Titre du document / Document title

Ambulatory 24-h blood pressure assessment of the felodipine-metoprolol combination versus amlodipine in mild to moderate hypertension

Auteur(s) / Author(s)

Lorraine General Physician Investigators Group, FRANCE
ZANNAD F. ⁽¹⁾ ; BOIVIN J.-M. ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Centre d'investigation clinique (CIC), INSERM-CHU, Nancy, FRANCE

Résumé / Abstract

Objective To measure the time effect profiles of a once daily administered combination tablet felodipine-metoprolol 5/50 mg (Logimax®, Astra) and amlodipine 5 mg (Norvasc®, Pfizer) on blood pressure and heart rate using 24-h ambulatory blood pressure monitoring. Design Randomized multicentre parallel-group study with a single-blind placebo run-in period of 4 weeks duration and a 6-week double-blind active treatment period. Patients and methods Out of 245 randomized outpatients (90 men, 155 women) with uncomplicated mild-to-moderate primary hypertension and mean sitting diastolic blood pressure (DBP) 95-115 mmHg inclusive, 212 (102 on felodipine-metoprolol 110 on amlodipine) were eligible for analysis. 24-h ambulatory blood pressure monitoring was performed at the end of the placebo run-in (baseline) and after 6 weeks active treatment (posttreatment). Results Both felodipine-metoprolol and amlodipine induced smooth and consistent reduction in DBP and systolic blood pressure throughout the 24-h period, hence not altering the diurnal rhythm. However, felodipine-metoprolol reduced all average blood pressures (24-h, day- and night-time) more than amlodipine (for 24-h average blood pressure 14.4/9.5 mmHg and 8.9/ 5.5 mmHg, respectively). Medians of individual diastolic trough-to-peak (T/P) ratios were similar for felodipine-metoprolol and amlodipine (54 and 50%, respectively), while for the systolic T/P ratios, the corresponding values were 74 and 35%, repectively; no significant difference between treatments was seen. As distinguished from amlodipine, both heart rate and rate pressure product were markedly decreased on felodipine-metoprolol throughout the 24-h period and even during the early morning hours. In general, both treatments were well tolerated. Conclusions Both felodipine-metoprolol and amlodipine achieved optimal control of blood pressure during the inter-dosing interval in line with their pharmokinetic profiles. The vasodilatory adverse events were slightly more reported with felodipine-metoprolol combination, but due to more pronounced lowering of the average blood pressures and the potent additional effect on heart rate and rate pressure product, the efficacy/tolerability balance seems to be equal to or better than that obtained with monotherapy such as amlodipine.

Revue / Journal Title

Journal of hypertension   ISSN 0263-6352   CODEN JOHYD3 

Source / Source

1999, vol. 17, n^o7, pp. 1023-1032 (34 ref.)

Langue / Language

Anglais

Editeur / Publisher

Lippincott Williams & Wilkins, Hagerstown, MD, ETATS-UNIS  (1983) (Revue)

Mots-clés anglais / English Keywords

Felodipine ; Treatment ; Chemotherapy ; Metoprolol ; Comparative study ; Combined treatment ; Amlodipine ; Blood pressure ; Exploration ; Hypertension ; Human ; Heart rate ; Treatment efficiency ; Toxicity ; Dihydropyridine derivatives ; Calcium antagonist ; Antihypertensive agent ; Beta blocking agent ; Antagonist ; β1-Adrenergic receptor ; Cardiovascular disease ;

Mots-clés français / French Keywords

Félodipine ; Traitement ; Chimiothérapie ; Métoprolol ; Etude comparative ; Traitement associé ; Amlodipine ; Pression sanguine ; Exploration ; Hypertension artérielle ; Homme ; Rythme cardiaque ; Efficacité traitement ; Toxicité ; Dihydropyridine dérivé ; Antagoniste calcium ; Antihypertenseur ; Bloquant β-adrénergique ; Antagoniste ; Récepteur β1-adrénergique ; Appareil circulatoire pathologie ;

Mots-clés espagnols / Spanish Keywords

Felodipino ; Tratamiento ; Quimioterapia ; Metoprolol ; Estudio comparativo ; Tratamiento asociado ; Amlodipino ; Presión sanguínea ; Exploración ; Hipertensión arterial ; Hombre ; Ritmo cardíaco ; Eficacia tratamiento ; Toxicidad ; Dihidropiridine derivado ; Antagonista calcio ; Antihipertensivo ; Bloqueador β-adrenérgico ; Antagonista ; Receptor β1-adrenérgico ; Aparato circulatorio patología ;

Localisation / Location

INIST-CNRS, Cote INIST : 20680, 35400008575673.0200