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Twenty-Four-Hour Ambulatory Blood Pressure Reduction with a Perindopril/Amlodipine Fixed-Dose Combination

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Abstract

Background

Most hypertensive patients need more than one agent to achieve blood pressure (BP) control. The fixed dose combinations can provide effective 24-h BP control, which is essential in hypertension management.

Aims

The primary objectives of the PErindopril/Amlodipine Reduction of blood pressure Level (PEARL) ABPM substudy were to assess the effect of a perindopril/amlodipine fixed-dose combination on mean 24-h BP, daytime BP, and nighttime BP in a subgroup of PEARL patients. Secondary objectives included assessment of office BP, metabolic parameters (blood glucose and lipids), heart rate, and safety and tolerability.

Methods

PEARL was a 3-month observational study with a perindopril/amlodipine fixed-dose combination for treatment of outpatients with essential hypertension uncontrolled by prior treatment (office BP ≥140/90 mmHg or ≥130/80 mmHg in those at high/very high cardiovascular risk). In this ABPM substudy of PEARL, treatment efficacy was assessed by 24-h ABPM. At inclusion, previous angiotensin-converting enzyme (ACE) inhibitors and/or calcium channel blockers (CCBs) were replaced by a perindopril/amlodipine fixed-dose combination at a dosage (5/5, 5/10, 10/5, or 10/10 mg) chosen by the physician and uptitrated at month 1, if required. ABPM and office BP measurements were assessed at inclusion, month 1, and month 3. Metabolic effects, heart rate, and adverse events were also monitored.

Results

Mean age of the 262 ABPM patients (144 males) was 60.4 ± 11.7 years, and mean baseline office brachial systolic BP/diastolic BP was 159.8 ± 16.0/94.3 ± 10.3 mmHg. After 3 months, the perindopril/amlodipine fixed-dose combination reduced mean 24-h ambulatory BP from 146.1/84.3 to 127.6/75.9 mmHg (p < 0.001). Mean office BP decreased to 131.1/80.0 mmHg (p < 0.001). Results were consistent in subgroups, defined by cardiovascular comorbidities or previous treatments. Favorable metabolic and heart rate effects were observed, and no serious adverse events were reported.

Conclusions

Further effective, safe, and sustained 24-h ambulatory BP and office BP reductions were obtained by switching from ACE inhibitors and/or CCBs to a perindopril/amlodipine fixed-dose combination in outpatients with uncontrolled essential hypertension in a practice setting. For this type of patient, the use of a perindopril/amlodipine fixed-dose combination can be considered an effective and safe option to normalize BP.

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Acknowledgments

This study was funded by Egis Pharmaceuticals, Budapest, Hungary. The authors acknowledge the contribution of all 38 participating medical centers in Hungary. Viktor Nagy has received lecturing honoraria from Egis Pharmaceuticals. In addition to the other members of the PEARL investigator group, the authors would like to acknowledge the assistance of Eva Lantos, MD (medical advisor), and Norbert Habony, MD (coordinator).

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Authors and Affiliations

  1. 2nd Department of Internal Medicine, Semmelweis University, Budapest, Hungary

    Viktor L. Nagy

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  1. Viktor L. Nagy
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Correspondence to Viktor L. Nagy.

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On behalf of the PEARL Study Investigators.

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Nagy, V.L. Twenty-Four-Hour Ambulatory Blood Pressure Reduction with a Perindopril/Amlodipine Fixed-Dose Combination. Clin Drug Investig 33, 469–476 (2013). https://doi.org/10.1007/s40261-013-0086-9

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  • DOI: https://doi.org/10.1007/s40261-013-0086-9

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