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Smooth Blood Pressure Control Obtained with Extended-Release Felodipine in Elderly Patients with Hypertension

Evaluation by 24-Hour Ambulatory Blood Pressure Monitoring

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Abstract

Objective

To assess, by smoothness index (SI), distribution of the antihypertensive effect of extended-release (ER) felodipine over 24 hours in elderly patients with hypertension.

Methods

After a 4-week washout phase, 35 elderly patients (mean age 69 ± 4 years) with mild-to-moderate hypertension received 2 weeks’ treatment with ER felodipine 5mg once daily. The dosage of ER felodipine was doubled to 10 mg/day and given for a further 2 weeks in non-responders (sitting clinic blood pressure > 140/90mm Hg). The study had an open-label design with no placebo control. After each period, clinic and ambulatory blood pressures were measured. Trough-to-peak (T/P) ratio was computed by dividing the blood pressure (BP) change at trough (22 to 24 hours after drug intake) by the change at peak (2 adjacent hours with a maximal BP reduction between the second and eighth hour after drug intake). SI was calculated as the ratio between the average of the 24, hourly, treatment-induced BP changes and its standard deviation.

Results

After the initial 2-week treatment period, clinic and 24-hour ambulatory BP values were higher in non-responders (145 ± 11/87 ± 8 and 135 ± 17/80 ± 6mm Hg, respectively) than in responders (133 ± 6/81 ± 3 and 130 ± 9/77 ± 7mm Hg). In non-responders, clinic and 24-hour BP values were lowered after a further 2 weeks of treatment with ER felodipine 10 mg/day (128 ± 11/78 ± 6 and 128 ± 12/75 ± 5mm Hg). SI was high in responders (0.8 ± 0.8/0.7 ± 0.7 for systolic/diastolic BP) and low in non-responders (0.5 ± 0.6/0.3 ± 0.6) during the first 2-week treatment period. It increased in non-responders after an additional 2 weeks of treatment with ER felodipine 10 mg/day (1.0 ± 0.8/0.7 ± 0.6). Median T/P ratios were 0.73 and 0.61 (systolic BP and diastolic BP) in responders and 0.41 and 0.61 in non-responders after 2 weeks of treatment. At variance with SI, T/P ratios did not increase in non-responders after doubling the dosage of ER felodipine (0.34 and 0.18). ER felodipine did not increase 24-hour heart rate. A total of nine adverse events were recorded in six patients (17%), but no patients withdrew from the study.

Conclusion

ER felodipine 5 to 10 mg/day smoothly and safely reduces 24-hour ambulatory BP in elderly patients with hypertension.

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Acknowledgements

No sources of funding were used to assist in the preparation of this manuscript. The authors have no conflicts of interest that are directly relevant to the content of this manuscript.

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Authors and Affiliations

  1. Centro di Ipertensione, INRCA, Ancona, Italy

    Roberto Antonicelli & Enrico Paciaroni

  2. Dipartimento di Medicina Clinica, Prevenzione e Biotecnologie Santarie, Università di Milano-Biococca, Cardiologia II, IRCCS San Luca, Istituto Auxologico Italiano, Milan, Italy

    Stefano Omboni & Gianfranco Parati

  3. Divisione di Cardiologia, Ospedale Civile di Giulianova, Teramo, Ancona, Italy

    Ciò Di Giovanni

  4. Servizio di Ipertensione, Ospedale Santa Croce, Fano, Pesaro, Ancona, Italy

    Roberto Ansuini

  5. Divisione di Cardiologia, Ospedale Civile, Macerata, Ancona, Italy

    Alfredo Mori

  6. Centro di Epidemiologia e Biostatistica, Università degli Studi di Ancona, Ancona, Italy

    Rosaria Gesuita

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  1. Roberto Antonicelli
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Correspondence to Roberto Antonicelli.

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Antonicelli, R., Omboni, S., Di Giovanni, C. et al. Smooth Blood Pressure Control Obtained with Extended-Release Felodipine in Elderly Patients with Hypertension. Drugs Aging 19, 541–551 (2002). https://doi.org/10.2165/00002512-200219070-00007

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