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

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
• angiotensin system inhibitor
• Single-pill combination
• Telmisartan

Transparency

Declaration of funding

This study was funded by Boehringer Ingelheim Pharma GmbH & Co. KG.

Declaration of financial/other relationships

S.N. and J.M.N. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. S.E.K. has disclosed that he has received honoraria for lecturing from Novartis, AstraZeneca, Bayer, Merck, Medtronic, Serodus and Takeda, has received honoraria for consultancy from AstraZeneca, Bayer, Merck, Medtronic, Serodus and Takeda, and has received unrestricted research grants from AstraZeneca and Pronova. H.S. has disclosed that he is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors were fully responsible for all content and editorial decisions, were involved at all stages of manuscript development and have approved the final version. Medical writing assistance, supported financially by Boehringer Ingelheim Pharma GmbH & Co. KG, was provided by Katherine Ayling-Rouse PhD and Lakshmi Venkatraman PhD of Parexel during the preparation of this article. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE) and received no compensation related to the development of the manuscript.

Previous presentation: The primary results of three non-responder studies and one dose response study are published18,20,21,28.