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Switching from a Free Association of Perindopril/Amlodipine to a Fixed-Dose Combination: Increased Antihypertensive Efficacy and Tolerability

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Abstract

Background and Objectives

Although single-pill, fixed-dose combinations (FDCs) are widely endorsed for the reduction of blood pressure and cardiovascular risk, studies to date have not evaluated the differences between FDCs and free associations using matched drugs and doses. The objective of this study was to determine whether switching from a free association of perindopril/amlodipine to the FDC formulation led to significant improvements in efficacy and tolerability.

Methods

In this subanalysis of the previously published SYMBIO study, we looked at the effect of switching patients from a free association of perindopril/amlodipine to an equivalent dose of FDC (N = 335). In the SYMBIO study, concomitant antihypertensive medications were allowed; however, they remained unchanged till the end of the study. Blood pressure was measured at baseline, 1, and 3 months. Targets were defined as blood pressure <140/90 mmHg or <130/80 mmHg for patients with type 2 diabetes mellitus or at high cardiovascular risk.

Results

Compared to baseline, mean blood pressure decreased significantly after 1 and 3 months of treatment with FDC perindopril/amlodipine. Mean changes from baseline were −15.6 ± 14.3/−7.7 ± 9.1 mmHg at 1 month (p < 0.0001) and −23.3 ± 16.4/−11.3 ± 9.8 mmHg at 3 months (p < 0.0001). The percentage of patients who reached their blood pressure target increased from 16.0 % at baseline to 50.6 % at 1 month, to 75.9 % at 3 months. The incidence of ankle edema decreased from 14.9 % at baseline, to 9.9 % at 1 month, to 5.4 % at 3 months. The relative risk reduction for ankle edema was −37.5 % at 1 month (vs. baseline; p < 0.001) and −57.2 % at 3 months (vs. baseline; p < 0.001).

Conclusions

These data suggest that switching from a free association of perindopril/amlodipine to the same dose of the FDC formulation led to significant improvements in efficacy and tolerability.

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Acknowledgments

The authors acknowledge the contribution of all 223 participating medical centers in Slovakia.

Author information

Authors and Affiliations

  1. P.J. Safarik University School of Medicine, Kosice, Slovakia

    Katarina Hatalova & Daniel Pella

  2. Cardioconsult-Cardiology Clinics, Cajkovskeho 5, 81104, Bratislava, Slovakia

    Katarina Hatalova

  3. First Department of Internal Medicine, Louis Pasteur Hospital, Kosice, Slovakia

    Daniel Pella

  4. Department of Statistics, Faculty of Economic Informatics, Economic University, Bratislava, Slovakia

    Rastislav Sidlo

  5. National Cardiovascular Institute and Slovak Medical University, Bratislava, Slovakia

    Robert Hatala

Authors
  1. Katarina Hatalova
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  2. Daniel Pella
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  4. Robert Hatala
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Corresponding author

Correspondence to Katarina Hatalova.

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Funding

This study was funded by Servier Slovakia sro. Editorial support was provided by Helene Dassule, Ph.D.

Conflict of interest

Katarina Hatalova, Daniel Pella, and Robert Hatala have received lecturing honoraria from Servier. Rastislav Sidlo has no conflicts of interest to report.

Ethical approval

The SYMBIO study conformed to the Declaration of Helsinki’s ethical principles for medical research involving human subjects. The protocol was approved by the Ethics Committee of the National Cardiovascular Institute in Bratislava, Slovakia. All patients were informed about the study by the participating physicians and patients provided their consent.

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Hatalova, K., Pella, D., Sidlo, R. et al. Switching from a Free Association of Perindopril/Amlodipine to a Fixed-Dose Combination: Increased Antihypertensive Efficacy and Tolerability. Clin Drug Investig 36, 591–598 (2016). https://doi.org/10.1007/s40261-016-0404-0

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  • DOI: https://doi.org/10.1007/s40261-016-0404-0

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