5/103.5 ± 6.8185.1 ± 4.5/103.5 ± 6.2
      Adjusted mean SBP/DBP change from baseline (±SD, mm Hg)−47.5 ± 13.3
      p<0.0001 to T80 alone.
      p=0.0002 to A10 alone.
      /−18.7 ± 8.1
      p<0.0001 to T80 alone.
      p=0.0006 to A10 alone.
      −36.9 ± 16.3/−13.8 ± 8.5−43.2 ± 12.4/−16.3 ± 7.9
      SBP control (<140 mm Hg, %)
      BP control (<140/<90 mm Hg, %)50.435.624.1
      SBP/DBP response (<140 mm Hg or ≥10 mm Hg decrease/DBP <90 mm Hg or ≥10 mm Hg decrease, %)99.7/91.491.5/69.398.5/83.9
      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.