Abstract
Background
Patients with grade 2 or 3 hypertension may require high-dose combination therapy
to achieve blood pressure (BP) targets in a timely manner.
Objectives
This study compared the effectiveness and tolerability of a single-pill combination
(SPC) of telmisartan/hydrochlorothiazide 80/25 mg (T80/H25) with T80 monotherapy.
Methods
In a Phase IV, multinational, randomized, double-blind, double-dummy, active-controlled,
parallel-group trial, 894 patients with mean seated trough cuff systolic BP [SBP]
≥160 mm Hg and diastolic BP [DBP] ≥100 mm Hg were randomly assigned in a 2:1 ratio
to receive T40/H12.5 SPC or telmisartan 40 mg monotherapy for 1 week before the dose
was uptitrated to T80/H25 SPC or T80, respectively, administered for 6 weeks. The
primary efficacy measure was the change from baseline in mean seated cuff trough SBP.
Adverse events (AEs) were recorded.
Results
A total of 888 patients received treatment (294 and 594 patients in the T80/H25 and
T80 groups, respectively) (mean age, 57.0 years; age ≥65 years, 25.7%; male, 53.8%;
white, 68.0%); 61 patients prematurely discontinued. Mean baseline SBP/DBP values
were 172.3/104.3 mm Hg (T80/H25) and 173.3/104.5 mm Hg (T80). After 7 weeks, SBP was
changed by −37.0 and −28.5 mm Hg in the T80/H25 and T80 groups (P < 0.0001); DBP was changed by −18.6 and −15.4 mm Hg respectively (P < 0.0001). These differences were significant after 2 weeks at the higher dosage
(P < 0.0001). BP target (SBP/DBP <140/<90 mm Hg) was achieved in 55.5% and 34.7% of
patients in the T80/H25 and T80 groups (P < 0.0001). T80/H25 SPC and T80 had a similar frequency of overall AEs (16.0% vs 17.0%).
The prevalences of treatment-related AEs with T80/H25 SPC and T80 were low (4.6% and
2.8%), as were the rates of AEs that led to discontinuation (1.0% and 2.8%).
Conclusions
In these patients with grade 2 or 3 hypertension, initial therapy with T80/H25 was
associated with a significantly greater reduction in mean seated cuff trough SBP compared
with T80 alone, as well as with improved hypertension goal attainment rates. Both
treatments appeared to be well tolerated. ClinicalTrials.gov identifier: NCT00926289.
Key words
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Article info
Publication history
Published online: June 21, 2012
Accepted:
May 23,
2012
Identification
Copyright
© 2012 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.
