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Comparative Study
. 2014 Sep;30(9):1715-24.
doi: 10.1185/03007995.2014.924912. Epub 2014 Jun 13.

Telmisartan in combination with hydrochlorothiazide 12.5 mg for the management of patients with hypertension

Steen Neldam  1 , Helmut Schumacher, Sverre E Kjeldsen, Joel M Neutel
Affiliations
Comparative Study

Telmisartan in combination with hydrochlorothiazide 12.5 mg for the management of patients with hypertension

Steen Neldam et al. Curr Med Res Opin. 2014 Sep.

Abstract

Objective: To compare the efficacy and safety of telmisartan 40 mg (T40) or 80 mg (T80) plus hydrochlorothiazide 12.5 mg (H12.5) single-pill combinations (SPCs) with telmisartan monotherapies, in a pooled analysis of patients with mild to moderate hypertension.

Methods: Six phase 3, double-blind studies of 8 weeks' duration that assessed the T/H12.5 SPC and T40 or T80 monotherapy, were included in the analysis. Data was pooled separately for the two T40 non-responder studies (T40 NR group, two T80 non-responder studies (T80 NR group), and the two factorial design dose-response studies (FD-DR group).

Results: After 8 weeks' treatment, the adjusted mean reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP), and the SBP, DBP, and blood pressure (BP) goal rates were significantly higher with the T40/H12.5 SPC than T40 in the T40 NR group and with the T80/H12.5 SPC than T80 in the T80 NR group. In the FD-DR group, the adjusted mean reduction in SBP and DBP, and DBP goal rates were significantly higher for T40/H12.5 versus T40. The percentage of patients with an adverse event was numerically higher with T40/H12.5 versus T40 in the T40 NR group, and was similar in telmisartan monotherapies and the T/H12.5 SPCs in the T80 NR group and FD-DR group. A limitation of this study is the retrospective and pooled nature of the analysis. Also, >75% of patients were <65 years of age, which limits the applicability of the results to older patients.

Conclusions: In patients with mild to moderate hypertension, 8 weeks' treatment with the T/H12.5 SPC is significantly more efficacious than telmisartan monotherapies. The safety and tolerability of the T/H12.5 SPC are comparable to that of telmisartan monotherapy and consistent with that reported in previous studies.

Keywords: Essential hypertension; Hydrochlorothiazide; Renin; Single-pill combination; Telmisartan; angiotensin system inhibitor.

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