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Randomized Controlled Trial
. 2009 Apr;11(4):207-13.
doi: 10.1111/j.1751-7176.2009.00098.x.

Results of treatment with telmisartan-amlodipine in hypertensive patients

Thomas W Littlejohn 3rd  1 , Claudio R Majul, Rafael Olvera, Mary Seeber, Maureen Kobe, Robert Guthrie, Wille Oigman; Study Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Results of treatment with telmisartan-amlodipine in hypertensive patients

Thomas W Littlejohn 3rd et al. J Clin Hypertens (Greenwich). 2009 Apr.

Abstract

This randomized 4 x 4 factorial study determined the efficacy and safety of telmisartan (T) plus amlodipine (A) in hypertensive patients. Adults (N=1461) with stage 1 or 2 hypertension (baseline blood pressure [BP]: 153.2[12.1]/101.7[4.3] mm Hg) were randomized to 1 of 16 treatment groups with T 0, 20, 40, 80 mg and A 0, 2.5, 5, 10 mg for 8 weeks. In-clinic BP reductions were greater with combination therapy than respective monotherapies. The greatest least-square mean systolic/diastolic BP reductions were observed with T80 mg plus A10 mg (-26.4/-20.1 mm Hg; P<.05 compared with both monotherapies). BP control was also greatest in the T80-mg plus A10-mg group (76.5% [overall control] and 85.3% [diastolic BP control]), and BP response rates >90% with this combination. Peripheral edema was most common in the A10-mg group (17.8%); however, this rate was notably lower when A was used in combination with T: 11.4% (T20/A10), 6.2% (T40/A10), and 11.3% (T80/A10).

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Figures

Figure 1
Figure 1
 Effect of 8 weeks of treatment with telmisartan (T) 0, 20, 40, 80 mg plus amlodipine (A) 0, 2.5, 5, 10 mg on the change from baseline in the in‐clinic seated trough (A) diastolic blood pressure (DBP) (mm Hg) or (B) systolic blood pressure (SBP) (mm Hg). *P<.05 vs T monotherapy. †P<.05 vs A monotherapy. Data are least‐square mean (SE) values adjusted for dosage, country/region, and baseline blood pressure.
Figure 2
Figure 2
Effect of 8 weeks of treatment with the combinations of telmisartan 40 mg (T40) or 80 mg (T80) plus amlodipine 5 mg (A5) or 10 mg (A10) on the unadjusted mean change from baseline in the in‐clinic trough (A) diastolic blood pressure (DBP) (mm Hg) or (B) systolic blood pressure (SBP) (mm Hg) according to baseline blood pressure categories.
Figure 3
Figure 3
 Incidence of peripheral edema (%) in the amlodipine 10‐mg (A10) group compared with combinations (telmisartan 40 mg [T40] or 80 mg [T80] plus amlodipine 5 mg [A5] or 10 mg). *P<.05. **P<.0001 vs A10. †Pooled for key combinations.
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