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Open-Label Study Assessing the Long-term Efficacy and Safety of Triple Olmesartan/Amlodipine/Hydrochlorothiazide Combination Therapy for Hypertension

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Abstract

Introduction

To reduce cardiovascular risk associated with hypertension, the majority of patients require at least two drugs to control their blood pressure (BP), and many require three or more.

Methods

An open-label extension of a 10-week double-blind study assessed the long-term efficacy and safety of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ) triple combination treatment in 2,509 patients with Grade 2–3 hypertension. After 8 weeks of single-blind OLM/AML/HCTZ 20/5/12.5 mg treatment, patients at BP goal [seated systolic/diastolic BP (SeSBP/SeDBP) <140/90 mmHg, or <130/80 mmHg for patients with diabetes, or chronic kidney or cardiovascular disease] entered open-label treatment for 36 weeks. Patients not at goal received 8 weeks of randomized, double-blind treatment before entering open-label treatment. During open-label treatment, patients received OLM/AML/HCTZ 20/5/12.5, 40/5/12.5, 40/5/25, 40/10/12.5 or 40/10/25 mg with up- or down-titration as needed to achieve BP goals.

Results

During open-label treatment, mean SeSBP/SeDBP levels remained within the ranges 120–140 and 75–85 mmHg, respectively. At study end, significant reductions from baseline were seen in each group for SeSBP (37–43 mmHg) and SeDBP (22–27 mmHg), and 78.1% of patients overall achieved BP goal. Categorical analysis of patients by baseline SeSBP (150–159, 160–169, 170–179, 180–189, 190 to <200 mmHg) correlated with changes in SeSBP. Patients in the lowest baseline category (150–159 mmHg) showed a reduction of 34.3 mmHg, and those in the highest category (190 to <200 mmHg) showed a 59.4 mmHg reduction. At baseline, 90.8% of patients had Grade 2 or 3 hypertension, but at study end 91.9% had normal/high-normal BP. The incidence of adverse events was similar across the treatment groups.

Conclusion

In patients with Grade 2–3 hypertension, long-term treatment with OLM/AML/HCTZ triple combination therapy was well tolerated and effective. A high level of BP control and a substantial reduction in the level of hypertension severity were achieved.

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Acknowledgments

Sponsorship and article processing charges for this study was funded by Daiichi Sankyo Europe GmbH (Munich, Germany).

Medical writing assistance for this study was provided by Phil Jones of inScience Communications, Springer Healthcare (Chester, UK), and was funded by Daiichi Sankyo Europe GmbH.

All named authors meet the ICMJE criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.

Conflict of interest

B Ammentorp is a current employee of Daiichi Sankyo Europe GmbH (Munich, Germany).

P Laeis is a current employee of Daiichi Sankyo Europe GmbH (Munich, Germany).

M Volpe has received honoraria from Daiichi Sankyo for lectures and participation in Advisory Boards.

A de la Sierra has received honoraria for his participation in scientific meetings sponsored by Daiichi Sankyo, Menarini and MSD.

Compliance with ethics guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for inclusion in the study.

Author information

Authors and Affiliations

  1. Division of Cardiology, Department of Clinical and Molecular Medicine, University of Rome “La Sapienza”, Sant’Andrea Hospital, via di Grottarossa 1035, 00189, Rome, Italy

    Massimo Volpe

  2. IRCCS Neuromed, Pozzilli (IS), Italy

    Massimo Volpe

  3. Department of Internal Medicine, Hospital Mutua Terrassa, University of Barcelona, Barcelona, Spain

    Alejandro de la Sierra

  4. Daiichi Sankyo Europe GmbH, Munich, Germany

    Bettina Ammentorp & Petra Laeis

Authors
  1. Massimo Volpe
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  2. Alejandro de la Sierra
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  3. Bettina Ammentorp
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  4. Petra Laeis
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Corresponding author

Correspondence to Massimo Volpe.

Additional information

Trial Registration: ClinicalTrials.gov identifier: NCT00923091.

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Volpe, M., de la Sierra, A., Ammentorp, B. et al. Open-Label Study Assessing the Long-term Efficacy and Safety of Triple Olmesartan/Amlodipine/Hydrochlorothiazide Combination Therapy for Hypertension. Adv Ther 31, 561–574 (2014). https://doi.org/10.1007/s12325-014-0117-9

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  • DOI: https://doi.org/10.1007/s12325-014-0117-9

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