Efficacy and tolerability of candesartan cilexetil vs. amlodipine as assessed by home blood pressure in hypertensive patients

Authors

  • J.-L. Imbs,

    Corresponding author
    1. Service de Cardiologie,1CHU, Strasbourg, Laboratoires TAKEDA,2Puteaux, France
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  • 1 S. Nisse-Durgeat,

    1. Service de Cardiologie,1CHU, Strasbourg, Laboratoires TAKEDA,2Puteaux, France
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  • and 2 THE FRENCH COLLABORATIVE CANDESARTAN STUDY GROUP

    1. Service de Cardiologie,1CHU, Strasbourg, Laboratoires TAKEDA,2Puteaux, France
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    • *

      The following investigators participated in this study: Airaudi Bernard, Lecat Eric, Chassery Brigitte, Alberto Jean-Pierre, Albert Jean-Paul, Allias Jean-Pierre, Alogna Philippe, Angeli Philippe, Assaf Charles, Avakian Aram, Bailly Jean-Paul, Ballin Jean-Pierre, Baroni Didier, Baruteau Jean-Pierre, Bas Bruno, Bastien Christian, Beaunier Philippe, Beille Jean, Benguigui Lucien, Benouaich Marc, Bernat Jacques, Bessiere Pascal, Bohbot Isaac, Bolo Alain Christian, Bosselut Serge, Bouquet J.-C., Bove Michel, Brousse Eric, Carcaillet Yves, Cartal Jean-Pierre, Casanova René, Castany Jacqueline, Catoir Jean-Luc, Cazenave André, Chayette Denys, Chambert Yves, Cicorelli Guy, Cimmino Pierre, Claisse Arnaud, Claroux Philippe, Clos Pierre, Corcelle Laurent, Coutin Jean-François, Damy Pierre, Daquigny, David Michel, De Bosschere Jean-Paul, Delmotte Pierre, Deme Jean-Claude, De Saint-Martin Etienne, Desestres Bernard, Dillinger Jean, Dorbon François, Doremus Pierre, Drevet Patrick, Duval Jean-Louis, Estienne Cyril, Estrada Joseph, Faure Jean-Claude, Fayat Jean-Claude, Faynot Vincent, Felicelli Jacques, Filipecki Claude, Fournier Michel, Franck Jacques, Francois Christian, Francoise Serge, Frankel Patrick, Freuchet Yannick, Garrigue Luc, Girard Didier, Gonthier Jean-Louis, Grau-Ortiz Serge, Grelot Jean-Luc, Gricourt Francis, Gross Philippe, Guy Isabelle, Harnie Pierre, Coussau Pierre, Hecquet François, Hector Daniel, Heral Jacques, Herledan Jean-Claude, Herrbach Henry, Hévin Jean-François, Hindamian Marc, Huet Jean-Michel, Jacq Marc, Jury Georges, Khatibi Alexandre, Kimmel Bertrand, Ladarre Robin, Larrode Jean-Michel, Laure Régis, Lecocq Laurent, Lecomte Franck, Leocard Jean-Daniel, Leonardi Dominique, Lesvier Patrice, Lion Odile, Lo-Rê Jean-Bernard, Maisonneuve Gérard, Marchand François, Martin Jean-Jacques, Massinon Carole, Melchior Philippe, Mimoun Albert, Moebs Jean-Paul, Mongin Gérald, Moretti Denis, Mouchet Jean-Claude, Nahabedian Hubert, Neumayer Alain, Niddam Roger, Pagliano Pascal, Pares Georges, Pawlowski Patrick, Pecastaing Michel, Pesque Guy, Petit Michel, Peynaud Jean-Pierre, Pfindel Marc, Pitoun Marc, Plaisant Alain, Rabatel Claude, Racine Jean-Luc, Ranvier Etienne, Ravier Christian, Rebot Joseph, Remond François, Reveillard Robert, Righi Jean-Michel, Rivoal Benoît, Roccaz Daniel, Roche Philippe, Sabban Hervé, Saint-Lannes Michel, Savary Eric, Savournin Jean-Luc, Scemama Guy-Rony, Serrero Albert, Siino Jean-François, Smila Denis, Soulet Jean-Michel, Taris Jean-Daniel, Testou Gilles, Tetart Jean-Pierre, Thomas Marc, Tran Trinh-Van, Trehou Philippe, Triot Pierre, Vansteene Hervé, Vasseur Jean-Jacques, Vovan André, Weber Jean-Marc, Weiss Hubert, Wemmert Maurice, Yoh Franck, Zingraff Joël.


Jean Louis Imbs, Institut de pharmacologie, Faculté de médecine, 11 rue Humann, F-67085 Strasbourg Cedex, France
Tel.: +33-3-90-24-34-06
Email: jean-louis.imbs@pharmaco-ulp.u-strasbg.fr

Summary

This randomised, double-blind study compared the anti-hypertensive efficacy and tolerability of Candesartan cilexetil (CC 8–16 mg) and Amlodipine (AML 5–10 mg) on home blood pressure (HBP) measurements in mild-to-moderate hypertensive patients. After a 2-week wash-out, patients aged 18–74 years, with a sitting diastolic blood pressure (sDBP) = 95–115 mmHg, untreated or intolerant to therapy or uncontrolled were randomised to CC 8 mg or AML 5 mg O.D. for 12 weeks (W12). Patients not normalised or not responders at W12 had their dose doubled for the remaining 6 weeks.

HBP was measured before each visit, during 5 days (three measurements in the morning, 24 h after last dose and before drug intake and three measurements before bedtime).

The primary criterion was the comparison of mean morning sDBP at baseline and post-treatment.

A total of 638 patients were enrolled, 540 of whom were randomised to CC or AML. The intent-to-treat and safety analyses were performed in 532 patients while 321 constituted the per protocol population.

Baseline characteristics and BP values of the two groups were similar. Morning sDBP did not differ between groups at W12, but AML patients had significantly more adverse events (AEs) than those treated by CC (28 vs. 20%, p = 0.03); 6% of AML patients vs. 1% of CC patients were withdrawn due to AEs (p = 0.009).

CC demonstrates a better tolerability over AML and an equivalent anti-hypertensive efficacy in terms of morning home DBP after 12 weeks of treatment.

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